Bulk Repackaging and Non–Sterile CompoundingChapter 11

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Proper Packaging and Repackaging Procedures1. Explain the need for packaging products in

the appropriate type and size of container. 2. List the steps in the bulk repackaging of

medications. 3. List five reasons pharmacies often repackage

bulk medications into unit dose packages. 4. Describe the proper handling of medications

during bulk repackaging. 5. Demonstrate how to complete a repacking

logbook with the necessary information.

Lesson 11.1

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Proper Packaging and Repackaging Procedures6. Explain the importance of the accurate

labeling of pharmaceuticals. 7. Explain the calculations used to determine

the beyond-use date when repackaging. 8. List the common reasons for using unit

dose medications.9. Describe the types of containers used for

repackaged and compounded medications. 10.Name three advantages of blister card

packaging.

Lesson 11.1

Introduction•Bulk repackaging medication is common

in the hospital pharmacy▫This is a technician duty in most settings

•Compounding non-sterile products is common in the community pharmacy

•Bulk repackaging is also called unit dosing

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Unit Dose Medications •Using these saves a lot of money•Creates an inventory for automatic

dispensing systems•It is easier to deliver one dose at a time

▫Nurses can ensure that the exact amounts are given to each patient

▫Even liquids can be divided into single 15- to 30-mL dose cups to allow the nurse to dispense just the correct amount for a single dose.

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Importance of Correct Packaging • Bulk containers have up to 1000 doses per

container▫100-count doses can be packaged into single

doses Easier for dispensing single doses to patients

• Containers: Unit dose (UD), single dose, bubble pack (blister card), dispensing machines

• Can be done manually or by means of an automated system, transferring medications from a manufacturer’s original container to another type of container before the need arises to dispense a prescriber’s order.

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Steps for Repackaging •Package one dose at a time; done in a

specific work area•Labels must have all required information

▫Label requirements include the proprietary and nonpropri etary names, dosage form, strength, strength of an individual dose, total contents delivered, beyond-use date, and lot number.

▫See Table 11-1 (p. 237) for repackaging guidelines.

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Steps for Repackaging •All medications must be checked •All equipment must be in good condition

and clean•Containers must be correct size•All necessary information must be logged

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Reasons for Bulk Repackaging •Drugs that cannot be bought from

manufacturer•Cost of unit dosing may be cheaper

(Why?)•Speed and efficiency increased•Individual labels result in decrease in

errors•Can be put back in stock if not used

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Unit Dose Medication Containers •Strip pack (unit dose pack)•Liquid cups•Blister card/bubble pack (punch cards)

▫May contain one or more doses of medication

•Applicators•Syringes •Foil cups•Plastic suppository shells

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Bulk Repackaging Techniques •Non-sterile technique:

▫Lab coat▫Hair tied back▫Hands washed▫Gloves if the tablets or capsules will be

touched▫Pill counting tray and spatula if the tablets

will be dispensed from the tray▫*Always prepare medication one at a time

to avoid cross-contamination in the packaging process*

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Bulk Repackaging Techniques (Cont.) •Keep equipment clean and in good

working order •Maintain records •Have enough packages and labels ready

for use•Calculate accurate beyond-use date•Record on documentation

▫It is important to be accurate in record keeping in case there is a recall on the bulk products used

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Documentation•Dosage forms that are repackaged:

Tablets, capsules, liquids•Unit dose labels: Computer generated to

save time and reduce errors•Technician determines amount needed,

calculates expiration date, documents components, generates labels, loads medication

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Documentation (Cont.) •Date the drug is repackaged: Date,

month, year•Drug name: Both generic and brand name•Dosage form and manufacturer•Manufacturer's lot number and expiration

date: Located on label or bottom of bottle; located with lot number

•Pharmacy lot number, beyond-use date, technician initial

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Labeling/Checking Bulk Repackaged Medications •Dosage forms that are repackaged:

Tablets, capsules, liquids•Unit dose labels: Computer generated•Technician determines amount needed,

calculates expiration date, documents components, generates labels, loads medication

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Storage and Stability •Expiration date given by manufacturer

and FDA•Beyond-use dates (BUD) given to

repackaged products is done by using USP <795>

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Repackage Guideline•Items repackaged for use in a hospital or

for a specific patient’s use cannot be mass produced.

•Only drug manufacturing companies following FDA guidelines may mass produce medications

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Beyond-Use Date •Different from expiration date•Calculated by pharmacy when

repackaging/compounding medications•Solid/liquid: One year from repackage date

or expiration date of ingredient, whichever is less

•Manufacture's expiration: Exact amount of time drug is usable▫Once a bulk bottle is opened and the

medication is repackaged, the manufacturer’s expiration date may no longer be valid.

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Blister Cards •Blister cards may contain one or more

doses of medication and are usually used for long-term care medications.

•The medications prescribed by a physician are put into individual pockets in a card that holds a month’s worth of medication. Morning doses and the night doses can be placed in different cards, and each dose is put in an individual pocket.

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Blister Cards • Advantages to using:

▫ Makes compliance easier for patients in taking their medication correctly

▫ Allows timely monitoring by health care team members▫ The unsteady hands of an elderly patient can get one

tablet from the card without spilling the entire contents of a bottle or touching the other tablets in the card

▫ If a dose is changed (often the case with long-term care patients due to their chronic or multiple disease states), the remaining uncontaminated medications in the card can be returned and reused

▫ The card is a visible way to easily identify missed doses and to aid the patient in medication compliance

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Equipment Used and Storage for Compounded Medications11. Define non-sterile compounding. 12. List the common reasons patients need compounded

medications. 13. Explain the important considerations in the storage

and stability of compounded products. 14. Describe the equipment used in compounding drugs. 15. Differentiate between the types of scales used to weigh

compounds. 16. Demonstrate how to complete a compounding sheet

with the necessary information. 17. Demonstrate compounding procedures. 18. Describe the types of dosage forms compounded for

animal use.

Lesson 11.2

Non–Sterile Compounding: History •Medicinal mixtures using plants, animals,

and minerals dates back 4000 years•In 1820, 80% of prescriptions in the first

U.S. pharmacopoeia were compounds•Premade dosages do not necessarily treat

everyone, are not always commercially available▫Pediatric doses, hospice patients

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Use of Non–Sterile Compounding •Non–sterile compounding: Done in

vertical hood or on clean work surface as stated in USP <795>

•Common items: Creams, ointments, oral suspensions

•Less common: Capsules, suppositories, syringe

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Reasons for Compounding •No longer manufactured•Patients may be allergic to something in a

drug•Specialized dosage/strength for specific

patients•Increased patient compliance•Patient unable to ingest normal dosage

form•Medication requires flavorings

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Equipment Used in Compounding •Personal protective equipment: Gloves,

goggles, gown, hair cover, lab coat, mask, shoe covers

•Measuring devices: Graduated cylinders, syringes, pipettes, electronic filling machines▫Measuring liquids requires reading a

meniscus•Mixing equipment: Mortar and pestle

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Weighing Equipment •Weighing equipment: Scales, electronic balances

▫Class A balance – Minimum of 120 mg, Sensitivity 6mg or less Torsion balance Pan balances such as the class A balance are

standard in pharmacies. Weights are placed on right side using

tweezers/forceps▫Class II – Analytical or digital – 100 g

The digital balances are common and can weigh heavier amounts.

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Weighing Techniques •Pharmacy balances are sensitive

▫Airflow: Keep to minimum▫Glass lid cuts air currents

•Spatula: Used to pick up small amounts; lightly tapping to flick few granules at a time

•Compounding: Time-consuming, accuracy important

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Additional Supplies •Mold forms: Metal and rubber•Excipients =?•Emollients =?•Flavorings: Added to mask bad taste of

ingredients

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Completing a Compounding Sheet •Clean countertops and other surfaces •Dispose of all cleaning products as soon

as cleaning is complete•Damp mop the floor•Check off each activity as it is completed

for each room•Prepare cleaning solutions on the day of

use

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Measuring Liquids •Liquids: There are simple steps to ensure

proper volume▫Water molecules will cling to sides of

container▫Have liquid at eye level▫Read at bottom of liquid line (meniscus)

Liquids can have a concave (U-shaped) meniscus, no meniscus, or a convex (domed) meniscus. The meniscus shape depends on the liquid and the container material.

Read the bottom of a convex meniscus and the top of a convex meniscus.

The liquids used in the pharmacy will almost always have a concave meniscus.

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Measuring Liquids•For maximum accuracy in measuring

liquids, use the 20% rule▫50mL graduated cylinder x 20%= 10mL

10mL is the smallest accurate amount a 50mL graduated cylinder can measure

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Meniscus

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Preparing Solutions •Solutions comprise:

▫Solvent (larger part)▫Solute (ingredient used in solvent)

•Measure carefully and mix thoroughly•Solubility will dictate the type of dosage

form that needs to be prepared•Reconstitution of premade oral

suspensions may be done away from the compounding area

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Solids: Tablets, Capsules, and Lozenges • Molds are used for forming these types of oral

dosage forms• Molded tablets disintegrate quickly when they

come into contact with moisture• Tablets or lozenges can be made one at a time or

in multiple doses• Lozenges: Normally made with flavors to

enhance their taste and sugar▫Hard▫Soft▫Chewable

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Semisolids: Ointments, Sticks and Suppositories •Medication sticks

▫Applied directly to a site on the body that needs treatment

•Ointment: Hydrophobic base▫ Petroleum jelly mixed with drug▫Jars or tubes

•Hard sticks and soft sticks•Suppositories: Oleaginous bases, water-

soluble bases, glycerinated gelatins

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Terms•Hydrophobic compounds do not dissolve

in water. Can you break the word hydrophobic down into its two root words? ▫Examples- ointments, oleagnious bases

•How about hydrophilic, which means “water soluble”?

•Suspensions have both hydrophilic and hydrophobic ingredients, so they must be shaken before use.

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Packaging•Containers must:

▫Be appropriate size▫Protect contents▫Have childproof caps (not for jars and

syringes)▫Have appropriate labels▫Common auxiliary labels placed on

medication containers: Suspensions: Shake well Ophthalmic: For the eye

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Storage and Stability of Compounded Drugs •Consider stability of any additives•Factors affecting stability:

▫Amount of light and air▫Temperature▫pH alters longevity

•Solid forms have longer shelf life than liquid forms▫It is easier for a liquid product to degrade

or for its components to separate

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Documentation•Documentation of records under quality

assurance of FDA guidelines•Compounding record (CR): Log•Formulation record (FR): Recipe

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Documentation• Date prepared; name of ingredients; manufacturer of each ingredient; lot number and expiration date of each ingredient [including sterile water]; amount or weight of each ingredient; dosage form of each ingredient; pharmacy lot number assigned; pharmacy expiration date assigned; date dispensed; patient’s name and medical record number

• In addition, a step-by-step recipe is required, and both the pharmacist and the technician must initial the records.

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Safety•Documentation: Safety Data Sheets (SDSs)

•All chemicals should be stored inside cabinets or behind shelf brackets to avoid spillage

•Method of cleaning and disposing of agents or any equipment used depends on the type of agents used

•SDSs contain emergency contact information in case of spillage or contact.

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Professionalism and Quality Control •Appearance is important

▫Great care must be taken when topping off jars of creams and ointments.

•Packaging affects medication inside and compliance▫Many medications can degrade with

ultraviolet (UV) light exposure; therefore, they must be placed in amber-colored containers to protect the medication.

•Follow all storage and labeling guidelines

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Veterinary Medications •Dosage in a form that avoids stress on the

animal•Medication may be mixed into a treat

▫Sticks to administer antibiotics to the inside of the ear

▫Liquids poured onto pet food •Flavorings

▫Bacon▫Tuna

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Compounding Calculations •The final product may need to be

prepared in a different strength or volume than what the recipe lists▫Standard formulas are provided by

agencies such as Professional Compounding Centers of America (PCCA).

•Pharmacist or technician will need to perform calculations to attain the correct weights and/or volumes for the final product

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