Chapter 11 - Bulk Packaging and Nonsterile Compounding

Institutional pharmacies often purchase medications in bulk quantities to repackage to a unit dose.

TRUE

The process of repackaging should be done in a horizontal flow hood.

FALSE

If a pill is used to guide tablets or capsules into their containers, the tray does not need to be washed with alcohol after use.

FALSE; needs to be washed with alcohol after every use.

Keeping track of the products you are repackaging is a major step that must not be overlooked.

TRUE

Medications in a solid form (e.g. tablets) usually have a shorter shelf life than liquid forms.

FALSE; they have longer shelf life than liquid forms because it is easier for a liquid product to degrade or for its component to separate.

No expiration date is necessary for repackaged products.

TRUE

If the expiration date includes the month and year, the drug expires on the last day of the month.

TRUE

Daily tasks such as maintenance cleaning of equipment are a very important part of quality control and patient safety.

TRUE

A technician who is sick or has any open wounds can compound any products.

FALSE; should not be compounding any products.

You must read the graduated cylinder at the bottom of the meniscus.

TRUE

Which of the following is NOT an example of Good Manufacturing Practices for repackaging?

Prepare two items at a time.

The dosage form normally repackaged in a pharmacy is the:

All of the above;

-tablet form

-capsule form

-liquid form

The expiration date on a drug is 4/18, the drug expires on:

April 30, 2018; there are only 30 days in April.

Compounding pharmacies must follow each state's board of pharmacy regulations, in addition to ____ standards.

USP 795

The punch method is used to prepare:

Capsules

Which of the following could be used as a base when preparing a compounded ointment?

Aquaphor

Which of the following is commonly used as an additive when compounding tablets?

Dextrose

Which of the following would be the most suitable flavoring additive for an antibiotic?

Cherry

Documents are kept on the pharmacy premises for no less than ____ from the time the medication was prepared.

3 years

The beyond-use date of a preparation is set from:

One year from when the compound was prescribed.

Added to a tablet or capsule blend to help break up compacted mass when put into a fluid environment; especially important for rapid-release agents

Disintegrants

Have a wide variety of functional properties (retarding drug release) and allow for flexibility in coating

Plasticizers

Surrounding layer of polymeric material of a tablet, capsule, or pellet; done to change color; protect active ingredient from moisture, light, pH of stomach; avoid bad taste or odor when taken by mouth

Coatings

Maintains dispersion of finely divided liquid droplets in a liquid vehicle; made from two or more immiscible liquids, such as water and oil, and can be liquid or semisolid (creams and lotions)

Emulsifying agents

Additive for powder blend to prevent compacted powder mass from sticking to equipment during process of making tablets or capsules

Lubricants

Naturally occurring plant derivatives that are water soluble; provide a variety of properties, including gelling, thickening, and film forming

Gums

Insoluble particles that are dispersed in a liquid; act by increasing the viscosity of the liquid vehicle; reduces rate or sedimentation of particles

Suspending agents

Ophthalmics

For the eye

Otics

For the ear

Ointments, creams and lotions

For topical use; external use

Suppositories

For rectal use

Suspensions

Shake well

Patches

Apply to skin

List five reasons a pharmacy may repackage a medication.

1) Certain medications are not available unit dosed

2) The cost of repackaging bulk medication may be less than purchasing it unit dosed

3) Repackaging may allow the pharmacy to provide a patient with a new medication more quickly, rather than having to order the drug and wait for it to be delivered

4) Labeling each individual dose reduces the chance of errors

5) If unit dose medication is not used, it can be returned to stock and used for another patient at a later time

List six reasons medications may need to be compounded by a pharmacy.

1) The medication is no longer manufactured by the drug company

2) The patient is allergic to a preservative, dye, or other additive in the normal drug

3) A specialized dosage or strength is needed for a patient with unique needs (e.g. an infant or a patient with diabetes)

4) Combining several medications will increase patient compliance

5) The patient cannot ingest the normal dosage form

6) The medication requires flavorings and/or additives to make it more palatable for patients, most often children.

Why is it necessary to use tweezers to grasp metal weights?

The use of tweezers prevents hand oils from being transferred to the surface of the metal and oils can corrode the metal, altering the exact weight

Why is it necessary to clean counting trays?

To reduce cross-contamination of patients' prescriptions, if residue is left behind on the pill counter and the next patient is allergic to the previous counted medication, that patient may have an allergic reaction.