Compounding

COMPOUNDINGCOMPOUNDINGCompounding: the preparation, mixing,

assembling and packaging or labeling of a drug or device.

Extemporaneous Compounding: the on-demand preparation of a drug product according to a physician’s prescription, formula or recipe.

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Compounding (continued)

• Nonsterile compounding: done on countertop

• Common items: creams, ointments, oral suspensions

• Less common: capsules, suppositories, syringes

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Compounding

• Customized medications: elixirs, suspensions, ointments, creams, lotions, capsules, tablets, suppositories

• Made in specialized compounding pharmacies

Solutions• Elixirs, suspensions, tinctures• Flavoring commonly added to improve taste

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Common Types of Equipment• Mortar (dish portion) and pestles (grinding

portion) can be glass or porcelain• Other compounding station equipment: filter

paper, spatulas, beakers/graduated cylinders, glass stir sticks, glass compounding slab, blender, funnel, sink, solvents

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Equipment (Continued)

• Balance scales– Weigh powders– Differ in range of weight and style

• Electronic scale:– Digital readout of weight– Calibrations are electronic

TYPES OF SCALES

• Class A Scale– 6 mg sensitivity– Accurately weighs

between 120 mg and 15 gm

• Class B Scale– 30 mg sensitivity– Accurately weighs between 650 mg and 120 gm

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Expiration Dates

• Stability of drug affected by light, air temperature, pH

• Expiration date found in manufacturer’s literature or compounding books

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Packaging• Containers must:

– Be appropriate size

– Protect contents

– Have childproof caps (not for jars and syringes)

– Have appropriate labels

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Packaging

• Syringes –Used to prepare vaginal compounds–Drug loaded in barrel of syringe, cap placed

over top• Suppository

–Base: wax and mineral oil

–Made in molds

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Packaging

• Other containers:–Glass and plastic bottles–Dropper bottles–Jars

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Preparation• Pharmacies: countertop station for

compounding products• Technician responsibilities: clean items,

ensure good working order• Long hair tied back• Lab coat and gloves worn• No illness, no open wounds

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Preparation (Continued)

• Recipe book or formula cards: list compounds, weights, step-by-step instructions for common items

• Additional ingredients: sweeteners, flavorings (such as berry, lemon, or grape), colorings

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Record-keeping• Documentation of records under quality

assurance of FDA guidelines• Documents kept for 3 years from time

medication was prepared

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Techniques for Compounding: Weighing

• Components of typical balance:–Paper and weights–Tweezers for grasping metal weight–Arrest knob locks balance in place

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Techniques for Compounding:Measuring

• 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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Measuring cont’d• Liquids: 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)

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Compounding Techniques

• Ointment: hydrophobic base– Petroleum jelly mixed with drug

• Creams: hydrophilic base–Eucerin, Aquaphor

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Compounding Techniques (Continued)

• Capsules–Punch method techniques

slow and arduous–Capsule machines load

capsules quickly and accurately

LAMINAR FLOW HOODSEstablishes and maintains an ultraclean

work area for the preparation of IV admixtures.

How the Flow Hoods Operate1. Room air is drawn into a prefilter to remove

relatively large contaminants, such as dust or lint.2. The air is then channeled through a high

efficiency particulate air (HEPA) filter that removes even smaller particles (microns).

3. The purified air then flows over the work surface.4. The constant flow of air from the hood prevents

room air from entering.

TYPES OF FLOW HOODS• Vertical Hood

– Air flows from the top to the bottom– Most of the purified air leaves the front of the

hood but some does exit the back and sides.• Horizontal Hood

– Air flows from the back towards the front, where the operator is.

– This prevents room air from entering the hood.

MAINTAINENCE OF HOODS• Should be kept on at all times.• If it shuts down it must be in operation

for 30 mins before use.• Wipe the hood with 70% isopropyl

alcohol ONLY!!!• Should be cleaned at the beginning of the

shift and when a spill occurs.

Check for UnderstandingDiscuss with your neighbor…. What factors would a pharmacy need to consider when deciding whether to offer compounding services?

Possible Answers:•Involves financial, staffing, inventory, and customer demand considerations.•Pharmacist must be willing to be trained and continue education in compounding skills.•Pharmacist must be willing to be engaged in physician-patient-pharmacist relationship with intended goal of providing customized meds.•Some financial investment: site renovations and purchasing of compounding equipment.•Will have to maintain inventory of raw drug chemicals.•Will be necessary to have access to or develop compounding formulas.•Pharmacist will need to be committed to take the time necessary to compound correctly, including training and supervision of technicians