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1 Chapter 8 Nonsterile Pharmaceutical Compounding Paradigm Publishing Inc 2 The Need for Compounding Before largescale pharmaceutical manufacturing pharmacists compounded most prescriptions ID: 779510

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Slide1

© Paradigm Publishing, Inc.

1

Chapter 8

Nonsterile Pharmaceutical Compounding

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The Need for Compounding

Before large-scale pharmaceutical manufacturing, pharmacists compounded most prescriptions.Compounding is still necessary, but most chain pharmacies do not have the time, space, or expertise for compounding.

A growing number of independent pharmacies are specializing in compounding service.

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Terms to Remember

compounding the process of preparing a prescribed medication for an individual patient from bulk ingredients created by a pharmacist in order to treat a specified medical condition according to a prescription by a licensed prescriber

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The Need for Compounding

Sterile compoundingNonsterile compounding

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Sterile Compounding

Includes preparation of injectable medicationsDone mostly in hospital pharmaciesRequires special

Equipment

Workspaces

Expertise

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Terms to Remember

sterile compounding the preparation of a parenteral product in the hospital, home healthcare, nuclear, or community pharmacy setting; an example is an intravenous antibiotic

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Terms to Remember

nonsterile compounding the preparation of a medication, in an appropriate quantity and dosage form, from several pharmaceutical ingredients in response to a prescription written by a physician, such as tablets, capsules, ointments, or creams; sometimes referred to as extemporaneous compounding

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Nonsterile Compounding

There are many examples of nonsterile compounding preparations:

Solutions and suspensions

Ointments and creams

Suppositories and capsules

Many dermatologists and gynecologists prefer to individualize prescriptions for their patients.

Pharmacists also compound prescriptions from dentists and veterinarians.

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Nonsterile Compounding

Why compound?If prescription calls for a smaller dose than is commercially available

If a patient requires alternative dosage form

Cannot swallow pills

Oral medication may harm stomach

May be allergic to preservatives or colorings

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Nonsterile Compounding

Solution – liquid dosage formActive ingredient (solute) dissolved in a solution (solvent), which may be water-based or alcohol-based

Suspension – active ingredient not dissolved but dispersed

Has a tendency to settle

Suspending agent prevents settling

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Nonsterile Compounding

Regardless of their apparent stability, all suspensions should be dispensed with an auxiliary label reading “Shake Well.”

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Nonsterile Compounding

Ointments – water-in-oil emulsionsOcclusiveGreasy

Not water washable

Creams – oil-in-water emulsions

Nonocclusive

Nongreasy

Water washable

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Nonsterile Compounding

Powder is a finely divided admixture of drugs and/or chemicals.Powders range in size from very coarse (No. 8) to very fine (No. 80).

Dispensing of medicines in powder from is very rare.

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Nonsterile Compounding

Suppository – solid dosage form for insertion into body orificeRectum

Vagina

Urethra

Consists of active ingredient(s) in a base such as

Cocoa butter

Hydrogenated vegetable oil

Glycerinated gelatin

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Nonsterile Compounding

Suppositories are prepared byMelting base material

Adding active

ingredient(s)

Pouring into a mold

Chilling to solidify

the suppository

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Nonsterile Compounding

Capsules – solid dosage form with medicinal preparation inside a gelatin shellMedicinal preparation may be

Powder

Granules

Liquid

Compounding for capsules may be necessary to provide an unusual dosage form.

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Nonsterile Compounding

Capsule shells consist of a body and cap and are made ofGelatin

Sugar

Water

Available in standard sizes

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Nonsterile Compounding

Commercially available synthetic hormones come in fixed doses forHormone replacement therapy (HRT)

Estrogen replacement therapy (ERT)

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Terms to Remember

hormone replacement therapy (HRT)therapy consisting of some combination of estrogen, progestin (female), and androgen (male) hormones

estrogen replacement therapy (ERT)

treatment consisting of some combination of female hormones

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Nonsterile Compounding

Physician may want to individualize these hormones instead.

Bio-identical hormones can be compounded to meet individual needs.

Dosing can be based on clinical observations or lab analysis of serum or saliva.

Hormones can be compounded as a gel or cream formulation.

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Laws, Regulations, and Standards for Compounding

Compounding pharmacies must be licensed.Federal and state laws and national standards guide safety practices.

Compounding pharmacies must follow good compounding practices (see Table 8.2).

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Terms to Remember

good compounding practices (GCP) USP standards in many areas of practice to ensure high-quality compounded preparations

anticipatory compounding

preparing excess product (besides an individual compound prescription) in reasonable quantities; these preparations must be labeled with lot numbers

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USP Chapter 795

US Pharmacopeia developed standards for nonsterile compounding (Chapter 795):Enhances patient safety

Protects pharmacists from law suits

FDA elects to use and enforce USP standards.

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Terms to Remember

manufactured products products prepared off-site by a manufacturer

compounded preparation

a patient-specific medication prepared on-site by the technician, under the direct supervision of the pharmacist, from individual ingredients

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USP Chapter 795

Contains policies and procedures for

Quality control, including quality of source ingredients

Verification

Patient counseling

Quality control also includes

Training of personnel

Maintaining stability and consistency of finished product

Preventing errors

Documenting expiration dates

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USP Chapter 795

Material Safety Data Sheet must be filed for all stored ingredients.Contains information onHazards and flammability

Procedures for treating accidental ingestion or exposure

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USP Chapter 795

Compounded products have beyond-use dating, which is initiated at the time of compounding, not at the time of dispensing.Product stability must be documented.

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Terms to Remember

beyond-use dating

the documentation of the date after which a compounded preparation expires and should no longer be used

stability

the extent to which a compounded product retains the same physical and chemical properties and characteristics it possessed at the time of preparation

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USP Chapter 795

Chapter 795 provides estimates for beyond-use dating:Refrigerated aqueous solutions = 14 days

Solids and nonaqueous solutions = 6 months or less

All other formulations = 30 days

When manufactured or bulk materials are used, take the earlier of these:

25% of the remaining expiration date

6 months

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USP Chapter 795

Technician should always have pharmacist check beyond-use dating.Beyond-use dating for sterile preparations is stricter:

It may be as little as 24 to 72 hours.

Both stability and sterility must be documented.

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Accreditation of Compounding Pharmacies

Many compounding pharmacies seek national accreditation:Protects patients

Protects businesses from legal challenges

Differentiates their practices from those of other pharmacies

Pharmacy Compounding Accrediting Board (PCAB) is responsible for accrediting pharmacies.

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Accreditation of Compounding Pharmacies

To be accredited, pharmacy must agree to follow all specified standardsMust follow continuous quality improvement (CQI) process, including

Periodic spot-checks of technicians’ work

Random selection of product to be analyzed at an outside lab

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The Master Control Record

The master control record is the recipe for making the compounded prescription.It is prepared bythe pharmacist

or provided by a

compounding

service.

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Terms to Remember

master control record a recipe for a compound preparation that lists the name, strength, dosage form, ingredients and their quantities, mixing instructions, and beyond-use dating

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The Compounding Log

Generated for each prescription

Pharmacist uses it to complete the initial calculations and document them

Copy of the log

(called the

prescription

record) is filed

and used for

refills

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Terms to Remember

compounding loga printout of the prescription for a specific patient, including the amounts or weights of all ingredients and instructions for compounding; used by the technician to prepare a compounded medication for a patient

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Terms to Remember

prescription record a computer-generated version of the compounding log that documents the compounding recipe for a specific prescription and patient

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The Compounding Log

Compounding log listsAll ingredients of the compounded preparation

Manufacturer

Wholesaler source

Assigned lot number

NDC number

Expiration date for each ingredient

Quantity made

Date of compounding

Initials of pharmacist and compounding technician

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Calculations in the Compounding Pharmacy

Technician in a compounding pharmacy should haveKnowledge of mathematical conversions

Aptitude for performing calculations

Pharmacist is legally responsible for all calculations made by technicians

Good practice to double-check pharmacist’s calculations and those in the master control record

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Equipment

Weights and BalancesPharmaceutical Weights

Forceps and Spatulas

Compounding Slab

Mortar and Pestle

Graduate Cylinders, Pipettes, and Beakers

Other Equipment

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Weights and Balances

Class III prescription balance

Two-pan balance

Used

to weigh

small amounts

(120 g or less)

Sensitivity requirement around +/

6 mg

Uses pharmaceutical weights to offset ingredient weight

Technician must become familiar with weights and balances

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Weights and Balances

CounterbalanceTwo-pan balanceUsed for larger weights (up to 5 kg)

Sensitivity requirement in the range of +/- 100 mg

Used for bulk materials, not for compounding

Ingredients and weights should be placed on weighing paper

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Terms to Remember

weighing paper a special paper that is placed on a weighing balance pan to avoid contact between pharmaceutical ingredients and the balance tray; also called powder paper

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Weights and Balances

Digital electronic balanceSingle panEasier to operate than two-pan balance

More accurate

Much more

expensive than

two-pan balances

($2,500 or more)

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Terms to Remember

digital electronic analytical balance a single-pan balance that is more accurate than Class III balances or counterbalances; has capacity of 100 g and sensitivity as low as +/–1 mg

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Pharmaceutical Weights

Used with two-pan balances to offset ingredient weight

Made of polished brass with noncorrosive coating

Set usually

contains both

metric and

apothecary

weights

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Forceps and Spatulas

Forceps are used for grasping small objects.

Forceps are used with pharmaceutical weights to avoid transferring moisture or oil from hands, which can change weight and cause measurement errors.

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Forceps and Spatulas

Spatulas are used for various tasks:

Transferring solid ingredients to weighing pans

Preparing ointments and creams

Removing material from mortar and pestle

Spatulas can be made of

Stainless steel

Plastic

Hard rubber

(useful for

corrosive

materials)

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Terms to Remember

forceps an instrument used to pick up small objects, such as pharmacy weights

spatula

a stainless steel, plastic, or hard rubber instrument used for transferring or mixing solid pharmaceutical ingredients

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Compounding Slab

Plate is made of ground glass:Flat, hard, nonabsorbent surfaceUsed for mixing compounds

Disposable,

nonabsorbent

parchment paper

can be used

instead.

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Mortar and Pestle

Used for grinding and mixing ingredientsCan be made of glass, porcelain, or Wedgwood

Coarse-grained porcelain or Wedgwood best for pulverizing

materials

Smooth glass sets

best for mixing

liquids and

semisolids

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Graduate Cylinders, Pipettes, and Beakers

A Graduate cylinder is a flask used for measuring liquids:

Can be glass or polypropylene

Can be conical (wide top, narrow base) or cylindrical

Conical graduates are calibrated in both metric and apothecary units.

Cylindrical graduates are calibrated in metric units and are more accurate.

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Graduate Cylinders, Pipettes, and Beakers

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Graduate Cylinders, Pipettes, and Beakers

Beakers are used to measure larger volumes of liquids:Not as accurate as graduate cylinders

Used when precision is not required

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Graduate Cylinders, Pipettes, and Beakers

A pipette is a long, thin, hollow tube:

Calibrated

Used to measure and transfer liquid volumes less than 1.5 mL

Sometimes suction device used to draw up liquid

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Other Equipment

Freezers and refrigerators – for storing ingredients and final productsContainer hood, masks, and gowns – for protection when working with powders

Tablet press – for combining tablet ingredients

Capsule machine – for making larger quantities of capsules

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Other Equipment

Sterile preparations require additional equipment and space:Autoclave to sterilize instruments

Incubator to culture products

Clean room environment

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Attire and Preparation Requirements

Minimum requirements for nonsterile compounding

Hairnet

Long lab coat

Gloves

And for hazardous chemicals

Eye goggles

Mask

Double gowning

Eyewash station

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Attire and Preparation Requirements

USP Chapter 795 also specifies the following:All personnel must wash hands before and after each compounding procedure.

Disposable gloves must be discarded after each procedure.

No food items should be stored or consumed in the staging area.

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Technique for Weighing Pharmaceutical Ingredients

Accurately weighing ingredients is one of the most important parts of compounding.

The

electronic balance

is the preferred piece of equipment.

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Technique for Weighing Pharmaceutical Ingredients

Must be perfectly level (front to back and side to side)Should be warmed up and calibrated each day prior to use

Should be locked when not in use

Must be cleaned after each use

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Technique for Weighing Pharmaceutical Ingredients

Class III prescription balance is sufficient for occasional compounding.Pharmacist must check all measurements done by technician.

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Calculating Percentageof Error

Error in measurement is expected in nonsterile compounding.Allowances are made for a certain percentage of error.

Most balances are marked with their degree of accuracy.

Percentage of error is calculated as

(amount of error / quantity desired) x 100

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Terms to Remember

percentage of error the acceptable range of variation above and below the target measurement; used in compounding and manufacturing

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Technique for Measuring Liquid Volumes

Always select the measuring device that yields the most accurate volume.Use the smallest device that holds the required volume.

Measure the liquid at eye level.

Read the level at the bottom of the meniscus.

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Terms to Remember

meniscus the moon-shaped or concave appearance of a liquid in a graduate cylinder used in measurement

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Technique for Measuring Liquid Volumes

Always measure liquids on a solid, level surface at eye level.

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Techniques for Mixing Compounded Drugs

Technician should first gather these items:

Master control record

Ingredients

Equipment

Mixing directions

Adequate and uninterrupted time must be provided.

Best mixing technique should be retrieved from the master control record or from the pharmacist.

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Techniques for Mixing Compounded Drugs

Comminution is the act of reducing a substance to small, fine particles.Blending is the act of combining two substances.

Trituration

involves rubbing or grinding a substance to create fine particles:

Generally done with mortar and pestle

Rapid motion with minimal pressure produces best results

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Terms to Remember

comminution the act of reducing a substance to small, fine particles, including trituration, levigation, pulverization, spatulation, sifting, and tumbling

blending

the act of combining two substances

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Techniques for Mixing Compounded Drugs

Levigation is used when reducing particle size for use in ointments.A paste is formed with the solid and a levigating agent:

Castor oil

Mineral oil

The paste is then triturated with a mortar and pestle.

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Terms to Remember

levigation a process usually used to reduce the particle size of a solid during the preparation of an ointment

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Techniques for Mixing Compounded Drugs

Pulverization by intervention reduces particle size with the use of a volatile solvent:

Camphor

Alcohol

Iodine

Ether

The solvent is then permitted to evaporate.

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Techniques for Mixing Compounded Drugs

Spatulation uses a spatula to combine and mixSifting is used to blend powdersTumbling involves placing powders into a container and shaking

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Techniques for Mixing Compounded Drugs

Most ointments and creams are prepared with manual incorporation of materials.In some cases, dry ingredients must be triturated to avoid a gritty appearance.

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Techniques for Mixing Compounded Drugs

Powders can be combined using one of the following techniques:Spatulation

Trituration

Sifting

Tumbling

Levigation

A diluent powder may be necessary for pediatric doses.

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Terms to Remember

diluent powder mixing

an inactive ingredient that is added to the active drug in compounding a tablet or capsule

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Techniques for Compounded Drugs

Hand-filling capsules can be done with the punch method.

The body of the capsule

is punched into a cake

of powder until it is full.

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Techniques for Mixing Compounded Drugs

Mortar and pestle can be used to mix more than one drug.Geometric dilution method begins by adding the most potent drug.

An equal amount of the next most potent drug is added and mixed.

Each successive addition should equal the amount in the mortar.

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Terms to Remember

geometric dilution method the gradual combining of drugs using a mortar and pestle

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The Compounding Process

USP Chapter 795 lists fourteen steps for compounding a nonsterile preparation.These steps, or something similar, should be included in the pharmacy’s procedure manual.

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The Compounding Process

Compounding should never be rushed.

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The Compounding Process

The pharmacist judges the suitability of the prescription to be compounded in terms of safety and intended use.

The pharmacist retrieves and reviews the master control record in the computer.

(See Table 8.6)

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The Compounding Process

The pharmacist prints out a compounding record or log sheet for the technician to make the nonsterile preparation.

A medication container label is typed or created by the computer software using information in the compounding log.

(See Table 8.6)

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The Compounding Process

The pharmacist performs all necessary mathematical calculations and identifies the necessary equipment for the technician; the technician double-checks all calculations.

The pharmacy technician uses appropriate protective clothing and handwashing technique.

(See Table 8.6)

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The Compounding Process

The technician gathers all necessary active and inactive ingredients, as well as prepares and calibrates any necessary equipment.

The technician weighs and adds all ingredients for the preparation, initials each step, and adds documentation to the compounding record.

(See Table 8.6)

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The Compounding Process

The technician labels and stores the medication in a suitable container.

The pharmacist reviews the compounding record and medication container label and assesses the pharmaceutical elegance of the preparation

(See Table 8.6)

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The Compounding Process

The technician prepares a medication container label, affixing it to the proper container.

The pharmacist signs and dates the compounding record and/or prescription, files the records, and places the compounded preparation in a storage bin for patient pickup.

(See Table 8.6)

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The Compounding Process

The technician cleans all equipment thoroughly and promptly, reshelves all active and inactive ingredients, and properly labels and stores any excess preparation.

The pharmacist counsels the patient at the time of pickup.

(See Table 8.6)

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The Compounding Process

Selecting medication containersLabeling and cleanupFinal check by the pharmacist

Patient counseling by the pharmacist

Reimbursement

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Selecting Medication Containers

Technician should choose the best container for the specific drug dispensed.

Amber-colored vials protect product from light.

Oral syringes are calibrated for dispensing creams and gels.

New TopiClick container dispenses a measured amount of medication.

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Labeling and Cleanup

After compoundingPrescription must be labeled with all required information.

Prescription balance should be locked and covered.

Equipment and work area should be thoroughly cleaned.

Ingredients should be properly stored.

Expired or discarded product should be sealed and placed in a biohazard container.

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Final Checkby the Pharmacist

Pharmacist is legally responsible for checking the final product:

Master control record

Mathematical calculations

Weight measurements

Container label

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Final Checkby the Pharmacist

Pharmacist also checks the pharmaceutical elegance of the product:

Adequacy of mixing

Odor

Color

Consistency

pH balance

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Terms to Remember

pharmaceutical elegance the physical appearance of the final compound preparation

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Patient Counselingby the Pharmacist

Pharmacist must offer counseling to all patients regarding compounded preparations.

Pharmacist should ensure that the patient knows

How to take the medication

How to properly store the medication

The beyond-use or expiration date of the medication

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Reimbursement

Insurance generally does not cover compounded preparations.The cost to the patient is based on time and experience of staff, not on the cost of the ingredients.

Some insurance companies will accept a Universal Claim Form from the pharmacy and reimburse the patient later.