extemporaneous compounding of pharmaceutical products

compounding

refers to the special preparation of small quantities done by a compounding pharmacist of drug products using bulk ingredients that are uniquely tailored or match a patient's needs medically or treat a specific patient's medical condition in response to a prescription written by a licensed practitioner

compounding

administering the drug to the site of action in the most effective dosage form available

preparation

compounded ________________

manufacturing

prepare bulk quantities without prescription or medication order

manufacturing

the mass production of compounded prescription products for resale to pharmacies

food and drug administration

regulates manufacturing of drug products

manufacturing

no specific patient in mind when the drug is produced

products

manufactured ________________

extemporaneous compounding

the timely preparation of a drug product according to a physician's prescription, a drug formula, or a recipe in which calculated amounts of ingredients are made into a homogenous mixture

extemporaneous compounding

done when certain medical needs of individual patients cannot be met by the use of an approved commercial drug product

extemporaneous compounding

preparation, mixing, assembling, packing, and labeling of a drug product based on a prescription order from a licensed practitioner for the individual patient

error, prescriber's intent

the goal of compounding is to minimize ___________ and maximize _________________

avoid errors, avoid cross-contamination

only 1 preparation should be compounded at a time to (2):

unavailable dosage strength, dilution of adult doses, conversion of dosage forms, combination of topical products, inactive ingredients causing allergic reactions, compounding of specialty areas

6 reasons for extemporaneous compounding

non-sterile, sterile

2 types of extemporaneous compounding

non-sterile

compounding used in the preparation of commercially unavailable drug formulations from bulk ingredients in the community pharmacy

individualized prescriptions, unique medication requirements

2 uses of non-sterile compounding in the community pharmacy

chapter 795

non-sterile compounding quality protocols are outlined in this chapter of USP

master formulation record, individual record, compounding record, listing of ingredients, compounding equipment, instructions for preparing formula, compounded drugs filed alphabetically

7 things outlined in USP Chapter 795 to maintain

simple, moderate, complex

3 categories of non-sterile compounding

degree of difficulty, availability of information

the categories of nonsterile compounding are based on (2):

simple

category; include those for which clear data are available, such as information from a manufacturer in the FDA-approved labeling or information detailed in most USP compounding monographs

simple

category; example: the supplier of an 80-mL Amoxicillin oral suspension, USP, instructs compounders to add 59 mL of water to the bottle to create a final concentration of 250 mg/5 mL

moderate

category; includes either mixing a preparation for which no stability data are available for that particular formulation

moderate

category; mixing a preparation that requires specialized calculations or procedures that exceed what would be considered simple

moderate

category; example: a mixture of two topical ingredients when the stability of the mixture is not known

moderate

category; example: morphine sulfate compounded to suppositories

complex

category; includes creating a preparation that requires special training, facilities, equipment, or procedures

complex

category; example: making transdermal dosage forms

complex

category; example: modified-release preparations

complex

category; example: modified-release preparations

demonstrably difficult

in complex compounding, compounders must be aware of the FDA documents on preparations considered ________________ to compound and should follow the outcomes of the FDA's pharmacy compounding advisory committee

sterile

the process of using an aseptic technique to prepare sterile solutions or solutions that are free of microorganisms for parenteral products or ophthalmic preparations

clean room environment

most sterile compounding is performed in the _________________

positively

rooms are usually ___________ pressurized to push contaminates out and to keep other particles from being pulled in

chapter 797

usp chapter that consists of standards for the environment to be considered in the preparation of sterile products

food and drug administration modernization act of 1997, united states pharmacopeia

laws, regulations, and standards (idk katong two ka arrow hayst)

monthly, quarterly

laws, regulations, & standards; includes ____________ or ______________ spot check

outside lab

laws, regulations, & standards; random product sent to an _____________ for analysis

+-2

laws, regulations, & standards; product must be ______% of potency

Rx

according to the FDAMA of 1997, extemporaneous compounding is...; made to dispense a product based on an ____ for a specific patient's needs

can not

according to the FDAMA of 1997, extemporaneous compounding is...; pharmacists ____________ compound a copy of a commercially available product

Rx

according to the FDAMA of 1997, extemporaneous compounding is...; pharmacists cannot sell their product without an ___________

USP standards

FDAMA of 1997; allow pharmacists to compound non-sterile (and/or sterile medications) for an individual patient if these medications meet established _____________________

board of pharmacy

FDAMA of 1997; compounding pharmacies overseen by the ________________

commercially available product

FDAMA of 1997; compounding a ___________________ is prohibited

product labeling, drug approval

FDAMA of 1997; compounding pharmacies are not required to follow current good manufacturing practices but only adhere to _____________ or submit ______________ applications

manufacturing license

FDAMA of 1997; if a community pharmacy selling products to healthcare professionals or an out-of-state pharmacy must apply for a _____________________

enhance patient safety, protect pharmacists from litigation

USP has developed standards to (2):

manufactured products

are prepared off-site by the large-scale drug manufacturer

compounded preparations

are patient-specific medications prepared on-site

pharmaceutical compounding centers of america

primary source for many large-volume compounding pharmacies

shortage, backorder, product recall

in sources for bulk ingredients, more than one source is recommended in case of ________, __________, or _____________

beyond-use dating

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

beyond-use dating

initiated when the product is compounded, not when dispensed

14-30 days

BUD estimates for refrigerated aqueous solution or suspension

6 months or less

BUD estimates for solids such as tablets and capsules (non-aqueous)

25% of remaining expiration date or 6 months, whichever is earlier

BUD estimates for a prescription with two or more active or inactive ingredients

beyond-use date

date; a term that applies to compounded preparations

expiration date

date; a term that applies to manufactured products

clean, sanitized

compounding working environment guidelines; highly ________ and ____________

space, storage area

compounding working environment guidelines; adequate _________ and _________________

equipment, ingredients

compounding working environment guidelines; orderly placement and storage of ________ and ______________

dispensing bench

compounding working environment guidelines; ______________ containing different containers and ingredients

temperature/lighting

compounding working environment guidelines; controlled __________________

handwashing, equipment cleaning

compounding working environment guidelines; sink with hot and cold running water essential for ___________ and ____________

eyewash

compounding working environment guidelines; must have an _____________ station

dispensing area

compounding working environment guidelines; physically separated from the _________________

class 100 environment

is an environment that has air that contains no more than 100 particles or larger in one cubic foot of air

laminar flow hoods

hoods that provide class 100 environment

horizontal flow hoods

hoods that filter air and pass it through a HEPA filter and outward out of the hood

vertical flow hoods

hoods that blow filtered air down towards the surface of the hood

biological safety cabinets

are vertical flow hoods that pull air though vents in the front and back of the hood to prevent the preparer from receiving this air

biological safety cabinets

hoods used to make chemotherapy drugs

90%, 110%

compounded preparations guidelines; should contain between __________ and ___________ of labeled active ingredients

purity, quality

compounded preparations guidelines; ___________ and standard __________________ of ingredients

official references

compounded preparations guidelines; compounding methods must be followed from _______________

master recipe

compounded preparations guidelines; always keep the formula or _______________

special certification training

certification of pharmacy technicians

policies and procedures, safety data sheets, master formulation records, compounding records/log, prescription record

5 key types of documents that are required for safe and contemporary compounding concerning documentation

policies and procedures

documentation; should be designed to standardize practices

policies and procedures

documentation; SOPs need to be designed and clearly written to ensure accuracy, quality, safety, uniformity in compounding, and accountability

safety data sheets

documentation; are required to be available for pharmaceuticals that the drug manufacturer has determined to be hazardous and that are known to be present in the workplace

safety data sheets

documentation; required medications and chemicals should be available to staff for reference

material safety data sheets

older name for SDSs

master formula record

documentation; recipe card is not required when preparing a compound according to the manufacturer's instructions in the labeling

compounding records

documentation; documents that detail the specific compound dispensed to a particular patient

prescription record

documentation; computer-generated copy of the log, stored and retrievable for future refills

master control record

a recipe for a compounded preparation

compounding log

a printout from the master control log used to prepare a compounded prescription

magistral, official

2 types of formula

magistral formula

any medicinal product prepared extemporaneously in a pharmacy (and dispensed immediately after preparation and not kept in stock) in accordance with a medical prescription for an individual patient

official formula

any medical product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopeia

official formula

it is maintained in stock and intended to be supplied directly to the patients served by the pharmacy in question

calculation, measurement

two of the most crucial steps in compounding any pharmaceutical product is the accurate __________ and _____________ the component ingredients of the formulation

percentage of error

the acceptable range of variation above and below the target measurement

weighable quantity

percentage of error is based on the least ________________ of an ingredient

small

if a sample is too __________, the margin of error may be unacceptable

5

compounded nonsterile preparations must have an error range of less than ____%

(amount of error/quantity desired) x 100

percentage of error formula