Chapter 8 - Nonsterile Pharmaceutical Compounding
Terms in this set (43)
What is Compounding?
defined as the process of preparing a prescribed medication for an individualized patient from bulk ingredients by a pharmacist in order to treat a specific medical condition and is made according to a prescription from a licensed prescriber
What is Sterile Compounding?
used in the production of medications that must be free of microorganisms such as those used for injections or instillation of the eyes, most of these are performed in hospital pharmacy
What is Nonsterile Compounding?
used in the production of solutions, suspensions, ointments and creams, powders, suppositories, capsules and tablets. Dermatologists and gynecologist use individualized prescriptions; also used by dentists and veterinarians
What is Compounding Pharmacy?
similar to those in hospital pharmacies, these pharmacies have the necessary equipment, space and expertise to prepare compounded prescriptions safely
What is USP 795?
the United States Pharmacopeia has developed uniform standards for Nonsterile Compounding to enhance patient safety and to protect pharmacists from litigation known as USP Chapter 795
the prescription calls for doses smaller than those that are commercially available as is sometimes the case with pediatric medications
What is a Solution?
a liquid dosage form in which the active ingredients are dissolved in a liquid vehicle
What is a Solvent?
the vehicle that makes up the greater part of a solution
What is a Solute?
an ingredient (medication) dissolved in a solution
What is Suspension?
as opposed to a solution, the active ingredient is not dissolved in the liquid vehicle but rather is dispersed throughout it
What is an Ointment?
a water-in oil (w/o) emulsion that is occlusive, greasy, and not water washable
What is a Cream?
an oil-in water(o/w) emulsion that is nonocclusive, nongreasy, and water washable
What is a Suppository?
solid dosage forms that are inserted into bodily orifices, generally rectum or the vagina or less commonly the urethra and are composed of one or more active ingredients placed into one variety of bases, such as cocoa butter, hydrogenated vegetable oil or glycerinated gelatin
What are Bio-Identical Hormones?
manufactured in the lab to have the same molecular structure as the hormones made by your own body, a specialist may want to individualize these hormones in a compound prescription and attempts to match the individual requirements for each woman in a compounded gel or cream
What is Hormone Replacement Therapy?
consists of some combination of estrogen, progestin (female) and androgen (male) to relieve specific postmenopausal symptoms
What is Anticipatory Compounding?
a pharmacy prepares excess product as long as quantities are reasonable. These preparations must be labeled with lot number *important for recalls and beyond-use dating
What is a Good Compounding Practice (Standard)?
A facility designated area with adequate space; separate area for sterile compounding; must include Lot # for recalls
Why is it Important to have a Manufacturing License?
if a community pharmacy is selling compounded drug products directly to health professionals (rather than individual patient), including to out-of-state pharmacies then the pharmacy must apply to FDA
What is a Material Safety Data Sheet (MSDS)?
needs to be filed by the technician for all bulk chemicals or drug substances that are stored in the pharmacy. This record contains important information on hazards and flammabilty of chemicals and procedures for treatment of accidental ingestion or exposure
What is Beyond-Use Dating?
initiated at the time of compounding, but not at the time of dispensing; this is another reason why preparations should be prepared as close to the time of patient dispensing as possible
What is Chapter 795 for Beyond-Use Dating?
provides estimates for beyond-use dating. For example, refrigerated aqueous solution has a beyond-use date of 14 days. Solids (tablets and caplets) and nonaqueous solutions have a beyond-use date of 6 months or less depending on ingredients making up compound. All other formations have beyond-use date of 30 days. Manufactured or Bulk medications have 25% of remaining expiration date or 6 months whichever is earliest
What is a Master Control Record?
formula or recipe of compound for medication being prepared
What is a Compounding Log?
generated for each compound prepared, unique for each prescription and intended for a specific patient
What is a Class III Prescription Balance?
two-pan balance that can be used for weighing small amounts of material (120 mg or less) and has a sensitivity requirement (SR) in the range of +/-6 mg; meaning that a 6 mg weight moves the indicator balance by 1 degree
What is Weighing Paper?
placed on the balance pad to avoid contact between pharmaceutical ingredients and balance tray when measuring and using weights
What are Forceps?
instrument used for grasping small objects, such as pharmaceutical weights
What is a Spatula?
instrument used for transferring solid pharmaceutical ingredients to weighing pans for various compounding tasks (i.e preparing ointments, creams and loosening material. Made of stainless steel, plastic or hard rubber (used when corrosives materials are handled)
What are Pharmaceutical Weights?
generally made of polished brass and may be coated with a noncorrosive material such as nickel or chromium
What are Mortars and Pestles?
used for grinding and mixing pharmaceutical ingredients. Come in glass, porcelain and Wedgwood. Wedgwood is used for triturating (pulverizing) crystals, granules and powders. Glass is used for mixing of liquids, creams, ointments and gels
What is an Important Step for Electronic Balance?
must be in a locked or "arrested" position when it is not in use and when being moved. Also, locked before removing measured substance
What is the Calculating Percentage of Error?
actual amount - quantity desired = amount of error
What is the Technique for Measuring Liquids?
always select a device that yields the most accurate volume. Select container that is at least half full during measurement, or using smaller device that holds the required volume
What is Meniscus?
moon-shaped body on the upper surface of a liquid that needs to be measured and read at eye level
What is Comminution?
the act of reducing a substance to small, fine particles
What is Blending?
the act of combining two substances
What is Trituration?
process of rubbing, grinding or pulverizing a substance to create fine particles, generally by means of mortar or pestle. Using rapid motion with minimal pressure provides best results
What is Levigation?
typically used when reducing the particle size of a solid during the preparation of an ointment. A paste is formed of a solid material and a tiny amount of a liquid levigating agent, such as castor oil or mineral oil, that is miscible or mixable with the solid
What is Pulverization?
by intervention, the process of reducing the size of particles in a solid with the aid of an additional material in which the substance is soluble-a volatile solvent such as camphor, alcohol, iodine or ether. The solvent is permitted to evaporate so it does not become part of final product
What is Spatulation?
the process of combining and mixing substances by means of spatula, generally on an ointment slab or tile. When an ointment slab and spatula are used, the edge of spatula should press against slab to provide shearing force, for smoother preparation
What is Sifting?
the process not unlike the sifting of flour in baking. Can be used to blend or combine powders
What is Tumbling?
placing powders into a bag or container and shaking it
What is the Punch Method when Filling Capsules?
powder is made in to a cake form with spatula, body of capsule is then punched repeatedly into cake form until capsule is full
What are the 2 Important Steps in Compounding Process?
pharmacist performs all mathematical calculations, identifying the necessary equipment, technician double-checks all calculations AND Technician weighs and adds all ingredients for preparation, initials each step and adds documentation (such as source & NDC number) to the compounding record
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