Revision as of 06:25, 4 May 2014

The glossary on Rx-wiki is an ongoing project to provide definitions to various terms used throughout the site and in the field of pharmacy. The terms have been placed in alphabetical order to aid in finding them.

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A

additive - An additive, in the context of sterile compounding, is a drug that is added to a parenteral solution.

admixture - An admixture is the resulting solution when a drug is added to a parenteral solution.

anabolic steroids - Anabolic steroids are synthetic derivatives of the male hormone testosterone, having pronounced anabolic properties and relatively weak andronergic properties (i.e., producing masculine characteristics), which are used clinically mainly to promote growth and to repair body tissue in senility, debilitating illness, and convalescence. Anabolic steroids may also be referred to as andronergic-anabolic steroids.

ante area - An area that is ISO class 8 or better where hand hygiene and garbing is performed. It also functions as a transition area between the buffer area and the rest of the facility.

antineoplastic agents - Antineoplastic agents are drugs that inhibit and combat the development of tumors.

aseptic techniques - Aseptic techniques are techniques or methods that maintain the sterile condition of products.

automated compounding device (ACD) - An automated compounding device is a machine used to prepare CSPs (e.g., PN).

B

batch preparation - A batch preparation is one in which multiple identical units are prepared in a single operation in anticipation of prescriptions.

behind the counter (BTC) - These are medications that do not require a prescription, but can only be obtained at the pharmacy counter. Examples of this include:

• products containing pseudoephedrine,
• emergency birth control,
• insulins, and
• some states allow cough syrups with small amounts of codeine.

Board of Pharmacy (BOP) - Each state has its own board of pharmacy. The BOP sets standards, roles, and requirements for pharmacy personnel and practice setting in their state.

brand name - This is the manufacturers trademark designation. Each brand name is owned by the company and begins with a capital letter, and it is protected by a trademark. Drugs often have several brand names. The terms trade name and proprietary name may also be used interchangeably with brand name.

buffer area - An area that is required to be ISO class 7 or better. A primary engineerirng control (PEC) such as a laminar airflow workbench would be located in this area.

C

classification - This is how a medication is grouped and is typically defined according to its use in treating a particular disease or disorder. A potential source of confusion is that many medications could be grouped multiple ways. An example of this is aspirin, which can be classified as an analgesic, antipyretic, and anti-inflammatory agent.

compounded sterile preparations (CSP) - Compounded sterile preparations are admixtures that need to be assembled under aseptic conditions to prevent contamination.

contraindication - A contraindication is a condition or factor that serves as a reason to withhold a certain medical treatment.

controlled substances - Controlled substances are medications with restrictions due to abuse potential. There are 5 schedules of controlled substances with various prescribing guidelines based on abuse potential counter balanced by potential medicinal benefit as determined by the Drug Enforcement Administration and individual state legislative branches.

coring - Coring occurs when a needle damages the rubber closure of a parenteral container causing fragments of the closure to fall into the container and contaminate its contents.

D

dietary supplements - A dietary supplement is intended to supply nutrients, (vitamins, minerals/electrolytes, and amino acids) that are missing or not consumed in sufficient quantity in a person's diet. This category may also include herbal supplements.

diluent - A diluent is a solvent that dissolves a lyophilized powder or dilutes a solution.

dosage form - A dosage form is the physical form of a dose of medication, such as capsule, patch, or injection. The route of administration is dependent on the dosage form of a given drug. As an example, persistent vomiting may make it difficult to use an oral dosage form; therefore, an antiemetic in suppository form may be desirable.

E

excipient - An excipient is anything in a medication other than its active ingredient. Common categories for excipients include antiadherents, binders, coatings, disintegrants, fillers, flavors and colors, glidants, lubricants, preservatives, sweeteners, and printing inks.

extemporaneous compounding - Extemporaneous compounding can be defined as the preparation, mixing, assembling, packaging, and labeling of a drug product based on a prescription from a licensed practitioner for the individual patient in a form that the drug is not readily available in (extemporaneous = impromptu, compounding = the act of combining things).

F

G

generic name - This is the official non-proprietary name assigned by the manufacturer with the approval of the USAN (United States Adopted Name) Council. The Federal Food and Drug Administration (FDA) requires that each drug has a generic name, even if currently it is only available as a brand name product. A generic name may also be referred to as the non-proprietary name.

geometric dilution - Geometric dilution, also called geometric incorporation, is the process by which a homogeneous mixture of even distribution of two or more substances is achieved. When using this method, the smallest quantity of active ingredient is mixed thoroughly with a proportion quantity of the diluent or base on the ointment slab. More diluent (base) is added in amounts proportionate to the volume of the mixture on the ointment slab. This process is repeated until all of the ingredients are incorporated in the mixture.

H

hazardous drugs - Hazardous drugs are drugs that are known to cause genotoxicity, which is the ability to cause a change or mutation in genetic material; carcinogenicity, the ability to cause cancer in animal models, humans or both; teratogenicity, which is the ability to cause defects on fetal development or fetal malformation; and lastly hazardous drugs are known to have the potential to cause fertility impairment, which is a major concern for most clinicians. These drugs can be classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents and immunosuppressive agents.

HEPA filter - A HEPA filter is a high efficiency particulate air filter.

hypertonic - A hypertonic solution has a greater osmolarity than that of blood

hypotonic - A hypotonic solution has a lesser osmolarity than that of blood

I

indication - This is the primary condition(s) treated by a particular drug. This may include both FDA approved uses as well as off-label (generally based on scientific studies but lacking FDA approval) medication uses.

interactions - Medications have the potential to interact with other medications, dietary supplements, and constituents of various foods. Medications may also interact with various diseases.

ions - Ions are molecular particles that carry electric charges.

ISO Class - The International Organization for Standardization has established various levels of air cleanliness. The lower the number the fewer particles that are suspended in it and the cleaner the air is. The ISO classes commonly discussed in sterile compounding are ISO Class 5 (3,520 particles of 0.5 micron or larger in a cubic meter), ISO Class 7 (352,000 particles of 0.5 micron or larger in a cubic meter), and ISO Class 8 (3,520,000 particles of 0.5 micron or larger in a cubic meter).

isotonic - An isotonic solution has an osmolarity equivalent to that of blood

J

K

L

laminar airflow - Laminar airflow provides continuous air movement at a uniform rate in one direction.

legend drug - Legend drugs are medications that require a prescription prior to dispensing. These medications may or may not be considered abusable, but consultation with a medical professional that has prescribing authority is necessary due to the complex health conditions that these medications may be able to treat or ameliorate. Often, you will see the phrase "Rx only" used to denote legend drugs.

levigation - Levigation is the process of reducing particle size of a solid by triturating it in a mortar or spatulating it on an ointment slab or pad with a small amount of a liquid called a levigating agent. Levigating agents make incorporating solids easier, and they make a smooth, elegant preparation.

lyophilized - Lyophilized powders are simply freeze-dried powders.

M

Material Safety Data Sheet (MSDS) - OSHA-required notices on hazardous substances which provide hazard, handling, clean-up, and first aid information.

N

National Drug Code (NDC) - Each medication is assigned a unique 10-digit, 3-segment number. This number, known as the National Drug Code (NDC), identifies the labeler or vendor, product, and trade package size.

• The first 4 or 5 digits indicate the manufacturer
• The second 3 or 4 indicate the medication, strength, and dosage form
• The third set of numbers always has 2 digits and indicates the package size

negative pressure room - If a pharmacy prepares more than a low volume of hazardous drugs the appropriate type of PEC should be located within a negative pressure room. A negative pressure room has a has a lower pressure than adjacent rooms and therefore the net flow of air is into the room.

nosocomial infection - A nosocomial infection is an infection acquired while in the hospital.

O

Occupational Safety and Health Administration (OSHA) - OSHA is a government agency within the United States Department of Labor responsible for maintaining safe and healthy work environments. off-label uses - Off-label use is the use of a medication in a manner different from that approved by the FDA including:

• for an unapproved indication,
• in an unapproved age group,
• unapproved dosage, or
• unapproved form of administration.

osmolarity - Osmolarity, also called osmotic pressure, is a characteristic of a solution determined by the number of dissolved particles in it.

over the counter (OTC) - Over the counter medications are drugs that do not require the use of a prescription for a patient to obtain it. These medications are generally considered sufficiently safe for a patient to acquire and self medicate with by following the instructions included on the vial.

P

parenteral - A parenteral can be defined as any administration route not involving the GI tract, but it is used more commonly used in reference to routes that require sterile preparations (injectable routes, ophthalmic, and inhalation).

parenteral nutrition (PN) - Parenteral nutrition is a complex solution with two base solutions (amino acids and dextrose) and additional micronutrients. Lipids may or may not also be present in parenteral nutrition.

personal protective equipment (PPE) - Personal protective equipment is worn by an individual to provide both protection to the wearer from the environment or specific items they are manipulating, and to prevent exposing the environment or the items being manipulated directly to the wearer of the PPE. pharmacology - The term pharmacology is derived from two Greek words "pharmakon" and "logos". Pharmakon can mean sacrament, remedy, poison, talisman, cosmetic, perfume or intoxicant, but in this case, it can be broadly defined as drug. Logos can be translated as a principle of order and knowledge. By combining the terms you can see that pharmacology is concerned with the knowledge of drugs.

positive pressure room - A room that has higher pressure than adjacent spaces and therefore has a net flow of air out of the room.

precipitate - A precipitate is an insoluble substance separated from a solution due to a reaction between incompatible substances.

pregnancy category - The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast milk. The United States FDA has the following definitions for the pregnancy categories:

• Pregnancy Category A - Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
• Pregnancy Category B - Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
• Pregnancy Category C - Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Pregnancy Category D - There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Pregnancy Category X - Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

primary engineering control (PEC) - A primary engineering control, which could include a room or device, provides an ISO Class 5 environment for compounding sterile products. Examples of primary engineering control may include laminar airflow workbenches (LAFW), compounding aseptic isolators (CAI), biological safety cabinets (BSC), compounding aseptic containment isolators (CACI), and clean rooms that create an ISO Class 5 environment.

pyrogens - Pyrogens are chemicals produced by microorganisms that can cause pyretic (fever) reactions in patients

Q

R

S

side effect - A side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended. The term is predominantly employed to describe adverse effects, but it can also apply to beneficial consequences of the use of a drug. A side effect of diphenhydramine (an antihistamine) is drowsiness, which would be an adverse effect is someone needed to be alert, but could be beneficial if they required help going to sleep.

spatulation - Spatulation is the mixing of powders and semi-solids (ointments, creams, etc.) on an ointment pad or slab using a spatula. With this method there is no particle size reduction, so the powders to be mixed must be fine and of uniform size.

T

The Joint Commission (TJC) - The Joint Commission, formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is a nonprofit organization that accredits more than 20,000 healthcare organizations and programs in the United States.

therapeutic equivalents - Drug products are considered to be therapeutic equivalents only if they are available in the same dosage strength, dosage form, achieve the same blood levels, and if they can be expected to have the same clinical effect and safety profile when compared to the original innovator drug. To ensure that a specific generic product is considered to be a therapeutic equivalent, it is recommended that you refer to the Orange Book, a publication from the Food and Drug Administration (FDA). If the products being compared in the Orange Book are considered therapeutic equivalents, it will be given a Therapeutic Equivalence (TE) Code that begins with an "A". If the products are not considered therapeutic equivalents, they will be given a TE Code that begins with a "B". Sometimes these will be referred to as "A" ratings and "B" ratings. These ratings are typically two letters long and will sometimes include a number as well. Usually, a tablet or capsule that is therapeutically equivalent to the innovator drug will have a TE Code 'AB' (with the first letter establishing whether or not the drugs are therapeutically equivalent, and the second letter establishing dosage form category). If a number is included after the two letter code that must also match to be considered therapeutically equivalent.

trituration - Trituration is a method to reduce particle size (comminution); it may also include the grinding together of two or more substances in a mortar to mix them as you should want a fine powder to make incorporation better. Trituration is achieved by firmly holding the pestle and exerting a downward pressure with it while moving it in successively larger circles starting at the center of the mortar, moving outward to the side of the mortar, then back again toward the center.

U

United States Pharmacopeia (USP) - The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. Prescriptions and over-the-counter medicines and other healthcare products sold in the United States are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below 1000 are considered enforceable, while chapters enumerated as 1000 or greater are considered guidelines. Therefore, USP 797 and USP 795 are considered enforceable, while USP 1075 and USP 1160 are simply considered guidelines for best practices.

USP 795 - USP Chapter 795, Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals.

USP 797 - USP Chapter 797, Pharmaceutical Compounding-Sterile Preparations, provides the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP Chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

USP 1075 - USP Chapter 1075, Good Compounding Practices, is intended to provide guidelines on applying best practices in compounding, both sterile and nonsterile.

USP 1160 - USP Chapter 1160, Pharmaceutical Calculations in Prescription Compounding, provides general information on the mathematical concepts required for compounding pharmaceutical preparations.

V

vaccines - A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins.

W

X

Y

Z