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AAC Actual Acquisition Cost - the actual price a pharmacist pays when purchasing units of a drug product. This price usually represents a discounted price from the Average Wholsale Price (AWP). AARP American Association of Retired Persons ADE or ADR Adverse Drug Experience or Adverse Drug Reaction AMP Average Manufacturer Price - average price paid by wholesalers to manufacturers for drugs to be sold at retail ANDA Abbreviated New Drug Application ATF Alcohol, Tobacco, & Firearms Agency AWP Average Wholesale Price - a published wholesale price for a drug product that can be used as a basis for pricing prescription drugs. Usually, pharmacies are able to purchase the drug at lower (discounted) prices from the AWP. CAM Complementary & Alternative Medicine CDC Centers for Disease Control CDER Center for Drug Evaluation and Research CFR Code of Federal Regulations - a compilation of final regulations and notices promulgated by the federal government; published annually by the US Government Printing Office; the above regulations and notices are first published in the Federal Register, a daily publication. CMS Centers for Medicare and Medicaid Services - responsible for administering Medicare and overseeing states' administration of Medicaid; formerly known as the Health Care Financing Administration CPSC Consumer Product Safety Commission DEA Drug Enforcement Administration - administration responsible for the federal Controlled Substances Act (CSA). It is part of the U.S. Department of Justice. DHHS Department of Health and Human Services - department which includes the Food and Drug Administration (FDA) DI Dietary Ingredient - may be a vitamin, mineral, herb, or other botanical, an amino acid, or another dietary substance that supplements the diet. DME Durable Medical Equipment - equipment that meets three standards: 1. It can stand repeated use 2. It is primarily for medical purpose (i.e. it is not useful to a person if they have no illness or injury) 3. It is appropriate for use in the home. Examples of DME's include wheelchairs, oxygen tanks, and walkers DRG's Diagnosis Related Gaps - a classification system for hospital inpatients based on the principal diagnosis; reimbursement is usually based on days of stay. DS Dietary Supplement - an over the counter product, containing one or more dietary ingredients, that is taken to improve upon a health condition, or simply enhance health, well being (mental and physical), or perhaps cosmetically to improve appearance. DSHEA Dietary Supplement Health Education Act DUR Drug Utilization Review - a review of prescription drug use, prescribing patterns, or drug utilization by patients. Its purpose is to determine if appropriate drugs are being prescribed and if those drugs are being used appropriately. EAC Estimated Acquisition Cost - an estimated cost of a drug to a pharmacy based upon information collected by the DHHS. Such costs are often based upon the quantity purchased. EOB Electronic Orange Book FDA Food and Drug Administration FDCA Food, Drug, & Cosmetic Act (FD & C or FDCA) FTC Federal Trade Commission - responsible for investigating unfair business practices including misleading advertising, etc. GMP Good Manufacturing Practice GRAS Generally Recognized As Safe - refers to a large number of relatively inert ingredients that are permitted to be used in pharmaceutical and food products as excipients or adjuvants because of their relatively high degree of safety GRASE Generally Recognized As Safe & Effective - Term usually used when considering the safety and effectiveness of non-prescription product ingredients HCFA Health Care Financing Administration - formerly responsible for policies relating to Medicare (federally managed) and Medicaid (controlled by individual states under the supervision of the HCFA). Now referred to as Centers for Medicare and Medicaid Services (CMS). HHA Home Health Agency - an organization licensed or certified by the government to provide home health care services. HIPAA Health Insurance Portability and Accountability Act HMO Health Maintenance Organization HP/HPUS Homeopathic Pharmacopoeia of the United States HSD Home-Use Sterlile Drug Products IND Investigational New Drug JCAHO Joint Commission on Accreditation of Health Care Organizations LVP Large Volume Parenteral MAC Maximum Allowable Cost - the highest price allowed under a specific plan for a specific drug (usually multi-source drugs). If a person wants a more expensive version, he/she must pay the difference NABP National Association of Boards of Pharmacy (creates the NAPLEX and MPJE) NDA New Drug Application NDC National Drug Code - a classification system for identifying a specific drug product; used nationally for reimbursement and for identification of drug products NIH National Institutes of Health NDI New Dietary Ingredient. Any substance that was not marketed as a dietary supplement ingredient in the U.S. prior to October 15, 1994. A manufacturer intending to market a New Dietary Ingredient must submit to the FDA, at least 75 days before introduction of the product into commerce, documented evidence establishing that the NDI is reasonable expected to be sage as used in the dietary supplement. Non-DI An excipient or other substance used in the manufacture of dietary supplement (DS). NPI National Provider Identifier OBRA Omnibus Budget Reconciliation Act - act passed each year by Congress to fund many activities; each OBRA is known by the year it was enacted. OSHA Occupational Safety and Health Administration - responsible for monitoring the work environment to assure worker safety OTC Over-the-counter - refers to drugs and drug products, which are available without a prescription; also referred to as "non-prescription". PBM Pharmacy Benefits Management - organization that manages pharmaceutical benefits for managed care organizations or employers PFFS Private Fee-For-Service plans that allow you to go to any doctor or hospital that accepts their terms PHS Public Health Service PI Package Insert PPI Patient Package Insert PPO Patient Provider Organization - a group of health professionals who are contractually favored to provide health services to individuals under a specific insurance plan PPPA Poison Prevention Packaging Act SDA Specially Denatured Alcohol SNDA Supplemental New Drug Application SNF Skilled Nursing Facility - a site that treats patients especially in need of rehabilitation or a lower level of medical care than is needed in a hospital. SNP Special Needs Plan - a category of Medicare Advantage plan designed for people living in long-term care facilities and receiving both Medicaid and Medicare or who have certain disabling chronic illnesses. SP Sterile Product or Supervising Pharmacist TCAM Traditional, Complementary, and Alternative Medicine TRP Tamper Resistant Packaging USAN United States Adopted Names USP/NF United States Pharmacopoeia/National Formulary USP/DI United States Pharmacopoeia Dispensing Information - a set of three volumes containing a variety of information, including: Volume 1 - Drug information for the Health Care Professional - contains information about individual drugs. It is written specially for health professionals. Volume 2 - Advice for the patient - contains drug information in lay language and includes information intended for the general public about the use of drugs (side effects, etc.) Individual pages may be photocopied and provided to patients as part of the counseling process. Volume 3 - Approved Drug Products with Therapeutic Equivalence Evaluations - contains information from The Orange Book, USP/NF definitions and regulations, portions of the Federal Controlled Substances Act, plus other information. Cosmetic Article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering the appearance. Also, any component of the above articles is considered to be a cosmetic. Soap is considered to be a cosmetic...True or False? False Device An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article which is: 1. Recognized in the USP/NF or HPUS or any supplement 2. Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals 3. Intended to affect the structure or any function of the body of humans or animals but are not foods Infusion Pumps, Cardiac Pacemakers, and Heart Monitors are considered to be (blank). Devices Drug Any of the following: 1. Article recognized in the official United States Pharmacopoeia/National Drug Formulary (USP/NF), or official Homeopathic Pharmacopoeia of the United States (HPUS), or any supplements of these references. 2. Article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals 3. Article (other than food) intended to affect the structure or function of the body of man or other animals. 4. Article intended for use as a component of any articles specified in the above, but does not include devices or their components, parts, or accessories. Drug Sample A unit of drug product not intended to be sold. Usually it is intended to acquaint a prescriber with a drug product by providing several doses for short-term or initial therapy. Food An article used for food or drink in humans or animals, chewing gum, and substances used as components of food or drink. Generic Name A name that is assigned to a specific drug structure. It is a simplified name as compared to the chemical name. Drug products may be marked under their "generic name" or a brand name (trade name). The general perception is that a drug marketed under its generic name is usually less expensive than the brand name product Hospice A facility or program that provides palliative and supportive care for terminally ill patients