Pharmaceutical Terms, Abbreviations and Meanings

Private Label

A "house brand" oTC drug, which usually sells for less than the equivalent national brand

Prescription Drug Marketing Act of 1987 (PDMA)

A U.S. law enacted to reduce the risk that prescription drugs are counterfeit, adulterated, or expired will be sold to the American Public. It banned the sale, purchase, or trade of drug samples and drug coupons; banned reimportation of prescription drugs produced in the U.S. except when reimported to the manufacturer or for emergency use; and required state licensure of wholesale distributors of prescription drugs. As a result of PDMA, physicians cannot sell the free samples they receive from pharmaceutical companies, and pharmaceutical companies must rigorously track samples distributed and collect unused ones

Vaccine

A biologic that the immune system recognizes as a disease-causing agent. The antibodies produced by the body as a result protect the body against a more serous attack by the same antigen. Some have essentially eliminated these diseases from the U.S. and many parts of the world

Active Metabolite

A biological active product of a medication's metabolism

Enteric Coating

A coating on a tablet which protects it from stomach acids

Nucleotide

A compound consisting of a nitrogen-containing base, a sugar and a phosphate group

Acute Illness

A condition or illness that only lasts for a short period of time. Ex. Common cold

Autoimmune Disease

A disease in which the body's immune system is turned on itself

Maintenance Dose

A dose of medication that keeps/maintains the necessary plasm concentration levels for therapeutic benefit

Agonist

A drug capable of combining with receptors to initiate drug actions

Parenteral Drug

A drug designed to bypass the gastrointestinal tract. IVs and injections are common routes of administration. Unlike drugs administered orally or through enteral tubes, which only gradually reach the blood stream, this type of drugs go directly into a blood vessel organ, tissue or lesion

Androgen

A male specific reproductive hormone

Lymphoma

A malignant tumor of the lymph nodes

Affinity

A measure of the binding of an antibody to an antigen

AMA (American Medical Association)

A national association based in Chicago that represents more than 700,000 medical doctors in the United States. Among other things, it defines ethical standards that physicians should observe in their relationships with pharmaceutical companies and in their prescribing behavior

Private Insurer

A non-government entity that provides health insurance benefits, including Blue Cross and Blue Shield plans, commercial insurers, and managed care plans

Angiotensin

A peptide. There are two form: I and II. ____ I is converted to ______ II by an enzyme. _______ II constricts blood vessels to increase blood pressure

Resident

A physician who has graduated from medical school but is undergoing additional training in his or her specialty. Most specialties require at least three years of residency training, and many specialties require four years or more

Endotoxin

A poison released by a bacterium when the cell wall is broken

Antibody

A protein secreted by B cells when they are stimulated by an antigen. These act specifically against particular antigens in an immune response

IDN (Integrated delivery network)

A single organization, usually built around a hospital or health system, which offers an array of inpatient and outpatient services

Receptor

A site in the body which generally resides on a cell surface or within the cytoplasm. When a it is stimulated or occupied, a biological change/activity takes place

Synergism

A situation where adding medication together achieves a better clinical effect that the sum of their effects individually.

Hospice

A special care setting for people who are terminally ill and their families. Services include both physical care and counseling

Accelerated Approval

A specialized FDA mechanism implemented in the early 1990s to speed approval of drugs that represent a major advance in addressing serious or life threatening disease for which no effective alternative treatments exist. The impetus was the demand for new AIDS therapies. Under accelerated approval, the FDA accepts a surrogate endpoint as evidence of effectiveness, and the requires post-marketing studies to confirm the drug's benefits

Federal Food, Drug and Cosmetic Act of 1938 (FDCA)

A statute requiring, for the first time, that manufacturers prove the safety of a drug before marketing it. Among other things, the law states that all print advertisements for durgs msut contain a short statement of side effects, contradictions, and effectiveness, known as the brief summary

Adjuvant

A substance that enhances the action of a drug or antigen. This therapy is the use of a second form of treatment in addition to the primary therapy, for example, having chemotherapy in addition to surgery or radiation therapy

HIPAA (Health Insurance Portability and Accountability Act of 1996)

Also known as the Kennedy-Kassebaum law. A federal law with two main components: (1) one pertains to health insurance "portability" - the ability to qualify immediately for comparable health insurance coverage after changing employment. (2) the other component, referred to as the Administrative Simplification Section, is designed to ensure and adequate, consistent national standard for controlling the flow of sensitive patient information, particularly through electronic media. Its goal is to protect the security and privacy of health data.

Approvable Letter

An FDA response to an NDA that lists minor issues to be resolved before marketing approval can be granted

ADME

An acronym for absorption, distribution, metabolism and excretion. Tests performed to assess the impact of a drug on the human body (sometimes referred to as pharmacokinetics) The ideal product will be rapidly absorbed. Distributed to the target organ, broken down (metabolized) efficiently without generating any toxic substances, and excreted effectively from the body without harming the kidneys or other organs

Peroxidase

An enzyme that catalyzes the oxidation of substances in the presence of hydrogen peroxide

Anaphylaxis

An extreme sensitivity and reaction to a foreign substance, including medications

AMCP (Academy of Managed Care Pharmacy)

An organization for pharmacy directors. It is the national professional society dedicated to pharmaceutical care in managed healthcare environments

Adverse Event

An unanticipated event that involves risk to the subject and that results in harm to the subject or others

Adverse Effect

An unwanted effect a medication may have on a person

Adverse Drug Reaction

An unwanted, negative consequence sometimes associated with the use of drug therapy. It is a more precise term than "side effect," as some side effects may be therapeutically useful.

Ace Inhibitors

Angiotensin-converting enzyme inhibitors. A class of drugs used to treat cardiovascular conditions such as hypertension and chronic heart failure

Amino Acid

Building block of peptides/proteins

Isomer Drugs

Compounds with the same molecular formula that differ in structure (linkages between atoms) or configuration (spatial arrangement of the atoms). An isomer version of an existing product may reduce side effects or have some other beneficial characteristics. Because isomers can be patented separately, they allow pharmaceutical companies with "aging" products to obtain a new period of patent protection

Recombinant DNA

DNA that has been cut and spliced in order to alter the genetic code (introduce a gene(s) tht codes for a protein not normally found in the organism)

Percutaneous

Defined as "through the skin"

Toxicology

Division of medical and biological science concerned with the study of the harmful effects of various substances, including drugs

Effective Dose

Drug dose that causes a defined magnitude of response in a given subject. ED50 is the median dose that causes 50% of maximal response

Orphan Drugs

Drugs for rare diseases and conditions affecting fewer than 200,000 people or a drug that is to be administered to fewer than 200,000 U.S. patients in any given year in the U.S. To encourage development of treatments for these small markets, Congress passed the Orphan Drug Act of 1983, which grants tax credits and seven years of marketing exclusivity to the pharmaceutical companies that create them

Distribution

During pharmaceutical development the delivery of the drug to target areas of the body following absorption. On the commercial side, it involves the movement of market-ready drugs from manufacturing sites to sites of consumer purchase or use. Wholesalers play a prominent role in this process

Wholesalers

Entities that purchase drugs from pharmaceutical companies and then resell and deliver them to pharmacies. Pharmaceutical companies often collaborate with wholesalers to monitor demand and ensure product availability in the marketplace.

Utilization Review

Evaluation by a health plan or healthcare institution of the cost efficacy of care decisions by a group of physicians, DUR, or drug utilization review, is a subcategory of evaluation of resource use

Indication

FDA approved condition for which a medication may be marketed

Indicated

FDA approved for diagnosis or treatment of a symptom, risk factor, condition or disease

Stark I and II

Federal laws whose combined effect is to prohibit any physician from referring Medicare and Medicaid patients to entities in which the physician or an immediate family member of the physician has an ownership interest or with which the physician or family member has some type of compensation arrangement. It is referred to as a law against self-referral; it applies more broadly to other arrangements in which a physician is financially rewarded for generating service or product sales. I limited the prohibition to clinical laboratories. __ II extended the prohibition to other "designated health services" including outpatient prescription drugs. This law has a number of safe harbor exceptions, which include (1) receipt by a physician of items of negotiable value (2) fair market value compensation for services actually rendered by the physicians (3) discounts on drug prices, as long as the same discount is offered to other similarly situated patients

Medicare

Federally funded health insurance for persons age 65 or older, as well as younger persons with certain disabling conditions, such as end-stage renal disease. It includes both Part A (free hospital insurance) and Part B (optional medical insurance for which beneficiaries must pay a monthly premium, which provides coverage for physician services provided outside the hospital, durable medical equipment, and selective other therapies.

Red Book

Formally the Drug Topics Red Book. An annual reference work containing pricing information for prescription and over-the-counter products. NDC numbers for FDA approved drugs, and Orange Book codes reflecting FDA evaluations of therapeutic equivalence

Medical Science Liaisons (MSLs)

Healthcare professionals (often with Medical Affairs) in a pharmaceutical company who work closely with key opinion leaders in the relevant therapeutic area to share preliminary findings from ongoing clinical trials, information about planned phase 4 studies, ad data on off-label drug use with interested prescribers, as allowed under guidelines set forth by the FDA. To avoid any taint of sales bias in presenting such product information, Medical Affairs does not report to Sales. They are resources to who prescribers turn with clinical and scientific questions

Inpatient Care

Healthcare provided in institutional settings to patients staying for at least 24 hours. Hospitals, skilled nursing facilities, and hospices all provide inpatient services

Community Hospital

Hospitals, usually unaffiliated with an academic institution or teaching facility, offering medical and surgical care and sometimes even highly specialized services (e.g. a cardiac unit or radiation oncology) to the local population

Dosage

How much and how frequent to take a medication

Primary Care

In health systems that use primary care physicians

Acute

In terms of diseases or conditions, abrupt onset and short-term (as opposed to chronic)

Tolerance

Increase in body's resistance to the effects of a drug, leading to the need for higher doses to produce the same benefits

Esophagitis

Inflammation of the esophagus

Parenteral

Injection

Gene Therapy

Insertion of normal or genetically altered genes into cells to treat genetic disorders and chronic diseases. Also known as gene delivery

Medicare Part A

Known as the hospital insurance component of Medicare. Part A pays for inpatient hospital stays, (relatively brief) care in skilled nursing facilities, some home healthcare, and hospice care.

Medicare Part B

Known as the medical insurance component of Medicare. This helps pay for physician services provided outside hospitals (and for drugs administered as part of those services), lab and radiology services, ambulance service, outpatient hospital care, durable medical equipment, some other medical services that Part A does not cover, such as physical and occupational therapy and limited home healthcare. Traditionally this coverage has been limited to a small number of products (typically very expensive products). Reimbursed pharmaceuticals and biologics included blood transfusions, immunosuppressive drugs, (for transplant patients), and oral anti-cancer drugs. A broader drug benefit has now been established, This coverage in not free and therefore, some people opt not to carry this coverage

Medical Devices

Like drugs, these are used in diagnosis, treatment, or prevention of diseases or conditions - or to affect the structure or function of the body. Unlike drugs, they produce their principal benefit in some way other than chemical action in or on the body. The many varieties include laser systems for vision correction, x-ray machines, crutches and wheelchairs, and materials used or inserted during surgery such as pacemakers and stents. In the pharmaceutical context, equipment used to administer drugs such as inhalers for asthma products and epinephrine auto injectors for severe allergic reactions are medical devices

Pathogen

Literally, "disease producer". Most frequently used in reference to infectious agents, such as bacteria, viruses, and fungi

Myeloma Cells

Malignant tumor cells

Therapeutic Index

Measure used to determine the safety of a medication. It is a ratio which compares the dose which produces toxicity, to the dose which produces the desired therapeutic effects

Steroid

Member of a large family of structurally similar lipid substances, but different classed have different functions. For instance, all the natural sex hormones are these. Anabolic _____ increase muscle mass, while anti-inflammatory _____ (also known as corticosteroids) can reduce swelling, pain and other manifestations of inflammation

MCG

Microgram (0.001 mg of 1/1,000 mg)

MG

Milligram (0.001 gram or 1/1,000 gram)

ML

Milliliters (0.001 liter or 1/1,000 liter)

Oligonucleotide

Molecule containing up to 20 nucleotides joined by phosphodiester bonds. Above this length, the term "polynucleotide" is used

Medicare Part D - Prescription Drug Benefit

New prescription drug benefits covered under the Medicare Prescription Drug Improvement and Modernization Act. This drug benefit, which goes into effect in January 2006, will be provided by private health plans and is a voluntary program for Medicare beneficiaries (except for dual-eligible individuals). All Medicare beneficiaries may obtain prescription drug coverage by either remaining in the traditional Medicare fee-for-service program and adding stand-alone prescription drug benefit provided by a PBM or MCO or selecting one of several alternative programs provided through private insurers, PPOs, HMOs, or PBMs. Beneficiary deductibles and co-pays will differ by federal poverty level.

Analgesic

Pain relief

Prescribers

Physicians and, depending upon state regulations, nurse practitioners, pharmacists, and physician assistants who have the legal authority to write a prescription drug

PCPs (Primary Care Physicians)

Physicians whom patients see for routine checkups and general healthcare needs, in contrast to specialists. A term that may encompass pediatricians, family and general practitioners, OB/GYN's and internists

Disease Management

Programs to diagnose, educate, and/or provide ongoing health status supervision to people with diseases or conditions (usually chronic ones) in order to prevent exacerbation of their health problems and unnecessary consumptions of healthcare resources - in other words, for the purpose of controlling costs and maintaining health. These programs are sometimes referred to as health management programs. Initiatives to enhance compliance with the recommended treatment regimen are a common form of this type of program

Diffusion

Redistribution of molecules and compounds to reach equilibrium

A.C.

Referring to medication dosage, means "before meals"

AD.LIB.

Referring to medication dosage, means "freely"

A.A.

Referring to medication dosage, means "of each"

GT/GTT

Refers to medication dosage, means "drops"

G/GM

Refers to medication dosage, means "gram"

Clinical Trial

Research study conducted with patients, usually to evaluate a new treatment or drug. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease

Bacillus

Rod-shaped bacteria

Ride Along

Sales calls (particularly office visits) in which a junior sales representative is accompanied by a sales manager or more senior sales representative. Their purpose is to train and evaluate the performance of the less experienced sales representative

DNA

Short for deoxyribonucleic acid, a molecule that encodes operating instructions for our bodies

Additions

Situations where two or more medication are used together and the clinical effect is equal to the sum of their individual effects

Outpatient

Someone receiving medical or surgical care that does not require an overnight stay in the treatment facility. It may be provided in a variety of venues, including a physician office, a clinic, or a hospital

Avidity

Strength of binding, especially the binding of an antibody to an antigen

Oncology

Study and treatment of cancer

Ancillary Care

Supplemental health services tht facilitate diagnosis and treatment, including lab work and x-rays

Central Nervous System

System of tissue that include the spinal cord and brain

Label

The FDA approved information about a medication. Includes all the necessary information a medical doctor needs to correctly and safely use a medication

Fair Balance

The FDA requirements that drug advertisements and promotions equivalently apprise consumers of positive and negative aspects of medication. For instance, if they extol a drug efficacy, he advertisements must also provide prominent coverage of side effects and contradictions

Action Letter

The FDA's official response to an NDA (also known as an NDA action). The message may be an approval letter, approvable letter, or a non-approval letter

Prescribing Information

The FDA-approved information about a medication. Includes all the necessary information a medical doctor needs to correctly and safely use a medication, based on the manufacturer's guidelines. Also known as Product Circular, Package Insert, and Product label

Package Insert

The FDA-approved information about a medication. Includes all the necessary information a medical doctor needs to correctly and safely use a medication, based on the manufacturer's guidelines. Also known s Product Circular, Prescribing Information and Product Label

Selectivity

The ability of a therapeutic dose of a drug to affect its intended target without affecting other parts of the body. It is generally desirable in a drug. E.g. it is desirable that an antibacterial agent kill bacteria without harming host cells. In a realm of diagnostic testing, it represents the ability to avoid "false negatives" - the failure to identify persons with a disease as having that disease

Toxicity

The degree to which a drug or other substances is poisonous to an animal or person. Also, the actual occurrence of adverse events in people taking the drug. The acceptable level of this will vary depending on the condition for which a drug is used

Compliance

The extent to which a patient follows the regimen ordered by his/her physician during a designated time frame (e.g. the observation period of study) Along with persistence, compliance is a component of adherence

Cell

The fundamental self-contained unit of life. IN complex organisms, such as humans, cells are the building blocks of different organs and tissues each charged with particular specialized tasks. Each human cell (except for blood cells) homes the entire genome - all the genetic information necessary to create a human being

OIG (Office of the Inspector General)

The group within a U.S. regulatory agency responsible for ensuring the integrity of programs administered by that agency. The ___ of greatest interest to the pharmaceutical industry is HHS. It combines its enforcement role with an advisory one: among other things the HHS has issued guidance on compliance with FDA rules about product promotion to physicians

Gene Mapping

The identification of the locations of genes on a chromosome - and the distance between various genes for the purpose of understanding the importance of genes in disease and illness

Gene Delivery

The insertion of genes into selected body cells for such uses as: triggering production of therapeutic agents, enhancing susceptibility to a therapeutic agent that has previously been ineffective, reducing susceptibility of healthy cells to a therapeutic agent, and countering the effects of abnormal genes by inserting normal ones

Minimum Effective Dose

The lowest amount of a medication that is able to produce an appreciable effect

Titration

The manipulation of the dose of a medication based on the response by a patient, until the desired effect is achieved. A medication by ____ up or down, based on the clinical response by the patient

First Pass Effect

The metabolism of an oral medication by the liver before it reaches the body's systemic circulation

American Pharmaceutical Association (APhA)

The national professional society of pharmacists, founded in 1852, it was the first and is still the largest professional association of pharmacists in the United States. The members include practicing pharmacists, pharmaceutical scientists, pharmacy students, and pharmacy technicians

pH

The negative logarithm of H30+ ion concentration. The scale ranges from 1 to 14; less than 7 is acidic and more than 7 is basic

Pathology

The practice of medicine dealing with the causes and nature of disease and/pr death

Absorption

The process in which a medication is absorbed into the bloodstream

Coding Systems

The process of assigning formal, standardized medical codes to patient medical records. When a patient goes into a clinic or hospital a medical record is created. This medical recod will include patient identifying and demographic information. IT will also include a description of the chieft complaint, any procedures that were performed, medications prescribed, a diagnosis, and follow-up instructions. The diagnostic and procedural information contained in the patient medical record must be converted into simplified numerical codes by trained medical coders. These numerical codes allow complex medical procedures and diagnoses to be recognized quickly and easily by health care computer systems where they can be electronically processed for payment by third party payers

Adherence

The proper use of a medication be a patient. Involves taking the medication on the correct schedule outlines by a physician, and using the proper technique

Absorption Rate

The rate at which a drug is taken into a person's blood stream within a specified time period. These rates can very from person to person, creating the challenge of refining a drug so that it is effective on people with slow rates but not toxic to people with fast rates

Medicine

The science of diagnosing, treating, or preventing disease and other damage to the body or mind. The term is also used to refer to any substances used to treat or prevent disease or other damage to the body or mind

Discovery

The search for molecules or compounds that can produce a therapeutic result. Chemical compounds (biologics or synthetics) are investigated in a laboratory setting. When promising candidates have been identified, this ends and pre-clinical research begins

Pharmacogenomics

The study of how an individual's genetic inheritance affects the body's response to drugs

Proteomics

The study of protein expression of normal and diseased cells and tissues

Pharmacokinetics

The study of the effects on a medication as it goes through the body. Includes absorption, distribution, excretion and metabolism.

Pharmacology

The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues and organisms. Clinical pharmacology is the study of drugs in man and it is an integral part of pharmacology

Antigen

The substance, usually protein based, that stimulates production of antibodies so as to meet the perceived threat

Formulation

The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms

Therapeutic

Treatment and healing of disease

FTC (Federal trade Commission)

U.S. regulatory agency charged with consumer protection and enforcement of antitrust laws. It regulates the advertising of OTC drugs, with a few exceptions, while the FDA regulates the advertising of prescription drugs. It's antitrust arm monitors the anti competitive impact of pharmaceutical company mergers, price-fixing efforts, and attempts to keep generic drugs off the market

Off-Label Drug Use

Use of a drug for a purpose (that is, an indication), in a dosage form, or dosage regimen, population, or other parameter other than those approved by the FDA as stated on the product label (package insert) Physicians are free to experiment with this type of use, but pharmaceutical companies cannot promote such uses to prescribers or consumers. The ways pharmaceutical companies can share information about this type of uses with physicians are sharply circumscribed by the FDA

Q.I.D.

Used when referring to medication dosage, means "4 times a day" ("quarter in die")

P.R.N

Used when referring to medication dosage, means "as needed". ("pro re nata")

Q.D.

Used when referring to medication dosage, means "once a day" ("quaque die")

SS

Used when referring to medication dosage, means "one-half" ("semis")

T.I.D.

Used when referring to medication dosage, means "three times a day" (abv. "ter in die")

B.I.D

Used when referring to medication dosage, means "twice a day"

S

Used when referring to medication dosage, means "without" ("sine")

P.C.

Used when referring to medication dosage. Means "after meals" (abbreviation for "post cibum")

B Cells

White blood cells that develop in the bone marrow and are the source of antibodies. Also known as lymphocytes

Epidemiology

a branch of medical science that deals with the incidence, distribution, and control of disease population

Saccharide

a carbohydrate

Glycoconjugate

a carbohydrate that is linked to a lipid or protein

Vector

a carrier

Glidants

a category of excipients commonly known as flow enhancers. They are added to the powders used in pill production to ease movement through the manufacturing equipment. Talc is one example

Metabolism

a chemical process of transformation

Reagent

a chemical substance to react in a specific manner that can therefore be used to detect or produce another substance. Reagents are sometimes used to manufacture a drug substance.

Lupus Erythematosus

a chronic inflammatory disease of connective tissue, affecting the skin and internal organs

Protein

a class of fairly common molecules in the human body that includes antibodies, hormones and enzymes

COX - 2 (cyclooxygenase - 2) Inhibitors

a class of non-steroidal anti-inflammatory drug, which works by blocking COX-2, an enzyme who activity contributes to inflammation

Therapeutic Area

a clinical discipline. It includes the basic internal medicine specialties (cardiology, gastroenterology, rheumatology, and nephrology, for example), as well as such other disciplines as psychiatric, neurology, oncology, infectious disease, and anesthesiology. Many pharmaceutical companies organize function with R&D by ___________. Sales figures for pharmaceutical products by this provide pharmaceutical marketers with a useful index of the commercial market

Cell Line

a collection of cells that will proliferate indefinitely when provided with appropriate space to grow and fresh medium to feed on

Plasmid

a cytoplasmic DNA that is capable of autonomous replication

Sustained release

a delivery mechanism that dispenses a drug in the body gradually, ensuring a steady level in the blood and relatively long-term effect. Sustained release products can be administered less frequently than those that are metabolized more quickly. Sometime referred to as extended release

Potency

a descriptive term which is relative to the amount of medication required to achieve an effect. For example, the more ___ a medication is, the less amount of actual medication is required to achieve the desired effect

Non preferred drug

a disfavored alternative to a preferred drug which may not be on the payer formulary at all. It usually carries a high copayment to discourage use and may also involve restrictions such as a prior authorization requirement

Compound (Chemical Compound)

a distinct substance formed by chemical union of two or more ingredients in definite proportion to weight. In the pharmaceutical context, it is not, properly speaking, a medicine or drug until clinical (human) trials have begun

National Center for Health Statistics (NCHS)

a division of the U.S. Department of Health and Human Services and one of the Center for Disease Control and Prevention (CDC) The principal source of health statistics for the nation, this gathers data on illness and disability, as well as one the use and availability of health services

Validated Target

a drug target (typically a protein) that has been proven to have an effect on human health. Therefore, interventions affecting that target have therapeutic potential

Immunosuppressant

a drug that suppresses the natural functioning of the immune system, used mainly to reduce the chance of rejection of a transplanted organ

Genetic Engineering

a form of biotechnology in which genetic material is manipulated to produce desired characteristics. It is also known as recombinant DNA technology. It has been used to manufacture such drugs as insulin, interferon, and growth hormones

Amyloid

a glycoprotein that is deposited extracellularly in tissues

Managed care

a largely but not exclusively private health insurance sector mase up of MCOs, which emphasize controls to ensure cost-effective care. Typicallly, a central administrator is paid a fixed amount of money per member per month and is at risk for losses if the actual cost exceeds that payment. That administrator uses a variety of devices to discourage healthcare providers (physicians and hospitals) from using unnecessarily costly therapeutic products and services)

Ischemia

a low supply of oxygen due to low blood flow

FDA Modernization Act of 1997 (FDAMA)

a lwa that made sweeping changes to the Federal Food, Drug and Cosmetic Act of 1938. This was designed to streamline clinical research and make it easier to test and market new drugs. Among other things, it established a fast-track process for high-priority drugs to treat life-threatening conditions, expanded patient access to investigational drugs, and instituted an extra exclusivity period for products tested in periatric populations

Entropy

a measure of disorder

Bioavailability

a measure of the rate and extent of medication absorption

Nucleic Acid

a molecule composed of nucleotides joined together

Polypeptide

a molecule consisting of many joined amino acids, but not as complex asa protein

Peptide

a molecule containing a number of amino acids linked together

Binding Ligand

a molecule that attached specifically to an active biological molecule or receptor by chemical bonds

Ligand

a molecule that binds another molecule

Average Wholesale Price (AWP)

a national average of list prices charges by wholesalers to pharmacists. Although it is supposed to reflect the sum of pharmacies pay wholesalers for the drugs they sell in reality it is often more like a "sticker price" - considerably higher than the actual price that larger purchasers (e.g. major retail pharmacy chains) normally pay

Medical Marketing Association

a non-profit organization whose membership consist of marketing professionals from pharmaceutical, medical device, and diagnostic industries

CDC (Center for Disease Control and Prevention)

a part of the U.S. Department of Health and Human Services, recognized as the lead federal agency for protecting the health and safety of Americans at home and abroad through programs addressing disease prevention and control, environmental health, and health education

Intern

a physician in training in the first year after graduating from medical school

General Practitioner (GP)

a physician who attends to a variety of medical problems in patients of all ages, rather than focusing on a narrow specialty. Have not completed a family practice residency

Hospitalist

a physician who oversees the care of patients when they are in the hospital. This practitioner will keep the patient's PCP apprised of progress and return the patient to the PCP'S supervision at discharge. PCP's avoid the inconvenience of visiting the hospital to check on just one or a few patients. The person is often employed by the hospital, as a means of encouraging PCP's to admit patients to their institution

Internist

a physician who practices internal medicines

Family practitioner (FP)

a physician who provides comprehensive health care to people regardless of age or sex, placing emphasis on the family unit. Similar to a general practitioner by these usually have completed a family practice residency

Intensivist

a physician who specializes in oversight of patterns admitted to hospital ICUs. A variant on a hospitalist

Specialist

a physician with advanced training in a highly specific area of medicine, such as a cardiologist or oncologist. In some health plans, specialists cannot be seen without a referral from a gatekeeper physician, such as a general or family practitioner or internist

Metabolite

a product of metabolism

Enzyme

a protein synthesized by the body

Prostaglandins

a protein that has many function, including medication of the inflammatory process

Limus Amebocyte Lysate

a reagent for determining the quantity of bacterial endotoxins. It is obtained from the aqueous extracts of circulating amebocytes of the horseshow crab

Dose-response Curve

a representation of the clinical effect of a medication versus the dose given

ICU (Intensive care unit)

a set of hospital rooms equipped with specialized equipment, typically used for patients whose condition is unstable and requires close monitoring. Specialized forms include the NICU (neonatal intensive care unit), SICU (surgical intensive care unit), and CCU (cardiac care unit)

Potentiation

a situation where adding medications together achieves a better clinical effect than the sum of their effects individually. See also synergism

Summation

a situation where two or more medications are used together, and the clinical effect is equal to the sum of their individual effects.

Target

a specific protein or enzyme upon which a drug acts

Liposome

a spherical vesicle formed by a lipid enclosing an aqueous part

Pyrogen

a substance of agent that causes fever

Cytochrome

a substance that contains iron and acts as a hydrogen carrier for the eventual release of energy in aerobic respiration

Large Molecule

a synonym for biologic compounds, which typically consists of large proteins. Because of their size, these must often be injected rather than administered orally in a pill or a capsule

Therapeutic Category

a system of grouping drugs by common therapeutic indication. Generally speaking, a less-broad grouping than therapeutic area. Hundreds of different categorization systems exist. One example, the American Hospital Formulary System, assigns a 6-digit classification code that combines category, class and subclass

Condition

a term used synonymously with disease

Small Molecule

a term used to refer to drugs that are non-biologic (that is, chemical) in nature

Assay

a test or trial

Diagnostic

a test which indicated the presence of disease

Prognostic

a test which provides predictive information as to the future course and outcome of a disease

Lead

a treatment idea that has shown enough promise to warrant being followed up some more

White Blood Cell

a type of blood cell that helps the body fight infection and disease. These cells originate in the bone marrow and then travel to other parts of the body. Also known as a leukocyte

Bacteriophage

a type of virus that destroys bacteria; also called phage

Dalton

a unit of measure equal to the mass of a hydrogen atom

Pandemic

a worldwide epidemic

Myelodysplasia

abnormal or defective formation of the bone marrow

Instillation

administering a medication into a body orifice

Peak Drug Concentration

after one dose, the maximum concentration of a medication in the blood

Non-approvable Letter

an FDA response to an NDA listing major deficiencies that will preclude approval if not corrected

Prophylactic

an agent that is used to prevent the development of a disease or condition

Dialysis

an artificial removal of waste products from the body. It can involve "cleansing" of either the blood (hemodialysis) or the digestive tract (peritoneal dialysis)

GPO (Group Purchasing organization)

an entity consisting of two or more member hospitals, clinics, or other healthcare entities that band together to obtain favorable purchasing terms for supplies including pharmaceuticals, biologics, and medical-surgical equipment. When members make purchases from suppliers with which the entity has contracts, they do so at reduced prices

Ligase

an enzyme involved in DNA replication

Protease

an enzyme that acts on proteins

Kinase

an enzyme that catalyzes the transfer of a phosphate group

Restriction Enzyme

an enzyme that cuts DNA into short segments

Cyclase

an enzyme that forms a cyclic compound

Hepatitis

an inflammation of the liver

Loading Dose

an initial dose of a medication that will provide the necessary plasma concentration levels for therapeutic benefit

PAI (Pre-approval Inspection)

an inspection by the FDA of a manufacturing site to verify data submitted in support of an NDA or ANDA and assess compliance with current good manufacturing practices (cGMP). The program covers domestic and foreign manufacturers of both finished dosage form products and APIs

Antagonism

an interaction where one medication may reduce the effects of another medication

Amide

an organic compound containing an (O-C-N) group

DIA ( Drug Information Association)

an organization in which healthcare professionals exchange information on the discovery, development, evaluation and utilization of drugs. The DIA is noted for the educational programs it provides healthcare professionals

Stem Cell

an undifferentiated cell with the potential to become any type of specialized cell, Most embryo cells are these. They might provide an unlimited source of health adult cells, such as bone, muscle, liver or blood to treat people with various diseases. That are already used as therapies for blood disorders and some forms of cancer

Side Effect

an unwanted effect a medication may have on a person

Beta Blocker

are a class of drugs used for various indications, but particularly for the management of cardiac arrhythmias and cardio protection. While once first-line treatment for hypertension, their role was downgraded as they did not perform as well as other drugs. There is also increasing evidence that the most frequently used ones, especially in combination with thiazide type diuretics carry an unacceptable risk of provoking type 2 diabetes

Subcutaneous

beneath the outer skin

Intercellular

between cells

Switching

changing over from a previously utilized drug to a new one for the same condition, risk factor or disease

Institutional review Boards (IRB's)

committees of patient advocate, healthcare professionals, and laypersons such as clergy who serve as "watchdogs" to protect the rights and welfare of people participating in clinical trials. They make certain that proposed trials include such safeguards as informed consent to testing and protection of patient privacy. It decides whether a study can begin, oversee its progress, and has the power to stop a study if it seems necessary

Speaker Programs

conferences and meetings at which experts discuss topics of clinical or practical interest to pharmaceutical company cutomers. The pharmaceutical company may sponsor the conference or meeting as a promotional device to enhance relationships with the relevant customers (usually physicians and their office staff)

Generics

copies of drugs for which the patents have expired

Half-life

defined as the time required for ½ of the concentration of a medication to be eliminated from the body

Blood-Brain Barrier

defines the barrier of cells that surround the blood vessels which serve the central nervous system

Therapeutic Concentration

defines the necessary concentration of a medication in blood or tissue to achieve the desired effect

Single Nucleotide Polymorphism

difference at one nucleotide in a DNA sequence among individuals

Deciling

dividing a group of physicians and other potential prescribers for a certain category of drugs into ten segments based on anticipated prescription volume. The highest volume physicians are in decile 10 ( a variant, quintiling, divides physicians into 5 segments) This allows pharmaceutical companies to place a value on sales calls to each decile, decide which deciles merit in-person detailing, and determine how many sales representatives are required to support the resultant call plan

Validation

documentary proof offered by a drug manufacturer to the FDA that its manufacturing processes will produce the same drug batch to batch and year to year

Controlled Substances

drugs classified under the Controlled Substances Act of 1970 as having significant potential for addiction/abuse. There are 5 controlled-substance categories, known as schedules. Schedule 1 drugs, the most tightly controlled, have high potential for abuse and no recognized medical use. Heroin is one example. The DEA enforces controls on such drugs

Biopharmaceuticals

drugs derived from biological sources

Therapeutic Class

drugs that share both an indication and a method of operation. For instance, ACE (angiotensin-converting enzyme) inhibitors are a class of drugs that treat high blood pressure by inhibiting a particular enzyme. This is a narrower grouping than therapeutic category. This and drug class are synonymous.

Online Adjudication

electronic validation of a drug benefit claim at the location where a prescription is dispensed, for example, the pharmacy. The purpose is to determine potential coverage problems before the drug is dispensed to the patient

Suppression

elimination or prevention of manifestations (signs or symptoms) of a disease. Suppression treatment may be necessary over the entire lifetime of a person with a chronic disease. In the context of organ transplants, this involves the use of drugs to avert an immune response by the body to the foreign tissue

Preferred Drug

favorable formulary status that health plans usually accord to drugs for which they have negotiated a rebate contract. The favorable status usually translated into a lower copayment than for alternative products

Plasma

fluid portion of the blood

Tertiary Care

highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center, usually serving a region or state having highly sophisticated technology and support facilities

Dose

how much of a medication is given to a patient at a time

Expression

information from a gene is transcribed and translated, which results in the production of a protein

Hydrophobic

insoluble in water

Patient Advocacy Groups

interest groups for certain diseases (e.g. National Breast Cancer Coalition) or consumer segments (e.g. AARP for older Americans) that lobby for healthcare reform, additional research funding, and/or more generous insurance coverage. These advocacy groups are an increasingly powerful force in healthcare

Renal

kidneys (pertaining to)

LOG P

logarithmic function of the partition coefficient

Virus

minute infectious agents (much smaller than bacteria). These, which can replicate only within living host cells, cause many types of illness

Mycoplasma

minute primitive bacteria without a rigid cell wall. _______ pneumonia causes atypical pneumonia in humans

Delivery Mechanism

often used interchangeably with route of administration, but more specifically refers to the method through which a drug is delivered to the intended organ or receptor site within the body. For example, a drug may be delivered via subcutaneous injection ( the route of administration) in formulation that facilitates a controlled release of the active ingredient over time (the delivery mechanism)

Secondary Care

outpatient services from specialists and hospital care, both inpatient and outpatient. In non-emergency situations, access often requires a referral from PCP

Ex Vivo

outside a living body

Ethical Drugs

patented prescription drugs

PAR (Post-approval Research)

phase 4 studies conducted on a drug after it has won FDA marketing approval for the indication being studied. See post-market expansion studies.

Clinical Investigators

professionals (usually physicians) charged with overseeing the administration of an experimental compound in clinical trials. Also referred to simply as investigators. The one is charge at a site is known as the principal investigator

Plasma protein

protein found in the blood plasma. The plasma protein often binds to medications

Hormone

proteins that are chemical messengers in the body

Re-stenosis

recurrent stenosis, a condition where the blood vessel or heart valve is narrowed

H.S.

refers to medication dosage, means "at bedtime"

H

refers to medication dosage, means "hour"

Hepatic

relating to the liver

Tissue

section of an organ that consists of a largely homogenous population of cell types

Rx

shorthand for prescription. It may be derived from the Latin word for "recipes"

Tx

shorthand for treatment

Analogue

similar in chemical and physical structure

Bacteria

single-cell organisms that can sometimes cause infections, such as strep throat and bacterial pneumonia

Hydrophilic

soluble in water

Preclinical Studies

studies in which a drug is tested in vitro and on animals. Safety information from animal studies are used to support a drug application

Symptoms

subjective sensations related to a disease or condition. They are indicators that the diagnostician learns about only through patient self-report, By contrast, signs are manifestations that can be seen by the diagnostician and/or objectively measured

In Vivo

taking place in a living body

Lifestyle Drugs

term used for drugs that enhance quality of life, but are not considered medically necessary. Erectile dysfunction, skin care, and hair replacement therapies are key examples

LDL (Low Density Lipoprotein) Cholesterol

the "bad" cholesterol that is carried into the blood and is the main cause of harmful fatty buildup in the arteries. High levels increase the risk of heart disease

Circular

the FDA- approval information about a medication. Includes all the necessary information a medical doctor needs to correctly and safely use a medication. This is usually based on the manufacturer's guidelines. Synonymous with Prescribing Information and Product Label

Teratogenicity

the ability to cause abnormal development or malformation of the fetus

PharmD - Doctor of Pharmacy degree

the advanced degree for pharmacists. It requires 4 years of professional study, following a minimum of two years of pre-pharmacy study, for a total of six academic years following high school

CBER (Center for Biologics Evaluation and Research)

the arm of the FDA concerned with regulation of most biologic products. The mission stated on its Web page is "to protect and enhance the public health through regulation of biologic products including blood, vaccines, therapeutics, and relaxed drugs and devices, according to statutory authorities."

Systemic Circulation

the bloodstream

DO (Doctor of Osteopathy)

the degree earned by physicians who attend a college of osteopathic medicine. Physicians who graduate from medical school, by contrast, earn an MD. Colleges of osteopathic medicine emphasize a holistic approach to health, focusing on the role of the musculoskeletal system in illness

Efficacy

the degree to which a medication produces a therapeutic effect

Systemic Effects

the effects a medication may have on the body

Excretion

the elimination of a drug from the body, typically through urine or feces. It is one of the principal means by which the concentration of a drug in tissues is reduced and drug action is therefore ended

Phagocytosis

the engulfment of a particle or a microorganism by leukocytes

Genome

the entire DNA of a cell

National Institutes of Health (NIH)

the federally funded medical research organization based in Bethesda, MD. It spends billions of dollars each year on research to enhance understanding or disease. The information it has produced regarding mechanisms of disease has contributed to drug discovery efforts by pharmaceutical companies

Medicaid

the health insurance program for the poor and disabled administered by each state and funded by money from the state and federal government. In contrast Medicare, which is insurance for persons age 65 or older and certain disabled persons; Medicaid is for people under 65 who are below the poverty level and therefore cannot afford private health insurance. Medicaid plans very from state to state, although the federal government mandates that each program include certain basic elements. Medicaid plans include broad-based outpatient drug benefits

Placebo

the inactive control used in clinical research studies. May also be called a "sugar pill"

Excipients

the inert substances that are part of almost every drug formulation, in contrast to the active ingredient. They include coloring, flavors and preservatives. Their purposes include enhancing or maintain the stability, bioavailability, tolerability, or recognizability of the product

Launch

the initial entry of a drug into the marketplace - or the entry of an established drug into a new market for which the manufacturer has received an additional indication

Formulary

the list of drugs that a managed care organization or hospital favors for use by its enrollees (or that a hospital has approved for use on patients) Use of drugs not on the MCO formulary may be forbidden outright or discouraged through high copayment requirements. Most encourage use of lower-cost generic drugs and less expensive drugs and select one from a range of similar branded ("me too") drugs. There are two basic types - open and closed.

Diastolic Pressure

the lower reading obtained when blood pressure is measured. The diastole is the period when the heart chambers are relaxing and refilling with blood

Maximum Effect Dose

the lowest dose of medication that will provide the maximum therapeutic benefit

Pharmaceutical research and Manufacturers of America (PhRMA)

the main trade and lobbying group for drug makers in the U.S., whose stated mission is "to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical/biotechnology research companies." Its members include the country's leading research-based pharmaceutical and biotechnology companies. IT works to establish industry codes or conduct in such areas as in interactions with potential prescribers

Alignment

the manner in which client responsibilities are allocated among sales representatives in a pharmaceutical company e.g. by therapeutical area and/or geography, as well as by sales potential of a given assignment

Pathogenesis

the mechanism and cellular event leading to the development of a disease

Clinical Hold

the mechanism that the FDA uses when it is concerned that a study may pose an unreasonable risk to subjects. CDER may either delay the start of an early-phase trial on the basis of information in the IND, or stop an ongoing study. The sponsor must address the problems triggering the hold before the order will be lifted

Mechanism of Action

the method in which a medication produces its therapeutic effects

Cytometry

the method of counting cells using a cytometer

Genes

the microscopic packets that carry DNA, through which characteristics are passed from one generation to another. Many gene-based tests exist to determine whether a person has a gene mutation associated with a particular disease. Each gene is a segment of double-stranded DNA that holds the recipe for making a specific molecule, usually a protein, and controls the processes related to expression of that protein

HMOs (Health Maintenance Organizations)

the most restrictive form of MCOs, which strives to control healthcare and pharmacy costs by placing sharp limits on the network of covered providers and on utilization of services and products, including drugs. There are two basic models: (1) closed model - most or all participating physicians are housed in an HMO owned facility, which typically has an on-site pharmacy. This centralization increases opportunities to manage utilization. Variants included the staff-model HMO and the group-model HMO. (2) Independent Practice Association (IPA) Model-Independent physicians who have formed a loose affiliation for contracting purposes contract to see HMO patients as part of their private practices. Because IPA's are less cohesive than group practices and work in geographically dispersed offices, opportunities to control utilization through them are more limited than in the closed models

Etiology

the origin, or cause, of a disease or a patient's symptoms. When the origin is unknown, the disease is called idiopathic

Hemoglobin

the oxygen-carrying pigment of red blood cells. Tests for concentration of this and for abnormal types identify anemia and other blood diseases

API (active pharmaceutical ingredient)

the part of a drug formulation that is responsible for achieving a therapeutic effect. Also known as the drug substance or the active ingredient

Contradiction

the possible risk a medication may provide for patients with certain conditions. The risks involved with this particular condition may outweigh the benefits of the medication

AAHP (American Association of Health Plans)

the primary U.S. association of health plans, which includes health maintenance organizations (HMOs), preferred provider organizations (PPOs), other forms of managed care, and utilization review organizations (UROs)

Transcription

the process of transfer of genetic information form DNA to RNA

Open Formulary

the provision of reimbursement for drugs that are not on an MCO or PBM formulary (list of preferred products). While the payer favors use of formulary drugs, it will offer coverage for non-formulary products as well, but will usually require a higher copayment

Clinical Effect

the response produced by a medication

Placebo effect

the responses seen in patients taking placebo in clinical research studies

Pharmacodynamics

the study of a medication's mechanism of action and the effects the medication has on the body

Genomics

the study of genes and gene function

Immunology

the study of the body's defense mechanisms against foreign materials that may cause disease or infection

Clinical Pharmacology

the study of the effects of medications in humans

Xenotransplantation

the transplantation of cells, tissues or organs from non-human animal sources into humans

CDER (Center for Drug Evaluation and Research)

the unit of the FDA with responsibility for oversight of all non-biologic drugs and selected biologics (including monoclonal antibodies, enzymes, growth factors, and proteins). It approves drugs for clinical trials, set drug manufacturing standards, approves drugs for U.S. marketing, reviews drug labeling and promotions, and monitors marketed drugs for unexpected or severe health risks

Biotechnology

the use of biological processes (that is, the manipulation of living organisms) to developing or manufacture such products as drugs (including vaccines)

Chemotherapy

the use of toxic drugs in the treatment of cancer

Drug delivery

the way in which a drug enters the body, such as orally, through an IV, by inhalation, or by injection. By contrast, dosage form is the physical nature of the drug administered (e.g. tablet, liquid, spray, injectable)

Stead-State Concentration

this term describes the situation when a drug level remain somewhat stable, because the rate of absorption equals the rate of elimination

Detail

this term is used to define a product discussion with a physician. Which could include discussion of scientific data concerning a product and/or presentation of information from the FDA-approved prescribing information

Onset of Action

time period following the administration of a medication, to noticing a therapeutic effect

Duration of Action

time period where the medication effects persist

National Association of Pharmaceutical Sales representatives

trade group for the pharmaceutical and biotech industry. They represent sales reps for those industries as they educate, train, create standards and provide current information for pharmaceutical sales professionals. They also provide accredited training for individuals who wish to enter a pharmaceutical sales career.

Therapeutic Equivalents

two drugs that are roughly interchangeable in safety and efficacy when used at roughly the same dose to treat the same health problems. In compiling the Orange Book, the FDA uses the term solely for drugs with the same active ingredients, not for drugs with different active ingredients that are used to treat the same condition

Q

used when referring to medication dosage, means "every: (abbreviation for "quaque")

Non repeat

used when referring to medication dosage; means "not to be repeated". (Abbreviation for "non repeater")

Elimination

via metabolism and excretion, the removal of medication from the body

Cross Tolerance

where the tolerance of one medication may result in increased tolerance of another medication

In Vitro

within a glass, in a test tube - an artificial environment

Intracellular

within cells