915 Exam 1 Definitions

Administering

- Rx directions are clear for how to take and how much to take

Monitoring and Reporting

- adverse effects / reactions should be observed and corrected, as well as made aware to physician

Ordering/Prescribing

- prescriber is typically at fault; pharmacist must interpret orders and confirm with prescriber

Dispensing and Delivering

- verify Rx is correct for all fields (strength, etc)

Transcribing and Verifying

- verify written amount is correct strength/dose/form

Propriety name

AKA "brand" name or trademarked name (ex: Flagyl) / name given to the product by the manufacturer that refers specifically to that manufacturer's product

API (active pharmaceutical ingredient)

API means any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body / does not include intermediates used in the synthesis of the substance

Medicaid Fee for Service

Medicaid pays doctors and healthcare professionals directly for each service they provide

Medicare C

Medicare Advantage - like Health Maintenance Organizations [HMOs] or Preferred Provider Organizations [PPOs])Medicare-approved private insurance companies provide all Part A and Part B services and may provide prescription drug coverage and other supplemental benefits

MAC - maxiumum allowable cost

PBMs calculate reimbursement for retail pharmacies in their network / sets one price for set of clinically identical products

Medicare D

Prescription drug benefit medicare - approved private insurance companies provide outpatient prescription drug coverage

Legend drug

Prescription drug: means any drug defined by the Federal Food, Drug, and Cosmetic Act, as amended, and under which definition its label is required to bear the statement "Caution: Federal law prohibits dispensing without prescription" / labelled as such as they require health practitioner supervision to be considered safe for use - due to drug toxicity, potential harmful effects, or method of use

USP

United States Pharmacopeia

Rebate

a discount that occurs after drugs are purchased from a pharmaceutical manufacturer and involves the manufacturer returning some of the purchase price to the purchaser. When drugs are purchased by a managed care organization, a rebate is based on volume, market share, and other factors.

Medication Quantity Limit

a limit on the amount of medication dispensed as a measure of utilization management to ensure appropriate medication use

Premium

amount paid for an insurance policy; pay every month and comes out of check by provider usually

Utilization Management

any number of measures used to ensure appropriate medication use / such measures may include quantity limits, prior authorization, step-therapy, or other strategies deemed appropriate by the health plan's P&T Committee

Prior Authorization

approval process to encourage proper use of medications / an administrative tool used by health plans or prescription benefit management companies (PBMs) that requires prescribers to receive pre-approval for certain drugs to qualify those drugs for coverage under the terms of the pharmacy benefit. Guidelines and administrative policies for prior authorization are developed by pharmacists and/or other qualified health professionals who are employed by or under contract with a health plan or PBM

NADAC - National Average Drug Acquisition Cost

based on retail price survey and focuses on the retail community pharmacy acquisition costs

AWP - Average Wholesale Price:

benchmark used for pricing and reimbursement of prescription drugs for both government and private payers; set prices

Phase 3

build on the experience gained during the Phase II trials / purpose is to further define the efficacy and safety of the agent, often in comparison to current therapy / usually multicenter studies that treat from several hundred to 3000 patients, and the study will usually last about 3 years (although an individual subjects' participation may be significantly shorter) / pivotal studies that serve as the basis for the NDA/BLA for marking approval

Suffix

defines the pharmacological class and mechanism of action

Orphan drug

drugs for rare illnesses that affect <200,000 people / sponsors can apply for "orphan drug status" that entitles them to development incentives (e.g. tax credits, waived prescription drug user fee), enhanced patent protection and marketing rights, and clinical research subsidies

non-proprietary name / International Nonproprietary Names (INN)

facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients; each INN is a unique name that is globally recognized and is public property / also known as a generic name (ex: metronidazole)

Phase I

first use of the agent in humans to determine the safety and toxicity of the agent / usually includes 20-80 subjects who receive the investigational product / last an average of 6 months to a year / assist in identifying the preferred route of administration and a safe dosage range / when possible, these trials are initiated in normal, healthy volunteers

Infix

further subclassification that indicates drugs are similar in chemical structure

Medicaid Managed Care

health care delivery system organized to manage cost, utilization, and quality. provides for the delivery of Medicaid health benefits and additional services through contracted arrangements between state Medicaid agencies and managed care organizations (MCOs) that accept a set per member per month (capitation) payment for these services

Specialty drug

high-cost, high touch prescription medications for patients with complex disease states used to treat complex, chronic conditions like cancer, rheumatoid arthritis, and MS (includes limited distribution drugs as defined by FDA, but could also be defined by the payor as needed to be dispensed by specialty pharmacy)

Medicare A

hospital insurance - Inpatient hospital, inpatient skilled nursing facility, hospice, and some home health services

Providers

include all the people and places (actors and institutions) who provide goods and services

Payors

include self-pay (out of pocket), commercial (private) insurance either self purchased or employer based, and government (public) insurance either through Medicare, Medicaid, or other like VA.

Managed Care Organization

integrated entities in the healthcare system, which endeavor to reduce healthcare expenditures costs; goal to provide appropriate, cost-effective medical treatment

Drug

intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals / (other than food) intended to affect the structure or any function of the body of man or other animals

Limited distribution drug

limited distribution through a select network of pharmacies / may be mandated by FDA REMS (risk evaluation and mitigation strategies) / generally used to treat complex or rare medical conditions

Formulary

list of prescription drugs covered by a prescription drug plan or another insurance plan offering prescription drug benefits; hospitals have these for cost-effective purposes

Teritary care

management of rare and complex disorders such as pituitary tumors and congenital malformations

FUL - federal upper limit

maximum reimbursement amount allowed for certain drugs; set by Feds

Medicare B

medical insurance - Physician services, outpatient care, Durable Medical Equipment (DME), lab and X-ray services, home health services, and many preventive services / diabetes and breathing treatments included

Medicaid

network of statewide programs the federal and state governments fund. Each state administers their own program, following broad federal guidelines, statutes, regulations, and policies Each state 1). Established eligibility standards, 2). Decides type, amount, duration, and scope of services

Non-prescription drug

over-the-counter drug or OTC drug: may be used without a prescriber's authorization, must have an acceptable safely margin and low potential for misuse or abuse, must be adequately labeled so that consumers can self-diagnose the condition, self-select the medication, and self-mange the condition

Copay

pay at the time of service; flat fee paid directly each time you go to the doctor or fill a prescription

Managed care pharmacy

practice of developing and applying evidence-based medication use strategies that enhance patient and population health outcomes while optimizing health care resources

Secondary care

problems that require more specialized clinical expertise such as hospital care for patients with acute renal failure

Primary care

refers to common health problems (sore throats, diabetes, hypertension, etc.), preventive measures (mammograms, vaccinations, other preventative services recommended by USPHS), and accounts for 80-90% of visits to a physician or other caregiver

Chemical name

scientific names based on the molecular structure of the drug (ex: 2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethanol

Patient

the buyer

Pharmaceutical care

the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life

Phase 2

trial in which the drug is used in a small number of subjects who suffer from the disease or condition that the drug is proposed to treat to evaluate the efficacy of the agent / data from the Phase I trial, in vitro testing, and animal testing may be used to identify which groups of patients is most likely to benefit from therapy / usually treat between 100 and 200 patients and will average about 2 years in duration

Prefix

unique to each drug; unrelated to the chemical structure or clinical pharmacology or a drug; main function is to differentiate a drug from other members of the drug class

Step Therapy

use of a product required before an alternative can be chosen / the practice of beginning drug therapy for a medical condition with the most cost-effective and safest drug, and "stepping up" to alternative agents only when the initial therapy fails. These programs apply coverage rules at the point of service when a claim is adjudicated. If a claim is submitted for a second-line drug and the step therapy rule was not met, the claim is rejected, and a message is transmitted to the pharmacy indicating that the patient should be treated with the first-line drug before coverage of the second-line drug can be authorized

WAC - Wholesale Acquisition Cost

what a drug manufacturer charges a drug wholesaler of if purchased directly by pharmacy

Biologic

wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. They can be composed of sugars, proteins or nucleic acids or complex combinations of these substances, or maybe living entities such as cells and tissues / isolated from a variety of natural sources. Approved through submission of BLA (vs NDA)