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What is DEA 222 used for?
Purchasing and returning of outdated CII drugs.
What does the blue copy of DEA 222 represent?
The purchaser keeps it for 2 years.
What does the green copy of DEA 222 represent?
The seller sends it to the local DEA.
What does the brown copy of DEA 222 represent?
The seller keeps it on file.
What is DEA 106 used for?
To report lost or stolen controlled substances.
When is DEA 106 required to be filed?
When 5% of yearly product sold is missing.
How many tablets missing from a yearly supply of 1000 would require filing DEA 106?
50 tablets.
DEA 41
Used to document the destruction of controlled substances
DEA 224
needed for a pharmacy to dispense controlled substances
DEA 363
needed to operate a controlled substance treatment program or compound controlled substances
DEA 225
needed to manufacture or distribute controlled substances
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
compares therapeutic equivalency using an alphabetical rating system
What does "A" rated in the Orange Book mean?
products can be substituted because they are bioequivalent
What does "B" rated in the Orange Book mean?
products can be substituted because they are not bioequivalent
What does USP/NF stand for?
United States Pharmacopeia/National Formulary
What does the USP/NF contain?
monographs of recognized drugs and drug characteristics
USPDI US pharmacopoeia dispensing information
Volume I:Drug info for healthcare provider
Volume II: Drug info for patients
Volume III: Therapeutic equivalency information and pharmacy law
USP 797
Guidelines for sterile compounding
Drug Facts and Comparisons
Contains a comprehensive listing of drugs and comparative drugs. These drugs are organized by therapeutic class and provide general information with a list of monographs. Also contains listing of drug manufacturers, addresses and phone numbers. Updated monthly
Drug Topics Red Book
Gives a listing of drugs by pricing, strengths, sizes, manufacturers, brands, and generics
Mosby's Complete Drug Reference
Lists generic drugs in alphabetical order. Contains additional drug information
Physician's Desk Reference (PDR)
containes packet insert drug information for physicians and is published anually
American Drug Index
Drugs are listed alphabetically and provide brand,generic and the chemical names of the drugs. Gives alist of manufacturers, strengths and dosage forms of the drugs listed.
The Handbook of Injectable Drugs
References the compatibility of various parenteral drugs
Safety Data Sheet
include safety information about products compiled by the manufacturer, including hazardous ingredients, safe use and handling procedures, proper disposal guidelines, precautions to reduce the risk of accidental harm or overexposure, and more.
Pure food and drugs act of 1906
prohibit the interstate transportation or sale of adulterated or misbranded food or drugs
What does Adulterated mean?
Consists of any filthy, decomposed, putrid susbtance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous or deleterious substance
Containing unsafe color additives
Recognized in an official compendium but differing in strength, quality, or purity of the drugs
What does Misbranding mean?
False labeling
No label
Label lacks Name, place of business of the manufacturer/packer/distributor, lack accurate quantity of contents.
No Warning if the product is habit forming
No labeled direction for use and no warning against certain pathological conditions
Products that are dangerous to health under the labeled dosage
No ingredient/alcohol content if have alcohol
Failed to bear the established name of the drug
Durham-Humphrey Act of 1951
Amendment of FDCA 1938
Require all products to have adequate directions for use
Don't need to have adequate directions for use if the drug/products must be dispense with a prescription (not over-the-counter)
Separated drugs into Legend and Nonlegend (over the counter)
Allows verbal prescriptions over the phone
Allows refills to be called in from a doctors' office
Food, Drugs, and Cosmetic Act of 1938 (FDCA)
Created the US Food and Drug Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding
Kefauver-Harris Amendment of 1962
Requires all medication in the US to be pure, safe, and effective
Comprehensive drugs abuse prevention and control act of 1970
Established "Controlled substance" rating
Created the Drug Enforcement Agency (DEA)
Separated the controlled substance into 5 Schedule based on potential for abuse and accepted medical use in the US
Prescription monitoring programs. the federal National All Schedules Prescription Electronic Reporting Act in 2005
The Act establish an electronic system for practitioner monitoring of the dispensing of controlled substances in SCH 2, 3, 4. The act would require specific information to be reported. But the act was never enacted at the federal level. But many states have enacted similar legislation.
Poison prevention packaging act of 1970
to reduce accidental poisoning in children.
Requires that most OTC and legend drugs be packaged in child-resistant containers --> can't be opened by 80% of children <5 yrs old but can be opened by 90% of adults.
Occupational safety and health act (OSHA) of 1970
Created the Occupational Safety and Health Administration (OSHA)
OSHA ensures a safe and healthful workplace for all employees
Ensures job safety and health standards for employees
Maintain a reporting system for job-related injuries and illness, reduce hazards in the workplace, and conduct audits to ensure compliance with the Act
Address Air contaminants, flammable, and combustible liquids, eye and skin protection, and hazard communication standards.
Requires the MSDS to be use
Drug listing act of 1972
Establish the NDC (National Drug Code) number
5 - 4 - 2
First 5: the manufacturer
2nd 4: the drug product
Final 2: package size and packaging
Orphan Drug Act of 1982
Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medication
Orphan medication
medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world.
Drug Price Competition and Patent term restoration act of 1984
encouraged the creation of both generic and new medications
streamlining the process for generic drug approval and by extending patent licenses.
Prescription Drug marketing act of 1987
prohibits the re-importation of a drug into the US by anyone except the manufacturer.
prohibits the sale or distribution of samples to anyone other than those licensed to prescribe them
Required labels to appear on all medication for animals
Omnibus Budget Reconciliation act of 1987 (OBRA 87)
Revision to Medicare and Medicaid Conditions of participation regarding long term care facilities and pharmacy.
Anabolic Steroid control act of 1990
Harsher penalties for the abuse of anabolic steroids and their misuse by Athletes
Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
Required manufacturers to provide the lowest prices to any customer or medicaid patient by rebating each state Medicaid agency the difference between its average price and the lowest price
Offer to counsel is made to every patient and drug utilization review is performed for every patient --> failure to do so may result in loss of medicaid funding
Authorizes government-sponsored demonstration project relating to the provision of pharmaceutical care
FDA Safe Medical devices Act of 1990
Requires that all medical devices be tracked
Records be maintained for durable medical equipment such as infusion pumps
American with Disabilities Act (ADA) of 1990
Prevent discrimination against potential employees who may possess a disability.
Must make a reasonable accommodation for the potential employee.
Resources Conservation and Recovery Act
From the Environmental Protection Agency (EPA)
federal guidelines regarding the disposal of hazardous waste
FDA modernization Act
Replace the Federal Drug legend "Federal Law prohibits the dispensing of this medication without a prescription" with the Rx abbreviation.
An update of the Humphrey Act
Dietary Supplement Heath and Education Act (DSHEA) of 1994
Guideline to prevent Adulteration of Herbal products and Dietary supplements
Must be labeled as Dietary supplements
identifies all ingredients and quantities of the ingredient in the label
Packaging that identifies the plant and plant part that derives the ingredients
Meet the quality, purity and compositional specification
HIPAA of 1996
improve portability and continuity of health coverage in the group and individual markets
Combat waste, fraud, and abuse in health insurance and delivery
Promote use of medical saving accounts
Improve access to long term care services and coverage
Simplify the administration of health insurance
Maintain patient confidentiality
Isotretinoin safety and risk management act of 2004
Isotretionoin (Accutane) is a medication used to treat acne that cause sever birth defect and psychiatric effects
The act helps control the use of Accutane
Anabolic Steroid Control act of 2004
An update to the Same Act of 1990.
New definition of anabolic steroid
SCH 3 medications
Eliminate requirement to prove muscle growth.
Increase the number of anabolic steroids to 59 substances
Also implement requirement for handling and recording of the use of anabolic steroids substances
Any willing provider Law
allows any pharmacy to participate in a prescription drug benefit plan as long as the pharmacy agrees to the terms and conditions of the plan
Freedom of choice law
allows a member of a prescription drug plan to select any pharmacy as long as the pharmacy agrees to the terms and conditions of the plan
Freedom of choice with regard to long term care
Long term care residents may choose an outside pharmacy for their medication if the pharmaceutical service is not provided under their contract.
However the long term care facility may refuse admission to a resident if the resident refuses to use the drug distribution system already in place
The facility may have additional policies that the outside pharmacy must agree to
Prescription Drug Equity Law
prohibit a prescription drug plan from requiring mail order prescription drug coverage without also providing non-mail order coverage
Medicare Drug improvement and modernization act of 2003
Provide voluntary prescription drug benefit to medicare beneficiaries
Part B and Part D prescription plan
Add preventive medical benefits to senior citizens
Combat Methamphetamine epidemic Act of 2005
Place Ephedrine, pseudoephedrine, and Phenyl-propanolamine in the Controlled Substances in Schedule
Impose sale and production restrictions
Medicaid Tamper0resistant Prescription Act
2008
Special Prescription pad for any prescription that are paid by Medicaid (any portion)
Prevent unauthorized copying of the prescription form and modification of the prescription
Prevent counterfeit prescription forms
USP <797>
designed to cut down on infection transmitted to patients through pharmaceutical products and better protect staff working in pharmacies
Contain procedural training and quality assurance requirements for preparing sterile products
ATF stands for what regulatory agency? What is its responsibilities?
Bureau of Alcohol, Tobacco and FireArms
Set regulations regarding the purchase of tax-free alcohol (use in hospitals and clinics)
CMS stands for what regulatory agency? What is its responsibilities?
Centers for Medicare and Medicaid Services
Oversees medicare and medicaid
DEA stands for what regulatory agency? What is its responsibilities?
Drug Enforcement Agency
Enforces compliance with the Controlled Substance Act
It places medications into the appropriate schedule, monitor records, and reports of controlled substances, registering pharmacies, issuing Form 222 and 41, and monitor the destruction of controlled substances
DEA is overseas by Department of Justice
FDA stands for what regulatory agency? What is its responsibilities?
Food and Drugs administration
Ensure that all pharmaceutical products are pure, safe, and effective
Institutional Review Board stands for what regulatory agency? What is its responsibilities?
A board, committee, or other group designated by an institution to approve biomedical research in accordance with the FDA
TJC stands for what regulatory agency? What is its responsibilities?
The Joint Commission
address quality of patient care and patient safety.
establish standard and accredits health care providers (places): hospital, home health care agencies, long term care pharmacies...
NABP stands for what regulatory agency? What is its responsibilities?
National Association of The Boards of Pharmacy
Composed of all State Boards of Pharmacy.
No regulatory authority but meets to discuss current trends and issues in pharmacy that affect the practice of pharmacy
BOP stands for what regulatory agency? What is its responsibilities?
State Boards of Pharmacy
Regulatory state agency that oversees the practice of pharmacy in a given state
USP stands for what regulatory agency? What is its responsibilities?
United States Pharmacopeia
official public standards-setting authority for all prescription and oTC medicines and other health care products manufactured or sold in the US
Set standards for food ingredients and dietary supplements
-mycin
antibiotic; macrolides
-cycline
antibiotic; tetracyclines
-floxacin
antibiotic; fluoroquinolones
ceph-, cef-
antibiotic; cephalosporins
-cillin
antibiotic; penicillins
-cyclovir
antiviral; anti-herpetics
-pril
antihypertensive, ACE inhibitor
-sartan
antihypertensive; Angiotensin II Receptor blockers (ARB's)
-osin
antihypertensive, Benign Prostatic Hyperplasia (BPH); a 1-receptor blockers
-olol
antihypertensive;
cardioselective b-receptor blockers
nonselective b-receptors blockers
ISA
Mixed a & b receptor blockers
-dipine
antihypertensive, calcium channel blockers (CCB's)
-statin
Antihyperlipidemia; HMG-CoA Reductase Inhibitors
-glitazone
antidiabetic; thiazolidinedione
-glinide
antidiabetic; meglitinides
-dronate
osteoporosis; bisphosphonates
-tidine
Antiulcer H2 Receptor Antagonist
-prazole
Anti-Ulcer; Proton pump inhibitors (PPI's)
-triptan
Anti-migraine
-pam, -lam
anti anxiety/hypnotics, Benzodiazepines (BZD's)
-pramine
antidepressants, Tricyclic Antidepressants (TCA’s)
-triptyline
antidepressants, Tricyclic Antidepressants (TCA’s
-ine
antidepressants; selective serotonin reuptake inhibitors (SSRI'S)
-one
anti-inflammatory; corticosteroids
-steride
Benign prostatic hyperplasia (BPH)
-nacin
overactive bladder and incontinence; anticholinergics
-fil
erectile dysfunction
-terol
pulmonary, asthma & COPD
-mide, -nide
antihypertensive; diuretics
