1906 Federal Food and Drug Act
One of the first laws enacted to stop the sale of inaccurately labeled drugs
1914 Harrison Narcotic Act
Limitations on opium transport and use were attempted
1938 Federal Food, Drug, and Cosmetic Act
Enacted because the earlier federal food and drug act was not worded strictly enough and did not include cosmetics. Under this act, the FDA was created.
Adulterated
To corrupt, debase, or make impure by the addition of a foreign or inferior substance or element; especially: to prepare for sale by replacing valuable ingredients with less valuable ingredients
Misbranded
Deceptive or misleading labeling of a product that may lead the consumer to believe that the product will cure an illness
1951 the Durham-Humphrey Amendment
Added more instructions for drug companies and required the labeling "Caution: Federal Law prohibits dispensing without a prescription.
Legend
By prescription only
OTC
Doesn't need a prescription
1962 Kefauver-Harris Amendments
Amendment was passed in response to birth of thousands of infants with severe abnormalities due to the fact that the mothers had taken the tranquilizer Thalidomide.
Thalidomide Event
In 1962 a new sleeping pill containing thalidomide was found to cause severe birth defects when used by pregnant women
Thalidomide Event (FYI though)
Thalidomide has special prescribing rules in effect. Program is called STEPS (System for Thalidomide Education and Prescribing Safety)
1970 Comprehensive Drug Abuse Prevention and Control Act
This act was created to combat and control drug abuse an to supersede previous federal drug abuse laws. The act classified drugs into schedules according to potential for abuse. DEA was created to enforce the laws
Schedule or Class 1
Drug with no accepted medical use or other substances with high potential for abuse
Schedule or Class 1 (Examples)
Heroin, LSD, Marijuana, Peyote, etc
Schedule or Class 2
Drugs with accepted medical uses and high for potential for abuse which if abused may lead to severe psychological or physical dependence.
Schedule or Class 2 (Examples)
Percocet (oxycodone/APAP), OxyContin (oxycodone), Demerol (meperidine), morphine, Ritalin (methylphenidate)
Schedule or Class 3
Drugs with accepted medical use and a potential for abuse, but less than those listed in 1 and 2, if abused may lead to moderate psychological or physical dependence
Schedule or Class 3 (Examples)
Tylenol w/codeine #3 (APAP with codeine), Lortab/Vicodin (hydrocodone/APAP)
Schedule or Class 4
Drugs with accepted medical use and a low potential for abuse, if abused may lead to limited psychological or physical dependence
Schedule or Class 4 (Examples)
Valium (diazepam), Xanax (alprazolam), Ativan (lorazepam), Klonopin (clonazepam)
Schedule or Class 5
Drugs with accepted medical use and low potential for abuse, if abused may lead to limited psychological or physical dependence
Schedule or Class 5 (Examples)
Robitussin AC (guiatussin w/codeine), Phenergan w/Codeine (promethazine w/codeine)
Exempt Narcotics
Select cough and anti-diarrhea prescription items by an individual but must be dispensed in original manufacturer's container. Purchaser must be 18 and complete Exempt Narcotic Book with some info: date purchased, name, address, name of product, quantity,
DEA Form 222
Used to order C-II medications. Must be filled out in pen, typewriter or indelible pencil. Only RPh can order C-II
DEA Form 41
Must be submitted to the DEA for the destruction of outdated or damage controlled substances
DEA Form 106
Used to notify the DEA of a theft of controlled substances.
1970 The Poison Prevention Packaging Act
Requires that all OTC and legend drugs with a few exceptions must have childproof caps.
1972 Drug Listing Act
This act gives the FDA authority to compile a list of currently marketed drugs. Under this act came the NDC #.
NDC
National Drug Code, 11 digit # assigned by the manufacturer, 1st 5 will refer to the manufacturer, 2nd 4 is the drug product, and the last 2 is package size
1983 Orphan Drug Act
An orphan drug is one that will be used by so few people that developing and marketing it is prohibitively expensive
1984 Drug Price Competition and Parent-Term Restoration Act
Drugs will typically have several names including the chemical name or generic name and the trade or brand name
Generic
Non-proprietary name a drug with the same chemical composition as a brand name drug that can be substituted for the brand name
Brand
Proprietary name given by manufacturer like Motrin for ibuprofen
1984 Hatch Waxman Act
Provided for up to a 5 year extension of patent protection to patent holders to make up for time lost while products went through the FDA approval process
1987 Prescription Drug Marketing Act
The act helped to control the use of drugs in animals
1990 The Omnibus Budget Reconciliation Act
The act requires that as a condition of participating in the Medicaid program, states must establish standards of practice for RPh's and requiring a DUR by the RPh.
DUR should include potential drug therapy problems due to
Therapeutic duplication, drug-disease contraindications, drug-drug interactions including OTC, incorrect drug dosage or duration of treatment, drug allergy interactions, clinical abuse or misuse
1990 Anabolic Steroid Control Act
Stiffened the regulations on the abuse problems of anabolic steroids because of misuse by athletes
1996 Health Insurance Portability and Accountability Act (HIPAA)
Effective as of April 14, 2003 major changes became required of pharmacies to ensure the privacy rights of patients
1997 Food and Drug Administration Modernization Act
This act was passed by Bill Clinton regarding regulations pertaining to compounding
2002 Accutane
All Accutane (isotretinoin) prescriptions must bear a yellow sticker to be filled and certain conditions must be met.
2005 Combat Meth Act
Unitl 2004 pseudoephedrine was sold OTC as a decongestant and was not limited in quantity for purchase
Food and Drug Administration (FDA)
This is a federal agency under the Department of Health and Human Services that regulates the manufacture and safe guarding of medications
Drug Enforcement Administration (DEA)
This is the agency that controls the distribution of drugs that may be easily abused
Board of Pharmacy (BOP)
They are responsible for licensing all prescribers and dispensers; and administering regulations for the pratice of pharmacy in each state
Pharmacy Law Book
All pharmacies must have on hand at all times the Nevada Law Book
Nevada Revised Statutes (NRS)
Laws enacted by the Nevada State Legislature
Nevada Administrative Codes (NAC)
Adopted by the Nevada State Board of Pharmacy to regulate the practice of pharmacy and supplement the related chapter of NRS
Liability
Legal liability means you can be prosecuted for misconduct
Negligence
Failing to do something that you should or that must be done
Negligence in the following
Incorrectly labeling the Rx, failing to maintain patient confidentiality, failing to recognize expired drugs, calculation errors, dispensing the wrong medication, incorrect handling of controlled substances, inaccurate record keeping
Federal and State Statutes
Enacted by a legislative body such as congress or the state legislature that outline the conduct of persons or organizations subject to the law
Tort
Causing injury to a person intentionally or because of negligence
Expired Drug
a drug that has exceeded the federally mandated expiration date
Law
The oficial rules of conduct established and enforced by the authority
Punitive Damages
Damages, often monetary that are awarded by a court and mean not necessarily to compensate the victim but to punish the offender
Statutory Law
The body of law which consists of laws passed by legislative bodies at the federal, state, and local level
Criminal Law
The body of law that deals with violations of statutes and or regulations and with penalties established for such violations
Civil Law
The body of law that deals with non-criminal cases
Malpractice
Refers to a situation in which the standard of care for a particular healthcare profession was not met
Ethics
The subfield of philosophy that deals with the study of right action or the nature of good and evil. Morals in the workplace and in the public domain
Standard of Practice
Guidelines for professional practice, established by professional organizations that are often referred to by courts, especially in tort cases, that establish minimum guidelines for the behaviors of professionals
Code of Ethics
Standards for the RPh and technician. Ethics are the values and morals within a profession
Protocol
The customs and regulations dealing with diplomatic formality, precedence, and etiquette
New Drugs
All new drugs, whether made domestically or imported are required to have FDA approval before they can be marketed in the US
Patent Protection
A patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under the brand name
Generics
Once a patent for a brand medication expires, other manufacturers may copy the drug and release it under its pharmaceutical or generic name
Labels and Labeling
All drugs are required to have clear and accurate information for all labels, inserts, packaging, etc. but there are different information requirements for various categories of drugs
Controlled Substance Labels
Schedule II-V must carry the auxiliary label "Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
Controlled Substance
a drug which has the potential to be abused and for which distribution is controlled by one of five schedules
Storage
In Nevada, C-II's must be kept under lock and key and only the RPh can have access to key, but technicians can count and get the drug out by law
Joint Responsibility
By law both the prescriber and the dispenser of the Rx have a joint responsibility for the legitimate medical purpose of the Rx
Control Classifications
Manufacturers must clearly label controlled drugs with their control classification
DEA Number
The number all prescribers of controlled substances are assigned and which must be used on all controlled drug prescriptions
Record Keeping
Distributors are required to maintain accurate records of all controlled and non controlled substances. C-II's kept separately from all other records and minimum of 2 years
State Board of Pharmacy
Registers and Regulate the Pharmacists and Technicians
National Association of Boards of Pharmacy (NABP)
An association of state boards of pharmacy. Oversees state boards
Joint Commission on Accreditation of Health Care Organizations (JCAHO)
Now known as The Joint Commission. an independent non-profit organization that establishes standards and monitors compliance for nearly 20,000 healthcare programs in the US
American Society of Health-System Pharmacist (ASHP)
From RPh's to home healthcare, long term care, etc. it is an accrediting organization for pharmacy residency and pharmacy technician training programs
Health Care Financing Administration (HCFA)
HCFA inspects and approves hospitals to provide care for Medicaid and Medicare patients
The Department of Public Health (DPH)
The DPH is a state run organization that overseas hospitals including the pharmacy department
Board of Pharmacy (BOP)
The BOP is the agency that registers Pharmacists and Technicians
Pharmacy Technician Certification Board (PTCB)
The organization that gives pharmacy technicians their national certification license. CPhT. To maintain CPhT you must complete 20 hours of CE with at least 1 hour being in Law
American Pharmaceutical Association (APhA)
The largest of the national organizations
American Association of Pharmacy Technicians (AAPT)
National organization representing pharmacy technicians
National Pharmacy Technician Association (NPTA)
Created by pharmacy technicians for pharmacy technicians
United States Pharmacopeia (USP)
The USP is a non-profit organization that sets stands for the identity, strength, quality, purity, packaging and labeling of drug products
Physicians Desk Reference (PDR)
The PDR is an annual publication intended for physicians that provides prescription information on major pharmaceutical products
Facts and Comparisons (F&C)
a preferred reference for comprehensive and timely drug information
American Hospital Formulary Service Drug Information (AHFS)
Accepted as the authority for drug information questions
Handbook on Injectable Drugs
This is a collection of monographs on commercially available parenteral drugs that include concentration, stability, dosage, and compatibility information
Therapeutic Equivalence Evaluations (The Orange Book)
Source that lists drug products approved for use in the US
Goodman an Gilman's
An authoritative text on pharmacology and therapeutics containing 67 articles by leading experts in the field
Red Book
List the average wholesale price (AWP) of drugs, their NDC's and the manufacturer's address
Identa-Drug
Lists drugs by the imprint and description of the drug
Clinical Trials
Test on proposed new drugs (investigational drugs) by comparing the effect of a proposed drug on one group of patients with the effect of a different treatment on other patients
Blind Test
Patients in a trial are always "Blind" to the treatment
Placebos
An inactive substance. Not real medication that is given to patients to give them the impression that they are being given a potentially effective medication
Testing Phase in Humans
Phase 1: 20 to 100 pt's, several months, safety. Phase 2: several hundred, months to 2 years, safety, effectiveness. Phase 3: several hundred to thousand, 1-4 years, safety, dosage and effectiveness
Testing in Children
Children are not included in trials until a drug has been fully tested on adults
Animal Testing
Once a laboratory testing of a proposed drug is finished, the drug is tested on animals before it will be tested on humans
Recall
The action taken to remove a drug from the market and have it returned to the manufacturer.
Voluntary Recall
Manufacturer does it on their own
Involuntary Recall
One that is required by the FDA
Recall Class 1
The highest level of recall. Deals with products that could cause serious or even fatal harm
Recall Class 2
The next highest level. Deals with products that are found to cause serious but reversible harm
Recall Class 3
Lowest level of recall. Used for products that may have minor defects or other conditions that would not harm the patient, but the drug can not be resold
Tylenol Recall of 1982
When someone tampered with a small number of Tylenol capsule packages and fatally poisoned seven people, Johnson and Johnson immediately recalled the capsules from the market
Tylenol Recall of 2009
5 lots of Tylenol Arthritis was recalled after reports of unusual mold, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting, and diarrhea
Tylenol Recall of 2010
Children's Tylenol, Tylenol plus, Motrin, Zyrtec, and Benadryl were voluntarily recalled by the manufacturer due some of the products not meeting quality standards