chapter 3

adverse effect

an unintended side effect of a medication that is negative or in some way injurious to a patient’s health

civil law

laws pertaining to wrongs to an individual

combat methamphetamine epidemic act (CMEA)

federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine

compliance

doing that is required

contracts

legal agreements that have duties associated with them

controlled substance mark

the mark (CII-CV) that indicates the control category of a new drug with a potential for abuse

controlled substances

five groups of drugs identified by the 1970 controlled substances act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by five control schedules set forth by the CSA

criminal law

laws pertaining to a wrong to society

dual marketing

status of medications like plan B that are classified as both prescription and OTC drugs

ethics

a branch of philosophy that helps determine what should be done in a principled sense

exempt narcotics

medications with habit forming ingredients that can be dispensed without a prescription by a pharmacist to persons at least 18 years of age

health information technology for economic and clinical health act (HITECH)

a federal act that strengthens HIPAA and promotes electronic prescribing and electronic medical records

injunction

a court order preventing a specific action such as the distribution of a potentially dangerous drug

legend drug

any drug that requires a prescription and this legend on the label: Rx only

liability

legal responsibility for costs or damages arising from misconduct or negligence

malpractice

a type of negligence lawsuit brought against a person with a professional license

negligence

a tort arising from the breach of the duty of care

pediatric

having to do with the treatment of children

pharmaceutical equivalent

drug products that contain identical amounts of the same active ingredients in the same dosage form

placebo

an inactive substance given in place of a medication

product labeling

important associated information that is not on the label of a drug product itself

protocol

specific guideline for practice

recall

the action taken to remove a drug from the market and have it returned to the manufacturer

risk evaluation and mitigation strategies (REMS)

information and procedures that are required of manufacturers by the FDA for drugs with known risks

therapeutic equivalent

pharmaceutical equivalents that produce the same effects in patients

torts

civil wrongs that have duties associated

because of fatal poisoning from liquid sulfanilamide the…. required new drugs be shown to be safe before marketing

1938 food, drug, and cosmetic act

pharmacists were required to offer counseling to medicaid patients by the….

1990 omnibus budget reconciliation act (OBRA)

drugs that require prescriptions are….. drugs

legend

both domestic and imported drugs require approval the….. before they can be marketed in the united states

FDA

the main purpose of phase 2 clinical trials is

effectiveness

after a patent has expired for medication other manufactures may copy the drug and release it under the…

generic name

drugs that do not require a prescription are…. drugs

OTC

the combat methamphetamine epidemic act requires that OTC cold and allergy medications containing which of the following drugs be kept behind the counter

ephedrine and pseudoephedrine

purchasers of exempt narcotics must be at least… years of age

18

the second set of digits in an NDC represents the…

name of drug and strength

the FDA reporting system for adverse effects that occur from use of approved drugs is called

MedWatch

…. drug recalls are issued by manufactures when there is a strong likelihood that the product will cause serious adverse effects of death

class 1

amphetamines, opium, cocaine, and methadone are in DEA schedule…. because they have accepted medical use but have a high potential for abuse and may lead to physical or psychological dependence

II

the form for ordering schedule II controlled substances is DEA form…

222

the error that led to emily’s law involved…

sodium chloride

which FDA recall classification is the most serious

Class I

what law should be followed when federal and state laws don’t agree

the more stricter law

which USP chapter sets the legal standard for non-sterile compounded preparation

chapter

what does the first set of numbers in the national drug code indicate

the strength

according to the poison prevention packaging act who can request containers that are not child proofed

the physician and the patient

which drug has a REMS

isotretinoin

which phase of clinical trials involves healthy patients without the disease or condition

phase 1

what does the FDA stand for

Food and Drug Administration

what does the DEA stand for

Drug Enforcement Administration

when was the FDA established

1938

when was the DEA established

1973

when states allow non-physician to prescribe they limit…

their scope of authority

a non-physician prescriber may only prescribe for...

certain conditions and must follow a strict set of rules

non-physician prescribers include….

dentists, veterinarians, nurse practitioners, and physician assistant

American Society of Health-System Pharmacies (ASHP)

30,000 member association for pharmacists practicing in hospitals, HMOs, long term care facilities, home care agencies and other health care systems. it is an accrediting organization for pharmacy residency and pharmacy technician training programs

United States Pharmacopeial convention (USP)

voluntary not profit organizations that set standards for the manufacturers and the distribution of drugs and related products in the United States. these standards are directly referred to by federal and state laws and are published in the united states pharmacopeia and the national formulary

The Joint Commission (TJC)

Independent non profit organization that establishes standards and monitors compliance for nearly 20,000 health care programs in the united states

The American Commission for Health Care (ACHC)

sets standards for pharmacies that provide the services: infusion pharmacy, specialty pharmacy, community retail pharmacy and long term care pharmacy

which law defines compounding in pharmacies pursuant to a patient specific prescription and gives the FDA regulatory authority with regard to the Active Pharmaceutical Ingredients (APIs)

federal law 21 USCA 353a

food and drug act of 1906

prohibits interstate commerce in adulterated or misbranded food, drinks and drugs. government pre approval of drugs is required

1914 harrison narcotics tax act

in response to growing addiction to opiates and cocaine-containing medicines, the act established that manufactures, pharmacists, prescribing narcotics should be licensed and required to pay a tax

1938 food, drug, and cosmetic act (FDC)

passed in response to fatal poisoning of 107 people, many were children, by an untested sulfanilamide concoction. this law requires that before any new drug can be marketed it must be proven safe when used according to directions on its label

1951 Durham-Humphrey amendment

established two classes of drugs: legend drugs, and over the counter drugs. legend drugs are required to include this legend on their label: “caution: federal law prohibits dispensing without a prescription” or “Rx only” also allows for the provision of telephoned prescriptions and prescription refills

1962 Kefauver-Harris amendment

amendment to the FDC act, its passage required that all new drugs marked in the US must first be shown to be safe and effective. it also regulates prescription drug advertising under the authority of the FDA required “informed consent” by research subjects in clinical investigations

1970 poison prevention packaging act

requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies. non-childproof containers may only be used if the prescriber or patient requests one

1970 controlled substances act (CSA)

classifies five levels of controlled substances that have potential for abuse and therefore restricts their distribution establishes the drug enforcement administration (DEA) as a division of the justice department

1983 orphan drug act

provides incentives to promote research approval and marketing of drugs needed for the treatment of rare diseases

1984 drug price competition and patent term restoration act (Hatch-Waxman)

allows for both the extension of drug patent terms and quicker introduction of lower cost generic drugs

1987 prescription drug marketing act

restricts distribution of prescription drugs to legitimate commercial channels, requires drug wholesalers to be licensed by other states

1996 Health insurance portability and accountability act (HIPAA)

encourages providers to use electronic transactions and allows a minimum amount of patient health information to be transferred among providers without patient consent, for purposes of treatment, payment, or administrative operations. makes health care providers responsible for maintaining the privacy and security of patient information

2003 medicare modernization act

establishes optional medicare part D to provide coverage for prescription drugs and medication therapy management (MTM)

risk evaluation and mitigation strategies (REMS)

information and procedures that are required of manufacturers by the FDA for drugs with known risks, allows patients to have access to medicines with known risks by providing strategies for their safe use

what is an NPI

national provider identifier: ten digit number with a check digit in the last position to help detect keying errors

health insurance portability and accountability act (HIPPA)

federal act that protects the privacy of individuals and the sharing of protected health information

the FDA estimates that the testing processes (clinical trials) currently takes….

8\.5 years

clinical trials phase 1

20-100 patients, time:several months, purpose: mainly safety

clinical trials phase 2

up to several hundred patients, time:several months to 2 years, purpose: short term safety but not mainly effectiveness

clinical trials phase 3

Several hundred to several thousand patients, time: 1 to 4 years, purpose: safety, dosage, and effectiveness

pharmaceutical equivalent

drug products that contain identical amounts of the same active ingredients in the same dosage form

patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under a….

brand name

once a patent for a brand drug expires other manufacturers may copy and release it under its…..

generic name

product labeling

important associated information that is not on the label of a drug product itself but is provided with the product in the form on an insert, brochure, or other document

what is the information contained on the labels of OTC medications

product name, name and address of manufacturer or distributor, list of all active and other ingredients, amount of contents, adequate warnings, adequate directions for use

NSN (NATO stock number)

identification number used to identify material items of supply and is recognized in all NATO countries

class 1 for recalls

where there is a strong likelihood that the product will cause serious adverse effects or death

class 2 for recalls

where a product may cause temporary but reversible adverse effects or in which there is little likelihood of serious adverse effects

class 3 for recalls

where a product is not likely to cause adverse effect

adverse effect

an unintended side effect of a medication that is negative or in some way injurious to a patients health

injunction

a court order preventing a specific action such as the distribution of a potentially dangerous drug

controlled substances schedule I

drugs for a high potential of abuse and no accepted medical use in the US. they may not be prescribed

what are some schedule I drugs

heroin, various opium derivatives, and hallucinogenic substances

controlled substances schedule II

drugs that have high potential for abuse that may lead to physical or psychological dependance but also that also have currently accepted medical uses in the US

what are some schedule II dugs

amphetamines, opium, cocaine, methadone, and various opiates

controlled substances schedule III drugs

drugs with the potential of abuse less than those in schedule I and II. these drugs have currently accepted medical uses in the US but their abuse may lead to moderate or low physical dependence or high psychological dependence

what are some schedule III drugs

anabolic steroids and various compounds containing limited quantities of narcotic substances

controlled substances schedule IV drugs

drugs with low potential for abuse relative to schedule III drugs. these drugs have currently accepted medical uses in the US but their abuse may lead to limited physical dependence or psychological dependence

what are some schedule IV drugs

Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital

controlled substances schedule V drugs

drugs with low potential for abuse relative to schedule IV drugs these drugs have currently accepted medical uses in the US but their abuse may lead to limited physical dependence or psychological dependence

what are some schedule V drugs

compounds containing limited amounts of a narcotic such as codeine