Law and Ethics Flashcards

Question

What is the Durham-Humphrey Amendment of 1951?

Answer 1

prohibits dispensing of legend drugs (prescription drugs) without a prescription

Answer 2

amendment to the Food, Drug, and Cosmetic Act required that drug products, both prescription and nonprescription, must be effective and safe. required an unprecedented program of accountability from manufacturers

Answer 3

also called the Controlled Substances Act (CSA) enforced by the DEA, which is part of the US Department of Justice Drugs were classified into five schedules, with Schedule I drugs having the highest potential for abuse and addiction.

Answer 4

have a high potential for abuse, not accepted for medical use in the United States. Only used for research purposes

Answer 5

also have high potential for abuse, but accepted for medical use includes opiates and opium derivatives Prescriptions have to be written, and can not be refilled

Answer 6

moderate potential for abuse and accepted for medical use in US contain limited quantities of certain narcotic and non-narcotic drugs Can get refilled if authorized by a practitioner

Answer 7

low potential for abuse relative to those in Schedule III generally long acting barbiturates (central nervous system depressants), and minor tranquilizers

Answer 8

lowest potential for abuse, still require a prescription have a very low amount of narcotics some states allow for adults to request w/o a prescription (behind the counter drugs)

Answer 9

1st letter determines the type of practitioner and 2nd letter is first letter of practitioner's last name 1. Add together the first, third, and fifth digits. 2. Add together the second, fourth, and sixth digits. Multiply the sum by 2. 3. Add together the totals from Step 1 and Step 2. 4. Verify that the last digit of the result of Step 3 matches the check digit of the DEA number.

Answer 10

Individuals who manufacture, dispense, or distribute any controlled substance

Answer 11

used to order Schedule I or II drugs can only be done by people with a DEA license Only a maximum of 10 different items may be ordered on one DEA Form 222 Also used when returning controlled substances form Schedule II

Answer 12

used if a controlled substance is stolen or lost in a pharmacy

Answer 13

used when controlled substances go out of date a cover letter has to be attached, and can only be done once per year two witnesses

Answer 14

2 years Schedule II records must be kept separately.

Answer 15

Schedule II- locked cabinet Schedule III, IV, V- various locations throughout the pharmacy

Answer 16

authorized the Consumer Product Safety Commission to create standards for child-resistant packaging. Requires that most OTC and legend drugs be packaged in child-resistant containers

Answer 17

OSHA required medical medical facilities to comply with the Bloodborne Pathogens Standard and to be able to prove that compliance to OSHA inspectors if necessary Implemented a material safety data sheet (MSDS) for every potentially dangerous chemical used in the workplace

Answer 18

each new drug is assigned a unique National Drug Code (NDC) number so the FDA can create a database of all drugs

Answer 19

required manufacturers to register and list their products and to report their device failures

Answer 20

Class I- needles, scissors Class II- thermometers, catheters, and hearing aids Class III- life-supporting systems that can cause serious injury or death if they fail

Answer 21

Orphan drugs are used to treat disease that affect fewer than 200,000 people in US Offers federal financial incentives to commercial and nonprofit organizations for R&D of orphan drugs.

Answer 22

designed to lower drug prices by providing a mechanism to increase competition in the drug industry accelerated procedure for approval of generic versions

Answer 23

prohibits the reimportation of a drug in to the US by anyone but the manufacturer

Answer 24

placed anabolic steroids under the CSA used by athletes to become stronger

Answer 25

requires pharmacists to offer to discuss info about new and refill prescriptions with Medicaid recipients (patients) Drug utilization evaluation (DUE) must be conducted to ensure that all prescribed medications are reviewed for appropriateness

Answer 26

clarifies the regulatory framework applicable to nutritional supplements and to create specific labeling requirements

Answer 27

1. Electronic Health Transaction Standards- standard code sets for injuries, symptoms, etc. across all hospitals 2. Unique Identifiers 3. Security and Electronic Signature Standards- safeguards for physical storage and maintenance, transmission, and access to individual health information 4. Privacy and Confidentiality Standards- limited the nonconsensual use and release of private health information (protected health information)

Answer 28

allowed physicians to prescribe DEA-preapproved controlled substances from Schedule III, IV, or V to people who are addicted to opioids as a part of detoxification treatments

Answer 29

provided senior citizens and disabled people with a prescription drug benefit, additional choices, and more Medicare benefits established Medicare Part D, which is a voluntary prescription drug benefit program

Answer 30

designed to stop illegal use of drugs such as meth, crack cocaine, and others legal drugs that can make meth, etc. had to be kept behind counters

Answer 31

Accutane is used to treat severe cystic acne, but high risk of birth defects. Required patients and pharmacists to sign up through the iPledge web site and all factors are considered when allowing for the usage of the drug

Answer 32

Amended the CSA to prohibit the delivery and dispensing of a controlled substance that is a prescription drug over the Internet without a valid prescription, exempted telemedicine practitioners

Answer 33

Goal is to increase the quality and affordability of health insurance and lower the uninsured rate by expanding public and private insurance coverage

Answer 34

banned compounds commonly found in synthetic marijuana sold as K2 or Spice by placing them as a Schedule I drug

Answer 35

created FDA oversight for large-volume compounding operations and allowed pharmacists to provided traditional compounding services to patients.

Answer 36

oversees controlled substances enforce controlled substance laws and regulations and to prosecute both individuals and organizations who manufacture illegal drugs

Answer 37

Class I: The use of the product will cause severe adverse reactions or death Class II: The use of the product can cause temporary or medically reversable adverse health hazards Class III: The use of the product is not likely to cause adverse health hazards.