laws and ethics

Question 1

Regulatory agencies for pharmacy

Answer 1

Centers for Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), The Joint Commission, Occupational Safety and Health Administrations (OSHA), State Board of Pharmacy (SBOP)

Question 2

FDCA Requirements for prescription labels

Answer 2

• Name + address of the pharmacy
• Serial number of the prescription (Rx number)
• Date of the prescription or its date of filling or refilling
• Name of the prescriber
• Name of the patient
• Directions for use

Question 3

State law and requirements for prescription labels

Answer 3

• address of the patient
• initials or name of the dispensing pharmacist
• telephone number of the pharmacy
• drug name, strength, and manufacturer’s lot or control number
• expiration date of the drug
• name of the manufacturer
• amount of the drug dispensed
• refill information

Question 4

legend drug requirements

Answer 4

• name and quantity of active ingredients
• amount of drug in container
• usual dosage of the drug
• federal legend
• route of administration
• a federal warning, if the drug is habit-forming
• name of all inactive ingredients
• lot or control number of the drugs in the container
• statement specifying the type of container to be used in dispensing
• the name and location of the manufacturer, packer, and distributer
• expiration date

Question 5

FDA package insert requirements

Answer 5

• chemical structure of the drug, its clinical pharmacology, its indications, and its usage
• situations in which the drug should not be used (contraindications)
• warnings of side effects
• list of possible adverse reactions
• warnings of the potential for drug abuse and dependence
• usual dosage
• date of the most recent revision to the label
• how the drug is supplied

Question 6

OTC drugs

Answer 6

• product name
• name and address of the manufacturer, distributor, repacker, and others
• established name of all active ingredients and the quantities of certain other ingredients
• total net contents
• any applicable cautions and warnings (required)
• name of any habit-forming drug that might be an ingredient
• directions for sage and effective use

Question 7

contraceptives (auxiliary labels)

Answer 7

take as directed

Question 8

NSAIDS (auxiliary labels)

Answer 8

may cause dizziness or drowsiness

Question 9

narcotics (auxiliary labels)

Answer 9

this drug alone or with alcohol may impair your ability to drive

Question 10

antibiotics (auxiliary labels)

Answer 10

take until gone

Question 11

sulfa (auxiliary labels)

Answer 11

may cause sensitivity to light. take on an empty stomach and take with plenty of water

Question 12

warafin (auxiliary labels)

Answer 12

do not take aspirin

Question 13

C-1 Drugs

Answer 13

• no accredited medical use + no accepted safety standard
• high potential for abuse
• heroin
• LSD
• Marijuana

Question 14

C-2 Drugs

Answer 14

• accepted medical use + high potential for abuse/ risk of dependence
• hydromorphone (dilaudid)
• methadone (dolophine)
• morphine
• codeine
• hydrocodone

Question 15

C-3 Drugs

Answer 15

• accepted medical used + less potential for abuse than drugs in C-2
• moderate risk of physical or psychological dependence
• vicodin
• lortab
• tylenol
• anabolic steroids

Question 16

C-4 drugs

Answer 16

• accepted medical use + less potential for abuse than druge in C-2 and C-3
• limited risk of dependence
• valium
• xanax

Question 17

Drug approval process (phase 1)

Answer 17

clinical trials for maximum safe dose of the drug

Question 18

Drug approval process (phase 2)

Answer 18

clinal trials for effectiveness of the drug

Question 19

Drug approval process (phase 3)

Answer 19

double-blind study

Question 20

Drug approval process (phase 4)

Answer 20

FDA ongoing approvals

Question 21

medication modernization act of 2003

Answer 21

allows Medicare beneficiaries the opportunity to enroll in Medicare Advantage, or Medicare Part D, a voluntary prescription drug benefit plan for seniors

Question 22

drug addiction treatment act of 2000

Answer 22

permits physicians who complete a training course and who register with the DEA to prescribe approved C-3, C-4, and C-5 medications as a means of maintenance or detoxification to patients with opioid addiction

Question 23

health insurance portability and accountability act (HIPAA)

Answer 23

provides protections for patient confidentiality and privacy

Question 24

dietary supplement health and education act of 1994

Answer 24

amended the federal food, drug, and cosmetic act to establish standards with respect to dietary supplements

Question 25

consequentialism

Answer 25

the value of an action derives solely from the value of its consequences

Question 26

nonconsequentialism

Answer 26

certain actions, in and of themselves, are wrong

Question 27

social contracts

Answer 27

understood agreements between individual members of a society that lead to certain expectations of each other

Question 28

rights-based ethics

Answer 28

theory based on a belief in human rights. Individuals in a democratic society should be allowed to do what they want without interference from outside forces

Question 29

ethics of care

Answer 29

requires caregivers to focus on moral skills such as kindness, sensitivity, attentiveness, tact, patience, and reliability

Question 30

principle-based ethics

Answer 30

theory based on a belief in universal guides to action. Personal approach in that the individuals moral beliefs guide action

Question 31

virtue-based ethics

Answer 31

theory based on specific, idealized morals or virtues. An ideal-world approach, everyone agrees on what is correct or virtuous

Question 32

law

Answer 32

a formalized, enforceable system of rules

Question 33

patient bill of rights

Answer 33

- right to be treated with respect - right to participate in your own healthcare - right to access your medical records - right for a second opinion about diagnoses and treatments - right to confidentiality - right to have a family member with you when discussing your healthcare - right to know the names and titles/roles of healthcare staff - right to be examined in private - right to ask questions and express concerns