Pharmacy Law 2

Question 1

assessment of one’s characteristics, skills, and qualities, etc

Answer 1

personal inventory

Question 2

made health-care providers responsible for the privacy and security of identifiable patient health information; also called Protected Health Information (PHI)

Answer 2

1996 Health Insurance Portability and Accountability Act (HIPPA)

Question 3

leading association for pharmacists practicing in hospitals and other health care systems

Answer 3

American Society of Health System Pharmacists (ASHP)

Question 4

pharmacists located in hospitals are required to follow regulations of this organization

Answer 4

TJC (The Joint Commission)

Question 5

Drug with no accepted medical use in the United States

Answer 5

Schedule I

Question 6

which size needle is the most likely to cause coring? (coring is caused by using a large needle)

Answer 6

Ex: 13G (the smaller the needle number the larger the gauge)

Question 7

a solution of halperidol (haldol) contains 2mg/ml of active ingredient. How many grams would be in 473ml of this solution?

Answer 7

0.946g

Question 8

You have a 70% solution of dextrose 1000ml. How many kg of dextrose is in 400ml of this solution?

Answer 8

0.28kg

Question 9

which is the largest capsule size?

Answer 9

size 0

Question 10

the leading enforcement agency at the federal level for these regulations

Answer 10

The Food and Drug Administration

Question 11

prohibits interstate commerce in adulterated or misbranded food, drinks, and drugs

Answer 11

Food and Drug Act of 1906

Question 12

establishes that manufacturers, pharmacists, importers, and phyicians prescribing narcotics should be licensed and required to pay a tax.

Answer 12

1914 Harrison Tax Act

Question 13

requires new drugs be shown to be safe before marketing

Answer 13

1938 Food, Drug and Cosmetic (FDC) Act

Question 14

defines which drug require a prescription by a licensed practitioner and requires them to include this legend on the label

Answer 14

1951 Durham-Humphrey Amendment

Question 15

requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug

Answer 15

1962 Kefauver-Harris Amendment

Question 16

requires child proof packaging on all controlled and most prescription drugs dispensed by pharmacies

Answer 16

1970 Poison Prevention Packaging Act

Question 17

classified 5 levels of controlled substances that have potential for abuse and therefore restricts their distribution; established The Drug Enforcement Administration (DEA) = Justice Dept

Answer 17

1970 Controlled Substances Act (CSA)

Question 18

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

Answer 18

1983 Orphan Drug Act

Question 19

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

Answer 19

1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)

Question 20

requires pharmacists to offer counseling to medicaid patients regarding medications

Answer 20

1990 Omnibus Budget Reconciliation Act (OBRA)

Question 21

pharmaceutical equivalents that produce the same effects in patients.

Answer 21

therapeutic equivalent

Question 22

required by FDA for some potentially dangerous drugs and have information for patients on how to safety use medication

Answer 22

patients package inserts (PPI)

Question 23

requires pharmacists to keep all otc cold and allergy medications containing ephedrine, pseudoephedrine or phenylpropanolamine behind the counter.

Answer 23

Combat Methamphetamine Epidermic Act (CMEA)

Question 24

medications that contain habit forming ingredients but can be sold by a pharmacist without a script to persons at least 8 years of age

Answer 24

exempt narcotics

Question 25

identification number assigned by manufacturers to a drug product

Answer 25

NDC (National Drug Code)

Question 26

drugs with high potential for abuse and no accepted medical use in the U.S. may not be prescribed. Heroin, various opium dervatives, and hallucinogenic substances.

Answer 26

Schedule I

Question 27

drugs that have high potential for abuse which may lead to physical or psychological dependence but that also have currently accepted medical uses in the U.S. Amphetamines, opium, cocaine, methadone, and various opiates

Answer 27

Schedule II

Question 28

drugs with potential for abuse less that those in Sch I and Sch II. Currently accepted in U.S., but their abuse may lead to moderate or low physical dependence or hish psychological dependence. Anabolic steroids and various compounds containing limited quantities of narcotics such as cocaine

Answer 28

Schedule III

Question 29

low potential for abuse relative to Schedule III drugs

Answer 29

Schedule IV

Question 30

low potential for abuse relative to Schedule IV drugs

Answer 30

Schedule V

Question 31

What do all prescribers of controlled substances must be authorized by the DEA need?

Answer 31

DEA Number

Question 32

used C-1 and C-11 substances filled in pen, typewriters, or indelible pencil and signed by an authorized person

Answer 32

DEA Form 222 (copy 1 retained by supplier, copy 2 forwarded to DEA, copy 3 retained by the purchaser)

Question 33

encourages healthcare professional to report adverse effects that occurs from the use of an approved drug or other medical product

Answer 33

MedWatch

Question 34

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

Answer 34

adverse effect

Question 35

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

Answer 35

recall

Question 36

What recall class has strong likelihood that the product will cause serious adverse effects or death?

Answer 36

Recall Class I

Question 37

What recall class cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects?

Answer 37

Recall Class II

Question 38

What recall class is not likely to cause adverse effects?

Answer 38

Recall Class III

Question 39

independent non-profit organization that establishes standards and monitors compliance for nearly 20,000 healthcare programs in the U.S.

Answer 39

The Joint Commission (TJC)

Question 40

original reports of clinical and other types of research projects and studies

Answer 40

primary literature

Question 41

condensed worked based on primary literature, such as textbooks, monographs, etc

Answer 41

tertiary literature

Question 42

the extra pharmacopeia containing international drug monographs

Answer 42

martindale

Question 43

OSHA required information for handling hazardous chemicals

Answer 43

MSDS (Material Safety Data Sheets)