Pharmacy Law 2 Flashcards Preview

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Flashcards in Pharmacy Law 2 Deck (43)
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1
Q

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

A

personal inventory

2
Q

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

A

1996 Health Insurance Portability and Accountability Act (HIPPA)

3
Q

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

A

American Society of Health System Pharmacists (ASHP)

4
Q

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

A

TJC (The Joint Commission)

5
Q

Drug with no accepted medical use in the United States

A

Schedule I

6
Q

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

A

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

7
Q

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

A

0.946g

8
Q

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

A

0.28kg

9
Q

which is the largest capsule size?

A

size 0

10
Q

the leading enforcement agency at the federal level for these regulations

A

The Food and Drug Administration

11
Q

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

A

Food and Drug Act of 1906

12
Q

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

A

1914 Harrison Tax Act

13
Q

requires new drugs be shown to be safe before marketing

A

1938 Food, Drug and Cosmetic (FDC) Act

14
Q

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

A

1951 Durham-Humphrey Amendment

15
Q

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

A

1962 Kefauver-Harris Amendment

16
Q

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

A

1970 Poison Prevention Packaging Act

17
Q

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

A

1970 Controlled Substances Act (CSA)

18
Q

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

A

1983 Orphan Drug Act

19
Q

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

A

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

20
Q

requires pharmacists to offer counseling to medicaid patients regarding medications

A

1990 Omnibus Budget Reconciliation Act (OBRA)

21
Q

pharmaceutical equivalents that produce the same effects in patients.

A

therapeutic equivalent

22
Q

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

A

patients package inserts (PPI)

23
Q

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

A

Combat Methamphetamine Epidermic Act (CMEA)

24
Q

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

A

exempt narcotics

25
Q

identification number assigned by manufacturers to a drug product

A

NDC (National Drug Code)

26
Q

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.

A

Schedule I

27
Q

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

A

Schedule II

28
Q

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

A

Schedule III

29
Q

low potential for abuse relative to Schedule III drugs

A

Schedule IV

30
Q

low potential for abuse relative to Schedule IV drugs

A

Schedule V

31
Q

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

A

DEA Number

32
Q

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

A

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

33
Q

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

A

MedWatch

34
Q

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

A

adverse effect

35
Q

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

A

recall

36
Q

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

A

Recall Class I

37
Q

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

A

Recall Class II

38
Q

What recall class is not likely to cause adverse effects?

A

Recall Class III

39
Q

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

A

The Joint Commission (TJC)

40
Q

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

A

primary literature

41
Q

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

A

tertiary literature

42
Q

the extra pharmacopeia containing international drug monographs

A

martindale

43
Q

OSHA required information for handling hazardous chemicals

A

MSDS (Material Safety Data Sheets)