DRUG STANDARDS AND LEGISLATION

Question 1

first published in 1951 by the World Health Organization (WHO), provides a basis for standards in strength and composition of drugs for use throughout the world. The book is published in English, Spanish, and French

Answer 1

International Pharmacopeia

Question 2

attempts to protect the public from drugs that are impure, toxic, ineffective, or not tested before public sale.

Answer 2

Federal Legislation

Question 3

primary purpose of the legislation is to ensure safety.

Answer 3

Federal Legislation

Question 4

America’s first law to regulate drugs which prohibited the sale of misbranded and adulterated drugs but did not address drug effectiveness and safety

Answer 4

Food and Drug Act of 1906

Question 5

prohibited false therapeutic claims on drug labels.

Answer 5

1912: The Sherley Amendment

Question 6

It came about as a result of Mrs. Winslow’s Soothing Syrup, a product advertised to treat teething and colic, which contained morphine and led to the death of many infants. Under this amendment, the government had to prove intent to defraud a drug could be removed from the market.

Answer 6

1912: The Sherley Amendment

Question 7

required prescriptions for drugs that exceeded set narcotic limits

Answer 7

1914: The Harrison Narcotic Tax Act

Question 8

mandated increased record keeping by physicians and pharmacists

Answer 8

1914: The Harrison Narcotic Tax Act

Question 9

empowered the FDA to ensure a drug was safe before marketing

Answer 9

1938: The Federal, Food, Drug, and Cosmetic Act

Question 10

it also required that drugs be labeled with accurate information and have detailed literature in the drug packaging that explains adverse effects.

Answer 10

1938: The Federal, Food, Drug, and Cosmetic Act

Question 11

___ responsibility to ensure that all drugs are tested for harmful effects; it also required that drugs be labeled with accurate information and have detailed literature in the drug packaging that explains adverse effects.

Answer 11

FDA

Question 12

____ can prevent the marketing of any drug it judges to be incompletely tested or dangerous. Only drugs considered safe by the FDA are approved for marketing.

Answer 12

FDA

Question 13

distinguished between drugs that could be sold with or without prescription by a licensed health care provider

Answer 13

1951: Durham-Humphrey Amendment

Question 14

resulted from the widely publicized thalidomide tragedy of the 1950s in which European patients who took the sedative-hypnotic thalidomide during the first trimester of pregnancy gave birth to infants with extreme limb deformities.

Answer 14

1962: Kefauver-Harris Amendment Act to the 1938 Act

Question 15

tightened controls on drug safety, especially experimental drugs, and required that adverse reactions must be labeled and included in the literature.

Answer 15

1962: Kefauver-Harris Amendment Act to the 1938 Act

Question 16

The amendment also included provisions for the evaluation of testing methods used by manufacturers, the process for withdrawal of approved drugs when safety and effectiveness were in doubt, and the establishment of effectiveness of new drugs before marketing.

Answer 16

1962: Kefauver-Harris Amendment Act to the 1938 Act

Question 17

Enacted in 1965, this act attempted to control the abuse of depressants, stimulants, and hallucinogens

Answer 17

1965: Drug Abuse Control Amendments

Question 18

designed to remedy the escalating problem of drug abuse, included several provisions: (1) promotion of drug education and research into the prevention and treatment of drug dependence; (2) strengthening of enforcement authority; (3) establishment of treatment and rehabilitation facilities; and (4) designation of schedules, or categories, for controlled substances according to abuse liability.

Answer 18

1970: The Comprehensive Drug Abuse Prevention and Control Act

Question 19

Based on their abuse potential and acceptable medical use practices, controlled substances are categorized into five schedules.

Answer 19

1970: The Comprehensive Drug Abuse Prevention and Control Act

Question 20

designed to promote the development and manufacture of drugs used in the treatment of rare diseases

Answer 20

1983: The Orphan Drug Act

Question 21

act’s three primary incentives are (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a 50% tax credit for costs of clinical testing; and (3) exclusive rights to market the drug for 7 years from marketing approval date.

Answer 21

1983: The Orphan Drug Act

Question 22

established labeling requirements for dietary supplements and authorized the FDA to promote safe manufacturing practices.

Answer 22

1994: Dietary Supplement Health and Education Act

Question 23

classified dietary supplements as food

Answer 23

1994: Dietary Supplement Health and Education Act

Question 24

protects health insurance coverage for workers who change or lose their jobs and sets the standard for the privacy of individually identifiable health information

Answer 24

1996: Health Insurance Portability and Accountability Act

Question 25

The act provide patients more control over their health information, including boundaries on the use and release of health records.

Answer 25

1996: Health Insurance Portability and Accountability Act

Question 26

(1) review and use of new drugs is accelerated; (2) drugs can be tested in children before marketing; (3) clinical trial data are necessary for experimental drug use for serious or life-threatening health conditions; (4) drug companies are required to give information on off-label (non FDA approved) use of drugs and their costs; and (5) drug companies that plan to discontinue drugs must inform health professionals and patients at least 6 months before stopping drug production.

Answer 26

1997: The Food and Drug Administration Modernization Act

Question 27

gives a 6-month extension of patients to evaluate drugs on the market for their safety and efficacy in children.

Answer 27

2002: Best Pharmaceuticals for Children Act

Question 28

studies that involve children must be conducted with the same drug and in the same disease process as adults.

Answer 28

2003: Pediatric Research Equity Act

Question 29

authorizes the FDA to require drug manufacturers test certain drugs and biologic products for their safety and effectiveness in children, noting that “children are not small adults.”

Answer 29

2003: Pediatric Research Equity Act

Question 30

allows the FDA to do more comprehensive reviews of potential new drugs, mandates postmarketing safety studies, and affects the distribution of drugs found to be not as safe as premarket studies indicated.

Answer 30

2007: Food and Drug Administration Amendments Act

Question 31

Act was signed into law in 2010 and became effective January 1, 2014.

Answer 31

2010: Patient Protection and Affordable Care Act

Question 32

Essential provisions of the reform include (1) quality, affordable health care for all Americans; (2) improved quality and efficiency of health care; (3) prevention of chronic disease and improved public health; (4) improved access to innovative medical therapies; and (5) community living services and supports.

Answer 32

2010: Patient Protection and Affordable Care Act

Question 33

It the FDA’s ability to safeguard and advance public health by:
-Collecting fees from industry to fund reviews of drugs with the “breakthrough therapy” designation, medical devices, generic drugs, and biosimilar biologic products
-Expediting development of innovative, safe, and effective products
-Increasing stakeholder engagement in FDA processes
-Enhancing the safety of the global drug supply chain

Answer 33

2012: Food and Drug Administration Safety and Innovation Act

Question 34

signed into law on July 9, 2012.

Answer 34

2012: Food and Drug Administration Safety and Innovation Act

Question 35

All states and territories have rules and regulations in place to provide guidance and govern nursing practice, which includes drug administration by nurses.

Answer 35

NURSE PRACTICE ACTS

Question 36

nurses cannot prescribe or administer drugs without a health care provider’s order.

Answer 36

NURSE PRACTICE ACTS

Question 37

Practicing nurses should be knowledgeable about the nurse practice act in the state where they are licensed

Answer 37

NURSE PRACTICE ACTS

Question 38

Nurses who administer a drug without a licensed health care provider’s order are in violation of the Nurse Practice Act and can have their licenses revoked

Answer 38

NURSE PRACTICE ACTS

Question 39

In civil court, the nurse can be prosecuted for giving the wrong drug or dosage, omitting a drug dose, or giving the drug by the wrong route

Answer 39

NURSE PRACTICE ACTS

Question 40

before approval and becoming available to patients, drugs must be reviewed for safety, efficacy, and quality by the Health Products and Food Branch (HPFB) of Health Canada.

Answer 40

CANADIAN DRUG REGULATION

Question 41

In 1996, the Canadian government passed this which act broke controlled drugs and substances into eight schedules and two classes of precursors.

Answer 41

Controlled Drugs and Substances Act

Question 42

Counterfeit drugs may contain the incorrect ingredients, insufficient amounts of active ingredients, or no active ingredients. Additionally, they may contain impurities and contaminants or may be distributed in fake packaging.

Answer 42

INITIATIVES TO COMBAT DRUG COUNTERFEITING

Question 43

is a federal department tasked with the mission of improving the quality of life of all Canadians

Answer 43

health canada

Question 44

most common drugs counterfeited are those used to treat erectile dysfunction, high cholesterol, hypertension, infections, cancer, and HIV/AIDS.

Answer 44

INITIATIVES TO COMBAT DRUG COUNTERFEITING

Question 45

FDA and consumer groups are working on strategies to combat this problem, including tougher oversight of distributors, a rapid alert system, and better-informed consumers

Answer 45

INITIATIVES TO COMBAT DRUG COUNTERFEITING

Question 46

role of the nurse is critical in consumer education. The nurse must advise patients to report any differences in taste or appearance of a drug or in its packaging

Answer 46

INITIATIVES TO COMBAT DRUG COUNTERFEITING

Question 47

describes the drug’s chemical structure

Answer 47

chemical name

Question 48

the official, nonproprietary name for the drug; this name is not owned by any drug company and is universally accepted

Answer 48

generic name

Question 49

the official, nonproprietary name for the drug; this name is not owned by any drug company and is universally accepted

Answer 49

generic name

Question 50

is chosen by the drug company and is usually a registered trademark

Answer 50

brand (trade) name

Question 51

other term for brand name

Answer 51

propriety name