Society has the right to protect itself from the impact of drug use and society has the right to demand safe and effective drugs
What are the two major guidelines for controlling drug development and marketing
Patent medicines
The term _________ signified that the ingredients were secret, not patented. It demonstrates the problems of insufficient regulation of the drug industry
patent medicines
The __________ of the late 1800s and early 1900s demonstrated the problems of insufficient regulation of the drug industry
1906 Pure Food and Drug Act
The _______________________ required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin or marijuana extract in each product. Made misrepresentation of drugs as "non habit forming" illegal, but did not prohibit dis
1906 Pure Food and Drug Act
The __________________ represented the first real attempt to make consumers aware of the active contents in the drug products they were consuming
Sherley Amendment
The _________________________ was passed in 1912 to strengthen existing laws and required that labels should not contain "any statement... regarding the curative or therapeutic effect..which is false and fraudulent
Elixir sulfanilamide
The sale and use of _____________ led to a tragic accident that killed over 100 people. Companies were required to file applications with the government showing that new drugs were safe.
Food, Drug and Cosmetic Act
The __________________defined drugs to include products that affect bodily structure or function even in the absence of disease. Drug labels had to list all ingredients as well as provide instructions regarding correct use and warning about its dangers.
Durham Humphrey Amendment
_______________ established criteria for determining whether a drug should be classified as prescription or nonprescription
nonprescription
If a drug does not fall into one of the following three categories it is considered ______________ 1) Drug is habit forming 2) Drug is not safe for self medication because of its toxicity 3) The drug is a new could that has not been shown to be completely
Food, Drug and Cosmetic act
The _________ in 1938 defined drugs to include products that affect bodily structure or function even in the absence of disease. Also, drug labels had to list all ingredients as well as provide instructions regarding correct use and warning signs about it
Kefauver-Harris
The __________________ Amendments made drug manufacturers have to demonstrate the efficacy and safety of drugs. In addition, FDA was empowered to withdraw approval of a drug that was already being marketed, and FDA was permitted to regulate and evaluate d
thalidomide
The Kefauver -Harris Amendments were passed in part as a consequence of the ___________, tragedy; a sedative drug that was used in pregnancy that causes severe developmental damage to fetuses
Ensure the rights and safety of human subjects, Evaluate the safety and efficacy of new treatments, Compare benefits and risk of new drugs
The FDA is mandated by Congress to do 3 things. 1) ________________________ during clinical testing 2)_____________________ 3)_____________________ and determine if approval for marketing is appropriate
Preclinical research and development, Clinical research and development, permission to market
What are the three regulatory steps for new prescription drugs?
True
True or false - The amended Food, Drug, and Cosmetic Act requires that all new drugs be registered with and approved by the FDA
Preclinical Research and Development
Initial synthesis and animal testing take place during which regulatory step for new prescription drugs?
Clinical research and development
This regulatory step for new prescription drug has 3 phases 1) Initial clinical stage 2) Clinical pharmacological evaluation stage 3) Extended clinical evaluation
Initial clinical stage
Small numbers of volunteers (20-100), typically healthy people but sometimes patients are recruited to establish drug safety and dosage ranges for effective treatment and examine side effects
Clinical pharmacological evaluation stage
The effects of the drug are tested to eliminate investigator bias and to determine side effects and effectiveness of the treatment. A few patients (100-300) with the medical problem the drug is intended to treat participate in these studies.
extended clinical evaluation stage
By this time, the pharmaceutical company has a good idea of both drug effectiveness and dangers. The drug can be offered safely to a wider group of participating clinics and physicians who cooperate in the administration of the potential drug to thousands
3, Permission to market
In Step __, _________________________. The FDA can allow the drug to be marketed under its patented name.
4
The post marketing surveillance for new prescription drugs is often referred to as phase ___
New Drug Application (NDA)
If there is sufficient data to demonstrate that a drug is safe and effective, the company submits an _______________ as a formal request that the FDA approve it for marketing
Fast track rule, orphan drug law, prescription drug user fee act of 1992
What are three examples of special drug marketing laws that are considered exceptions to the lengthy process?
Fast track rule
__________________applied to the test of certain drugs used for treatment of rare cancers, AIDS and some other diseases.
Orphan Drug Rule
_________________ allows drug companies to receive tax advantages if they develop drugs that are not very profitable because they are useful in treating "rare diseases
Rare disease
__________________ is a defined as one that affects fewer than 200,000 people in the US or one for which the cost of development is not likely to be recovered by marketing.
Prescription Drug User Fee Act of 1992
This law requires drug manufacturers to pay fees to the FDA for the evaluation of NDAs. Congress required the FDA to use these fees to hire more reviewers to expedite the drug review process.
increased, decreased
The prescription drug user fee act of 1992 _____________ reviewers and ____________ review time
Safe and effective, Not safe and effective or unacceptable indications , insufficient data to permit final classifications
The FDA evaluated each active ingredient in OTC medications and placed ingredients into three categories I.______________, II._______________________________ and III.______________________
Switching policy
An FDA policy allowing the change of suitable prescription drugs to over the counter status
OTC ,3
The following criteria must be satisfied if a drug is to be switched to ______ status 1. The drug must be used by prescription for ____ 2. Use must have been relatively high during the time it was used by prescription 3. Adverse drug reactions must not be
true
True or False Promotional efforts by pharmaceutical companies have a large impact on the drug purchasing habits of the general public and health professionals
Food and Drug administration(FDA), Federal Trade Commission(FTC)
The _____ oversees most issues related to advertising of prescription products and the ______ regulates OTC and dietary supplement advertising
advantages of Direct to Consumer Advertising
-Most physicians surveyed agree that because of these advertisements their patient asked thoughtful questions during the visit
-Same percentage agreed it made their patients more aware of possible treatments
-Reminds a patient to get their prescriptions r
Disadvantages of direct to consumer advertising
-Approx. 75% of physicians surveyed indicated that these ads cause patients to think that the drug works better than it does
-physicians felt more pressure to prescribe something when patients mentioned these ads
false advertisement
The term ____________ means an advertisement, other than labeling, which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account not only representations, but the extent to which t
The Harrison Act of 1914
Marked the first legitimate effort by the federal government to regulate and control the production and importation of addicting substances
The Comprehensive Drug Abuse Prevention and Control Act
This 1970 act divided substances with abuse potential into categories base don the degree of their abuse potential and clinical usefulness
Comprehensive Drug Abuse Prevention and Control Act
Replaced previous laws and categorized drugs based on abuse and addiction potential as well as therapeutic value
I
Schedule ____ substances have high abuse potential and no currently approved medicinal uses; they cannot be prescribed
II
Schedule __ substances have high abuse potential , but are approved for medical uses and can be prescribed.
II, V
Schedule ___ -_____ substances reflect the likelihood of abuse and clinical usefulness
V
The least addictive and least regulated of the substances of abuse are classified as schedule ____ drugs
Patient ,doctor
Direct to Consumer (DTC) advertising affects the _________ to _______ relationship
Actual or relative potential for abuse of drug, scientific evidence of the pharmacological effects of the drug, scope, duration and significance of abuse, its history and current pattern of disease
What are 3 examples of factors that determine scheduling?
If a person abuses a drug should he or she be treated as a criminal or sick person, how is the user distinguished from the pusher and who should be harshly punished, are laws and associated penalties effective reasons to reject drug or abuse and how is th
What are the three principal issues influencing laws regarding substance abuse?
three principal issues influencing laws regarding drug abuse
The ___________________________ are the following1.If a person abuses a drug should he or she be treated as a criminal or sick person, 2.how is the user distinguished from the pusher and who should be harshly punished 3. Are laws and associated penalties
Supply reduction, inoculation, demand reduction,drug courts
What are 4 strategies for preventing drug abuse?
Supply reduction
A drug reduction policy aimed at reducing the supply of illegal drugs and controlling other therapeutic drugs. Includes interdiction. This strategy has been show to have limited success
interdiction
The policy of cutting off or destroying supplies of illicit drugs; Decreasing the amounts of these agents that are carried across US borders by using foreign crop eradication measures and agreements, by imposing stiff penalties for drug trafficking and by
Inoculation
A method of abuse prevention that protects drug users by teaching them responsibility
Inoculation
Aims to protect drug users by teaching them responsibility and explaining the effects of drugs on bodily and mental functioning
Demand reduction
Attemps to decrease individuals' tendencies to use drugs, often aimed at youth, while emphasis on reformulating values and behaviors
Controlled Substance Act
The ______________________ allows inclusion of immediate precursors on this basis alone into the appropriate schedule and thus safeguards against possibilities of clandestine manufacture
FALSE
True or False , Drug laws often serve as a satisfactory deterrent against the use of illicit drugs
Drug courts
_____________ integrate mandatory drug testing, substance abuse treatment, sanctions and incentives in a judicially supervised setting. They hold offenders accountable for their actions and provides them with support and tools necessary to rebuild their l
Drug courts
A process that integrates substance abuse treatment, incentives, and sanctions and places nonviolent, drug involved defendants in judicially supervise rehabilitation programs.
inoculation
Nonalcoholic parties and responsible drinkers who use designated drives are outcomes of applying _______ strategy for preventing drug abuse
Youth, education, attitudes, replacement
Some suggestions for reducing demand of drugs are...
A.Top priority of prevention should be to reduce demand by _________
B.__________ must be carefully designed for the target population
C._________ toward drug abuse must be changed
D.___________ therapy
violence and crime would decrease/increase, addiction would decrease/increase, consumption would increase/decrease
Give 3 examples of arguments commonly debated involving legalization of drugs
drug testing
In response to the demand by society to stop the spread of drug abuse and its adverse consequences, ______________ has been implemented in some situations to detect drug users.
breathalyzers, urine, blood , hair specimens
The most common type of drug testing used is _________ and laboratory studies of _______, _______ and ___________
Pragmatic
Examples of __________ drug policies include
- The government must develop programs that are consistent with the desires of the majority of the population,
- programs must consider de-emphasizing interdiction and stress programs that reduce demand
- gover
food drug and cosmetic act
The 1938 ____________ gave the FDA control over drug safety
true
T/F
All drugs to be considered for marketing must first be test for safety in animals