RXRS201 Exam With Complete
Solution
DEA (Drug Enforcement Administration) - Answer The Drug Enforcement Administration
(DEA) is a United States federal agency tasked with enforcing the controlled substances
laws and regulations of the United States.
The purpose behind the creation of the DEA
Enforce the controlled substances laws and regulations of the United States
Bring to the criminal and civil justice system of the United States, or any competent
jurisdiction, organizations and their principal members involved in the growing,
manufacture, or distribution of controlled substances appearing, in or destined for,
illicit traffic in the United States
Recommend and support non-enforcement programs aimed at reducing availability of
illicit controlled substances
Legalization - Answer the complete removal of sanctions, making a certain behavior
legal and applying no criminal or administrative penalties
Drug Liberalization - Answer the process of eliminating or reducing drug prohibition
laws
Decriminalization - Answer the removal of sanctions under the criminal law, with
optional use of administrative sanctions
Depenalization - Answer the decision in practice not to criminally penalize offenders,
such as non-prosecution or non-arrest
Ethics - Answer systematizing, defending, and recommending concepts and action
behind right and wrong conduct. Seeks to answer questions of human morality by
defining concepts such as good and evil, right and wrong, virtue and vice, or justice and
crime
Bioethics - Answer the study of ethical issues emerging from advances in biology and
medicine. The scope of bioethics is very broad and can keep pace with theoretical
applications of medicine and biotechnology, examples include
• Cloning
• Gene therapy
• Life extension
,• Human genetic engineering
• Astroethics and life in space
Medical Ethics - Answer study of moral values and judgments as they apply to medicine
• Medical ethics tends to be a narrowly applied professional ethics, whereas bioethics
has a broadly theoretical approach
• Medical ethics seeks to inform health care professionals and enable them to make
moral decisions by providing a set of values the professionals can refer to in instances
where confusion or conflict arise
Belmont Report - Answer Report issued in 1978 in response to the National research act
of 1974
Outlines 3 key principles of ethical research
Respect for persons (autonomy)
Beneficence
Justice
Autonomy or Respect for Persons - Answer • Respect for persons - (aka autonomy),
respect for persons encompasses at least two parts:
1. All individuals should be treated as autonomous agents
• They can deliberate about personal choices and act upon those deliberations
2. Individuals who are of diminished autonomy must be protected
• Diminished autonomy - illness, mental disability, cognitive deficits, or immaturity
• Four conditions flow directly from Respect for Persons:
1. Voluntary Consent
2. Informed Consent
3. Protection of privacy and confidentiality
4. Right to withdraw without penalty from a study
Beneficence - Answer • Beneficence - requires the examination of the risks and benefits
of the study
1. The study should do no harm (Non-maleficence)
2. Benefits must be maximized while harm is minimized
, 3. The risks are justified by the benefits of the study
Justice - Answer Justice - requires that the benefits and risks of research be evenly
distributed through society
• The disadvantaged must not bear the risks of research, which the advantaged reap the
benefits
• This unequal distribution has happened all too often throughout human history, and
this principle seeks to end that imbalance
Human subject research - Answer systematic, scientific investigation that can be either
interventional / experiential (a "trial") or observational (not "test article") and involves
human beings as research subjects
• Interventional / experiential research - is where the participants receive an
intervention, such as a new medicine, in order to evaluate the safety and efficacy
• Observational research - is a study in which a researcher simply observes behavior in
a systematic manner without influencing or interfering with the behavior
Food and Drug Administration (FDA) - Answer responsible for protecting and promoting
public health through the control and supervision of:
• Food safety
• Tobacco products
• Dietary supplements
• Prescription and over-the-counter pharmaceuticals (medications)
• Vaccines
• Biopharmaceuticals
• Blood transfusions
• Medical devices
• Electromagnetic radiation emitting devices
• Cosmetics
• Animal foods & feed
• Veterinary product
• FDA is a federal agency of the United States Department of Health and Human
Services (DHHS)
Drug safety - Answer the state of being certain that adverse effects will not be caused
Solution
DEA (Drug Enforcement Administration) - Answer The Drug Enforcement Administration
(DEA) is a United States federal agency tasked with enforcing the controlled substances
laws and regulations of the United States.
The purpose behind the creation of the DEA
Enforce the controlled substances laws and regulations of the United States
Bring to the criminal and civil justice system of the United States, or any competent
jurisdiction, organizations and their principal members involved in the growing,
manufacture, or distribution of controlled substances appearing, in or destined for,
illicit traffic in the United States
Recommend and support non-enforcement programs aimed at reducing availability of
illicit controlled substances
Legalization - Answer the complete removal of sanctions, making a certain behavior
legal and applying no criminal or administrative penalties
Drug Liberalization - Answer the process of eliminating or reducing drug prohibition
laws
Decriminalization - Answer the removal of sanctions under the criminal law, with
optional use of administrative sanctions
Depenalization - Answer the decision in practice not to criminally penalize offenders,
such as non-prosecution or non-arrest
Ethics - Answer systematizing, defending, and recommending concepts and action
behind right and wrong conduct. Seeks to answer questions of human morality by
defining concepts such as good and evil, right and wrong, virtue and vice, or justice and
crime
Bioethics - Answer the study of ethical issues emerging from advances in biology and
medicine. The scope of bioethics is very broad and can keep pace with theoretical
applications of medicine and biotechnology, examples include
• Cloning
• Gene therapy
• Life extension
,• Human genetic engineering
• Astroethics and life in space
Medical Ethics - Answer study of moral values and judgments as they apply to medicine
• Medical ethics tends to be a narrowly applied professional ethics, whereas bioethics
has a broadly theoretical approach
• Medical ethics seeks to inform health care professionals and enable them to make
moral decisions by providing a set of values the professionals can refer to in instances
where confusion or conflict arise
Belmont Report - Answer Report issued in 1978 in response to the National research act
of 1974
Outlines 3 key principles of ethical research
Respect for persons (autonomy)
Beneficence
Justice
Autonomy or Respect for Persons - Answer • Respect for persons - (aka autonomy),
respect for persons encompasses at least two parts:
1. All individuals should be treated as autonomous agents
• They can deliberate about personal choices and act upon those deliberations
2. Individuals who are of diminished autonomy must be protected
• Diminished autonomy - illness, mental disability, cognitive deficits, or immaturity
• Four conditions flow directly from Respect for Persons:
1. Voluntary Consent
2. Informed Consent
3. Protection of privacy and confidentiality
4. Right to withdraw without penalty from a study
Beneficence - Answer • Beneficence - requires the examination of the risks and benefits
of the study
1. The study should do no harm (Non-maleficence)
2. Benefits must be maximized while harm is minimized
, 3. The risks are justified by the benefits of the study
Justice - Answer Justice - requires that the benefits and risks of research be evenly
distributed through society
• The disadvantaged must not bear the risks of research, which the advantaged reap the
benefits
• This unequal distribution has happened all too often throughout human history, and
this principle seeks to end that imbalance
Human subject research - Answer systematic, scientific investigation that can be either
interventional / experiential (a "trial") or observational (not "test article") and involves
human beings as research subjects
• Interventional / experiential research - is where the participants receive an
intervention, such as a new medicine, in order to evaluate the safety and efficacy
• Observational research - is a study in which a researcher simply observes behavior in
a systematic manner without influencing or interfering with the behavior
Food and Drug Administration (FDA) - Answer responsible for protecting and promoting
public health through the control and supervision of:
• Food safety
• Tobacco products
• Dietary supplements
• Prescription and over-the-counter pharmaceuticals (medications)
• Vaccines
• Biopharmaceuticals
• Blood transfusions
• Medical devices
• Electromagnetic radiation emitting devices
• Cosmetics
• Animal foods & feed
• Veterinary product
• FDA is a federal agency of the United States Department of Health and Human
Services (DHHS)
Drug safety - Answer the state of being certain that adverse effects will not be caused
