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AUDE 6120 - Pharmacology and Ototoxicity > Controlled Substances > Flashcards

Controlled Substances Flashcards

1
Q

Who makes sure that patients with legitimate medical needs have access to these drugs while keeping them away from people who would abuse them?

A

Health care providers, government, and law enforcement officials

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2
Q

What is the Title 21 United States Code Controlled Substances Act (1970)?

A

Congress gave the United States Drug Enforcement Administration (DEA) authority to set the schedule of controlled substances and control laws related to these substances

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3
Q

What aspects determine which category or schedule a drug should fall into? (according to the controlled substances act)

A

The drug’s acceptable medical use
The drug’s potential for abuse
The drug’s safety or dependence liability
Abuse rate (schedule I are considered the most dangerous and schedule V is the least)

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4
Q

What are schedule I drugs?

A

These are substances or chemicals defined as drugs with no currently accepted medical use and a high potential for abuse
Schedule I drugs are the most dangerous of all drug schedules with potentially severe psychological and/or physical dependence

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5
Q

What are examples of schedule I drugs?

A

Heroin
Lysergic acid diethylamide (LSD)
3,4-methylenedioxymethamphetamine (ecstasy)
Peyote (some controversy regarding religious use by Native American People who have used it for centuries)

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6
Q

What are schedule II drugs?

A

These are substances or chemicals defined as drugs but with a high potential for abuse; less than Schedule I drugs
These drugs can potentially lead to severe psychological or physical dependence and are also considered dangerous

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7
Q

What are some examples of schedule II drugs?

A

Morphine & Fentanyl (100x more powerful than morphine)
Hydrocodone & combination acetaminophen with < 15 mgs of hydrocodone per dosage unit (e.g., Vicodin)
Oxycodone (OxyContin)
Cocaine (powerful local anesthetic and vasoconstrictor-not used much for medicinal purposes in the U. S.)
Methamphetamine
Methadone (used in drug addiction/detoxification programs)
Meperidine (Demerol)
Adderall and Ritalin (used for ADHD)

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8
Q

What is a schedule III drug?

A

These are substances or chemicals defined as drugs with a moderate to low potential for physical and psychological dependence
Schedule III drugs abuse potential is less than that of Schedule I & II drugs but greater than Schedule IV drugs

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9
Q

What are some examples of schedule III drugs?

A

Products containing < 90 milligrams of codeine per dosage unit (Tylenol with codeine)
Ketamine (used as a general anesthetic but abused as a recreational drug-hallucinogenic effects)
Anabolic steroids –Testosterone
Marijuana (cannabis)

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10
Q

What are schedule IV drugs?

A

These are substances or chemicals defined as drugs with a low potential for abuse and low risk of dependence

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11
Q

What are some examples of schedule IV drugs?

A

Xanax (alprazolam, a benzodiazepine used to treat anxiety and panic disorders)
Valium
Ativan (Benzodiazepine; treats anxiety, anxiety with depression, and insomnia
Ambien
Tramadol (non-narcotic pain medication)

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12
Q

What are schedule V drugs?

A

These are substances or chemicals defined as drugs with lower potential for abuse than Schedule IV
They consist of preparations containing limited quantities of certain narcotics
Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes

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13
Q

What are some examples of schedule V drugs?

A

Cough preparations with < 200 mgs of codeine or per 100 milliliters (e.g., Robitussin AC)
Lomotil (for diarrhea)
Lyrica (for nerve pain/neuropathy)

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14
Q

What are the different drug effects on the body?

A

Therapeutic effects (clinically desirable effects)
Adverse effects/reactions (any undesired action, side effects)

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15
Q

Are adverse drug effects dose related?

A

Yes
The more doses you have, the less symptoms you will have
Sometimes it won’t go away and could get worse

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16
Q

What are toxicity reactions?

A

Resulting in cell and tissue damage
Permanent (or take a long time to reverse) and generally intolerable reactions

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17
Q

Does general anesthesia increase the risk for adverse drug reactions?

A

Yes
GA agents and opiate analgesics are a significant cause of ADRs in hospitalized children
6x greater risk

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18
Q

What are some other factors that increased the risk of ADRs?

A

Increasing age of the child (more active and prone to disease)
Increasing number of drugs
Oncological treatment

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19
Q

What is a monograph?

A

Package inserts that must accompany prescription drugs in the pharmacy inventory
Info about drugs (including side effects)
FDA required that all ADRs are included in this

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20
Q

How are ADRs reported?

A

Systems/organs affected
Percentage of population affected

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21
Q

How can ADRs be categorized?

A

The body system or organ affected (cardiovascular system, respiratory system, digestive system, endocrine system, special senses, skin)
General side effects that affect the whole body (malaise, fatigue, body pain, back pain)

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22
Q

What are some signs of an ADR in the nervous system?

A

Dizziness
Drowsiness
Confusion
Depression
Delusions (belief or altered realty despite evidence to the contrary)
Hallucinations (sensory experiences that appear real but are not)
Anxiety or hyper-excitability/hyperactivity
Decreased mental acuity
Altered judgment
Delayed reaction time
Headaches

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23
Q

What are some signs of an ADR in the eyes?

A

Blurred/double vision
Increased ocular pressure
Damage to the retina and optic nerve
Erythema multiforme (allergic reaction to some antibiotics, NSAIDs, and infections, produces a variety of skin lesions - bumps, plaques, and blisters)

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24
Q

What is erythema multiforme in its most severe form?

A

Stevens-Johnson syndrome
Painful skin rash that spreads and blisters
Increased risk if the patient has a gene called HLA-B 1502

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25
Q

What are some signs of an ADR is the auditory-vestibular system?

A

Dizziness
Vertigo
Other balance disorders
Hearing loss
Tinnitus

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26
Q

What are the most common side effects of medications?

A

Tinnitus and dizziness

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27
Q

What are some signs of an ADR related to the skin?

A

Drug-induced itching and redness
Acne
Alopecia
Herpes simplex (viral infection that can produce cold sores, genital inflammation, or conjunctivitis)
Sweating
Urticaria (hives)
Skin ulcers
Steven Johnson syndrome

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28
Q

Are drug hypersensitivity and allergies adverse drug reactions?

A

Yes
They occur because of the body’s immune system

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29
Q

What are antigens?

A

Any substance that elicits an immune response

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30
Q

Does the immune system have many components?

A

Yes
Parts of the immune system are antigen-specific (recognize and act against particular antigens)
Parts of it are systemic (not confined to the initial infection site but work throughout the body)
Parts of the system have memory (recognize and mount an even stronger attack to the same antigen the next time)

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31
Q

What is the most important component of the immune system?

A

Self/non-self recognition
achieved by every cell displaying a marker based on the major histocompatibility complex (MHC)
Any cell not displaying this marker is treated as non-self and attacked

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32
Q

What are the major histocompatibility complex?

A

A group of genes that code for cell surface proteins essential for the immune system

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33
Q

What happens with the self recognition process breaks down?

A

The immune system attacks the body’s own cells even with MHC marker (autoimmune diseases)

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34
Q

What are some examples of autoimmune diseases?

A

Multiple sclerosis (MS), sudden sensorineural hearing loss, rheumatoid arthritis, and Type 1 diabetes

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35
Q

What are allergies?

A

An immune response to innocuous substances that is inappropriately overwhelming
Simple substances that elicit this response are called allergens

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36
Q

What are the two main fluid systems in the body that are part of the immune system?

A

Hematopoietic (blood) and lymphatic systems

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37
Q

What are the cells of the hematopoietic system?

A

Erythrocytes or red blood cells (RBCs) - Carry oxygen
Leukocytes or white blood cells (WBCs) - Fight infections
Thrombocytes or platelets - Help control bleeding

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38
Q

Do all of the hematopoietic system cells develop from a common cell in the bone marrow?

A

Yes
The pluripotent hematopoietic stem cell (will become cells of whatever organ they are put in)
They differentiate into these different cell types by interactions with dozens of glycoproteins called hematopoietic growth factors

39
Q

What is lymph?

A

Lymph is clear, transparent, and colorless
It flows in the lymphatic vessels alongside the blood vessels, bathing tissues and organs in its protective covering
Along the lymph vessels, there are lymph nodes that serve as filters of the lymphatic fluid
It is in the lymph nodes where antigens are usually presented to the immune system

40
Q

What are leukocytes or WBCs responsible for?

A

Protecting the body from infection and part of the immune system

41
Q

What are leukocytes subdivided into?

A

Granulocytes (containing large granules in the cytoplasm)
Agranulocytes (without granules)

42
Q

What are granulocytes?

A

WBCs with secretory granules & consist of neutrophils (55–70%), eosinophils (1–3%), and basophils (0.5–1.0%)

43
Q

What are agranulocytes?

A

Lymphocytes (large nucleus, no granules)
Consisting of B cells, T cells, and monocytes
Lymphocytes circulate in the blood and lymph systems and make their home in the lymphoid organs

44
Q

What are the primary organs of the immune system?

A

Bone marrow (B lymphocyte production)
Thymus gland (T lymphocyte maturation) - produced in bone marrow and mature in thymus

45
Q

What are the main cells of the lymphatic system?

A

T and B cells

46
Q

What are T cells involved in?

A

Cell-mediated immunity
Does not depend on antibodies for its adaptive immune functions and is primarily driven by mature T cells

47
Q

What are the B cells involved in?

A

Humoral immunity (related to antibodies)
Produces antigen-specific antibodies and is primarily driven by B cells

48
Q

What is the function of both T and B cells?

A

To recognize specific “non-self” antigens, during a process known as antigen presentation

49
Q

What are the secondary organs for the immune system? (at/near portals of entry for pathogens)

A

Adenoids, tonsils, spleen, lymph nodes, Peyer’s patches (within the intestines), and appendix

50
Q

Where do WBCs travel to?

A

Primary and secondary lymphatic organs

51
Q

What are antibodies or immunoglobulins?

A

Large, Y-shaped proteins secreted by the plasma and are offspring (clones) of primed B cells
They are used by the immune system to identify and neutralize foreign objects (bacteria and viruses)

52
Q

Do antibodies inactivate antigens through various mechanisms?

A

Yes

53
Q

How are antibodies developed?

A

An immuno-competent but immature B-lymphocyte is stimulated to maturity
When an antigen binds to its surface receptors, the B cell is sensitized or primed and undergoes clonal selection reproducing by mitosis (most clones become plasma cells)
These cells, after an initial lag (up to 14 days), produce highly specific antibodies at a rate of ~ 2000 molecules/second for 4 to 5 days (primary immune response, needed to neutralize antigen quickly)
The other B cells become long-lived memory cells (secondary immune response, quicker and more effective)

54
Q

Do antibodies constitute the gamma globulin part of the blood proteins?

A

Yes
A blood test can measure the levels of gamma globulins in the blood serum
High globulin levels may indicate infection, inflammatory disease, immune disorders, or certain cancers

55
Q

What are constituents of gamma globulin?

A

IgG - 76%
IgA - 15%
IgM - 8% (much larger than the other immunoglobulins)
IgD - 1%
IgE - 0.002%

56
Q

Does IgG dominate the secondary immune responses?

A

Yes

57
Q

Is IgG the only antibody that crosses the placental barrier?

A

Yes
It is responsible for the 3 to 6 month immune protection of newborns that is conferred by the mother

58
Q

What dominates primary immune responses?

A

IgM

59
Q

What is active natural immunity?

A

Contact with infection
Develops slowly, is long term, and antigen specific

60
Q

What is active artificial immunity?

A

Immunization - vaccines
Develops slowly, lasts for several years, and is specific to the antigen for which the immunization was given

61
Q

What is passive natural immunity?

A

Trans-placental mother-to-child
Develops immediately, is temporary, and affects all antigens to which the mother has immunity

62
Q

What is passive artificial immunity?

A

Injection of gamma globulin
Develops immediately, is temporary, and affects all antigens to which the donor has immunity

63
Q

What is the aim of vaccines?

A

To teach the body’s immune system to recognize and block viruses
T cells peak 10-18 days after the shot (detect the presence of virus)
Instructs B-cells to create antibodies that block the virus from being able to replicate and T-killer cells to destroy infected cells

64
Q

What is the body left with after the vaccine?

A

Left with a supply of “memory” T-lymphocytes as well as B-lymphocytes that will remember how to quickly fight that particular antigen (virus) in the future

65
Q

How do Covid-19 mRNA vaccines work?

A

Inject a spike protein that is found on the surface of the coronavirus
Spike acts as an instructional manual in our cells of our muscles
After the spike protein is made, our cells break down the original injected COVID-19 spike proteins
Our cells now display the replicated protein piece on their surface
Our immune system recognizes that the protein does not belong in the body and begins building an immune response against COVID-19 by making antibodies
Now our bodies have learned how to protect against future infection because the immune system’s memory cells will remember that COVID-19 spike protein

66
Q

What are the target cells in the immune system for the immediate reaction of allergies?

A

Mast cells (in connective tissue) and basophils (WBCs)
Both contain histamine (chemical for fighting infections)
When released into the body inappropriately or in too high a quantity, histamine is a potentially devastating substance resulting in allergic reactions

67
Q

How long does it take for mast cells and basophils to be sensitized and primed with IgE antibodies?

A

7-10 days
If a second exposure occurs to the same allergen , it triggers a destructive domino effect within the system called the allergic cascade

68
Q

Can drugs or drug metabolites act as a specific antigen to mast cells and basophils?

A

Yes
Can cause a reaction

69
Q

What is a mast cell?

A

Part of the immune system and contains granules rich in histamine and heparin (anticoagulant to prevent blood clots)
Antigens combines with adjacent molecules of the IgE antibodies that have become attached to the mast or basophil cell surface
The antigen-antibody combination causes release of histamine resulting in allergic manifestations

70
Q

What are the three types of allergic reactions to drugs?

A

Type 1 (IgE mediated) - most severe, anaphylaxis, asthma syndrome, dermatitis
Type 2 (IgG and IgM mediated) - break down of red blood cells (blood disorder)
Type 3 (IgG mediated) - muscle and joint pain, fever, swollen lymph glands

71
Q

What is anaphylaxis?

A

Severe, progressive, whole-body reaction to a chemical that has become an allergen
After being exposed and suffering a mid allergic reaction, the person’s immune system becomes sensitized to it
When the person is exposed to that allergen again, anaphylaxis happens quickly after; it is severe, and potentially life threatening

72
Q

Do some drugs cause an anaphylactic-like (anaphylactoid) reaction when they are first exposed to them?

A

Yes
These are systemic not immune system reactions that do NOT require prior sensitization to an antigen as required in true anaphylaxis
The symptoms, risk of complications, and treatment, however, are the same for both types of reactions

73
Q

What are some common causes of anaphylaxis?

A

Drugs (most commonly penicillin and anesthesia medications)
Food allergies (peanuts and shellfish)
Insect bites (bee stings and fire ants)

74
Q

Can pollen and other inhaled allergens cause anaphylaxis?

A

Yes but rare

75
Q

What is the risk of anaphylaxis?

A

History of any type of allergic reaction
For some people it may appear to occur with no known cause
But that is usually because first exposure caused mild/no symptoms

76
Q

How does anaphylaxis occur?

A

Tissues in different parts of the body release histamine and other substances, which causes the airways to tighten and leads to other symptoms

77
Q

What is the treatment for anaphylaxis?

A

Epinephrine (adrenaline) to reduce body’s allergic response
Oxygen to help compensate for restricted breathing
Intravenous (IV) antihistamines and cortisone to reduce inflammation and swelling in order to open airways
A beta-agonist (such as albuterol) to relieve breathing symptoms

78
Q

What are common teratogens for fetal development?

A

Accutane (99% teratogenic)
Thalidomide (treatment for nausea in pregnant women, caused limb defects, congenital heart disease, malformation of IE and OE, and ocular abnormalities)
Rubella (can cause hearing loss, heart, neurological, and eye defects)
Environmental factors like radiation (can cause miscarriage, birth defects, intellectual disability, intrauterine growth, childhood cancers)

79
Q

Can teratogenic drugs still be approved by the FDA?

A

Yes
The therapeutic benefits outweigh the risk
Physician labeling clearly contraindicates use during pregnancy
The FDA required testing of all new drugs for teratogenic potential during the drug toxicity trials in animal studies

80
Q

What is FDA pregnancy and lactation labeling?

A

Started in 2015 (improve risk vs. benefit assessment of drugs used for pregnant and nursing mothers PLLR recommendations include three main categories)

81
Q

What are the categories for FDA pregnancy and lactation labeling?

A

Fetal summary - likelihood that drugs increases the risk of four types of developmental abnormalities (structural anomalies, fetal and infant mortality, impaired physiologic function, and alterations to growth)
Clinical considerations - discussing fetal risk from inadvertent exposure and prescribing decisions based on drug effects on labor, delivery, and fetus
Data - Detailed discussion of available data; human data appears before animal data

82
Q

What is pharmacogenomics?

A

The study of the role of the genome in drug response
It is a fast emerging field that studies how the genetic makeup of a patient affects their response to drugs

83
Q

Are there inter-individual differences that exist for pharmacogenomics?

A

Yes
In genes that can encode these drug targets or in genes that encode proteins for drug metabolism
Can be highly significant for the success or failure of the drug

84
Q

What is it called when one nucleotide in a specific position is exchanges with another nucleotide?

A

Single nucleotide polymorphism or SNP (pronounced “SNIP”)
Majority of nucleotide variations are SNPs

85
Q

What are some other variations (mutations)?

A

Insertions, deletions, duplications, and translocations of one or more nucleotides or even entire chromosomes

86
Q

Can SNPs or other genetic variation affect protein amount or function by altering the coding sequence of transcription or mRNA translation?

A

Yes

87
Q

Are genetic polymorphisms common in major enzymes that metabolize both phase I and II reactions?

A

Yes

88
Q

What is an example of genetic polymorphisms?

A

1 in ~ every 2000 Caucasians has a genetic alteration of the plasma enzyme serum cholinesterase
One of the enzyme’s functions is to metabolize the muscle relaxant succinylcholine (given IV with general anesthesia)
The altered enzyme has a 1000 fold decreased affinity for succinylcholine, causing
Decreased metabolism, slow elimination, & prolonged circulation
A sufficiently high plasma level of succinylcholine would lead to respiratory paralysis and death if not supported with artificial respiration till the drug clears from the body

89
Q

How many liver enzymes can cytochrome P450 metabolize?

A

Greater than 30 classes of drugs
Genetic variations causing less active/inactive forms of CYP can influence drug metabolism for tons of drugs leading to overdoses

90
Q

Have clinically significant polymorphisms been identified in both phase I (CYP family of enzymes) and phase II of liver enzymes?

A

Yes
Most of these polymorphisms produce no clinically significant effects in the absence of drug therapy
But they can and do result in clinically significant drug efficacy and toxicity for individuals with these polymorphisms compared to those without

91
Q

What can pharmacogenomics produce?

A

The creation of personalized drug therapy that would result in greater safety and efficacy of drugs

92
Q

What are the potential benefits of pharmacogenomics?

A

Development of drugs to accurately target specific diseases based on genetic information resulting in improves therapeutic effects and decreased damage of healthy cells
Establishing gene phenotypes prior to the use of certain medications
Matching the right drug and correct dose to patients’ genotype
Removing the need to experiment with medication till patients shows desired improvement (e.g., blood pressure medication)
Advanced screenings for disease or disease susceptibility to monitor conditions and maximize therapy
Developing better vaccines
Decreasing overall health care costs

93
Q

What are some barriers that exist for pharmacogenomics?

A

Very complex and time consuming
Knowing a person’s genetic make up will not be helpful if the two drugs available are contraindicated and no alternative is available
Little incentive for drug manufacturers to spend huge amounts of money to bring a drug to market for an extremely small portion of the population
Development of state-of-the-art technologies to detect and analyze DNA sequencing data and translate that knowledge to the clinic

AUDE 6120 - Pharmacology and Ototoxicity (8 decks)

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