Controlled Subs, Adverse Drug Events, & Pharmacogenomics Flashcards
Under the Title 21 United States Code (USC) Controlled Substances Act (CSA) , congress gave the United States Drug Enforcement Administration (DEA) authority to
Set the schedule of controlled substances
Control and enforcement of laws related to these substances
The Controlled Substances Act (CSA) places all drugs, substances, and certain chemicals used to make drugs into _____ distinct categories or schedules
five (5)
what are the drug categories dependent on
drug’s acceptable medical use
drugs potential for abuse
drug’s safety or dependence liability
what is a determinate factor in the scheduling of the drug
abuse rate
considered the most dangerous class of drugs with a highest potential for abuse
schedule I
represents the least potential for abuse
schedule 5
what are schedule I drugs
substances or chemicals defined as drugs with no currently accepted medical use and a high potential for abuse
most dangerous of all the schedules
what are ex of schedule I drugs
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)
Small spineless cactus native to the desert of south TX and north
Small spineless cactus native to the desert of south TX and north Mexico (contains psychoactive alkaloids, particularly mescaline) used by Native Americans
peyote
what are schedule II drugs
substances or chemicals defined as drugs but with a high potential for abuse; less than Schedule I drugs
can potentially lead to severe psychological or physical dependence
dangerous
schedule II ex
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)
what are schedule III drugs
substances or chemicals defined as drugs with a moderate to low potential for physical and psychological dependence
abuse potential is less than that of Schedule I & II drugs but greater than Schedule IV drugs
ex of schedule III
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) – Moved from Schedule 1 in May 2024
Many states now have legalized medicinal and recreational use
what are schedule IV drugs
substances or chemicals defined as drugs with a low potential for abuse and low risk of dependence
ex of schedule Iv
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)
what are schedule V drugs
substances or chemicals defined as drugs with lower potential for abuse than Schedule IV
usually used for antidarrheal, antitussive & analgesic purposes
consist of preparations containing limited quantities of certain narcotics
consist of preparations containing limited quantities of certain narcotics
schedule V
schedule V ex
Cough preparations with < 200 mgs of codeine or per 100 milliliters (e.g., Robitussin AC)
Lomotil (for diarrhea)
Lyrica (for nerve pain/neuropathy)
Drug effects on the body can be
therapeutic effects
adverse effects (ADRs)
what are ADRs
Any undesirable action - side effects
toxicity reactions
maybe b/w 4th & 6th leading cause of death in US
ADRs
what is included in ADRs
undesired effects, many which can be tolerated
these are generally reversible upon drug discontinuation
they are dose-related
toxicity reactions seen in ADRs
esults in cell & tissue damage
permanent and generally intolerable reactions
what is dose related
will get better or worse based on the dose you have taken
the more you take the more you get the side effect or the more you take the more the side effect diminishes
dose related
Opiate analgesics and drugs for general anesthesia (GA) accounted for more than _____ of all drugs implicated in ADRs
50%
In the Thiesen, et al (2013) study, other factors that increased the risk of ADR were
increasing age of child (1.06 each yr)
incrasing # of drugs (1.25 for each additional drug)
oncological treatment (1.90 compared to other Rx)
ADRs were common in hospitalized children
yes
Children who had undergone GA were at 2x greater risk of developing an ADR
false
6x
______ & _____ were a significant cause of ADRs in hospitalized children
GA agents and opiate analgesics
why older children are at risk? why is age a risk factor?
because they are more active and more exposed to exposure to other infections and things that younger ones might not have exposure to
what is a monograph
package inserts that must accompany prescription drugs in the pharmacy inventory
contain information about the drug, including a listing of adverse effects
FDA requires that all ADRS observed for the drug to be included in the
monograph
ADRs are reported by
Systems/organs affected
Percentage of population affected
ADRs can be categorized according to
body or organ system affected (skin, cardiovascular, respiratory, etc.)
general side effects that affect whole body (malaise, fatigue, boy pain, back pain)
Signs of an ADR in the Nervous System can include
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
Signs of an ADR in the Eyes, with eyelids and conjunctiva being the frequent targets for drug toxicity
Blurred/double vision
Increased ocular pressure
Damage to the retina and optic nerve
Erythema multiforme
Stevens-Johnson Syndrome
Painful skin rash that spreads and blisters
Increased risk if the patient has a gene called HLA-B 1502
skin & mucuous membranes on the inside are affected
what is Erythema multiforme and signs
skin disorder that’s considered an allergic reaction to an infection or medicine
Allergic reaction to some antibiotics, NSAIDs, and infections
Allergic reaction involves mucous membranes, skin and eyelids
Produces variety of skin lesions from bumps, plaques, to blisters
In its most severe form, it is called Stevens-Johnson Syndrome
Signs of an ADR in the Auditory-vestibular systems can include
Dizziness
Vertigo
Other balance disorders
Hearing loss
Tinnitus
the most common side effects of medications
tinnitus & dizziness
Signs of an ADR related to the Skin can include
Drug-induced itching and redness
Acne
Alopecia
Herpes simplex
A viral infection, caused by a group of herpes viruses that can produce cold sores, genital inflammation, or conjunctivitis
Sweating
Urticaria (hives)
Skin ulcers
Steven Johnson syndrome (affects skin & mucous membranes)
viral infection, caused by a group of herpes viruses that can produce cold sores, genital inflammation, or conjunctivitis
herpes simplex
Drug hypersensitivity and allergies are an adverse drug reaction
true
why do Drug hypersensitivity and allergies occur
due to the immune system
how does the immune system attack a drug
The immune system is a constellation of responses mounted by the body to attacks from outside the body
anything that is coming in from the body elicitating an allergic reaction or immune response
antigen
any substance, from a virus to a wood sliver, that elicits an immune response
antigen
antigen specific
iparts of the immune system recognize and act against particular antigens
parts of I.S. is systemic
not confined to the initial infection site but work throughout the body
parts of I.S. have memory
recognize and mount an even stronger attack to the same antigen the next time
how to vaccines work
you take covid vaccine and now when you get covid next time the body has a quick response and doesn’t make virus multiply and make you sick
The most important component of the immune system is
Self/Non-self Recognition
what is Self/Non-self Recognition
achieved by every cell displaying a marker based on the major histocompatibility complex (MHC)
what are mhc
group of genes that code for cell surface proteins essential for the immune system
Any cell not displaying marker MHC is treated as non-self and attacked
true
examples of autoimmune diseases
multiple sclerosis (MS), sudden sensorineural hearing loss, rheumatoid arthritis, and Type 1 diabetes
Sometimes the process breaks down and the immune system attacks the body’s own cells
autoimmune disease
instances when the immune response to innocuous substances is inappropriately overwhelming
allergies
two main fluid systems in the body that are partof the immune system and also transport agents of this system
Hematopoietic (blood) and Lymphatic systems
cells of hematopoietic system
Erythrocytes or red blood cells (RBCs) - Carry oxygen
Leukocytes or white blood cells (WBCs) - Fight infections
Thrombocytes or platelets - Help control bleeding
Carry oxygen
Erythrocytes or red blood cells (RBCs)
fight infections
Leukocytes or white blood cells (WBCs)
help control bleeding
Thrombocytes or platelets
simpe substances that elicit this response of allergies is called
allergens
clear, transparent, and colorless
lymph
what is lymph
clear, transparent, and colorless
flows in the lymphatic vessels alongside the blood vessels, bathing tissues and organs in its protective covering
examples of allergens
dust & pollen
what are lymph nodes
Along the lymph vessels
filters lymphatic fluid
area where antigens are usually presented to the immune system
lymph nodes
RBCs, WBCs, & thrombocytes and platelets all develop from a common cell in the bone marrow
true
develop at the pluripotent hematopoietic stem cell
how do the different cell types differentiate
They differentiate into these different cell types by interactions with dozens of glycoproteins called hematopoietic growth factors
glycoproteins
hematopoietic growth factors
what are pluripotent hematopoietic stem cell
whatever organ or system they go in, they will becomes cells or organs of that area
type of stem cell that can differentiate into cells from any of the three germ layers in the body, and are thought to be the source of most cell types.
what are glycoproteins
they have a carbohydrate (sugar) attached to proteins
hematopoietic growth factors
naturally occurring substances which regulate the production of circulating blood cells