Unit 1: Pharmacology resources Flashcards
(225 cards)
1
Q
Drug manufacturers must submit prescription drug label information (prescribing information) in an _______
o Do a Google search for the drug prescribing information o For example: Nexium prescribing information o Then, look for the PDF link from the manufacturer
• The DailyMed System is available online to all. The full prescribing information (FPI) will be organized in a _________ SPL) format o You can even email it to yourself!
A
electronic format
“structured
product labeling”
2
Q
WHAT IS THE PERFECT DRUG?? _____ of the drugs we study will meet ALL these criteria!!
• highly potent
• 100% selective for the part of the body being treated
• completely safe
• have no side effects or drug interaction
• be universally affordable.
A
none
3
Q
3) What is the basic pharmacological profile for the drugs in a particular class?(usually, this will be labeled as the “CLASS” of drug) ?
A
absorption degradation and elimination potential drug-drug interactions monitoring requirements use in subpopulations like pediatrics and pregnancy
4
Q
What is the safety profile of the drug or drug class? What ______ monitoring should be done for this drug.
A
special patient
5
Q
What is the safety profile of the drug or drug class? What ______ monitoring should be done for this drug.
A
special patient
6
Q
5) What NON-pharmacologic interventions might be included in treating this condition?
• how do they contribute to holistic care of the patient? 6) Selection of drugs for special patient populations:
A
- age, sex, reproductive status
- comorbidities, medication history, allergies
- cultural issues
- polypharmacy
7
Q
Drugs change biologic functioning via _____ on cells.
A
chemical action
8
Q
______ is the study of how chemicals interact with living systems (cells, organs, organisms) and involves understanding cell biology, receptor theory, biochemistry.
A
pharmacology
9
Q
Some drugs are actually chemicals our own body makes called ____.
A
endogenous substances
10
Q
Drugs administered to a person are called _____.
A
exogenous substances
i.e. our bodies make endogenous cortisone every day, and we use exogenous prednisone as a drug
11
Q
______ is when humans use drugs to treat and prevent disease, sometimes for recreational or religious/cultural use.
A
Applied pharmacology
12
Q
______ is the undesirable effects of chemicals on living systems.
A
Toxicology
13
Q
______ is the undesirable effects of chemicals on living systems.
A
Toxicology
14
Q
______ are harmful drugs and/or inorganic toxins
A
Poisons
15
Q
______ are poisons of biologic origin (organics).
A
Toxins
16
Q
An ____ is the smallest part of matter, elements are made up of only one type of atom (e.g. Oxygen), molecules (compounds) are composed of more than one type of atom (e.g. H2O).
A
atom
17
Q
______ is the total atomic weight of all the atoms in a molecule.
A
Molecular weight (MW)
18
Q
_____ exists in three physical states of solid, liquid, gas; these characteristics are determined by ambient pressure & temperature.
A
matter
19
Q
_____ are
based on carbon (C), hydrogen (H), oxygen (O), nitrogen (N) and some Sulfur (S). o Often written as “CHONS”…98% of the earth’s crust is made of these chemicals,
including our bodies.
A
Organic compounds
20
Q
_______ are elements other than CHONS o may be BULK inorganics (e.g. calcium, sodium) o may be TRACE inorganics (e.g. selenium, boron)
A
Inorganic compounds
21
Q
_____ is the solid substance that is dissolved in the liquid o Solvent: the liquid (which is always water in living systems)
A
Solute
22
Q
_____ are electrically charged particles in solution.
A
ions
23
Q
_____ are positive charged ions.
A
cations
24
Q
______ are negatively charged ions.
A
anions
25
______ are ions in living systems.
electrolytes
26
Neutral means no _____ charge.
electrical
27
pH measures how ___ the solution is which is defined by the concentration of positively charged hydrogen ions (H+)
acidic
28
____ are chemicals that can accept a hydronium ion (H+) in solution.
bases
29
The _____ state of the chemical(drug) affects the route of administration possible when the drug is given to the body.
physical state
30
Liquids or solids can be taken _____.
orally
31
Liquids can be injected via intravenous, intramuscular, and _____.
intradermal
32
_____ are inhaled such as anesthetic gases.
gases
33
The state of matter of a substance depends on the environmental temperature and ______, so normally we think of a drug as existing in liquid, solid or gas state at “standard” room temperature and pressure. Sometimes, we alter the environment
pressure
Example: we compress gases such as oxygen by putting them under pressure in pressurized canisters so that we can transport larger amounts of oxygen in a smaller space (the same number of molecules takes up less space when pressurized into a liquid in the canister)
34
The size and shape of the chemical (drug) is the ____.
molecular weight (MW)
35
Drug sizes range from very small (atomic Lithium, MW 7) to huge (like alteplase, t-PA, protein MW 60,000) but the average drug is somewhere in the middle, MW _____.
100 - 1,000
36
____ must be big enough so that the drug unique enough to have specific biochemical activity. But, if it is TOO large, it may have difficulty moving between body compartments
Size
example: the drug alteplase is very large & cannot leave the vascular space,
works intra-vascular as a thrombolytic clot-buster that we give to patients having a heart attack or stroke
37
Some _____ come in the racemic form.
drugs
38
Mirror images around a central axis (called optical chirality, chiral drugs,
stereoisomerism, enantiomer, isomers, dimers, racemes) o ____ based on the rotation around a carbon atom due to the rotation of polarized light
racemes
39
Racemes with a carbon atom that rotates to the left of polarized light is called _______
left or levo rotatory
40
Racemes with a carbon atom that rotates to the right of polarized light is called _______
right or dextro-dextrorotatory oriented
41
______ are therefore mirror images of each other.
isomers
42
_____ activity of the left/right isomers may vary
biologic
43
Receptor binding may be different, enzyme activity may be different and may even be ______ in one orientation and helpful in the opposite orientation !
toxic
44
Biologic systems NORMALLY make right/left versions of ________ synthesized molecules
endogenously
o biologic example: "reverse" T3 from the peripheral tissue de-iodination of T4 o drug example: ofloxacin and levofloxacin (Levaquin) – the levo-rotatory
version of the drug is much more powerful as an antibiotic o Other common example:
• dextrose is simply D-glucose (dextro-rotatory glucose, dextro- glucose), an isomer of glucose that is found in honey and sweet fruits; dextrose (dextrorotatory form of glucose found naturally in animal and plant tissue and also can be derived synthetically from starch)
• Dextrose 5% in water (D5 W) is a “maintenance fluid” and isotonic (iso- osmotic) as administered intravenously and thus does NOT hemolyze cells
• HOWEVER, since the cells take up the glucose and metabolize it, the net effect is as though you are giving PURE WATER (“FREE” water) and is distributed as such throughout the total body water (2/3rd to ICF and 1/3rd to ECF with the ECF fluid distributed one fourth to plasma & three-fourths to interstitial fluid) • think of how things appear in the mirror
• hold up your own hands, thumb to thumb – the right hand and the left hand look like mirror images of each other – but you CANNOT superimpose one hand over the other (due to the “handedness” they are NOT exactly the same!!)
45
Chemical bonding is when one chemical ____ or associates with another
attaches
46
______ bonds are less common in drug effects, since they are strong and are rarely reversible
Covalent
47
Weak bonds more commonly used by drugs; more _____ in action as drug can dissociate (separate) away after the initial bonding
reversible
48
Electrostatic bonds rely on ______ attraction.
electrical
49
Hydrophobic (water hating) bonds are very _____.
weak
50
Sometimes the specific actions of a drug rely on the “fit” into a cell’s enzymes or
______. The better the “fit” using these weak bonds allows for a more ______ drug action
receptors
| specific
51
Inert substances do not bond, but can still have _____ effects, e.g. some anesthetics.
clinical
52
Laws of thermodynamics promote _____ (disorganization) of substances
entropy ?
53
Concentration differences (gradients) causes solute to passively diffuse from high to low concentration areas without any _____ being required.
energy.
54
Remember, the electrical charge of a substance is dependent on the ____ of the solution as well as the acid/base characteristics of the substance.
pH
55
Hydrophilic ionized (charged) substances are more water _____
soluble
56
Lipophilic (Hydrophobic): neutral (uncharged) substances are more lipid ______
soluble
57
Amphiphilic means that the drug is BOTH water AND ____ soluble.
lipid
58
Water solubility drugs need to get into the “water compartment” (the plasma in our bloodstream) in order to travel to their location of ______ in the body
activity
59
Lipid solubility drugs need to get past the phospholipid cell membrane to get
out of the bloodstream and into the ______
tissues
60
Transport proteins (TP): SOME drugs that are more ______ are still able to get across cell membranes due to the presence of a transporter protein (TP) molecule embedded in the cell membrane that carries the drug into the cell
hydrophilic
▪ Examples: the very hydrophilic statin drug, pravastatin (Pravachol), needs a special TP to get into the liver cell and do its work o Toxicity may occur if the drug is able to enter a part of the body where it has
the potential to do harm, theoretical increased risk of adverse effect
61
_______ drugs can cross the Blood Brain Barrier (BBB)
Lipophilic
62
The BBB blocks ______ drugs from entering the brain
hydrophilic
63
Any drug needed to work in the _____ must be lipophilic
brain
▪ example: may affect which antibiotic can be used to treat meningitis o Trapping of drugs can occur in certain areas of the body due to the pH of the body fluids there; not all body fluids are the same pH (urine, semen, breast milk)
▪ example: we can use this to our advantage by choosing drugs that concentrate in the urine and thus can be used to treat urinary tract infections (UTI)
64
Everything in blood plasma doesn't get into _____ and the brain
CSF
65
Once a substance gets into the CSF, the entire brain is exposed to the ______. This can occur if substances are able to cross the BBB o this can occur if substances are injected directly into the ______ (intrathecal drug
injections)
substance
| ventricles
66
________ (astrocyte cells that are supporting cells of the brain) that selectively
absorb substances from the blood
neuroglia
67
________ between endothelial cells that make up the brain capillaries (brain
capillaries are less "leaky").
Tight junctions
68
Brain areas without the BBB include the pituitary, hypothalamus, and _____. Why? in these areas, the brain needs to _______ the body's internal environment
for regulation of bodily functions.
pineal
| sample
69
What crosses the BBB important clinically? Enters _____: similar to cell membrane rules.
easily
70
What crosses the BBB? lipid soluble (alcohol, anesthetic agents ---lipophilic and water and gases (carbon dioxide, _____)
oxygen
71
Proteins & Electrolytes or any other large molecules → many therapeutic drugs (e.g. antibiotics) are _____ in plasma & can't enter CSF.
protein
bound
CLINICAL: difficulty in treating meningitis/encephalitis/cerebral abscesses & brain
dysfunction (e.g. depression) – can’t get some chemicals into the brain.
72
Therapeutic objectives (target outcomes) are the expected ______ of the drug. These should make sense within the context of the pathophysiology of the condition
benefit
73
The DOC is the ____.
drug of choice
74
Usually, the drug of choice (DOC) is first-line therapy for that condition. This means this drug will probably:
o work the ____
o be effective when used alone (monotherapy)
o will have the least ____ to the patient with the condition
best
| toxicity
75
______ are the reason to use the drug (the medical condition)
Indications:
76
______ are what the Food & Drug Administration (FDA) has legally determined the clinical condition for which the drug should be used – this is called label approved
Label indications
77
_______ use often clinicians will prescribe drugs that are not label approved for a specific condition because the science of the drug and the available clinical evidence has demonstrated that the drug will work.
OFF label
78
___________ are possible reasons NOT to use the drug in that particular patient. These reasons may be patient age, sex, reproductive status, allergies,
comorbidities or other factors.
Contraindications
79
_______ do not give the drug under any circumstances.
Absolute contraindications
80
_____ the need for the drug is so great as to overcome
the possibility of an adverse drug reaction; the provider should perform extensive documentation in the chart and disclosure of potential risks to the patient – this is a ________
Relative contraindications
| “risk/benefit decision”
81
Legal (Licit) Drugs in the USA consist of ____ classes of licit (legal) drugs. The two classes are prescription (legend) and _____.
two
| Over-the-counter (OTC) and Behind-the-counter (BTC)
82
______ and marketing is subject to federal authority through the Food and Drug Administration (FDA); only drugs approved by the FDA are legal in the USA
drug labeling
83
The ____ book lists all approved drugs in the USA>
organge
84
Drugs with abuse potential are further regulated under the restrictive authority of the Drug Enforcement Administration (DEA). These are _____ and are also called “Schedule Drugs”
“controlled substances” (CS)
85
Controlled substances or schedule drugs are grouped into Schedules ______ based on abuse potential. Federal laws (and sometimes state laws) govern their availability and who may
prescribe
1-V
86
Some drugs are illegal in the USA due to their ______.
CS schedule
87
Often you will hear the acronym CSA which refers to the ______(the legislation passed in 1970 that created these “schedules”) which are updated annually
Controlled Substances
| Act
88
_____ (in some years, more than half) of all drugs consumed in the USA are OTC.
Half
89
____ can be safely self-administered by the lay person for self-limiting conditions that are non- life-threatening, and that do not represent potential for loss of LIFE, LIMB or EYESIGHT.
OTC
90
Labeling on these OTCs should be such that a ______ can understand indications, contraindications & directions for use.
lay person
91
No OTCs are meant for chronic use or as a ______ for diagnosis and definitive treatment of disease conditions
substitute
92
Many times, an OTC product was originally a ________ product – the FDA can review its safety record and allow it to be marketed OTC
prescription
93
The consumer is required to check with the pharmacist before they can purchase these non-prescription items called ______. Other drugs may be added to this category over time.
behind-the-counter (BTC)
Example: To purchase some decongestants (cold remedies) such as pseudo-ephedrine, the consumer can only purchase limited amounts from “behind the counter” – the pharmacist may ask information regarding the consumer’s name and address and ask if the purchase is bona fide
94
Herbals and ______ are not under FDA control, sold as dietary supplements
nutritional supplements
95
With herbal and nutritional supplements there is a large opportunity for drug-drug interactions as well as _________.
adverse effects
96
There is a government office called the “Office of _______” which is part of the National Institutes of Health (NIH)
Dietary Supplements
97
This simply means that in the USA a person needs a _______ from a licensed provider to obtain this drug from a dispensing agent (pharmacist). Note that in other countries, this may not be the case
prescription
98
You must be sure of the _____ or chemical name of the drug.
generic
99
The generic name of the drug may follow _______ (naming) rules.
nomeclature
| ▪ example: the 5HT-blockers all end in “-setron” (gastrointestinal drugs)
100
The brand name is _____ by the drug company and it is a marketing tool. It is approved by the Food & Drug Administration (FDA)
and is ______.
owned
| trademarked
101
realize, however, that even if you buy a drug by the same name in another country, you may not be getting the same _____ – drug companies own brand names and use them to market different products in different countries under the same name
drug
102
Sometimes, the FDA requires drug companies to _______ of a drug that has already been released to market. This occurs USUALLY because the pronunciation or the spelling sounds or looks like other drugs & thus causes ________.
change the name
medication errors
Example: the proton-pump inhibitor dexlansoprazole (Kapidex) will have its name changed to “Dexilant” in April 2010. This is because it kept getting confused with brand names of two other drugs (Casodex & Kadian):
103
Usually written as C-I, C-II, C-III, C-IV, C-V for the different _______.
“scheduled drugs”
104
Controlled substances or scheduled drugs considered to have ______ and are under control of the DEA
abuse potential
105
Controlled substances or schedule drugs are determined to have a risk of ______ with chronic use, or a high risk of drug diversion
addiction
106
The Schedules are determined by the _____.
Drug Enforcement Agency (DEA)
107
Schedule I drugs are _____ and illegal in the USA.
illicit
| i.e peyote, heroin
108
Schedules II-V are ___ and legal and require additional prescriptive authority from the federal government in addition to the basic prescriptive authority granted by the state.
licit
109
Some ____ have additional certification requirements in addition to the federal requirements of scheduled drugs.
states
110
Some states also require the ________ for schedule drugs be written on state-provided RX pads and be kept on file for a specified number of years
prescriptions
111
Scheduled drugs are mostly analgesics, ______, or have other CNS effects
stimulants
112
Scheduled drugs are mostly analgesics, ______, or have other CNS effects
stimulants
113
C-I have high potential for abuse, no accepted medical use in treatment in the USA, lack of accepted safety for use in ________. NOBODY may prescribe these drugs.
Exceptions:
Use for religious purposes (e.g. Native Americans & peyote) DEA approval case-by- case
treatment
Example: LSD, mescaline, PCP, heroin, marijuana; mostly fall into the classes of opium derivatives, hallucinogens, depressants, stimulants. Usage is illicit (use subject to legal penalties).
114
Many states have enabling legislation for ______ as an anti-emetic & pain control, but still not officially sanctioned by the DEA
medical marijuana
115
Use of ______ as medical marijuana has been added to many clinical practice guidelines (e.g., for multiple sclerosis)
THC
116
C-II drugs with a high potential for abuse, abuse may lead to severe psychic or physical ______.
dependence
Narcotic (Opioid) Examples: methadone, meperidine, hydromorphone (Dilaudid), oxycodone (Tylox), uncombined codeine (combining with non-narcotic analgesics reduces their abuse potential), Percodan, Percocet. RECENT (2014) addition of combined hydrocodones (e.g., Vicodin, Lortab)
• Non-narcotic Examples: amphetamines (methylphenidate -- Ritalin), barbiturates (amobartibal, etc).
117
Provider AND the pharmacist must keep a record of the prescription and/or dispensing of CS -II drugs. Some states have even more _______ requirements for usage & prescribing that others (triplicate pads, etc.). No _____ prescriptions or refills allowed by any provider.
stringent
| telephone
118
C-III drugs have the potential for abuse, but less than ______.
Schedules I & II
Narcotic Examples: combined codeines
Non-narcotic Examples: different forms of barbiturates and anabolic steroids. Refills and telephone prescription rules vary by state.
119
_____ drugs with less potential for abuse than II & III. Telephone prescriptions are usually permitted.
C-IV
• Examples: depressants (e.g. Xanax, Valium, phenobarbital), stimulants (Fenfluramine)
120
C-V: drug with a ___ potential for abuse relative to the above.
low
Examples: Tylenol III with codeine elixir, Novahistine DH, Lomotil. (Generally, codeine combinations with 200 mg/200 mL or less) (Some states allow dispensing without a prescription, such as low dose codeine combinations in cough suppressant formulas)
121
DEA assigns each CS a schedule number (Roman numerals I through V) according to its _______, harmfulness, and potential for abuse or addiction.
medicinal value
122
A ________ indicates the substance has more medicinal value
| and less potential for abuse or addiction.
higher schedule number
123
What is the LETTER after the Roman numeral?
o The letter "N" can also accompany the schedule number, signifying the
substance is a ______. The absence of the "N" (e.g. II) means it is a ______.
non-narcotic
| narcotic
124
A ____ codes number is a 4 digit number assigned to each CS.
DEA
125
Prescribers need special ______ to prescribe CS drugs in addition to their state license or certification they need a federal Drug Enforcement Administration (DEA) number. Some states require ADDITIONAL certifications as well.
licensing
126
To _____ of drugs in the trash, preferably mixed with non-drug substances (e.g. kitty litter or coffee grounds) o Some drugs should be _______ the toilet (too toxic in one dose to take
the chance of a child or pet ingesting the drug)
dispose
| flushed down
127
_________ nutrition maintains a healthy body & prevents illness.
Preventive
128
_____ nutrition is designed to help cure illness and alleviate symptoms
Prescribed
129
If you PRESCRIBE nutrition, this is written down for ______ (& also insurance
reimbursement purposes) as Medical Nutrition Therapy (MNT)
charting
130
A ______is “a food which is formulated to be consumed or administered entirely under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
medical food
131
A medical food is prescribed by a physician when a patient has special ______ in order to manage a disease or health condition, and the patient is under the physician's ongoing care.
nutrient needs
132
The label of medical food must clearly state that the product is intended to be used to manage a specific _______ or condition.
medical disorder
o An example of a medical food is a food for use by persons with
phenylketonuria, i.e., foods formulated to be free of the amino acid phenylalanine
133
Medical foods are not those foods included within a healthy diet intended to
______the risk of disease, such as reduced-fat foods or low-sodium foods, nor are they weight loss products.
decrease
134
Medical food is now being marketed more aggressively – they have an _______ over dietary supplements. Dietary supplements CANNOT claim to treat a medical condition
advantage
135
Medical foods ____ claim to treat a medical condition
CAN
```
Examples:
o flavocoxid (Limbrel) for arthritis (sounds like a COX-2 inhibitor but it isn’t) o Phenyl-free-1 for PKU babies o Pro-Phree for celiac disease o Ketonex-1 for maple syrup disease
```
136
Medical foods are used to have their own ______ (unique drug identifier number assigned by the FDA), like any other drug; but now, the FDA considers this labeling to be misleading and they no longer have their own NDC number.
NDC number
137
______ are the actions of drugs on the body.
PHARMACODYNAMICS:
138
_______ are the actions of the body on drugs. (Usually refers to detoxification processes leading to inactivation and excretion of drugs)
PHARMACOKINETICS
139
What are some possible mechanism of action (MOAs)?
• Receptors and Receptor Activation or Antagonism:
When receptors are _______ (on cell membranes, in cytoplasm, on
DNA) that bind substances called ligands Ligands can be drugs, endogenous hormones, or any chemical that binds to receptors.
endogenous molecules
140
The affinity of a drug reflects its _____ of bonding to its specific receptor.
strength
141
______ drugs bind & activate the receptor to produce the desired biologic effect.
Receptor Agonist
• Example: some oral hypoglycemic agents are secretagogues that induce the pancreas to produce insulin by interacting with pancreatic receptors that would normally respond to foodstuffs (glucose, amino acids)
142
__________ drugs inhibit or blocks somehow the effect of agonists. They may block the body’s ______ substances from exerting their normal effects – this is a competitive receptor antagonist that competes for the same binding site on the cell’s receptor as our endogenous molecules
Receptor antagonist
endogenous
• Examples: beta-blocker drugs block the beta-receptor and prevent endogenous catecholamines (epinephrine, norepinephrine) from exerting their effects
143
_________ on endogenous chemicals that can bind other chemicals. This binding does NOT change the physiology of the cell, but may STILL cause an effect on drug activity.
Inert binding sites
o Example: albumin binds drugs in the bloodstream (vascular space), reducing the amount of free circulating (active) drug → this reduces the BIOAVAILABILITY of the drug o Example: we can actually use this to our advantage and make it the MOA of the drug itself → the drug Digibind works like this to reduce digoxin toxicity (binds digoxin)
144
Drug effects on body enzymes can be the ____ of the drug
MOA
145
________ are proteins in the cell that make chemical reactions go faster (catalyze
or speed up)
Enzymes
146
An enzyme works on chemicals called ______ to form products o the name of an enzyme always ends in the suffix “-ase.”
substrates
```
o example: some drugs are enzyme inhibitors, such as the cardiovascular class of
drugs called ACE-inhibitors (ACEI)
```
147
A sequential series of chemical reactions catalyzed by enzymes; the product of
one enzyme becomes the substrate of the next enzyme in the sequence o these intermediate steps thus produce “intermediate metabolites”. Inborn errors of metabolism cause symptoms due to the ______ of intermediary metabolites that occur due to a lack of necessary enzymes to complete the sequence. Drugs can affect the ______ in the sequence, blocking synthesis of a final product.
toxic buildup
enzymes
Example of a metabolic biosynthetic pathway:
A is a substrate for Enzyme 1, & its product, A B C FINAL PRODUCT
B, becomes the Enzyme 1 Enzyme 2 Enzyme 3
substrate for Enzyme 2.
148
________ prevent normal physiologic activity of cell “pumps”
Pump Poisoners
149
Proton pump inibitors (PPIs) prevent release of H+ from ______ and are therefore useful in treating gastric acid conditions like peptic ulcer disease.
gastric parietal cells
150
Osmotic effects the _____ of the body’s compartments
water balance
o Example: osmotic diuretics that draw water into the bloodstream like mannitol
151
________ sometimes you’ll hear this word used and it means “Many & Varied”. So the drug may have effects on the body _____ what is expected from its MOA
Pleiotropic effects
BEYOND
Example: statin drugs have an MOA that prevents synthesis of cholesterol in the liver, but OTHER effects include beneficial effects on the body’s blood vessels and stabilizing atherosclerotic plaque
152
_______ naturally restore the “normal” balance of the bacterial flora in the body. They are usually given together with antibiotics to reduce or prevent antibiotic-associated diarrhea.
Probiotics
Example: Lactobacillus and Saccharomyces (found in supplements as well as
natural sources like buttermilk and active culture yoghurt).
153
_______ engineered to act at the micro-molecular biochemical level. Most drugs _______ in some form in nature. These drugs are designed totally in the lab. Therapeutic procedures and special diagnostics: May also be under FDA control
Designer drugs
| originated
154
Results of placebo-controlled, double-blind, cohort matched randomized controlled trials tells us if drug claims are valid.
Evidence Based Medicine (EBM)
155
_________ (RCT) is the gold standard of drug trials and placebo effect.
Randomized Controlled Trial
156
When both the investigator and the patient are unaware (“blinded”) regarding who is receiving active drug or placebo (to measure placebo effect) it is called _____.
“double blind”
157
A _______ is a substance given to the patient with no known drug effect o however, the placebo effect occurs – patients report improvement or even.
objectively measured data (e.g. blood pressure) can actually improve - why? Unknown – some sort of effect of the mental EXPECTATION that a drug will have effect. If we tell you the drug is to treat your hypertension, the placebo actually delivers this effect due to your psychological EXPECTATION that it will (mind-body connection)
placebo
158
Subject _____ are matched by age, sex and other clinical criteria.
cohort groups
159
Subject _____ are matched by age, sex and other clinical criteria.
cohort groups
160
Statistical analysis tells us if we can _____ the results patients in the drug trial should be a diverse sampling (e.g. not just white males ages 40 - 60 yo) to give a “real world” result. Length of time of trial (for a chronic drug, the longer the better). Statistical significance (p) is 0.05 or less (results are less than 5% due to chance – difference in the treatment group actually exists) o confidence interval of 95+% (the process is right 95% of the time – gives you a
more narrow range of those needed to treat to arrive at the result)
trust
161
“Pediatric Rule” passed by Congress allows FDA to require pediatric _____ &
provides for incentives for pharmaceutical companies to test on kids.
testing
162
Note that herbal products are rarely subjected to the same ______ as drugs, since they do not have to obtain FDA approval for marketing!!
rigorous studies
163
Often, herbal remedies occur in ____ and you’ll see their popularity wane when a true RCT is conducted that fails to show evidence of benefit
“fads”
o Example: RCT testing Echinacea to prevent or treat rhinovirus infection (cause of
the common cold) failed to show benefit.
164
```
An ______
involve an investigator and patient that are aware of the therapy (not “blinded”). May create a bias due to the placebo effect or other beliefs of patient/investigator. Usually a _______ trial of two drugs of the same class to see which is “better”
```
open-label drug trial
| "head-to-head"
165
When we talk about drugs, the normal way to do this is to FIRST give the GENERIC name and then follow that with the ––––––– (in parentheses when written).
BRAND NAME
| o Example: Cephalexin (Keflex), famotidine (Pepcid)
166
In academic discussions, most people would use the generic name; in casual use, many people use the generic and brand names ______.
interchangeably.
167
A _________ is a patented trademark (and in fact, patents are given for a specified period of time to one manufacturer)
BRAND NAME
168
Once a drug goes off _____, and generic manufacturers are allowed to make it for sale to the public, the prescription should indicate if ONLY the brand name should be dispensed, or if a generic substitution is allowed.
patent
169
_______ of generic drugs is set by the standards of the United States Pharmacopeia (USP)
BIOEQUIVALENCE
170
The FDA has specific rules regarding the manufacture (quality, consistency) of
______ drugs, and they are usually appropriate for substitution with the brand name drug in most clinical cases.
generic
171
Occasionally, with a _______ drug (a very consistent blood level is required for this drug that cannot vary), substitution is denied
critical dose
▪ example: some seizure medications may NOT have bioequivalence between generics and brand name
172
Sometimes, when a drug “goes generic” the original manufacturer may seek to extend the life of its _____ by several methods:
o Combining the drug with another drug into one pill (Vytorin = Zocor + Zetia)
o Reformulating the drug in a different delivery system as an “extended release” (XR,CD, XL) drug rather than the original “immediate release” (IR) formulation
patent
173
_______ are the medical conditions that the drug is FDA-approved to treat. This is determined by the FDA after the manufacturer (pharmaceutical company) provides evidence of ____ and safety to the FDA
Label indications
| efficacy
174
However, in many cases, _____ prescribing is done
o There is no label-approved drug for the condition (e.g. only in 2007 was a drug approved to treat fibromyalgia)
o There is no label-approved drug for the age group (often occurs in pediat
o This is also called _______ or unlabeled indications prescribing o this is not malpractice, but the provider must be able to justify off label usage using criteria of a scientific basis, with clinical literature/studies to determine reasonableness.
off-label
| unapproved
175
What must the provider do with off-label prescribing:
▪ disclose to patient the off-label use (e.g. say “this drug is for pain but I’m giving it to you for your cough”)
▪ carefully _______the disclosure, the reason for off-label use, and any supportive documentation you may have (e.g. recent clinical trials data, publications by specialty journals indicating correctness of practic)
document
▪ Example of off-label prescribing: nifedipine (a CCB, calcium channel blocker) is used to treat Raynaud’s disease since it is a peripheral vasodilator.
176
New Drug Development is enormously _____, so mostly done by large corporations
expensive
177
With new drug development only about __% of drugs studied are ever approved for marketing.
10%
178
With new drug development a ____ need must be demonstrated.
clinical
179
With new drug development animal testing also determines the _____ (LD50 is the dose that kills 50% of the animals)
lethal dose
180
With new drug development the initial dose for human trials is usually about _____ of the animal LD50’
1/10 - 1/100
181
With new drug development human testing begins once an ______ (Notice of Claimed Investigational Exemption for a New Drug) is filed with the Food & Drug Administration (FDA)
IND study
182
______ drugs with limited usage for really rare diseases
Orphan
183
Why do companies make orphan drugs if there is no money in it?
The FDA gives incentives to pharmaceutical companies to research (develop) & produce them – other drugs in development by this same company will receive preferential treatment in the approval process
* EXAMPLE: DHEA (Fidelin) orphan drug for adrenal insufficiency (Addison’s disease)
* URL: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm
184
CDER stands for
Center for Drug Evaluation and Research
185
Drug Safety Initiative from CDER aims to provide drug _____ to consumers with internet sites for drugs.
information
186
Drug Safety Initiative from CDER aims to provide drug _____ to consumers with internet sites for drugs.
information
187
Drug Registry programs are for when the drug is known to cause specific problems, FDA allows _____ concurrent with a registry
adverse effects. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforP atientsandProviders/ucm094307.htm
marketing
188
Providers must be _____ in prescribing (usually a drug company educational program). Pharmacists check for such certification before dispensing.
certified
189
Prescribing requires _____ and/or special monitoring and joining the registry to monitor adverse effects
blood tests
Example:
o iPledge program for isotretinoin (Accutane) – a drug for acne that has
many possible SERIOUS
190
A ____ number is a unique identifier number for all human drugs (manufacturer, drug, dose, formulation)
NDC
191
The _____ or package insert is a summary of chemical and biological information on the drug. That includes data from RCTs, warnings, prescribing guidance, how supplied, dosing, etc.
prescribing information
192
Drug manufacturers must submit prescription drug label information in an _____ format.
electronic
193
Daily Med from the NIH is supposed to have up-to-date information for both prescribers & consumers on all _______
marketed drugs
194
VAERS stands for
Vaccine Adverse Events Reporting System
195
Parent/guardian should have been questioned about _____ adverse reactions to vaccines.
previous
196
Reactions to vaccines can be ____ or life-threatening.
trivial
197
Many diseases occur in ____ that are also confused with vaccine adverse events.
childhood
198
Under the National Childhood Vaccine Injury Act of 1986, certain vaccines must have _______ kept, and adverse events of clinical significance reported under the "Vaccine Adverse Events Reporting System" (VAERS) which is part of the FDA
permanent records
• Additionally, since vaccine manufacturers were raising vaccine prices and in some instances, refusing to make vaccines, due to fear of liability, the Vaccine Injury Compensation Program (1988) is supposed to financially compensate a child for a significant adverse event and/or disability.
199
The Vaccine Injury Compensation Program (1988) is funded by a ______ on the vaccine included in the price of the vaccine.
surcharge
200
____ is ONLY for vaccine-related injuries or adverse effect reporting. EVERYTHING else is reported to Med-Watch
VAERS
201
Center for Food Safety and Applied Nutrition (CFSAN) is a new adverse event reporting system for a food, ____ or dietary supplement
• Actually this is part of the FDA
cosmetic
202
The _________ is put at the very top of the Prescribing Information (PI) for the drug to highlight a serious adverse effect risk
• It is the strongest labeling requirements for _____ medicines.
• Includes risk of serious infection, dependence, other toxicities (for example, ACEI drugs causing fetal toxicity)
Black Box Warnings (BBW)
high-risk
203
_________ are given to the patient by the pharmacist. They are also part of the PI (tacked onto the end of the PI)
Patient MedGuides
204
________ is when patient takes the medication as prescribed. This term has somewhat fallen into disfavor – implies controlling the patient.
Compliance
205
________ is when a patient takes the medication as prescribed, AND follows through on other elements of the management plan (non-pharmacologic interventions such as diet, exercise, etc.). This term implies a partnership of the patient with the healthcare team. A newer term that indicates the patient's willingness & ability to follow a recommended regimen of therapy
Adherence:
206
_____ is when a continued administration results in decreased response to the same dose. Thus, a higher dose will be needed to obtain the same drug effect.
tolerance
207
_____ is when the tolerance develops rapidly.
TACHYPHYLAXIS
208
Physical (physiologic) ______ means that if the drug is stopped a withdrawal (abstinence) syndrome will develop.
dependence
209
Dependence is an undesirable physiologic changes that occur when drug is ______ or when its effect is counteracted by another agent o that is why “weaning,” or gradual discontinuation, is required
discontinued
210
```
___________ are when drugs within the same class can be used to prevent or relieve the symptoms of
withdrawal from another drug in the same class
```
Cross-dependence (Cross-tolerance):
o Example: replace alcohol with Librium to prevent withdrawal delirium tremens
reaction (both sedative-hypnotics)
211
________ is the feelings of satisfaction & desire to repeat drug experience despite knowing that the drug is causing harm
Psychologic dependence (sometimes also called "addiction")
212
Recreational drug use implies _____ use without dependence, often practiced with rituals & in company of others.
episodic
213
Some healthcare settings include drug _______
which are limitations of what drugs can be prescribed to the patient.
Usually in an insurance situation or hospital setting.
formularies
214
JCAHO has mandated that medication reconciliation be done on patients transiting different ________ (in and out of hospital, nursing home, etc.). This is to assure that patients are getting the right drugs. Done every time a patient ______ into, within, or out of a healthcare facility. This is a critical area for medication errors, and reconciliation can reduce errors by ___%
o drug history is essential, including OTC/BTC drugs and supplements (vitamins,
herbals)
medical settings
transitions
70%
215
________ are drugs are marketed by a pharmaceutical company in a combined form (tablet, capsule). The prescriber can use the combination of these two drugs by giving one prescription
Fixed-drug (fixed dose) combination
216
The benefits of fixed-drug (fixed-dose) combinations include a _______ “pill burden” for the patient o possibly less cost if the combined drug costs less that the two drugs separately
reduced
217
The drawbacks of fixed-drug (fixed-dose) combinations include the prescriber _______change the dose of the individual components – that is why it is called “fixed-dose”
cannot
218
______ is the degree to which a drug (or class of drug) is able to induce maximal effects of a defined outcome (e.g. pain relief).
efficacy
219
_______ plots dose of a drug vs. response. In general, as doses increase, concentration of drug at receptor sites increases. Maximal response to a drug occurs when ______ are occupied by the drug
DOSE-RESPONSE CURVES
| all receptors
220
______ means the dose at which 50% of the population exhibits the desired effect.
ED50
221
Suddenly stopping many ______ (especially peripheral vasodilators) can cause acute vasoconstrictive hypertensive crisis
anti-hypertensives
222
Suddenly stopping SSRI antidepressants may cause withdrawal ________
symptoms
223
Suddenly stopping epilepsy drugs may induce _______.
seizures
224
These syndromes that occur with sudden discontinuation are called discontinuation syndrome or ______.
withdrawal syndrome
225
TOXICITY AND ADVERSE DRUG REACTIONS (ADRs):
| may be caused by the drug’s primary _________ (the same MOA as for therapeutic effect)
pharmacologic effect
