2: Medication List Centric Approach

Question 1

Tofranil

Answer 1

antidepressant (tricyclic amine- TCA) for depression and enuresis (FDA) and neuropathic pain, panic disorder, PTSD, ADHD-peds, bullemia nervosa (off label)

Question 2

is off label use of a medication FDA approved?

Answer 2

no, off-label use is not an approved FDA indication

Question 3

what does off label mean?

Answer 3

the medication is being used in a manner not specified in the FDA’s approved packaging label, or insert

Question 4

the information contained on the FDA- approved label is based on what?

Answer 4

the results of clinical studies that the drug maker submitted to the FDA

Question 5

what 3 things does the FDA say a physician should do if they use a product off label?

Answer 5

• have the responsibility to be well-informed about the product
• to base its use on firm scientific rationale and on sound medical evidence
• to maintain records of the product’s use and effects

Question 6

is an off label medication use investigational drug use?

Answer 6

no

Question 7

is it legal for a physician to use medications off label?

Answer 7

yes

Question 8

is it legal for drug companies to market their drugs for off-label uses?

Answer 8

no

Question 9

pharmacologic category of amitriptyline (Elavil)

Answer 9

antidepressant (Tricyclic Amine, TCA)

Question 10

approved and off-label uses of amitriptyline (Elavil)

Answer 10

approved: depression

off-label: diabetic neuropathy, migraine prophylaxis, PNH, PTSD, IBS

Question 11

ocular side effects of amitriptyline (Elavil)

Answer 11

accommodation disturbance, blurred vision, increased IOP, mydriasis

Question 12

gabapentin (Neurotin) classification is

Answer 12

anticonvulsant (GABA analog)

Question 13

approved and off-label uses of gabapentin (Neurotin)

Answer 13

approved: seizures, post-herpetic neuralgia (PHN)

off-label: diabetic neuropathy, neuropathic pain, fibromyalgia, restless leg syndrome

Question 14

ocular side effects of gapapentin (neurontin) and %s

Answer 14

nystagmus (8%), diplopia (1-6%), amblyopia (4%), blurred vision (3-4%)

Question 15

Bevacizumab (Avastin) classification

Answer 15

antineoplastic VEGF inhibitor (vascular endothelial growth factor), monoclonal antibody (mAb)

Question 16

approved and off-label uses of bevacizumab (Avastin)

Answer 16

approved: colorectal, cervical, NSCLC (non-small cell lung cancer)
off-label: age related macular degeneration, breast cancer (metastatic)

Question 17

ocular side effects of bevacizumab (Avastin)

Answer 17

blurred vision (2%), eye infections and vision loss due to endophthalmitis from intravitreal administration

Question 18

GRADE system stands for

Answer 18

grading of recommendations
assessment
development
evaluation

Question 19

2 components of the GRADE system

Answer 19

• 2 level representation of the strength of recommendation (strong or weak)
• 4 level representation of the quality of the evidence (high, moderate, low, very low)

Question 20

the study of science of the effects of drugs on the function of living systems (cells, tissues, organisms)

Answer 20

pharmacology

Question 21

the effects of drugs on physiologic systems of patients

Answer 21

clinical pharmacology

Question 22

the study of the therapeutic uses and effects of drugs

Answer 22

pharmacotherapeutics

Question 23

what is the type of pharmacotherapeutic that is used to “aid in examination, evaluation, and diagnosis of the patient or a patient condition” and what is an example?

Answer 23

diagnostic
example: fluorescein dye strip for disclosing corneal injury, or injection in ophthalmic angiography or contrast media for radiographic visualization

Question 24

what is the type of pharmacotherapeutic that is used to “prevent an illness, infection, complication, adverse effect, etc.” and what is an example?

Answer 24

prophylactic
example: proparicaine, local ophthalmic anesthetic for tonometry, gonioscopy, removal of FB from cornea, influenza vaccination

Question 25

what is the type of pharmacotherapeutic that is used in the "therapeutic management of disease or medical conditions" and what is an example?

Answer 25

treatment example: moxiflocacin (Vigamox) a fluoroquinolone antibiotic for treatment of bacterial conjunctivitis or metoprolol in the treatment of hypertension

Question 26

official FDA definition of a drug

Answer 26

a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Question 27

how are vitamins regulated by the FDA?

Answer 27

they are regulated as "dietary supplements" as food, not as drugs

Question 28

what are some other things listed under the dietary ingredient category?

Answer 28

minerals, botanicals products, amino acids, and substances such as enzymes, microbial probiotics and metabolites

Question 29

how is regulation of biological products both similar and different from drugs?

Answer 29

biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing process (chemical process versus biological process)

Question 30

like drugs, biologics are used to:

Answer 30

treat disease and medical conditions and to prevent or diagnose diseases

Question 31

list examples of biological products

Answer 31

- vaccines - blood and blood products - allergenic extracts (both diagnostic and treatment) - gene and cellular therapies - recombinant DNA derived proteins and monoclonal antibodies

Question 32

what is an example of a recombinant DNA derived protein?

Answer 32

etanercept (Enbrel) - TNF blocker used for rheumatoid arthritis, plaque psoriasis, etc. - a disease modifying anti rheumatic (DMARD)

Question 33

what is an example of a monoclonal antibody

Answer 33

infliximab (Remicade) - TNF blocker used for rheumatoid arthritis, plaque psoriasis, etc. - a disease modifying anti rheumatic (DMARD)

Question 34

recombinant DNA molecules are DNA molecules formed by what laboratory methods?

Answer 34

genetic recombination (such as molecular cloning)

Question 35

describe recombinant DNA technology:

Answer 35

joining together of DNA molecules from two different species that are inserted into a host organism to produce new genetic combinations that otherwise would not be found in the genome

Question 36

what was the first clinically important human molecule to be produced by means of recombinant DNA technology?

Answer 36

pure human insulin | followed the cloning of the human insulin gene

Question 37

how do monoclonal antibodies work?

Answer 37

they are directed at specific targets and have fewer adverse effects

Question 38

how are monoclonal antibodies formed?

Answer 38

created from B lymphocytes fused with immortal B-lymphocyte tumor cells, these hybrid antigens then cloned and produce antibodies directed against certain antigen type

Question 39

how can you tell if a drug is a monoclonal antibody based on the name?

Answer 39

ends in "mab" prefixed by an indication of their species nature

Question 40

antibodies with a mixture of mouse and human components are known as

Answer 40

chimeric antibodies

Question 41

chemical name is:

Answer 41

- name of chemical entity, references chemical structure of drug - IUPAC naming convention

Question 42

generic name is:

Answer 42

nonproprietary name, non-trade name, common name - often derived from chemical name - USAN designations selected by council

Question 43

trade name is:

Answer 43

proprietary name or brand name | -only name selected by manufacturer

Question 44

the desired pharmacologic effect(s) of a drug are called:

Answer 44

therapeutic effect

Question 45

decreased effectiveness of a drug over time with repeated use is called

Answer 45

tolerance

Question 46

an unusual or unexpected response to a drug that are considered type B adverse drug reactions are called

Answer 46

drug idiosyncrasy or idiosyncratic drug reactions

Question 47

drug idiosyncrasy or idiosyncratic drug reactions make up what % of total adverse drug reactions?

Answer 47

only 10-15%

Question 48

possible results of drug idiosyncrasy or idiosyncratic drug reactions

Answer 48

- allergic reaction (rash, hives) - liver injury - effects on bone marrow, anemia, thrombocytopenia

Question 49

2 types of adverse drug reactions are

Answer 49

``` type A (side effect, adverse drug effects) type B (idiosyncratic drug reactions, allergic reactions) ```

Question 50

what is the definition of adverse drug event?

Answer 50

an injury resulting from medication use which causes patient harm

Question 51

WHO definition for adverse drug reactions (ARDs)

Answer 51

any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function

Question 52

type A ARDs account for what % of all ARDs

Answer 52

85-90%

Question 53

main characteristics of type A ARDs are:

Answer 53

- can affect any individual (given sufficient dose and exposure) - predictable from the known pharmacologic properties of the drug

Question 54

main characteristics of type B ARDs

Answer 54

- hypersensitivity reactions - mediated by immunologic mechanisms - occur in susceptible subgroup of patients - have signs and symptoms that are different from the pharmacologic actions of the drug - usually cannot be predicted

Question 55

adverse drug events (ADEs) include:

Answer 55

medication errors, adverse drug reactions, allergic reactions, and overdoses which cause patient harm