Psychopharm Midterm Flashcards

1
Q

Cost of bringing typical psychotropic drug to market

A

$1-2 billion

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2
Q

Time it takes a promising drug to be approved by the FDA

A

20 years

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3
Q

In order for a drug to be approved for a psychiatric condition, it must demonstrate safety and efficacy in ___ or more randomized placebo controlled trials regardless of the size of the study

A

2

  • can have many failed trails and still get drug approved with 2 successful trials
    • trials usually made up of young, healthy, etc. participants
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4
Q

FDA’s primary duty is to ______

A

Protect the public safety

Including: drug/food/cosmetic labels are accurate and drug is being used for/prescribed for given indication

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5
Q

Most commonly prescribed drug = ?

A

ADMs

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6
Q

The Split Model

A

Advantages:
Keeps psychotherapy focused on psychological issues.
Helps manage transference issues
Allows at least 2 observers to have input
May be superior to tx w/ different experts handling different aspects of care
May reduce cost

Disadvantages:
May undermine one modality of tx
May exacerbate splitting (e.g. w/ individual w/ BPD)
May retard integration through the dichotomy
May lead to a diffusion of responsibility (e.g. problematic if therapist thinks it’s prescribers job to handle meds only and don’t communicate when you see something that may be of concern and vice versa)
May be more expensive
Requires more work; communication

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7
Q

Possible patient responses to medication prescription/referral

A

Rejection
I’m too sick
This is a bio, not psych issue
I’m not in control
I’m cared for by powerful authority figures
It’s not my fault
I am one w/ my tx team as medication become a part of me
The medication = useful transitional object

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8
Q

Choosing a prescriber

A

Good working relationship (esp. regular communication)
Acceptance of role of psychotherapy
Clinically competent in psychopharm (won’t always be a psychiatrist, could be PCP or another med doctor)
Comfort w/ split tx
Personal style
How to:
Ask colleagues, university centers, ACNP/ACP, APA referral, phone book

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9
Q

At what points in time should you communicate with a psychopharmacologist?

A
At first consultation
When pts condition changes acutely
If the pt is significantly suicidal
When a change in meds has occurred
When there is a clinical question
When there is significant splitting
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10
Q

Prescription privileges for psychologists offer what advantages (1) and what disadvantages (3)

A

Advantages:
Accessibility, esp. in rural areas

Disadvantages:
Can you feasibly train someone w/o medical background in 1-2 years?
Medicine is highly legislated
Malpractice issues

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11
Q

Define: Pharmacokinetics*

A

What the body does to the drug (to make use of it, then to eliminate it from the body). This includes the following processes: absorption, distribution, metabolism, and excretion.

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12
Q

Define: Absorption

A

the degree to which the drug is absorbed from the GI tract, affected by:
Solubility of the drug
Size of the drug
Presence of food in the GI tract
Will lessen presence of side effects such as nausea and vomiting
PH of the stomach
Blood flow in GI tract
Ex. taking antacids can impact absorption of drug

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13
Q

Define: Distribution

A

The degree to which a drug distributes itself throughout the body, affected by:
Membrane permeability
Plasma protein binding
Depot storage
Most drugs are lipophilic (love fat–chubby chasers)
Many drugs must be lipophilic to pass blood-brain barrier

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14
Q

Define: Metabolism*

A

Process by which the body transforms a drug to prepare it for removal. Process includes Phase I (liver oxidation) and Phase II (conjugation)
If there’s a liver issue, this can affect ability to break down drug → may need to avoid drugs, or reduce dose to accommodate

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15
Q

Define: Excretion

A

Removal of drug from the body, through urine (most commonly), as well as fecal and respiratory routes.

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16
Q

Define: Agonist*

A

Drug which binds to a receptor and thus change cellular actions; stimulatory effect of receptor
If a drug (e.g. Trazedone) affects serotonin receptors → activates receptors, “turns on the switch”

17
Q

Define: Antagonist*

A

Drugs that block receptor and prevent the actions of an agonist → “turns off the switch”

18
Q

Define: Potency*

A

Amount of drug required to produce maximal effects (e.g. high potency drugs require smaller amount of drug to produce desired effects, such as Haldol, Klonopin); high potency drugs are not more efficacious, just require lower dose

19
Q

Receptor targets for psychiatric drugs

A

Monoamines (most antipsychotics and antidepressants work via these transporters)
- 5HT (serotonin)
- NE (norepinephrine)
- DA (dopamine)
Other: histamine, steroid, glutamate, ACH, hypocretin, benzo, NA channel, Ca channel

20
Q

FDA approval of a drug means…

A

An “approved” product

A package insert → guides safe use, promotes effective tx, sets the marketing parameters

21
Q

Phases of Drug Development*

A

Phase I: First human safety studies
Phase II: First proof of concept studies
Phase III: Large efficacy studies leading to FDA approval
Phase IV: Post marketing studies for new indications

22
Q

Phase I

A

Small, short studies, usually 10-20 pts, usually done in young, healthy males (done primarily at university medical centers)

First studies in humans, focus on safety, explore pharmacokinetics, explore dosing ranges

End of Phase 1 assessment: is it safe? How is it excreted/metabolized? Is the formulation suitable? Do we have enough drug and resources to go forward?

23
Q

Phase II

A

Evaluate safety and efficacy in a selected patient population(e.g. those w/ PTSD, schizophrenia, etc.)
Does for longer period of time - weeks or 1-2 months
Refine the dose and dosing regimes
Usually RCTs
Control group
Placebo control (required in US, vs. active control aka comparator drug, dose comparison, historic controls)

Goals:
Establish “proof of concept” - does it work as expected?
Evaluate relationship of dose to effect (i.e. dose response)
Refine the dosing and formulation
Evaluate the risk-benefit profile of the drug (FDA)
End of Phase 2 Assessment: is it safe enough to go on? Does it work as expected? Do we know the right dose? Is the formulation okay? Do we know how to measure results? Do we have enough drug to proceed? Is it good enough to go on?

24
Q

Phase III

A

“Pivotal studies” → basis for drug approval
Larger, longer studies to establish safety and efficacy → 100s or 1000s of pts for weeks or years
Study designs usually randomized, controlled; fewer protocol exclusions (“real world setting”), confirm safety and efficacy, show statistical significance
Many pts, many sites, may be multinational
Usually really expensive
Likely to be audited
Will examine raw data
Need financial disclosure statements
End of Phase 3 Assessment: is it safe and effective? Is it good enough to market? Is the data good enough to support an approval? Can we manufacture enough drug? Pricing/distribution?

25
Q

Phase IV

A

post-approval/post-marketing
May be required under FDAMA
Evaluate new topics, e.g. decreasing side effects, compliance aids, testing same drug for new reason
Compare to competitors to support advertising claims
Disease management
Study designs = randomized, controlled; observational, epidemiologic, post-marketing surveillance may explore new indications

26
Q

How long do antidepressants take to work?

A

3-8 weeks; side effects may occur from day one

27
Q

Are antidepressants addictive?

A

No, not addictive in traditional sense

28
Q

True or False: Any effective antidepressant can induce mania

A

True

29
Q

All current antidepressants work on ___, ___, or ____

A

Serotonin, Norepinephrine, or Dopamine

30
Q

True or false: It is not difficult to show that a given antidepressant is superior to another in most patients

A

False. It is difficult to show superiority

31
Q

Antidepressants are chosen by ____ more than efficacy

A

side effect profile

32
Q

Most antidepressants also help what disorder? (Except for Bupropion)

A

Anxiety disorders

33
Q

Which types of depression show better responses to which classes of medication or ECT

A

Atypical:
MAOIs> TCAs, antidepressant > ECT

Melancholic:
TCAs > SSRIs, ECT> antidepressants

Psychotic:
ECT > antidepressant , antidepressant + antipsychotic

34
Q

Selective Serotonin Re-uptake Inhibitors (SSRIs)

A

Mechanism: Inhibit serotonin reuptake which results in more serotonin in the synapse.
Prototype = Fluoxetine (Prozac)
Uses: MDD, OCD, Social Anxiety, Panic, Premenstrual Dysphoric Disorder, PTSD, Bulimia
Common side effects: acute GI issues, headache, and insomnia
Long term side effects: sexual (low libido, delayed orgasm)
Overdose: vomiting, seizure; rarely lethal
Discontinuation/Withdrawal: dizziness and unusual sensations (most common)