MHNP Clinical Psychopharmacology – Exam #1
P
Summary – Nurse Practitioner Program – Study
Guide with Key Concepts and Terms
1 .Introduction To Clinical Psychopharmacology:- Psych meds discovered
on accident - All targeted sx, not disorders - Then Pharma got involved-> meds
became designed for disorders
Psych meds discovered on accident - All targeted sx, not disorders - Then
Pharma got involved-> meds became designed for disorders
2.Med Impact DOES NOT EQUAL Dx Models (T/F):
True
3.Psychiatrists:
medical doctors
4.Mental Disorders:
disease/illness to be cured
5. 6 Reasons For Pharma Dominance (Pharmer's Market): 1) Public
Familiarity/Comfort 2) Expectations 3) Rx is "simple and easy" compared
to psytx 4) Externalizes problems and issues 5) Illusion of conformity 6)
$$$
. Public Familiarity/Comfort
1
2. Expectations
3. Rx is "simple and easy" compared to psytx
4. Externalizes problems and issues
5. Illusion of conformity
6. $$$
, *Low number of psychiatrists, but high rates of mental illness
. 2 Psychological Influences on Medication Use: 1) Patient
6
beliefs/attitudes/biases 2) Clinician beliefs/attitudes/biases
. Patient beliefs/attitudes/biases
1
2. Clinician beliefs/attitudes/biases
. 3 Diversity Influences on Medication Use: 1) Cultural Attitudes
7
(especially illness/health model, and role of authority) 2) Systemic
Racism, health disparities and inequity 3) Bio-Based Racial/Ethnic
Differences (liver enzymes + pharmacogenetics)
. Cultural Attitudes (especially illness/health model, and role of authority)
1
2. Systemic Racism, health disparities and inequity
3. Bio-Based Racial/Ethnic Differences (liver enzymes + pharmacogenetics)
* 8. 2 Socioeconomic Influences: 1) Financial (big money for pharma, insurance
companies, medical industry incentives) 2) Marketing (big persuasion can
outweigh evidence) Low number of psychiatrists, but high rates of mental
illness
1. Financial (big money for pharma, insurance companies, medical industry
incentives)
2. Marketing (big persuasion can outweigh evidence)
. Overall Notes About Clinical Psychopharmacology: - Unsure how most
9
psych meds work - Unsure how long to prescribe them for Efficacy rates
of most psych meds are unimpressive (.3-.4) Side effects are large issue
Significant placebo effect Common Trend: strong meds have worse side
effects; mild meds have low efficacy TRADE OFF BETWEEN SX or SE
● nsure how most psych meds work
U
● Unsure how long to prescribe them for
● Efficacy rates of most psych meds are unimpressive (.3-.4)
● Side effects are large issue
● Significant placebo effect
● Common Trend: strong meds have worse side effects; mild meds have low
efficacy TRADE OFF BETWEEN SX or SE
, 1 0. Ethical and Legal Considerations For Prescribing: - Unless you are
licensed to prescribe, it is unethical and illegal to tell Pts to: 1) Stop taking
meds 2) Change dose of meds
Unless you are licensed to prescribe, it is unethical and illegal to tell Pts to:
●
1. Stop taking meds
2. Change dose of meds
1 1. FDA Goal:
Monitor safety and efficacy
12. FDA Approval:
med is safe and effective for the approved indication (labeled) of specific dx,
sx, pop, dose
*13. FDA Basis For Approval (2): 1) 2 successful large scale studies conducted
by pharma company Involves preclinical and clinical phases 2) Significant
response compared to placebo as measured by formal scale
1. 2 successful large scale studies conducted by pharma company
*Involves preclinical and clinical phases
2. Significant response compared to placebo as measured by formal scale
1 4. Preclinical Phase (Labwork): molecule synthesis and purification
(pharmacology studies) safety studies on animals - takes ~12 years from here
to approval; $1-3B Note: most frequent time of patent (20 year brand
exclusivity starts here)
molecule synthesis and purification (pharmacology studies)
safety studies on animals
● takes ~12 years from here to approval; $1-3B
Note: most frequent time of patent (20 year brand exclusivity starts here)
1 5. 4 Clinical Phases: 1) Phase 1-> safety and tolerability on healthy
volunteers 2) Phase 2-> efficacy (proof of concept) 3) Phase 3-> large N
(efficacy and safety) 4) Phase 4-> post-marketing reporting
. Phase 1-> safety and tolerability on healthy volunteers
1
2. Phase 2-> efficacy (proof of concept)
3. Phase 3-> large N (efficacy and safety)
4. Phase 4-> post-marketing reporting
P
Summary – Nurse Practitioner Program – Study
Guide with Key Concepts and Terms
1 .Introduction To Clinical Psychopharmacology:- Psych meds discovered
on accident - All targeted sx, not disorders - Then Pharma got involved-> meds
became designed for disorders
Psych meds discovered on accident - All targeted sx, not disorders - Then
Pharma got involved-> meds became designed for disorders
2.Med Impact DOES NOT EQUAL Dx Models (T/F):
True
3.Psychiatrists:
medical doctors
4.Mental Disorders:
disease/illness to be cured
5. 6 Reasons For Pharma Dominance (Pharmer's Market): 1) Public
Familiarity/Comfort 2) Expectations 3) Rx is "simple and easy" compared
to psytx 4) Externalizes problems and issues 5) Illusion of conformity 6)
$$$
. Public Familiarity/Comfort
1
2. Expectations
3. Rx is "simple and easy" compared to psytx
4. Externalizes problems and issues
5. Illusion of conformity
6. $$$
, *Low number of psychiatrists, but high rates of mental illness
. 2 Psychological Influences on Medication Use: 1) Patient
6
beliefs/attitudes/biases 2) Clinician beliefs/attitudes/biases
. Patient beliefs/attitudes/biases
1
2. Clinician beliefs/attitudes/biases
. 3 Diversity Influences on Medication Use: 1) Cultural Attitudes
7
(especially illness/health model, and role of authority) 2) Systemic
Racism, health disparities and inequity 3) Bio-Based Racial/Ethnic
Differences (liver enzymes + pharmacogenetics)
. Cultural Attitudes (especially illness/health model, and role of authority)
1
2. Systemic Racism, health disparities and inequity
3. Bio-Based Racial/Ethnic Differences (liver enzymes + pharmacogenetics)
* 8. 2 Socioeconomic Influences: 1) Financial (big money for pharma, insurance
companies, medical industry incentives) 2) Marketing (big persuasion can
outweigh evidence) Low number of psychiatrists, but high rates of mental
illness
1. Financial (big money for pharma, insurance companies, medical industry
incentives)
2. Marketing (big persuasion can outweigh evidence)
. Overall Notes About Clinical Psychopharmacology: - Unsure how most
9
psych meds work - Unsure how long to prescribe them for Efficacy rates
of most psych meds are unimpressive (.3-.4) Side effects are large issue
Significant placebo effect Common Trend: strong meds have worse side
effects; mild meds have low efficacy TRADE OFF BETWEEN SX or SE
● nsure how most psych meds work
U
● Unsure how long to prescribe them for
● Efficacy rates of most psych meds are unimpressive (.3-.4)
● Side effects are large issue
● Significant placebo effect
● Common Trend: strong meds have worse side effects; mild meds have low
efficacy TRADE OFF BETWEEN SX or SE
, 1 0. Ethical and Legal Considerations For Prescribing: - Unless you are
licensed to prescribe, it is unethical and illegal to tell Pts to: 1) Stop taking
meds 2) Change dose of meds
Unless you are licensed to prescribe, it is unethical and illegal to tell Pts to:
●
1. Stop taking meds
2. Change dose of meds
1 1. FDA Goal:
Monitor safety and efficacy
12. FDA Approval:
med is safe and effective for the approved indication (labeled) of specific dx,
sx, pop, dose
*13. FDA Basis For Approval (2): 1) 2 successful large scale studies conducted
by pharma company Involves preclinical and clinical phases 2) Significant
response compared to placebo as measured by formal scale
1. 2 successful large scale studies conducted by pharma company
*Involves preclinical and clinical phases
2. Significant response compared to placebo as measured by formal scale
1 4. Preclinical Phase (Labwork): molecule synthesis and purification
(pharmacology studies) safety studies on animals - takes ~12 years from here
to approval; $1-3B Note: most frequent time of patent (20 year brand
exclusivity starts here)
molecule synthesis and purification (pharmacology studies)
safety studies on animals
● takes ~12 years from here to approval; $1-3B
Note: most frequent time of patent (20 year brand exclusivity starts here)
1 5. 4 Clinical Phases: 1) Phase 1-> safety and tolerability on healthy
volunteers 2) Phase 2-> efficacy (proof of concept) 3) Phase 3-> large N
(efficacy and safety) 4) Phase 4-> post-marketing reporting
. Phase 1-> safety and tolerability on healthy volunteers
1
2. Phase 2-> efficacy (proof of concept)
3. Phase 3-> large N (efficacy and safety)
4. Phase 4-> post-marketing reporting
