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Use Efficacy Safety Advocacy

Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

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Page 1: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

UseEfficacySafety Advocacy

Page 2: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

Today We Will Cover…

• The Use of Psychotropic Medicines• What is Available and How They Work• What are The Side Effects?• Are These The Right Drugs?• Drug Classes, Types and Names• Advocating for A Child on Psychotropic Drugs• Prescribing, Ordering, Monitoring and Changing

Drugs in Dependency Cases

Page 3: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

Number0-5 Years on Psychotropic

Percent0-5 years on Psychotropic

Number6-12 yrs. on Psychotropic

Percent6-12 yrs. on psychotropic

Number13-17 yrs. on Psychotropic

Percent13-17 yrs. on Psychotropic

2009 40 44% 672 11.5% 1237 22.43%2013 137 51.40% 1072 20.34% 1087 28.26%

Florida Recent History For Children Tracked in FSFN on Psychotropic Medication

Total Children on Psychotropic Meds in 2009 1,949 9.53%Total Children on Psychotropic Meds in 2013 2,296 12.95%

Growth Rate of Prescribing of Psychotropic Medicine for

Dependent Children in Florida

Page 4: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

Psychotropic or Psychoactive Drugs affect the central

nervous system and alter feeling, thinking

and behavior.

Page 5: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

Approved Use means…1. FDA has reviewed

limited data on safety and efficacy for ONE indication, usually in ONE population.

2. A “label” for the drug is established to guide dosage and describe observed side effects.

Fewer than 10% of psychotropic drugs are FDA-approved for any psychiatric use in children.

Many times we are “trying them out” when prescribing for children.

HOW DRUGS ARE APPROVED

Page 6: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

Brain Neurons

A neuron is a nerve cell in the brain.

We have 100 billion neurons in our heads (30,000 neurons can fit on the head of a pin)Each neuron may be linked with another 5,000-10,000 neurons. The brain has the potential for a quadrillion neural connection.

These neuronal pathways/bundles determine or shape our individual temperaments, talents, foibles and quirks as well as the quality of our thinking processes.

As neurons connect with other neurons and form ‘pathways’ they lay the biological foundation for what we call ‘learning’.

Page 7: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

The process of neurons talking to one another is electro-chemical. The action within the neuron is electrical but the message becomes chemical as it travels between neurons. The chemicals traveling between neurons are called neurotransmitters.

Synapse In The Brain

The process neurons use to “talk” with one another is called synapse.

When two neurons come together, they don’t actually touch. The dendrites of one neuron take information from the axon of another neuron through chemicals (neurotransmitters) flowing across what we call the SYNAPSE.

Electricity fires the synapse and propels chemicals from the axon of one neuron to the dendrites of another, thus connecting the two neurons.

Page 8: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”
Page 9: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

Neurotransmitter Malfunction

The chemicals messengers transmitinformation to the brain through theneurotransmitters. When there is abreakdown in the electro-chemical processthe neurotransmitters send incorrectinformation to the brain.

Psychotropic medicines are designed tocorrect the electro chemical process and helpthe neurotransmitters transmit the correctmessages.

Page 10: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

Malfunction and Pruning of Brain Neurons

The more synaptic firing that occurs across a specific connection, the stronger/denser the pathway becomes.

The brain is very efficient. When the brain is 8 months old, it actually has twice as many neurons as the adult brain. As the brain ages, neurons that are weak or unused or simply don’t fit the job that needs to be done are pruned away.

This pruning leaves more efficient connections for those neurons that are performing the brain’s work. The principle of ‘Use it or lose it’ begins, with non-working cells dying off while those that are exercised get stronger and develop more connections.

At first, the neuronal activity that determines survival is random and spontaneous, but it becomes more organized as the fetus, and then the baby, receives input from its environment. Neurons that are heavily used form connections with other neurons.

Page 11: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

TYPES OF PSYCHOTROPIC

• Psychostimulants• Selective Serotonin Reuptake Inhibitors

(SSRI’s)• Antidepressants• Tricyclic Antidepressants (TCA’s)• Monoamine Oxidase Inhibitors (MAOI’s)• Mood Stabilizers• Benzodiazepines

Page 12: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

PSYCHOSTIMULANTS

P R E S C R I B E D T OStimulants increase the brain’sability to slow itself down resultingin:

• Reduce Hyperactivity

• Improve behavioral control

• Improve cognitive performance

• Increase focus

• Inhibit impulsiveness

C O M M O N N A M E S• Amphetamine / Adderall

• Methylphenidate / Concerta

• Pemoline / Cylert

• Dextroamphetamine/Dexedrine

• Methylphenidate/ Ritaline

Page 13: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

DESIRABLE AND UNDESIRABLE EFFECTS

D E S I R A B L E

• Increased alertness and wakefulness

• Induce sense of wellbeing

• Improve accuracy on brief mental and physical tasks

• Increase repetitive, persistent behavior

• Decreased exploration and social behavior

• Increased compliance

U N D E S I R A B L E

• Insomnia

• Agitation

• Depression “Zombie” look

• Irritability & Aggression

• Mania, Psychosis

• Increased blood pressure

• Dizziness & Headaches

• Weight loss

• Stunted growth

Page 14: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

EVIDENCE OF BENEFITS DOUBTFUL

The American Pediatric Association notes a lack of data supporting the long-term efficacy or safety of stimulant use in children, in fact in a 2013 studythe APA stated:

• Stimulants show minimal efficacy ingeneral life domains of the child,including social and academic success.

Page 15: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRI)

P R E S C R I B E D T OWork by stopping the reuptake ofserotonin, thus allowing moreserotonin to be available:

• Depression

• Anxiety

• Obsessive-compulsive disorder

• Tic disorders

• Bed wetting

• Selective mutism

C O M M O N N A M E S• Fluoxetine/Prozac

• Sertraline/Zoloft

• Paroxetine/Paxil

• Fluvoxamine/Luvox

• Citalopram/Celexa

• Escitalipram/Lexapro

Page 16: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

ANTIDEPRESSANTS

P R E S C R I B E D T OWork by stopping the reuptake ofserotonin, thus allowing moreserotonin to be available:

• Depression

• Anxiety

• Obsessive-compulsive disorder

• Tic disorders

• Bed wetting

• Selective mutism

C O M M O N N A M E S• Fluoxetine/Prozac

• Sertraline/Zoloft

• Paroxetine/Paxil

• Fluvoxamine/Luvox

• Citalopram/Celexa

• Escitalipram/Lexapro

Page 17: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

TRICYCLIC ANTIDEPRESSANTS

P R E S C R I B E D T O

TCA’s have some efficacy intreating depression in adults,but is not proven in children,however is used for:

• Major depression

• Anxiety

• Bed wetting

• ADHD

C O M M O N N A M E S

• Amitriptyline/Elavil

• Imipramine/Tofranil

• Desipramine/Norpramin

• Clomipramine/Anafranil

• Desiprmine/Norprmin

Page 18: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

MONOAMINE OXIDASE INHIBITORS (MAOI’S)

P R E S C R I B E D T O

Another class of anti-depressants that work bystopping the breakdown ofchemicals in the sending andreceiving of informationbetween brain cells.

• Major depression

C O M M O N N A M E S

• Tranylcypromine/Parnate

• Phenelzine/Nardil

Page 19: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

NEW TO MARKET ANTIDEPRESSANTS

P R E S C R I B E D T OThe newest class ofantidepressants do not have thesame side effects as the olderones. Doctors are testing them inpatients as young as five.

• Major depression

• ADHD

• Anxiety

• Depression

C O M M O N N A M E S• Venlafaxine/Effexor

• Duloxetine/Symbalta

• Bupropion/Wellbutrin

• Nefazodone/Serzone

• Trazadone/Desyrel

Page 20: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

DESIRABLE AND UNDESIRABLE EFFECTS

D E S I R A B L E

• Increased physical activity

• Induce sense of wellbeing

• Elevated Mood

• Decreased expressions of distress, crying, hopelessness

• Improved sleep and appetite

U N D E S I R A B L E

• Insomnia

• Agitation

• Depression “Zombie” look

• Irritability & Aggression

• Weight Loss/Gain

• Headaches

• Thoughts of suicide

• Attempted or actual suicide

Page 21: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

6 CLUSTERS OF WITHDRAWAL EFFECTS

There are six clusters of withdrawal effects when antidepressants aresuddenly discontinued. Older children will tend to stop taking this medicationwhen they start to feel better.

1. Neurosensory (vertigo, tingling & burning)2. Neuromotor (tremor, spasms, visual changes)3. Gastrointestinal (nausea, vomiting, diarrhea, weight loss)4. Neuropsychiatric (anxiety, depression, crying spells, irritability,

suicide ideation)5. Vasomotor (heavy sweating, flushing)6. Other (insomnia, vivid dreaming, fatigue)

Page 22: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

ANTIPSYCHOTIC MEDICATIONS

P R E S C R I B E D T OReduce psychotic symptoms inchildren with psychotic disorders.

• Schizophrenia

• Tourette Syndrome

• Mania

• Autism

• Mental Retardation

C O M M O N N A M E S• Atypical or Second Generation

• Clozapine/Clozaril• Risperidone/Risperdal• Olanzapine/Zyprexa• Quetiapine/Seroqual• Ziprasidone/Geodon• Ariprprazole/Abilify

• Typical or First Generation• Chlorpromazine/Thorazine• Haloperidol/Haldol• Loxapine/Loxitane• Pimozide/Orap• Perphenazine/Trilafon

Page 23: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

MOOD STABILIZERS

P R E S C R I B E D T OUsed in children that are overactive and aggressive or havemood swings that causebehavioral issues. This medicationin also used for seizure control.

• Bi-Polar Disorder

• NS Oppositional Disorder

• Seizures

• Aggression

C O M M O N N A M E S

• Lithium Carbonate• Eskalith• Lithonate• Lithobid

• Lithium Citrate• Cibalith-S

Page 24: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

DESIRABLE AND UNDESIRABLE EFFECTSD E S I R A B L E

• Reduced aggression and impulsivity

• Calm restlessness and excitability

• Produce more even mood variation

U N D E S I R A B L E• Sedation

• Agitation

• Depression “Zombie” look

• Irritability & Aggression

• Weight Loss

• Headaches

• Intestinal distress

• Slurred Speech

• Hostility

• Fatal Skin Rash

• Blood Disorders

• Pancreatitis, liver disease

• Birth defects & Menstrual Irregularities

• Withdrawal Seizures

Page 25: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

BENZODIAZEPINES

P R E S C R I B E D T OWidely used (and abused in thisarea) by adults for the treatment ofanxiety and sleep problems

• Anxiety

• Panic Attacks

• Sleeplessness

• Obsessive Compulsive Disorder

• Phobia

C O M M O N N A M E S

• Clonazepam/Klonopin• Lorazepam/Ativan• Alprazolam/Xanax• Loratabs (Daytona’s

Favorite)

Page 26: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

DESIRABLE AND UNDESIRABLE EFFECTS

D E S I R A B L E

• Induce a sense of calm• Reduce fear associated

with anxiety• Promote sleep and rest• Reduce jitters

U N D E S I R A B L E

• Sedation• Depression “Zombie” look• Weight Loss • Headaches• Slurred Speech• Addiction

Page 27: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

PRESCRIPTION CASCADE

Continued long term exposure to manypsychotropic can lead to the effects of themedication being interpreted as psychiatric. Sothen more medication or different medicationsbegin being added when reducing or stoppingthe medication would relieve the patient’sdiscomfort.

Page 28: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

POLYPHARMACY WITH PSYCHOTHERAPYMore than 90% of children diagnosed with Bipolar Disorder received more

than 1 psychoactive drug while less than 40% received psychotherapy.

1. Advocate for at a minimum quarterly psychiatric visits.2. Advocate for a psychologist and psychiatric team for the child.3. Communicate with ALL of the medical team.4. Request until you get them MDT Staffing.

Psychiatrist Psychologist Therapist Medical Doctor Caregiver Parent

Child

Page 29: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

WHAT TO MONITOR AND LOOK FOR• Hormonal Dysfunction

• Sexual and menstrual disturbance• Infertility• Loss of bone mass• Male breast development

• Tardive Dyskinesia• Abnormal movements –affects 12%-35% of kids after just 3 months

• Neuroleptic Malignant Syndrome• Fatal muscular rigidity and altered consciousness

• Extrapyramidal Symptoms• Akathisia-inner distress, rocking, pacing, agitation• Dystonia-Sudden, bizarre muscle spasms• Dyskinesia-rhythmic movements of face, mouth and tongue• Parkinsonism- rigid muscles, loss of facial expression, drooling

• Weight Gain and Diabetes• Metabolic Syndrome -50% of patients gain 20% of the their weight primarily as

body fat

Page 30: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

KNOW YOUR CHILD/KNOW THEIR MEDICATION• Weight and Build• Hair and Skin Health• Eating Habits• Physical Movements• School Grades• Wakefulness and Alertness• Ability to Communicate• Psych and Medical Evaluations• Talk to Everyone, Teacher, Docs, Caregivers, Relatives,

ect.• What’s changing?

Page 31: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

DO THE RESEARCH-CHALLENGE WHEN NEEDED

• Research a need for the drug do you need another opinion?• Are there other options beside medications?• What are the side effects?• What should be monitored –get it in the order!• Watch for positive and negative changes?• Once it starts don’t let it stop abruptly.• Keep case managers on task with psychiatric appointments.• Watch out for “Cascading” and add-ons.• Check out all drugs a child “comes with” at shelter.• Provide data and statistics to back up your claims.• Educate yourself.• Be open minded – not all drugs are bad and not all reasons are wrong.

Page 32: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

RESEARCH RESOURCES

MedlinePlus a service of the US National Medical Library -http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601059.html

University of Florida MedConsult Line - http://dcf.psychiatry.ufl.edu On-line submission of the pre-consent review form for children under age 11 receiving two or more psychotropic medications

Centers for Disease Control - http://www.cdc.gov/

National Institute for Mental Health http://www.nimh.nih.gov/health/publications/mental-health-medications/index.shtml

Mayo Clinic – www.mayoclinic.com

Page 33: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

GOVERNMENT RESOURCES

National Institute of Mental Health - www.nimh.nih.govNational Library of Medicine - www.nlm.nih.gov Substance Abuse and Mental Health Services Administration - www.samhsa.govWorld Health Organization - www.who.int/mental_health/en/

American Academy of Child and Adolescent Psychiatry - www.aacap.orgAmerican Psychiatric Association - www.psych.orgAmerican Academy of Pediatrics - www.aap.org

National Alliance on Mental Illness - www.nami.orgParents Medication Guide - www.parentsmedguide.orgFDA Official Information – www.drugs.com

Page 34: Use Efficacy Safety Advocacy · 2014-01-04 · Approved Use means… 1. FDA has reviewed limited data on safety and efficacy for ONE indication, usually in ONE population. 2. A “label”

ASSOCIATIONS

Anxiety Disorders Association of America - www.adaa.orgAutism and Asperger Syndrome Resources - www.autismspeaks.orgBroad Spectrum Autism - www.autismsource.orgAsperger's Syndrome - www.aspergersyndrome.orgThe Balanced Mind Foundation - www.thebalancedmind.orgChildren and Adults with Attention-Deficit/Hyperactivity Disorder - www.chadd.orgDepression and Bipolar Disorder Alliance - www.dbsalliance.orgNational Association of Anorexia Nervosa & Associated Disorders - www.anad.orgObsessive Compulsive Disorder Foundation - www. Ocfoundation.orgTourette Syndrome Association – www.tsa.usa.org