Community Care PHARMACY NEWS - Community Care Behavioral ...

Community Care PHARMACY NEWS
Welcome to the third edition of the Community Care
Provider Pharmacy Newsletter.
On June 5, 2008, Community Care sponsored a conference
in York, PA, about the role of medications and physical
health in members’ recovery. The conference was attended
by hundreds of participants. Keynote speakers included:
Patricia E. Deegan, PhD, President, Pat Deegan &
Associates, LLC; Joan Erney, JD, Deputy Secretary,
Pennsylvania Department of Public Welfare (DPW)
Office of Mental Health and Substance Abuse Services
(OMHSAS); Joseph Parks, MD, Chief Clinical Officer,
Department of Mental Health Director, Division of
Comprehensive Psychiatric Services, Missouri Department
of Mental Health; Molly Finnerty, MD, Director, Bureau
of Evidence-based Medicine and Guidelines, New York
State Psychiatric Institute/Office of Mental Health; and
Judith Dogin, MD, Sr. Medical Director, Community
Care.
Presentations noted the critical issue of physical health
problems among our members and suggested ideas for
both prevention and treatment. Community Care’s ongoing
initiatives to improve the quality of behavioral health
medication prescribing and to increase collaboration
between members and physicians were also outlined.
Community Care is sponsoring a conference in Chester
County in September titled IMAGINE...A World That
Works for Everyone: Recovery and Resilience for Children
and Youth. Intended for members, providers, and other
behavioral health stakeholders, this conference will
provide information about specific areas of concern and
approaches to working with systems of care for children
and youth.
Please visit www.ccbh.com for more information about
this and other upcoming events.
Community Care Pharmacy Team:
James M. Schuster, MD, MBA, Chief Medical Officer
Judith Dogin, MD, Senior Medical Director
Kim Castelnovo, RPh, Behavioral Health Pharmacist

MEDICATION AND PREGNANCY
More than 500,000 U.S. pregnancies each year
involve women who have psychiatric illnesses
that either predate or emerge during pregnancy,
and an estimated one-third of all pregnant women
are exposed to a psychotropic medication during
pregnancy (1). There is much to consider when
deciding if and when to use psychotropic medications
during pregnancy. Risks of the medication to the
unborn infant must be balanced against risks to the
mother and fetus if the behavioral health illness is
left untreated.
The American College of Obstetricians and
Gynecologists (ACOG) has developed a practice
bulletin on the clinical management guidelines for
using psychiatric medication during pregnancy. The
information below is summarized from this bulletin
and other references noted below.
In many cases, the overall benefit of psychotropic
medication to pregnant women is greater than the risk,
and being maintained on medication is appropriate.
Maternal psychiatric illness, if inadequately treated or
untreated, may result in poor compliance with prenatal
care, inadequate diet, increased alcohol and tobacco
use, deficits in mother-infant bonding, disruptions
within the family environment, and increased risk for
postpartum symptoms and suicide attempts.
General recommendations / conclusions include:
• Multidisciplinary management to facilitate care.
• A single medication at a higher dose is favored
over multiple medications.
• Avoid changing medications unless necessary, as
multiple medications increase the exposure to the
unborn infant.
• Selection of medication to minimize the risk of
illness should be based on history of efficacy, prior
exposure during pregnancy, and available
reproductive safety information.
• Medications with fewer metabolites, higher protein
binding (decreases placental passage), and fewer
interactions with other medications are preferred.
• Before prescribing medication to a pregnant
woman, document all fetal exposures (alcohol,
other medications, environmental) in the record
to avoid assignment of causality to a prescribed
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medication in the event of a poor pregnancy
outcome.
Antidepressant considerations include:
• Findings suggest that individual SSRIs may
confer increased risks for some specific defects,
specifically with paroxetine exposure. But it should
be recognized that the specific defects are rare and
the absolute risks are small (2).
Mood stabilizer considerations include:
• Lithium exposure in pregnancy may be associated
with a small increase in congenital cardiac
malformations, with a risk ratio of 1.2–7.7.
• Fetal assessment with fetal echocardiogram should
be considered in pregnant women exposed to
lithium in the first trimester.
• Valproate exposure in pregnancy is associated with
an increased risk of fetal anomalies, including
neural tube defects, fetal valproate syndrome,
and long-term adverse neurocognitive effects and,
if possible, should be avoided, especially during the
first trimester. If used, the patient should be on
4mg of folate daily.
• Carbamazepine exposure in pregnancy is
associated with fetal carbamazepine syndrome and,
if possible, should be avoided, especially during the
first trimester. If used, the patient should be on
4 mg of folate daily.
• Lamotrigine is a potential maintenance therapy
option for pregnant women with bipolar disorder.
There is a small risk of oral cleft palate. If used,
the patient should be on 4 mg of folate daily.
Benzodiazepine considerations include:
• Maternal benzodiazepine use shortly before
delivery is associated with floppy infant syndrome.
• Prenatal benzodiazepine exposure increased the
risk of oral cleft, although the absolute risk
increased by 0.01%.
Antipsychotic considerations include:
• Treatment is often indicated when members are
pregnant and psychotic.
(continued on page 3)

FORMULARY UPDATES
MEDICATION AND
PREGNANCY
(continued from page 2)
• High-potency typical
antipsychotics are
preferred though there are
reports of extrapyramidal
effects in exposed infants.
• Safety data regarding
the use of atypical
antipsychotics is
extremely limited.
The November 2007 issue
of the ACOG bulletin
provides more detailed
information on medication
management options. For
the complete bulletin, visit:
http://www.accessplus.
org/downloads/Maternity/
ACOGPsychiatric
Medication.pdf
Behavioral Health Formulary Changes
Community Care would like to update you regarding behavioral health
formulary changes that have occurred or will occur for Medical Assistance
members. The physical health MCOs that manage the Medical Assistance
pharmacy benefits have informed us of the changes in the attached table.
Health Plans that have formulary changes will contact members and providers
who are using any of the drugs affected by the formulary update. If you have
any questions concerning these updates, please contact the respective Health
Plan’s Pharmacy Services number as provided.
Physical Health Plan -
Pharmacy Services
AmeriChoice
1-800-922-1557
www.americhoice.com
PHARMACY UPDATES 2008
Updates
• Chantix requires Prior Authorization
• Gabitril, Keppra, Lamictal, Topamax,
Trileptal, and Zonegran – require Prior
Authorization for NEW starts only.
Current users will be grandfathered.
Effective
April
2008
For referral information,
call the Community
Care Provider Line,
1-888-251-2224.
AmeriHealth Mercy/KMHP
1-866-610-2774
1-800-521-6007
www.amerihealthmercyhp.com
www.keystonemercy.com
• Vyvanse added to formulary
• Chantix covered for up to 24 weeks of
therapy (members > 18 years old)
April
2008
Sources:
1. Doering PL, Stewart RB.
The extent and character
of drug consumption
during pregnancy. JAMA
1978;239: 843–6.
Health Partners
1-888-991-9023
www.healthpart.com
Gateway Health Plan
1-800-528-6738
www.gatewayhealthplan.com
• No updates to report at this time.
• No updates to report at this time.
July
2008
July
2008
2. Louik C, Lin AE, Werler
MM, Hernandez-Diaz
S, Mitchell AA. First-
Trimester Use of Selective
Serotonin-Reuptake
Inhibitors and the Risk of
Birth Defects. N ENGL J
MED 2007;356: 2675-83.
Unison Health Plan
1-877-651-2217
www.unisonhealthplan.com
UPMC for You
1-800-396-4139
www.upmchealthplan.com
• No updates to report at this time.
• Suboxone and Subutex will require
prior authorization for continuation
therapy past 3 months.
• NEW Starts to Abilify will require
prior authorization. Current users will
be grandfathered.
July
2008
Sept
2008
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PRODUCT UPDATES
Please be aware that the information discussed in this section is solely for informational
purposes. It does not dictate availability on health plan formularies.
New Formulations
February 2008 – Luvox CR 100mg and 150mg
(extended release capsules) has been approved by
the FDA for the treatment of Social Anxiety Disorder
and Obsessive Compulsive disorder in adults.
New Indications
February 2008 - Abilify received FDA approval for
the acute treatment of manic and mixed episodes
associated with Bipolar I Disorder in pediatric
patients (age 10-17).
February 2008 – Vyvanse is now available in 20mg,
40mg, and 60mg capsule strengths. Vyvanse is FDA
approved for the treatment of ADHD.
March 2008 – Pristiq (desvenlafaxine succinate)
50mg and 100mg extended release tablet has been
approved by the FDA for the treatment of adult
patients with Major Depression Disorder.
March 2008 - Liquadd (dextroamphetamine sulfate)
Oral Solution 5 mg/5 mL has been approved by the
FDA for the treatment of Attention Deficit Disorder
with Hyperactivity (ADHD).
New Generic
May 2008 – Zaleplon 5mg and 10mg now available
(generic Sonata).
May 2008 – Paroxetine CR 12.5mg, 25mg. and
37.5mg now available (generic Paxil CR).
June 2008 – Bupropion XL 150mg now available
(300mg strength has been available).
April 2008 – Vyvanse received approval from
the FDA for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in adults.
Previously, it was only approved for children
age 6-12.
May 2008 – Strattera approved for maintenance of
ADHD in children and adolescents.
May 2008 - Abilify receives expanded indications
for maintenance treatment in both pediatric patients
(age 10-17) with manic and mixed episodes of
Bipolar I Disorder and adolescents (age 13-17) with
Schizophrenia.
June 2008 – Cymbalta received FDA approval to
treat Fibromyalgia. It is already approved for diabetic
nerve pain, MDD, and GAD.
June 2008 – Concerta received expanded FDA
approval for the treatment of Attention Deficit
Hyperactivity Disorder in adults (age 18 to 65).
Previously, it was only approved for children and
adolescents.
June 2008 – Teva receives 180 days of generic
exclusivity to market Risperidone tablets (generic
Risperdal). The patent on Risperdal expired on June
29, 2008. Generics to Risperdal M-Tabs and the oral
solution have not been approved yet.
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SAFETY UPDATES
Increased risk of suicidality with
antiepileptic medications
New warnings added to
Chantix
The FDA is informing all health care professionals of
increased risk of suicidality (suicidal behavior or ideation)
in patients being treated with antiepileptic medications.
The warning is based on analyzed reports from placebocontrolled
clinical studies of 11 drugs used to treat epilepsy
as well as psychiatric disorders and other conditions. In the
FDA’s analysis, patients receiving antiepileptic drugs had
approximately twice the risk of suicidal behavior or ideation
(0.43%) compared to patients receiving placebo (0.22%). The
increased risk of suicidal behavior and suicidal ideation was
observed as early as one week after starting the antiepileptic
drug and continued through 24 weeks. The results were
generally consistent among the 11 drugs. The relative risk for
suicidality was higher in the patients with epilepsy compared
to patients who were given one of the drugs in the class for
psychiatric or other conditions.
All patients who are currently taking or starting on any
antiepileptic drug should be closely monitored for notable
changes in behavior that could indicate the emergence or
worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include:
• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol,
Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene,
Depacon)
• Zonisamide (marketed as Zonegran)
Although 11 drugs were included in the analysis, FDA
expects that the increased risk of suicidality is shared by
all antiepileptic drugs and anticipates that the class labeling
changes will be applied broadly. For the complete MedWatch
Safety Summary, please refer to the FDA website, http://www.
fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic.
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Since the FDA first informed the
public about the possibility of serious
neuropsychiatric symptoms associated
with the use of Chantix, it has become
increasingly likely that the association exists.
As a result, the FDA has requested that this
safety information be added to the warnings
and precautions sections of the Chantix
prescribing information. These symptoms
include changes in behavior, agitation,
depressed mood, suicidal ideation, and
attempted and completed suicide.
While some patients may have experienced
these types of symptoms and events as a
result of nicotine withdrawal, some patients
taking Chantix who experienced serious
neuropsychiatric symptoms and events had
not yet discontinued smoking. In most cases,
neuropsychiatric symptoms developed during
Chantix treatment, but in others, symptoms
developed following withdrawal of Chantix
therapy.
The FDA is working with the manufacturer
to finalize a Medication Guide for patients.
For the complete MedWatch Safety
Summary along with information for health
care professionals on using Chantix therapy
please refer to the FDA website, http://www.
fda.gov/medwatch/safety/2008/safety08.
htm#Varenicline.

SAFETY UPDATES
Possible link between Singulair and
suicidal behavior
The FDA is investigating a possible association between the use of
Singulair and behavior/mood changes, suicidality (suicidal thinking and
behavior) and suicide.
Singulair is a medicine in the drug class known as leukotriene
receptor antagonists. It is used to treat asthma and the symptoms of
allergic rhinitis and to prevent exercise-induced asthma. Over the
past year, the maker of Singulair, Merck & Co, Inc., has updated the
prescribing information for Singulair to include the following postmarketing
adverse events: tremor (March 2007), depression (April
2007), suicidality (suicidal thinking and behavior) (October 2007), and
anxiousness (February 2008).
The FDA is working with Merck to further evaluate a possible link
between the use of Singulair and behavior/mood changes, suicidality,
and suicide in response to inquiries received by FDA. Due to the
complexity of the analyses, FDA anticipates that it may take up to 9
months to complete the ongoing evaluations. Once completed, the FDA
will communicate the conclusions and recommendations to the public.
Until further information is available, health care providers should
monitor patients taking Singulair for suicidality (suicidal
thinking and behavior) and changes in behavior and mood.
For the complete 2008 FDA MedWatch Safety
Summary, please refer to the FDA website at:
http://www.fda.gov/medwatch/safety/2008/
safety08.htm#Singulair.
Conventional antipsychotics
to carry boxed warning
The FDA announced on Monday, June 16, 2008, that
manufacturers must now add a boxed warning to
conventional or first-generation antipsychotic medications to
alert physicians of the increased risk of death in elderly adults
being treated for dementia-related psychosis.
Back in 2005, the agency issued a similar warning for the
atypical antipsychotics.
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Please send your article suggestions,
comments, and questions to:
Kim Castelnovo, RPh
Community Care
One Chatham Center, Suite 700
112 Washington Place
Pittsburgh, PA 15219
E-mail: castelnovokm@ccbh.com