Transcript A Pharmacist Role in Detecting, Preventing, and Avoiding Insurance

Controlled Substances Update
MANP Summer Conference
July 19, 2105
Richard L. Ogletree, Jr., PharmD
Co-ordinator, Drug Information and
Investigational Drugs
University of Mississippi Medical Center
Faculty Disclaimer
Nothing to disclose in regards to
commercial support.
Part 2610
Chapter 2: CME Requirements
Rule 2.1
Basic Requirement
Every Mississippi licensee must earn or
receive not less than forty (40) hours of
Category 1 continuing medical education in
a two-year cycle as a condition precedent to
renewing his or her license for the next
fiscal year.
Part 2610
Chapter 2: CME Requirements
Rule 2.1
Basic Requirement
For every Mississippi licensee with an active
DEA certificate, five hours must be related to
the prescribing of medications with an
emphasis on controlled substances.
Prescription Monitoring Program
(PMP)
•
•
•
•
Purpose
To enhance patient care by providing
prescription monitoring information to
assure legitimate use of controlled
substances
To help curtail misuse and abuse of
controlled substances
To assist in combating illegal trade
To enable access to prescription
information by authorized individuals
Prescription Monitoring
Program
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Reduce prescription drug abuse and
diversion
Electronically collect, monitor, and
analyze prescribing and dispensing data
PMPs do not interfere with the
appropriate medical use of controlled
substances
50 states with legislation enacted
41 states with an operational PMP
Can a PMP be effective?
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ED providers checked 179 patients
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PMP changed Rx 41%
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61% decreased Rx
39% increased Rx
Baehren DF et al: A statewide prescription monitoring program affects emergency department prescribing. Ann Emerg Med 2010
56:24-26.
American College of Emergency Physicians
What prevents you from checking the PMP on every
patient for whom you prescribe controlled
substances?
Perrone et al: Prescribing practices, knowledge and use of prescription monitoring programs by
a national samp of clinicians, 2012
How often are you using the
PMP?
What would you like to change about your state's
Prescription Drug Monitoring Program?
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Who is Provided Access?
•
•
•
•
•
Law Enforcement for drug investigations (open
investigations and sometimes court orders are
required)
Licensing and Regulatory Boards for investigating
health care professionals who prescribe or
dispense prescription controlled substances
State Medicaid Programs for Medicaid member or
provider reviews
State medical examiners or coroners for cause of
death investigations
Research organizations that may be provided deidentified data for analysis and research
What Drugs are Monitored?
Schedules
Collected
States
Number
Schedule II
PA
1
Schedules II-III
CT
1
Schedules II-IV
AZ, CA, FL, IA, KS, ME, MN, NV, NJ,
NM, OR, RI, SC, SD, VT, VA, WI, WV,
WY
17
Schedules II-V
AK, AL, AR, CO, DE, GA, Guam, HI, ID,
IL, IN, KY, LA, MA, MI, MS, NY, NC,
28
ND, MD, MT, OH, OK, TN, TX, UT, WA
To be determined
NE
1
Who Administers PMPs?
Agency Type
Number
Consumer Protection
1
Substance Abuse
3
Law Enforcement
7
Professional Licensing
7
Departments of Health
15
Boards of Pharmacy
18
TOTAL
49
Mississippi’s PMP
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Reporting for Schedule II – V, including
carisoprodol, tramadol, and butalbital
Pharmacies and other dispensers must
provide such reporting
Authorized users include: prescribers,
pharmacists, law enforcement officers,
licensure board, Medicaid, grand jury,
judges, probation, or parole officers
https://mississippi.pmpaware.net/login
Preliminary Analyses of PMPs

Can PMPs really help limit opioid abuse?
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Goal: to facilitate informed prescribing
Limited data for effectiveness

One study observed a 4.9% per quarter increase in
opioid treatment admissions in states w/o PMP

Barriers identified for physicians and other health
care providers participating

What would be the ideal PMP?
“What about Inter-state DoctorShopping?”
•
Problem: people abusing medications may not stay in one
state
•
Result: the state PMP may not be a complete picture
•
Possible solution: PMP Interconnect
Hub created through NABP that
shares information within member
states
Physicians and pharmacists log into
their own state PMP and check boxes for
information through other states
–
Prescription Monitoring Program



Sign up:
https://mississippi.pmpaware.net/login
Can not use an email address that
anyone else is able to access
Nurse Practitioners must use the system
themselves and may not delegate this
responsibility to anyone else
Regulations
DEA Regulations –
Controlled Substances
A prescription for a controlled substance
must be dated and signed on the date
when issued. The prescription must
include the patient’s full name and
address, and the practitioner’s full
name, address, and DEA registration
number.
DEA Regulations –
Controlled Substances
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The prescription must also include:
Drug name
Strength
Dosage form
Quantity prescribed
Directions for use
Number of refills authorized (if any)
DEA Regulations –
Controlled Substances
A prescription must be written in ink or indelible
pencil or typewritten and must be manually
signed by the practitioner on the date when
issued. An individual (i.e., secretary or
nurse) may be designated by the practitioner
to prepare prescriptions for the practitioner’s
signature. The practitioner is responsible for
ensuring the prescription conforms to all
requirements of the law and regulations, both
federal and state.
MSBN Regulations –
Controlled Substances
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Do not let anybody else sign Rx for you
Do not pre-sign Rx blanks
Cannot mechanically or photostatically
reproduced signature or controlled
substance prescribed
No e-mailed prescriptions
Regulations –
Controlled Substances

Rx for controlled substances expire 6
months from the date written
Regulations –
Controlled Substances

No more than one (1) controlled
substance shall be issued on a single
prescription blank.
Regulations –
All Prescriptions
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Preprinted or clearly printed name of
prescriber
Multiple preprinted prescribers –
indicate which one
Multiple meds – clear refills for each
No fax for nalbuphine, carisoprodol,
butalbital compounds, or tramadol
(MSBML)
Repeat
No fax for tramadol,
carisoprodol, butalbital
compounds, or nalbuphine!
(MSBML)
electronic transmission of controlled
substance prescription data is limited to
computer to facsimile (fax)
transmissions or traditional fax to fax
transmissions.
Requirements for fax prescription orders
and systems utilized for faxing
prescriptions are as follows
The prescription order shall contain the
date, time, telephone number and
location of the transmitting device.
Prescription blanks utilized in this manner
shall bear a pre-printed heading that
indicates the blank is a “Fax
Prescription Form.”
Fax prescription orders must contain a
manual or authenticated
electronic/digital signature of the
prescriber.
Diet Medications
It is unlawful to prescribe, dispense or
administer any amphetamine or
amphetamine-like anorectic and/or
central nervous system stimulant
classified as Schedule II for the
exclusive treatment of obesity, weight
control, or weight loss.
Diet Medications
As to the administration, dispensation or
prescription of controlled substance
anorectics in Schedules III, IV and V,
use of said medications in the treatment
of obesity or weight loss should be
done with caution.
Diet Medications
Medications for the purpose of weight
loss in the treatment of obesity should
be used only as an adjunct to a regimen
of weight reduction based on caloric
restriction, provided, that all of the
following conditions are met:
Diet Medications
Review of records indicate a good faith
effort to lose weight has been made
utilizing:
a regimen of weight reduction based on
caloric restriction, nutritional counseling,
behavior modification, and exercise,
without the utilization of controlled
substances, and that said treatment has
been ineffective.
Diet Medications
Before initiating treatment utilizing a
Schedules III, IV or V controlled
substance, the prescriber
 obtains a thorough history
 performs a thorough physical
examination of the patient
Diet Medications

rules out the existence of any
recognized contraindications to the use
of the controlled substance to be
utilized. “Recognized contraindication”
means any contraindication to the use
of a drug which is listed in the United
States Food and Drug Administration
(hereinafter, “F.D.A.”) approved
labeling for the drug.
Contraindications
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Advanced arteriosclerosis
Cardiovascular disease
Moderate to severe HTN
Hyperthyroidism
Allergy to this or other
sympathomimetic amines
More Contraindications
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Agitated states
Hx of drug abuse
MAO inhibitors within 14 days
Diet Medications
The prescriber shall not utilize any
Schedules III, IV or V controlled
substance when he or she knows or has
reason to believe that a recognized
contraindication to its use exists.
Diet Medications
The prescriber shall not utilize any
Schedules III, IV or V controlled
substance in the treatment of a patient
whom he or she knows or should know
is pregnant.
Diet Medications
As to those controlled substances in
Schedules III, IV or V which are
classified as amphetamine or
amphetamine-like anorectics and/or
central nervous system stimulants,
hereinafter referred to as “stimulant”…
Diet Medications
the prescriber shall not initiate or shall
discontinue utilizing said controlled
substance stimulant immediately upon
ascertaining or having reason to
believe:
Diet Medications

A. That the patient has failed to lose
weight while under treatment with said
stimulant over a period of thirty (30)
days, which determination shall be
made by weighing the patient at least
every thirtieth (30th) day …
Diet Medications

except that a patient who has never
before received treatment for obesity
utilizing a stimulant, and who fails to
lose weight during his or her first such
treatment attempt may be treated with
a different controlled substance for an
additional thirty (30) days.
Diet Medications
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B. That the patient has developed
tolerance (a decreasing contribution of
the drug toward further weight loss) to
the anorectic effects of said stimulant
being utilized.
Diet Medications
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C. That the patient has a history of or
shows a propensity for alcohol or drug
abuse.
D. That the patient has consumed or
disposed of any controlled substance
other than in strict compliance with the
treating physician's directions.
Diet Medications
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In addition to the above the prescriber
shall not issue a prescription or
dispense a stimulant for any greater
than a thirty (30) day supply;
Diet Medications
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And a patient’s use of stimulants,
whether by dispensation or prescription
shall be limited to no more than six (6)
thirty (30) day supplies during any
twelve (12) month period of time.
No longer valid – As of November 2012,
this regulation has been deleted.
Diet Medications
And further, before subsequent new
prescriptions can be issued the patient
shall receive a thorough reevaluation of
the effectiveness of the medication,
including a physical examination to
document any potential harmful side
effects.
Diet Medications
A prescriber shall not utilize a Schedules
III, IV or V controlled substance or
legend drug for purposes of weight loss
unless it has an FDA approved
indication for this purpose and then
only in accordance with all of the above
enumerated conditions.
Diet Medications
A prescriber shall not utilize a Schedules
III, IV or V controlled substance or
legend drug for purposes of weight loss
unless it has an FDA approved
indication for this purpose and then
only in accordance with all of the above
enumerated conditions.
Diet Medications
The purpose of this rule is to prohibit
the use of such drugs as diuretics and
thyroid medications for the sole
purpose of weight loss.
Other considerations
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Expiration of rx
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Copies (between pharmacies)
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Controlled 6 months
Non-controlled – 1 year
Only non-controlled
Pseudoephedrine – RX only in MS
Dispense as Written
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Pay attention to the Rx pad
Medicaid has different requirements hand write “ Brand Medically
Necessary”
Dispense as Written
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Pay attention to the Rx pad
Medicaid has different requirements hand write “ Brand Medically
Necessary”
Dispense as Written
Consider DAW 1
 Coumadin
 Antiepileptics
 Thyroid medicines
FDA Approval
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Presence on the market does not
equate to FDA approval
1938 – safety
1962 – efficacy
Many products “grandfathered”
FDA AB Rating
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Required for substitution by many
chains
Expect telephone calls
No FDA Approval
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Midrin
Novahistine DH
Pyridium
Anusol HC
Levsin
FDA Withdrawals
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Quinine
Guaifenesin ER
Hydrocodone cough syrups
Codeine products
Morphine
Oxycodone
FDA Approved
Hydrocodone cough syrups
 Hycodan
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Tussionex
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Hydrocodone and homatropine
Adults - one tsp q4-6h prn cough
Adults - one tsp q12h
Hydrocodone with APAP liquid is still
available (pain)
FDA Approved
Hydrocodone cough syrups
 Hycodan
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Tussionex
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Hydrocodone and homatropine
Adults - one tsp q4-6h prn cough
Adults - one tsp q12h
Hydrocodone with APAP liquid is still
available (pain)
Speaking of Hydrocodone…
Requirements Applicable to
Prescriptions
a. Authority To Prescribe HCPs as
Schedule II Controlled Substances
In Mississippi Nurse Practitioners and
Physician Assistants can obtain DEA
authority to prescribe C II medications.
b. Transmittal Method of HCPs as
Schedule II Controlled Substances
Oral and Facsimile Prescriptions – in
general this is not allowed
Triplicate Prescriptions – not required in
Mississippi
c. Quantity and Frequency of Fills
and Refills for HCPs as Schedule II
Controlled Substances
Although the CSA prohibits refills of
prescriptions for schedule II controlled
substances, a practitioner may issue
multiple schedule II prescriptions in order
to provide up to a 90-day supply of
medication in accordance with 21 CFR
1306.12.
Date should be the date actually written
Can utilize a “Do Not Fill Before…“
message
Remember…
•Date should be the date actually written
•Can utilize a “Do Not Fill Before…“
message
Prescriptions
All prescriptions for HCPs must comply
with 21 U.S.C. 829(a) and must be issued
in accordance with 21 CFR part 1306 and
subpart C of 21 CFR part 1311 as of
October 6, 2014.
Prescriptions
No prescription for HCPs issued on or
after October 6, 2014 shall authorize any
refills.
Prescriptions
Any prescriptions for HCPs that are issued
before October 6, 2014, and authorized
for refilling, may be dispensed in
accordance with 21 CFR 1306.221306.23, 1306.25, and 1306.27, if such
dispensing occurs before April 8, 2015.
Discontinued Medications
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Tylenol with codeine elixir
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Robitussin AC
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Write APAP with codeine elixir
Write guaifenesin with codeine
Or Cheratussin AC
Mepergan Fortis
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Generics are discontinued also
Medications Causing Confusion
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Adderall vs Adderall XR
Focalin vs Focalin XR
Metadate ER vs Metadate CD
Ritalin vs Ritalin SR vs Ritalin LA
FDA Safety Alerts –
Zolpidem
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Next-day impairment a significant
concern, especially with extendedrelease products and in women
Recommended lower dose (women):
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Immediate release – 10mg  5mg
Extended release – 12.5mg  6.25mg
FDA Safety Alerts –
Zolpidem
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
Always use lowest dose possible
Intermezzo already has lower dosage
recommendation for women
incorporated into FDA labeling
FDA later added language to Ambien CR
package insert to warn patients not to
drive or engage in activities requiring
mental alertness the day after taking
the drug.
FDA Safety Alerts –
Eszopiclone
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Recent study found 3mg dose can
cause impairment of driving skills,
memory, and coordination that may last
>11 hours
Recommended decreasing initial dose
from 3mg to 1mg.
Applies to both men and women
FDA Safety Alerts – Codeine
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[ 7-1-2015 ]
FDA Drug Safety Communication:
FDA evaluating the potential risks
of using codeine cough-and-cold
medicines in children
FDA Safety Alerts – Codeine
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The U.S. Food and Drug Administration (FDA) is
investigating the possible risks of using codeinecontaining medicines to treat coughs and colds in
children under 18 years because of the potential for
serious side effects, including slowed or difficult
breathing. We are evaluating all available
information and will also consult with external
experts by convening an advisory committee to
discuss these safety issues. We will communicate our
final conclusions when our review is complete.
FDA Safety Alerts – Codeine

Parents and caregivers who notice any
signs of slow or shallow breathing,
difficult or noisy breathing, confusion, or
unusual sleepiness in their child should
stop giving their child codeine and seek
medical attention immediately by taking
their child to the emergency room or
calling 911.
FDA Safety Alerts – Codeine

In April 2015, the European Medicines Agency
(EMA) announced that codeine must not be
used to treat cough and cold in children under
12 years, and that codeine is not
recommended in children and adolescents
between 12 and 18 years who have breathing
problems, including those with asthma and
other chronic breathing problems.
Medical Literature

Article: Rubinstein A, Carpenter DM.
Elucidating Risk Factors for Androgen
Deficiency Associated with Daily Opioid
Use. The American Journal of Medicine
[Internet]. 2014 Jul; Available from:
http://linkinghub.elsevier.com/retrieve/
pii/S0002934314005956
Medical Literature
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Retrospective cohort study
The Kaiser Permanente Northern
California databases (approximately 3.2
million lives served) was used to
identify men on stable doses of opioids.
The study included 1585 men.
Medical Literature
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Men on long-acting opioids were more likely
to be androgen deficient than men on shortacting opioids (57% vs. 35%, P < 0.001;
odds ratio [OR] 3.39, 95% CI 2.39–4.77).
Medical Literature
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As dose increased, the odds of androgen
deficiency increased;
Dose was more strongly associated with
androgen deficiency in men on short-acting
opioids (OR 1.16, 95% CI 1.09–1.23, for each
10-mg increase in dose) than in men on longacting opioids (OR 1.01, 95% CI 1.01–1.02).
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FDA Safety Alerts –
Testosterone

Announced in Jan 2014 that FDA is
investigating risk of stroke, heart
attack, and death in men taking
testosterone.
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JAMA article showed 30% increase in risk
of stroke, heart attack, and death
PLOS article found RR=2.9 for MI in
younger patients with pre-existing heart
disease
FDA Safety Alerts –
Testosterone
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No conclusions at this point
At this point, prescribers urged to weigh
risk vs. benefit of therapy
FDA reinforced that currently approved
products are only approved for patients
with low testosterone and and
associated medical disease.
FDA Safety Alerts –
Testosterone
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Testosterone products are approved
only for men who have low
testosterone levels caused by certain
medical conditions
Labels have been updated to clarify the
approved uses of these products and
include information about a possible
increased risk of heart attacks and
strokes in patients taking testosterone.
FDA Safety Alerts –
Methylphenidate
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FDA warned in Dec 2013 that
methylphenidate products may cause
priapism in males taking product for
ADHD
Younger patients may not recognize
problem or may be too embarrassed to
report.
Male patients and caregivers should be
taught signs and symptoms of priapism
FDA Safety Alerts –
Methylphenidate


Safety communication discouraged
prescribers from switching to Strattera
(atomoxetine) due to fears of priapism,
since priapism appears to be more
common with this drug.
Unclear whether amphetamines
associated with priapism
FDA Safety Alerts –
Methylphenidate
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
[ 06-24-2015 ]
FDA Drug Safety Communication:
FDA reporting permanent skin
color changes associated with use
of Daytrana patch
(methylphenidate transdermal
system) for treating ADHD
FDA Safety Alerts –
Methylphenidate

The U.S. Food and Drug Administration
(FDA) is warning that permanent loss of skin
color may occur with use of the Daytrana
patch (methylphenidate transdermal system)
for Attention Deficit Hyperactivity Disorder
(ADHD). FDA added a new warning to the
drug label to describe this skin condition,
which is known as chemical leukoderma.
FDA Safety Alerts –
Methylphenidate
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FDA 52 cases April 2006 - December 2014
The time to onset - 2 months to 4 years
All of the patients described a decrease in or loss
of skin color.
In most cases, the loss of skin color was limited
to the areas around where the patch was rotated.
However, a small number of patients also
reported skin color changes on parts of the body
where the patch was never applied. In all cases,
the decreased skin color was permanent..
New FDA Approved

Belviq
 Lorcaserin hydrochloride
 Indicated as adjunct to a reduced-calorie
diet and increased physical activity for
chronic weight management with an
initial BMI of:
 30 kg/m2 or greater (obese)
 27 kg/m2 or greater (overweight) and
one weight related comorbidity (e.g.
HTN, DLD, T2DM)
New FDA Approved

Belviq
 one 10 mg tablet PO BID
 evaluate response to therapy by week 12

if patient has not lost at least 5% baseline
body weight, d/c Belviq as continued
treatment not likely to be efficacious
New FDA Approved

Belviq
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Schedule IV
Warnings
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Serotonin syndrome
 DDI: triptans, MAOIs, SSRIs, SNRIs dextromethorphan,
TCAs, bupropion, lithium, tramadol, tryptophan, St.
John's wort
Cognitive impairment
Hypoglycemia in T2DM
Priapism
Increase in heart rate
Pregnancy category X
New FDA Approved

Qsymia
 Schedule IV
 Phentermine and topiramate
 For weight management
New FDA Approved

Qsymia
 one capsule 3.75mg/23mg daily for 14 days, then
increase to 7.5mg/46mg daily
 D/C or escalate dose if 3% weight loss is not
achieved after 12 weeks on 7.5mg/46mg
 D/C if 5% weight loss is not achieved after 12 weeks
on maximum daily dose of 15mg/92mg
 D/C 15mg/92mg dose gradually to prevent possible
seizure
 Do not exceed 7.5mg/46mg with moderate or severe
renal impairment or patients with moderate hepatic
impairment
New FDA Approved

Qsymia
 Contraindications
 Pregnancy
 Glaucoma
 Hyperthyroidism
 During or within 14 days following the
administration of MAOis
 Known hypersensitivity or idiosyncrasy to the
sympathomimetic amines
New FDA Approved

Qsymia
 Warnings
 Increase in heart rate
 Suicidal behavior and ideation
 Mood disorders
 Acute myopia
 Oligohydrosis and hyperthermia
New FDA Approved

Qsymia
 DDI
 MAOis
 Oral contraceptives
 CNS depressants including alcohol(e.g. barbiturates,
benzodiazepines, and sleep medications)
 Non-potassium sparing diuretics(e.g.
hydrochlorothiazide)
 Antiepileptic drugs(e.g. valproic acid)
 Carbonic anhydrase inhibitors(e.g. zonisamide,
acetazolamide, dichlorphenamide)
New FDA Approved

Fycompa
 perampanel
 For seizures (adjunct therapy – partial
onset)
 One 2 mg tablet daily at bedtime,
increased by 2 mg/day increments no more
frequently than weekly to a dose of 4 to 8
mg daily
New FDA Approved

Fycompa
 Warnings
 Psychiatric and behavioral reactions
 Suicidal behavior and ideation
 Dizziness, gait disturbance, somnolence and fatigue,
increased risk of falls
 Schedule III
 DDIs
 Levonorgestrel
 Alcohol and other CNS depressants
New FDA Approved
New FDA Approved

Suvorexant

MOA - orexin (hypocretin) receptor
antagonist. The orexin neuropeptide
signaling system is a central promoter of
wakefulness. Blocking the binding of wakepromoting neuropeptides orexin A and
orexin B to receptors OX1R and OX2R is
thought to suppress wake drive.
New FDA Approved

Suvorexant


Indication - treatment of insomnia
characterized by difficulties with sleep
onset and/or sleep maintenance.
Contraindaction - narcolepsy
New FDA Approved

Suvorexant

Dosage and administration




Use the lowest dose effective for the patient
Recommended dose is 10 mg, no more than
once per night taken within 30 minutes of
going to bed, with at least 7 hours remaining
before the planned time of awakening.
If the 10 mg dose is well tolerated but not
effective, the dose can be increased, not to
exceed 20 mg once daily.
Time to effect may be delayed if taken with or
soon after a meal
New FDA Approved

Suvorexant

Drug interactions

Avoid with strong
inhibitors of CYP3A







ketoconazole
itraconazole,
posaconazole
clarithromycin
nefazodone
ritonavir,
saquinavir






nelfinavir
indinavir
boceprevir
telaprevir
telithromycin
conivaptan
New FDA Approved

Suvorexant

Drug interactions
5 mg in subjects receiving moderate CYP3A inhibitors






amprenavir
aprepitant
atazanavir
ciprofloxacin
diltiazem
erythromycin





fluconazole
fosamprenavir
grapefruit juice,
imatinib
verapamil
The dose can be increased to 10 mg in these patients
if necessary
New FDA Approved

Suvorexant – potential issues




CNS depressant effects and daytime
impairment
Abnormal thinking and behavioral changes
Worsening of Depression/Suicidal ideation
Sleep paralysis, hypnagogic/hypnopompic
hallucinations, cataplexy-like symptoms
New FDA Approved

Suvorexant

Side effects

Drowsiness – including next day. Caution
those using 20 mg against next-day driving
New FDA Approved

Suvorexant

Keep in mind exposure to drug increased in



Females
Obese
A particular problem in obese females –
use lower doses
Pharmacology
Pain Pathways
Pharmacology - Opioids
Pharmacology - Opioids

Histamine release
Pharmacology - Opioids

Histamine release - itching
Pharmacology - Opioids


Histamine release - itching
Nausea
Pharmacology - Opioids



Histamine release - itching
Nausea
Analgesia
Pharmacology - Opioids




Histamine release - itching
Nausea
Analgesia
Sedation
Pharmacology - Opioids





Histamine release - itching
Nausea
Analgesia
Sedation
Euphoria
Pharmacology - Opioids






Histamine release - itching
Nausea
Analgesia
Sedation
Euphoria
Respiratory depression
Don’t Forget
Don’t Forget

Constipation
Don’t Forget

Constipation


Stool softener
Stimulant
Side notes
Side notes

NSAIDS

Naproxen vs Naproxen Sodium
Side notes

NSAIDS


Naproxen vs Naproxen Sodium
Naproxen Sodium works faster – better
when prn needed
Side notes

NSAIDS

Ketorolac
Side notes

NSAIDS


Ketorolac
Limit to 5 days therapy
Side notes

NSAIDS

CV safety
Side notes

NSAIDS


CV safety
Worst seem to be


celcoxib
diclofenac
Side notes

Simvastatin


Max dose = 40 mg
20 mg if on




Amlodipine
Amiodarone
Ranolazine
10 mg if on


Diltiazem
Verapamil
Side notes

Citalopram


Max dose = 40 mg
20 mg over 60 years old
New FDA Approved - Opiates

Nucynta (tapentadol)





Schedule II Controlled Substance
Available IR and ER
Unique MoA - μ-opioid and NE
 Additional receptor target an attempt to treat chronic,
neuropathic pain
 Post-marketing reports of serotonin syndrome with
concomitant use of SSRIs and SNRIs
Use with caution in pts with hx of seizures
Initiate 50 mg, 75 mg, or 100 mg q 4-6 hours depending on
pain intensity
New FDA Approved - Opiates

Nucynta (tapentadol)
 Contraindications
 Respiratory depression
 Acute or severe bronchial asthma
 MAOIs within 14 days
 DDI
 Alcohol, other opioids, CNS depressants
 MAOIs
 Serotonergic drugs (e.g. SSRIs and SNRIs)
 Anticholinergic agents (e.g. diphenhydramine)
New FDA Approved - Opiates

Zohydro ER (hydrocodone bitartrate)
 First extended release hydrocodone product without
acetaminophen
 Approximately 1:1 conversion with oxycodone per package
insert
 Not tamper-resistant
 Initiate with 10 mg capsule BID, titrated in increments of 10
mg every 3 to 7 days to achieve adequate analgesia
 Single 50 mg capsule or total daily dose greater than 80 mg is
only for patients tolerant to an opioid of comparable potency
 Schedule II
New FDA Approved - Opiates

UPDATE: Zohydro ER with BeadTek




New formulation approved January 30, 2015 with abuse-deterrent
properties
Mix of inactive beads, active IR hydrocodone beads and active ER
hydrocodone beads
When crushed and dissolved in liquids or solvents, the inactive beads are
designed to immediately form a viscous gel
Available: 10, 15, 20, 30, 40, and 50 mg capsules
New FDA Approved - Opiates

Hysingla ER (hydrocodone bitartrate)
 First hydrocodone with FDA-approved labeling that describes
abuse-deterrent characteristics
 Indicated for the mgmt of pain severe enough to require
daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate
 Available in 7 dosage strengths: 20, 30, 40, 60, 80, 100, 120
mg
 Starting dose for patients who are not opioid tolerant is
Hysingla ER 20 mg tablet orally every 24 hours
 Do not abruptly discontinue Hysingla ER
New FDA Approved
Formulations

Quillivant XR
 Methyphenidate HCl
 For ADHD
 First and only extended-release liquid medicine for ADHD
 Starting dose is 20 mg ER PO suspension once daily in the
morning, titrated weekly in increments of 10 to 20 mg.
 Schedule II
 Available as 5mg/mL in different quantities:




300
600
750
900
mg/60 mL
mg/120 mL
mg/150 mL
mg/180 mL
New FDA Approved
Formulations

Targiniq ER (Oxycodone HCl and Naloxone HCl)



Schedule II
For the long-term management of severe pain that requires daily,
around-the-clock treatment
BBWs
 Addiction, abuse and misuse
 Respiratory depression
 Accidental ingestion
 Neonatal opioid withdrawal syndrome
 CYP 3A4 interaction (initiation of 3A4 inhibitors or
discontinuation of 3A4 inducers can result in overdose)
New FDA Approved
Formulations

Targiniq (continued)

Contraindications






Significant respiratory depression
Acute or severe bronchial asthma
Known or suspected paralytic ileus or GI obstruction
Moderate to severe hepatic impairment
Hypersensitivity to oxycodone or naloxone
Available in 10 mg/5 mg, 20 mg/10 mg, and 40 mg/20 mg
New FDA Approved
Formulations

Targiniq (continued)


Starting dose for opioid naïve or intolerant patients is 10
mg/5 mg every 12 hours
Conversion from other opioids (per package insert):


Convert total daily dose to the morphine equivalent
Convert to starting dose using the table below
New FDA Approved
Formulations

Subsys
 fentanyl sublingual spray
 Not bioequivalent with other fentanyl
products
 Used for breakthrough cancer pain in those
receiving and tolerant to around-the-clock
opioid pain medicine
New FDA Approved
Formulations

Subsys



Initial dose is always 100 mcg except in patients
already using Actiq
 Subsequent titration steps are 200 mcg, 400
mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600
mcg
One dose should be consumed, wait for 30
minutes, if needed ONLY ONE additional dose until
at least 4 hours. If inadequate relief with one dose
then increase dose to next highest strength
Schedule II
New FDA Approved
Formulations

Suprenza
 phentermine hydrochloride ODT
 For weight management
2
2
 BMI ≥ 30 kg/m or ≥ 27 kg/m with
other risk factors
 One ODT tablet (strengths are 15 mg, 30
mg, or 37.5 mg) in the morning
New FDA Approved
Formulations

Suprenza
 Avoid in evening due to possibility of
insomnia
 Common side effects include dry mouth,
nervousness, constipation, nausea
 Rare but serious side effect includes
primary pulmonary hypertension
 Schedule IV
New FDA Approved
Formulations

Zubsolv
 buprenorphine and naloxone sublingual ODT
 For treatment of opioid dependence
 one or two sublingual tablets once daily (available
as 1.4 mg/0.36 mg or 5.7 mg/1.4 mg) in the
range of 2.8 mg/0.72 mg to 17.1 mg/4.2 mg for
opioid dependence to be adjusted in 1.4 mg/0.36
mg increments
 Schedule III
New FDA Approved
Formulations

Xartemis XR
 First and only oxycodone and acetaminophen extended
release tablet
 Not interchangeable with other oxycodone/APAP
formulations
 For acute severe pain
 Two tablets q 12 hours (supplied as 7.5 mg oxycodone/325
mg APAP tablets)
 One tablet at a time, don’t pre-wet prior to placing in
mouth but should be taken with enough water to allow
for immediate swallowing
 Schedule II
New FDA Approved
Formulations

Natesto (testosterone) – nasal gel



Schedule III
Two actuations (11mg) in each nostril TID
Contraindications



Men with carcinoma of the breast or prostate cancer
Pregnant or breast feeding women
Adverse effects – increased PSA, headache, rhinorrhea,
epistaxis, nasal discomfort, nasopharyngitis, bronchitis,
upper respiratory tract infection, sinusitis, and nasal scab
New FDA Approved
Formulations

Vogelxo (testosterone) – topical gel



Schedule III
BBWs are related to secondary exposure to testosterone
Warnings and precautions:



Monitor for worsening of BPH
Gel is flammable until dry
No claims of benefit over other testosterone gels currently
on the market
New FDA Approved
Formulations

Aveed (testosterone undeconate) – injectable that
requires less frequent dosing


3 mL (750 mg) IM (only in gluteus medius) at 0, 4, and
every 10 weeks thereafter
BBWs:




Anaphylaxis
Pulmonary oil microembolism (POME)
Must be observed 30 minutes in a healthcare setting after
injection to look for anaphylaxis and/or POME
Only available through the Aveed REMS Program
New FDA Approved
Formulations

Evzio (naloxone)



Autoinjector for opioid
overdose
Autoinjector with electronic
voice instruction system
similar to Auvi-Q
0.4 mg / 0.4 mL in each prefilled autoinjector as a onetime dose
New FDA Approved
Formulations

Bunavail (buprenorphine/naloxone)




Schedule III
For opioid addiction
Buccal film
Has better absorption than Suboxone (about half the dose of
buprenorphine) and therefore harder to abuse
New FDA Approved
Formulations

Zubsolv
 Schedule III
 physicians only
 buprenorphine and naloxone sublingual ODT
 For treatment of opioid dependence
 one or two sublingual tablets once daily (available
as 1.4 mg/0.36 mg or 5.7 mg/1.4 mg) in the
range of 2.8 mg/0.72 mg to 17.1 mg/4.2 mg for
opioid dependence to be adjusted in 1.4 mg/0.36
mg increments
New FDA Approved
Formulations

Xartemis XR
 Schedule II
 First and only oxycodone and acetaminophen extended
release tablet
 Not interchangeable with other oxycodone/APAP
formulations
 For acute severe pain
 Two tablets q 12 hours (supplied as 7.5 mg
oxycodone/325 mg APAP tablets)
 One tablet at a time, don’t pre-wet prior to placing
in mouth but should be taken with enough water to
allow for immediate swallowing
New FDA Approved
Formulations

Tuzistra™ XR
(Codeine polistirex and
chlorpheniramine polistirex)
extended-release oral suspension,
CIII


The lead programme in Vernalis' cough cold pipeline,
Tuzistra™ XR, was approved by the US FDA in April 2015
for the relief of cough and symptoms associated with
upper respiratory allergies or a common cold in adults 18
years of age and older.
New FDA Approved
Formulations




pink to reddish pink, cherry-flavored liquid
oral suspension containing in 5 ml
codeine polistirex, providing 14.7 mg of
codeine (equivalent to 20 mg codeine
phosphate), and
chlorpheniramine polistirex, providing 2.8
mg chlorpheniramine (equivalent to 4 mg
chlorpheniramine
maleate)
New FDA Approved
Formulations


for the relief of cough and symptoms
associated with upper respiratory allergies
or a common cold in adults 18 years of age
and older
Tuzistra XR is administered as an oral dose
of 10mL every 12 hours and may be taken
with or without food.
New FDA Approved
Formulations


05.27.2015
Actavis Receives FDA Approval for
VIBERZI (eluxadoline) for the
Treatment of Irritable Bowel
Syndrome with Diarrhea (IBS-D) in
Adults
New FDA Approved
Formulations




as a twice-daily, oral treatment for adults
suffering from irritable bowel syndrome
with diarrhea (IBS-D). VIBERZI
(eluxadoline) has mixed opioid receptor
activity, it is
mu receptor agonist,
delta receptor antagonist
a kappa receptor agonist.
Abused Meds

Tussionex


10 ml/day is normal dose
“Small” quantities may actually be large
Abused Meds





Promethazine with codeine
Party substance
Prefer the purple
Contraindicated under 6 years old
More than 8 ounces
Abused Meds


Hydrocodone pain meds
Lortab vs Lorcet vs Vicodin vs Norco
Abused Meds


Hydrocodone pain meds
Lortab vs Lorcet vs Vicodin vs Norco



Lortab and Lorcet no longer exist
Norco 5, 7.5, 10 – 325 mg APAP
Vicodin 5, 7.5, 10 – 300 mg APAP
Non-controlled substances can
still be abused







Alcohol
Gabapentin
Clonidine
Dextromethorphan
Promethazine
Diphenhydramine
Krill oil?





Herbs

Salvia divinorum

Jimsonweed
Epoetin alfa
Nitrous oxide
Volatile solvents
Aryl nitrites

http://www.usatoday.com/story/news/n
ation/2015/04/07/mississippi-spiceoverdoses/25428467/
Thank You