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Transcript
David Todd Loffert
B.S., M.H.S., (Ph.D. Candidate)
Addiction is a primary, chronic, neurobiologic disease
with genetic, psychosocial, and environmental factors
influencing its development and manifestations.
Addiction is characterized by behaviors that include
one or more of the following:
• Impaired control over drug use
• Compulsive use
• Continued use despite harm
• Cravings
Rx Addicted
Doctors
Lawyers
Attorneys
Newscasters
Housewives
Businessmen
Young Teenagers
Athletes
Politicians
Celebrities
1
• Sobriety
2
• Jails /
Institutions
3
• Death
2011
• 21 Million Americans using
prescriptions for non-medical use
(addicted)
2011
• Non-medical use of prescription drugs
the #1 drug of abuse in U.S.
2011
• 30,000 overdoses in U.S.
2011
• Prescription Drug Abuse Results in
One Death Every 19 Minutes in U.S.
2010
• 39 out of 50 states have a Prescription
Drug Monitoring Program
2009
• Over 1 million visits to ERs for drug
related complications
Rates of Prescription Painkiller Sales,
Deaths and Substance Abuse Treatment
Admissions (1999-2010)
SOURCES: National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System (ARCOS)
of the Drug Enforcement Administration (DEA), 1999-2010; Treatment Episode Data Set, 1999-2009
Prescription Drug Overdose Death Rates
By State per 100,000 People (2008)
SOURCE: National Vital Statistics System, 2008
1
• The drug or other substance has a high potential for
abuse, no medical use.
2
• The drug or other substance has a high potential for
abuse, medical use.
3
• The drug or other substance has a potential for abuse
less than the drugs or other substances in Schedules I
and II.
4
• The drug or other substance has a low potential for
abuse relative to the drugs or other substances in
Schedule III.
5
• The drug or other substance has a low potential for
abuse relative to the drugs or other substances in
Schedule IV.
1 • Prescription Drugs (2-5)
2 • Marijuana (1)
3 • Cocaine (2)
4 • Heroin (1)
5 • Methamphetamine (2)
1
• University of Northern Colorado, B.S. in Biology and
Chemistry
2
• Johns Hopkins University, Master of Health Science in
environmental/radiation/respiratory health
3
• Medical College of Virginia/Virginia Commonwealth
Universtiy, Ph.D. in respiratory medicine
4 Peer-Reviewed Journal Articles
53 Papers Presented At Various Medical
Conferences & Meetings
Contributing author for the book, “Inhalation Aerosols,
Physical and Biological Basis for Therapy” by Anthony
J. Hickey
Masters Thesis: Fundamentals of Aerosol Delivery
to the Respiratory Tract with an Emphasis on the
Performance of Medicinal Spacer Devices
Delivery of glucocorticoids by jet nebulization: Aerosol characteristics and output
Jeffrey Leflein, MD, a Eleanor Brown, MT(ASCP), a Malcolm Hill, PharmD, a
H. William Kelly, PharmD, b David Todd Loffert, BS, a Harold S. Nelson, MD,"
and Stanley J. Szefler, MD ~ Denver, Colo., and Albuquerque, N.M.
Background: Since inflammation has been identified as a critical factor in the
pathogenesis of asthma, use of inhaled glucocorticoids has increased. Because young
children are often unable to coordinate properly the use of metered-dose inhalers and no
glucocorticoids preparations for nebulization have been approved in the United States,
parenteraI and intranasal glucocorticoids preparations are occasionally administered by
nebulization.
Methods: We examined whether a parenteral preparation (triamcinolone acetonide [TAA];
Kenalog) could be delivered by nebulization. TAA, 1000 txg (0.1 ml), was placed in the
nebulizer bowl (MB5 [MeFar, Brescia, Italy] or Pari-Jet [Dura Pharmaceuticals, San Diego,
Calif.]), then diluted with 2. 9 ml normal saline solution for a total volume fill of 3 ml. Using
a laser panicle analyzer, high-performance liquid chromatography, and cascade impactor, we
examined the percentage of aerosol volume produced with panicles in the respirable range of
1 to 5 lazn in diameter, actual TAA output (in micrograms) and concentration of TAA
contained in the panicles within the respirable range.
Results: Laser particle analysis indicated that 34% +- 3% (mean +- SEM) (MB5) and 47 +3% (Pari-Jet) of the total aerosol volume produced were within the respirable range of I to 5
txm in diameter, and this remained consistent throughout nebulization. The nebulizer was
stopped serially for determination of TAil output with high-performance liquid
chromatography. TAA output (1000 tzg less the amount in micrograms remaining after
nebulization) was essentially complete after 2 minutes with the Pari-Jet and within 4 minutes
with the MB5 and totaled 352 +- 19 ixg and 367 +-- 9 Ixg, respectively. Finally, cascade
impactor studies confirmed that 33.4% of the TAil aerosol generated by the MB5 nebulizer
was contained in panicles in the respirable range.
Conclusion: Approximately 35% (Pari-Jet) and 37% (MB5) of the initial 1000 lag of TAA
was delivered with the two nebulizers tested. The panicles generated within the respirable
range were limited to 34% (MB5) and 47% (Pari-Jet) of the amount delivered. TAA was
equally distributed in the particles generated. The theoretic amount delivered in the respirable
range was approximately 12.5% for the MB5 nebulizer on the basis of the cascade impactor
and 16.5% for the Pari-Jet (assuming TAA distribution equivalence) of the TAA placed in
each of the nebulizers. Additional clinical studies are needed to define efficacy and safety in
view of the excipients used in preparing the parenteral preparation. (J ALLERGY CLIN
IMMUNOL 1995;95:944-9.)
Key words: Triamcinolone acetonide, glucocorticoids, laser panicle analyzer, high-performance
liquid chromatography, cascade impactor.
COMPARISON OF DISPOSABLE JET NEBULIZERS, A METHOD FOR DETERMINING WHICH
BRAND TO USE. D. Todd Loffert, PARI Respiratory Equipment, 7493 Whitepine Road, Richmond,
Virginia, 23237.
Four commercially available nebulizers from 4 sources were studied (Misty-Neb/Baxter, PARI LCD/PARI, Updraft II/Hudson RCI, and Whisper Jet/Marquest medical). The nebulizers were operated
using an PARI Master compressor and reanalyzed with an Devilbiss Pulmo-Aide compressor. Delivery
rate(Ml/Min), percent Particles in the Respirable Range(PRR), Respirable Particle Delivery
Rate(RPDR), and standard deviation of all parameters were compared. All nebulizers were filled with
2.5 ml of saline. PRR was measured by continuous sampling by Laser Particle Analyzer, Malvern
Mastersizer X. The nebulizers were sampled at a simulated flow rate of 20 liters per minute.
PARI MASTER COMPRESSOR
Ml/Min varied from 0.23 to 0.56 ml/min. The Whisper Jet (0.23) had the lowest ml/min while the PARI
LC-D (0.56) had the highest.
PRR varied 22.74 to 59.89%. The Misty-Neb (22.74%) had the lowest PRR while the PARI LC-D
(59.89%) had the highest.
To combine the previous variables RPDR was calculated, = Ml/Min multiplied by PRR. The Misty-Neb
(0.06) had the lowest RPDR while the PARI LC-D (0.34) had the highest RPDR (means significantly
different at p<0.0001).
PULMO-AIDE COMPRESSOR
Ml/Min varied from 0.14 to 0.48 ml/min. The Whisper Jet (0.14) had the lowest ml/min while the PARI
LC-D (0.48) had the highest.
PRR varied 25.00 to 51.92%. The Misty-Neb (25.00%) had the lowest PRR while the PARI LC-D
(51.92%) had the highest.
To combine the previous variables RPDR was calculated, = Ml/Min multiplied by PRR. The Misty-Neb
(0.04) had the lowest RPDR while the PARI LC-D (0.25) had the highest RPDR (means significantly
different at p<0.0001).
The Ml/Min, PRR, and RPDR of the commercially available nebulizers varies greatly with each
compressor used. Consideration must be given to these efficiency parameters when deciding which
nebulizer brand to use.
Comparison of the bronchodilator response to albuterol
administered by the OptiHaler, the AeroChamber, or by metered dose
inhaler alone.
Nelson HS, Loffert DT.
National Jewish Center for Immunology and Respiratory Medicine, Denver, CO 80206.
Eighteen subjects with moderate asthma participated in this double-blind
study comparing the bronchodilator response to albuterol or placebo used
in conjunction with three inhalation devices; the metered dose inhaler
(MDI) actuator alone, the AeroChamber, and the OptiHaler. The principal
comparison was the increase in FEV1 over 30 minutes. Also recorded
were heart rate, time required to use each device, and patient acceptance
of each device. There was a large bronchodilator response with albuterol
with each of the devices, but there was no difference in the promptness or
the magnitude of the bronchodilator response among the three devices.
There was a small but statistically significant increase in heart rate which
did not differ among devices. Subject ratings of acceptability were MDI
alone best, followed by OptiHaler, then AeroChamber. We conclude (1)
the bronchodilator response obtained with use of the MDI alone, the
AeroChamber and OptiHaler were not significantly different; (2) patients,
as a group, found the MDI required less time to use and they favored it
over either spacer; (3) while in subjects employing good MDI technique,
the addition of either an AeroChamber or an OptiHaler did not improve
bronchodilator response. Spacers may have a role in those with poor
inhaler technique or in conjunction with inhaled corticosteroids.
“If you were
stranded on a
desert island,
what pain
medicine
would you
want to have
with you”
FDA
Schedule Visit #
2
1
Prescription
Demerol 100mg tubex
shots (needles)
#RX
Ordered/Refills
5
Date Rx
Written
7/30/1998
Last Filled
XXX
2
1
Demerol 100mg Tablets
60
7/30/1998
XXX
2
1
Dexedrine 5mg Tablets
30
7/30/1998
XXX
2
1
Mepergan (Demerol &
Phenergan)
60
7/30/1998
XXX
4
1
Valium
100 / w3
Refills
7/30/1998
XXX
2
1
Percocet 10mg Tablets
100
7/30/1998
XXX
FDA
Schedule
Visit #
2
Called in between
visit 1-2
Prescription
Percocet 10mg
Tablets
#RX
Ordered/Refills
100
Date Rx
Written
8/10/1998
Last Filled
7/30/1998
2
Called in between
visit 1-2
Dexedrine 5mg
Tablets
60
8/11/1998
7/30/1998
2
Called in between
visit 1-2
Dexedrine 5mg
Tablets
60
9/15/1998
8/11/1998
2
Called in between
visit 1-2
Demerol 100mg
Tablets
60
10/6/1998
7/30/1998
2
Called in between
visit 1-2
Demerol 100mg
Tubex (needles)
20
8/28/1998
7/30/1998
FDA
Schedule
2
#RX
Ordered/Refills
100
Date Rx
Written
10/20/1998
Visit #
2
Prescription
Percocet 10mg
Tablets
Last Filled
8/10/1998
2
2
Dexedrine 5mg
Tablets
100
10/20/1998
9/15/1998
2
Called in between Demerol 100mg
visit 2-3
Tubex Shots
(needles)
20
11/18/1998
8/28/1998
2
Called in between Demerol 100mg
visit 2-3
Tablets
60
11/18/1998
10/6/1998
4
Called in between Valium 5mg
visit 2-3
Tablets
100 / w4
Refills
11/18/1998
7/30/1998
FDA
Schedule
2
Visit #
3
2
3
2
3
#RX
Ordered/Refills
100
Date Rx
Written
12/4/1998
Last Filled
10/20/1998
Dexedrine 5mg
Tablets
120
12/4/1998
10/20/1998
Mepergan (Demerol &
Phenergan)
100
12/4/1998
7/30/1998
Prescription
Percocet 10mg
Tablets
FDA
Schedule
Visit #
Prescription
#RX
Ordered/Refills Date Rx Written
Last Filled
2
Called in between visit
3-4
Percocet 10mg
Tablets
100
12/21/1998
12/4/1998
2
Called in between visit
3-4
Demerol 100mg
Tablets
100
12/15/1998
11/18/1998
2
Called in between visit
3-4
Demerol 100mg Tubex
Shots (needles)
20
12/21/1998
11/18/1998
4
Called in between visit
3-4
Valium 5mg Tablets
100 / w4 Refills
12/15/1998
11/18/1998
2
Called in between visit
3-4
Dexedrine 5mg
Tablets
120
12/21/1998
12/4/1998
2
Called in between visit
3-4
Percocet 10mg
Tablets
100
12/31/1998
12/21/1998
2
Called in between visit
3-4
Dexedrine 5mg
Tablets
120
12/31/1998
12/21/1998
2
Called in between visit
3-4
Mepergan (Demerol
& Phenergan)
100
2/15/1999
12/4/1998
2
Called in between visit
3-4
Demerol 100mg
Tablets
100
2/24/1999
12/15/1998
FDA
Schedule Visit #
2
4
Prescription
Dexedrine 5mg Tablets
#RX
Ordered/Refills
100
Date Rx
Written
3/10/1999
Last Filled
12/31/1998
3
4
Vicodin HP 10mg Tablets
100 / w3
Refills
3/10/1999
XXX
4
4
Valium
100 / w3
Refills
3/10/1999
12/15/1998
xx
4
Ultram 50mg
100 / w6
Refills
3/10/1999
XXX
xx
4
Ultram 50mg
100 / w3
Refills
3/10/1999
XXX
4
4
Klonopin
60 / w3
Refills
3/10/1999
XXX
FDA
Schedule
Visit #
3
Called in
after visit
4
3
Prescription
Vicodin HP 10mg
Tablets
#RX
Ordered/Refills
100 / w3
Refills
Date Rx
Written
3/28/1999
Last Filled
3/10/1999
100
3/31/1999
3/28/1999
Called in
after visit
4
Vicodin HP 10mg
Tablets
Total # of
Visits
Total Days Under Dr.
Suter’s Care
Total # of
Pills
Average
Pills Per Day
4
243 (7.9 Months)
6,647
27.35
655
• FIRST VISIT
710
• DEXEDRINE
5MG
380
• DEMEROL 100MG
600
65
1800
• VALIUM 5MG
900
• VICODIN HP
10MG
260
• MEPERGAN
(DEMEROL &
PHENERGAN)
• PERCOCET 10MG
• DEMEROL SHOTS
100MG
1100
• ULTRAM
50MG (1 VISIT)
09-24-99 Cary G. Suter, M.D., 0101-011492, Richmond, VA –
Acceptance of surrender of license, in lieu of further
administrative proceedings, based upon inappropriate
prescribing of controlled substances and inadequate
documentation and monitoring of this prescribing.
1
• After months under Dr. Suter’s care, I decided
to stop.
2
• On my way home from school.
3
• Started to have a horrible feeling.
4
• Ended up in the hospital that night with severe
withdrawal complications/symptoms.
9
2
8
7
0
6
0
0
0
9
15
7
13
16
0
10
0
23
87
29
20
5
4
16
3
419
20
21
16
1
24
1
19
2
12
8
109
18
648
31
11
0
46
13
24
32
• GERMANY
12
• CARIBBEAN
8
• AUSTRIA
21
• MEXICO
10
• HOLLAND
4
• JAPAN
12
• PAKISTAN
5
• SPAIN
15
• CANADA
9
• BRAZIL
17
• BERMUDA
65
11
• INDIA
Controlled
Substance Rx
Doctors
Internet
ER’s
Walk-In Clinics
Forged
Insurance When
Had It
Rehab Facilities
Foreign
Countries
THROUGHOUT MY 9 YEARS OF ADDICTION THE FOLLOWING EVENTS
HAD A SIGNIFICANT DETRIMENTAL EFFECT IN MY LIFE
1) 67,457 controlled substance pills ingested
9) Fired from 5 prominent scientist positions
2) 45 grand mal seizures
10) 19 prescription related arrests
3) 323 narcotic related hospital visits
11) 180 forged prescriptions
4) 9 in-patient rehabilitation programs
12) 2 suicide attempts
5) Homeless 3 different times
13) 167 bad checks for prescriptions/Dr. visits
6) 35 hospitalizations from drug overdoses
14) 1,434 medical visits to obtain narcotics
7) Total medical debt over 9 years = $310,650.00
8) Dropped out of my Ph.D. due to addiction issues
Lecture in Atlanta
Forged Demerol Rx
Arrested At Conference
Taken Past Colleagues In
Handcuffs
Spent 2 Weeks In Atlanta Jail
On Way To Conference
Had Drug Seizure
Hit Wall, Rolled 3 Times
High On Prescription Drugs
Looking For My Dog
Woods Behind House
4 Masked Individuals With Guns
Burglarizing Houses
Walking Away Waiting To Be Shot
Desperation
No Way Out
Continuous Physical &
Emotional Pain
1
• Denver Cares
2
• PEER I (Needed at least 1 yr.)
3
• Family
4
• Acceptance/Responsibility
5
• Has Become a High Risk
1
• During Employment (1 Day)
2
• Arapahoe House (1 Week)
3
• West Pines (2.5 Weeks)
4
• Step 13 (2 Months)
5
• Denver Rescue Mission (6 Months)
6
• PEER 1 (1 Year)
1
• Publish From Hopkins to Homeless: My True
Story of Prescription Drug Addiction
2
• Complete My Doctorate In Public Health
Education (1 Year Before Completion)
3
• Find Full-Time Job In Public Health or In The
Addiction or Addiction Related Field
4
• PRePARe (People Recovering from
Prescription Addiction and Relapse)
5
• Maintain Positive Outlook
1
• CELL = 303-898-7859
2
• E-MAIL = [email protected]
3
• P.O. BOX 631344, LITTLETON, CO.
80163-1344