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Writer
"Everyone here went all
out for me and I noticed how they did the same for
every patient! It really made a huge impact
that they knew from personal experience what I was
going through and were willing to share their
personal struggles and triumphs with me. The
food was excellent, healthy home cooking adjusted
immediately to my personal dietary
requirements! Just wonderful to always have
access to food any time day or night was very
important to me. The grounds have lovely
trees and I discovered that I could play
basketball for the first time at age
51. I realized my addictions were
serious. I realized I would survive
withdrawal. I realized I was loved and
respected despite my failings. I realized
that I have a future as a happy, healthy
person. I did it!"
Marketing
Professional
"It is perfect! I
love it, I would stay forever if I could. I
realized that I have a new chance at life,
relationships, sobriety. I don't need
substances to have a happy fulfilling life.
I love my life and am thankful to Novus for
helping me realize that."
"I've got no
complaints. You guys and gals were great. I
really want to thank JJ, Jessica, Kara, Patty,
Andrew, Cate and of course Eric for getting me
here. I realized that my family is the most
important and I will not let drugs or anything
come between us again. Also, I don't know if
I would have been able to detox without the help
of Novus. Thanks for
everything."
Lawyer
"JJ, Kara and Kathy were
very kind and helpful. Everyone else was
very friendly and supportive. They made
suggestions but did not force a point of view on
you. The food-awesome. What I enjoyed
was not having a roommate. This is a top
notch facility. I am clean and am leaving
with a positive attitude. By allowing me the
freedom to relax and not be forced into constant
activity when I was feeling bad, I am stronger
today. This experience has reinforced my
need for sobriety but the desire is to do it for
myself and not anyone else."
Business
Owner
"Novus was very
organized; very friendly; very clean; excellent
food and has great personnel.
When I came to Novus I was having terrible pain in
my legs and calves. It was hard to walk,
even stand up from the sitting position. I
spoke with the doctor here at Novus about
this. She noticed that there was no hair on
my toes. She instantly thought
dehydration. She was right! By the
third day of constantly hydrating with vitamin
IV's, exercise and nerve assists, I could notice a
difference in my legs. The pain was
subsiding. It was progressively getting
better and better every day. Walking around
the grounds became easier and easier. I was
finding that getting out of my chair after the
ball game wasn't a task. Hydrating along
with exercise really helped me out, and I realize
now how important that is to the human
body."
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The Fentanyl
Patch |
By Steven L. Hayes, Director
Recently
there was alarming news about yet
another drug that some of our patients arrive at
Novus using and from which they want to
detox. A number of people are suffering
overdoses and deaths from the fentanyl skin patch
("patch") which contains the opioid fentanyl, a
potent narcotic. As the name implies, the
patch is stuck directly on the skin and, over a 72
hour period, the opioid is released from the patch
and is absorbed through the skin. This
process is called transdermal-through the skin.
The patch was developed by ALZA Corp, and
approved by the FDA in 1990 as the Duragesic Patch
for use by people with persistent,
moderate-to-severe pain who have been taking other
opioids. It is marketed by Janssen Pharmaceutical
Products, LP. (Alza and Janssen are subsidiaries
of Johnson & Johnson.) Janssen sells
Duragesic patches, which accounted for $1.5
billion in total sales for Johnson & Johnson
in 2005.
If you have to take a drug, the patch seems
to have advantages:
* They don't hurt.
* You don't have to suffer
through a shot.
* You don't
have to have an IV put in your arm.
*
The drug doesn't have to be swallowed.
* You don't have to worry
about a patient taking too much or too little or
forgetting to take a dose.
*
The drug enters the bloodstream directly and
doesn't go through the stomach which is slower and
thus doesn't cause stomach irritations like some
tablets or capsules.
One of the warnings required by
the FDA when the patch was approved is that the
patch is only for someone who is currently using
an equivalent dosage of other opioids.
Otherwise, the fentanyl released by the patch can
cause an overdose leading to respiratory failure
and, if not immediately addressed, death.
(An overdose of heroin or methadone can cause
respiratory failure and death.)
Because it
transfers the opioid through the skin directly
into the bloodstream over a 72-hour period, it is
very important that dosage being transferred
through the patch is carefully calculated.
The Duragesic patch is measured in micrograms-not
milligrams.
For example, a person switching from 100
milligrams a day of OxyContin to the Duragesic
patch should use no more than a 50 micrograms/hour
patch. Higher doses can lead to respiratory
depression and death in even a person who is used
to taking opioids for
pain.
NOT OPIOID
TOLERANT
Unfortunately, some doctors
ignored the FDA warnings and prescribed the patch
for patients who had just come out of surgery but
were not used to taking opioids. Many of
these patients experienced severe respiratory
depression and some died. Other doctors
ignored the warning and prescribed the patches to
address pain in children who had not previously
used opioids and they suffered severe respiratory
depression and some of them also died.
An August 27, 2007, article in
the Los Angeles Times by Ricardo Alonso-Zaldivar
told the story of Army Master Sgt. Harold
Kinamon. Sgt. Kinamon entered a military
hospital in Ohio for routine respiratory surgery
to help him sleep better. The operation, in
October 2005, progressed smoothly. He went home
with nothing more than a raw throat and the patch
on his skin.
That night, Kinamon, 41, died in
his sleep -- killed by an overdose of the drug
delivered through the patch.
This was three months after the
FDA's first warning that fentanyl patches should
be used with great caution, and not for
postoperative pain relief.
However, not
all of the deaths attributed to the patch were
from careless doctors or improper use by
patients. Some of the patches "leaked" when
shipped by Janssen. In 2004, Janssen was
forced to recall 2.2 million Duragesic patches
that were defective.
If a patch is leaking,
then instead of being delivered over 72 hours, the
drug is released much more rapidly and this can
lead to an overdose and
death.
Janssen and
ALZA were sued by the family of 28-year-old Adam
Hendelson following his death on Dec. 17, 2003.
Mr. Hendelson suffered chronic hip pain as a
result of an automobile accident, and wore a
Duragesic patch. Attorneys for the family
were able to show that the death was caused by a
leak in the patch that led to an opioid overdose
and the family was awarded $5.5
million.
Heat on the patch will increase the
amount of the opioid released into the body,
possibly creating an overdose that can lead to
death. People using the patch when they had
fevers overdosed and some died. People wore
the patch in saunas or applied heating pads to the
area or sunbathed while wearing the patch and
overdosed and some died.
The Los
Angeles County coroner's office investigated 32
accidental deaths related to fentanyl in 2006, the
same number as in 2005, the year the FDA issued
its first warning. Florida authorities reported
126 accidental deaths related to fentanyl in 2006,
a rate one expert in the state described as
"steady."
In 2007, the
Division of Public Health Sciences, Wake Forest
University School of Medicine, and the Institute
for Safe Medication Practices performed an Adverse
Events Reporting System Review of the U.S. FDA's
most dangerous drugs. The study discovered
fentanyl to be the second most dangerous drug
available on the market with the second highest
number of suspect drug deaths. During the
study, fentanyl was involved in no fewer than
3,500 suspect drug deaths during the 8-year
period.
In July of 2005, the FDA issued
an alert warning doctors and patients about the
problems being experienced by people using the
patch. They explained that over 120 people
using the patch had died. However, people
continued to die and doctors continued
inappropriately prescribing the patch.
Accordingly, on December 21,
2007, the FDA issued a new update which is quoted
in part below.
In July 2005, FDA issued a
Public Health Advisory and Information for
Healthcare Professionals that emphasized the
appropriate and safe use of the fentanyl
transdermal system (fentanyl patch), marketed as
Duragesic and generics). Despite these
efforts FDA has continued to receive reports of
death and life-threatening adverse events related
to fentanyl overdose that have occurred when the
fentanyl patch was used to treat pain in
opioid-naïve patients and when opioid-tolerant
patients have applied more patches than
prescribed, changed the patch too frequently, and
exposed the patch to a heat
source.
The fentanyl patch is only
indicated for use in patients with persistent,
moderate to severe chronic pain who have been
taking a regular, daily, around-the-clock narcotic
pain medicine for longer than a week and are
considered to be opioid-tolerant. Patients
must avoid exposing the patch to excessive heat as
this promotes the release of fentanyl from the
patch and increases the absorption of fentanyl
through the skin which can result in fatal
overdose. The directions for prescribing and
using the fentanyl patch must be followed exactly
to prevent death or other serious side effects
from fentanyl overdose. These directions are
provided in the current prescribing information
and Instructions for Applying a Fentanyl
Transdermal Patch and the new Medication Guide for
patients
http://www.fda.gov/cder/foi/label/2005/19813s039lbl.pdf
At a news conference given on the
day the new alert was released, Dr. Rob Rappaport,
director of the FDA's Division of Anesthesia,
Analgesia, and Rheumatology Products, acknowledged
that people were still dying from the improper use
of the patch.
As part of its second alert,
the FDA ordered manufacturers of fentanyl patches
to create medication guides for patients that
describe in detail the dangers of fentanyl
overdoses and simple directions about proper
use.
At Novus Medical Detox Center of
Pasco County, LLC we work to not only safely and
comfortably detox people from unneeded and unsafe
drugs but we also try to work with them to find
solutions to the cause of their problems-not just
the symptoms. People can find other ways to
address pain and these don't require harmful
drugs.
DISCLAIMER: THE
INFORMATION CONTAINED HEREIN IS NOT INTENDED AS
MEDICAL ADVICE. THE READER SHOULD ONLY
DECIDE TO TAKE OR NOT TAKE ANY SUPPLEMENTS OR
DRUGS AFTER RECEIVING THE ADVICE OF THEIR MEDICAL
DOCTOR.
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