INFORMED CONSENT AND CONDITIONS
FOR TREATMENT OF CHRONIC PAIN
Basic
Information
Chronic
Pain
- Chronic pain is a progressive disease of the nervous
system, caused by failure of the body's internal pain control systems. The disease is accompanied by changes in the
chemical and anatomical makeup of the spinal cord. Chronic pain is a malignancy, in the sense that when it goes
untreated, it increases in intensity and spreads to areas that weren't
previously affected, damaging the sufferer's health and functioning.
1)
Lowering
of pain levels.
2)
Reducing
suffering through restoration of functioning in life activities, as close to
normal as possible.
3)
Arresting
and reversing the damage done by chronic pain to the nervous system and overall
health of the patient.
Opioids - Opioids are substances naturally produced within the body to regulate
pain. They are known to the public as
endorphins, which produce a state of euphoria called the runner's high. Chronic
pain victims, who can't produce enough of these substances within their own
bodies, often benefit from supplementation with pharmaceutical opioids.
Opioid analgesic pain medications are recognized by
medical boards around the country as the cornerstone of treatment in chronic
pain. Unfortunately, their use is
limited by widely held, but mistaken, beliefs about their dangers, most of
which are wildly overstated.
The principal opioid
medications are: Morphine, Oxycodone (OxyContin), Hydrocodone (Vicodin,
Lortab), Hydromorphone (Dilaudid), Methadone, Fentanyl (Duragesic, Actiq), and
Codeine.
Addiction -
Addiction is defined as, cravings for a substance, compulsive use, and
continuing use in spite of harm. It is
widely feared that exposure to opioids will lead to addiction. Research projects, such as the Boston
Collaborative Study, involving over 10,000 patients treated with opioids, have
revealed that this is not the case, and that addiction to opioids in pain
patients is rare.
It is fairly easy to tell if a patient is addicted
to opioids. If they make life better by controlling pain, he is a pain
patient. If they make life worse, and
use continues, addiction may be suspected. The differences are not subtle:
It is of major importance to recognize the distinction between the
dysfunction that marks addiction and the improved function that marks effective
pain management. Thus, addiction and effective pain treatment have
diametrically opposite endpoints and are distinguishable.
-Dr. Scott Fishman, The
Massachusetts General Hospital Handbook of Pain Management
p. 499
Dependence - Dependence
occurs in most patients who regularly use opioids, but is not a sign of
addiction. It is a physical reality, meaning that a patient using opioids is
likely to have a flu-like withdrawal reaction if he discontinues the medication
abruptly. This syndrome can be
prevented, if opioids are to be discontinued, by gradually tapering the dose,
rather than discontinuing the medication abruptly.
The implication of the above information is that
opioids can be tried in the treatment of chronic pain, and safely withdrawn if
they are not useful, or if problems arise. This is called a therapeutic trial.
Respiratory
Depression/Tolerance - When an individual
unaccustomed to opioids takes too large a dose it can slow or even stop
breathing. But when a patient's dose of
opioids is raised gradually, in a process know a titration, tolerance builds,
and he can eventually take amounts that would kill a person not accustomed to
these doses. Pain stimulates breathing,
making respiratory depression unlikely in pain sufferers.
Tolerance also quickly develops to the
"high" caused by opioids.
Within as couple of days to weeks the patient returns to feeling
completely normal, although he may be taking enormous doses of medication.
Getting
"High" - Government sponsored research at the National Institute of Drug
Abuse, has determined that the majority of people do not even enjoy opioids:
The
majority of healthy non-drug-abusing volunteers do not report euphoria after being administered opioids in the lab
either with or without pain.
Robert Mathias,
NIDA NOTES Staff Writer, Research Eases Concerns About Use of Opioids To
Relieve Pain, Volume 15, Number 1 (March, 2000)
Titration – This
term describe the process of gradually increasing the dose of opioids until
pain is controlled, and the patient reaches his best level of functioning. In patients who have been debilitated by
pain for months or years, this process may go on over an extended period of
time.
Many
patients require a variation in their dosage from day to day, depending on
their pain levels and activities. This day to day variation makes pain a moving
target, which requires ongoing mini-titrations both upwards and downwards. Once
a general dosage range is established, it is likely to remain stable over long
periods of time.
Dosage – The
range of possible doses needed to control pain varies from one patient to
another, more than with any other drug in the entire field of Medicine, which
means that some patients will receive dosages of a size that is staggering to
the uninformed observer. Taking a
higher dose has nothing to do with addiction, and does not increase danger.
The amount that allows optimal functioning is the
correct dose. There is no upper limit to the dose of opioids that can be safely
used, when the medicine is increased gradually.
Safety
– Overall, opioids are the
safest analgesics a doctor can prescribe. When they are used as directed,
serious problems are rarely encountered.
Toxicity - Opioids are not toxic to
any organ system in the body. They do
no damage, even with long-term use.
While an array of different side effects is possible in a patient taking
any given medication, the side effect most commonly observed in opioid users,
is constipation, which is easily managed. A possible exception to the statement
about toxicity, is the suspicion that high dose methadone may provoke cardiac
arrythmias in susceptible individuals.
Side
Effects - Opioid
medications may cause a variety of side effects, including, but not limited to,
nausea, vomiting, itching, dizziness, constipation, sedation dry
mouth, fluid retention, weight gain, weight loss, suppression of the immune
system, suppression of thyroid function, suppression of menstrual cycle, suppression
of male hormone, itching, and allergic reactions.
Diversion - Opioids
are dangerous when they are diverted into the hands of non-patients who intend
to abuse them. These individuals are
not protected against the respiratory depressant effects of opioids, by either
tolerance or pain, and are likely to combine them with respiratory depressants,
including alcohol and tranquilizer. The
results can be tragic. The majority of deaths attributed to opioids occur in non-patients
who have deliberately abused a combination of these substances.
Security - For
the above reasons, the bulk of a patient's supply of opioids must be kept
locked in a safe and never given, sold, or traded to anyone else.
Driving - When opioids are taken on
a regular schedule, tolerance quickly develops, and the psychological "high",
if there ever was one, goes away, leaving the user feeling completely
normal. Long-term opioid users, as a
group, have driving records for accidents and violations that are the same as
everyone else's.
Pain
Relief/Functioning - Opioids reliably reduce pain
levels in chronic pain sufferers, however they seldom make the pain go
completely away, as regularly occurs in patients with acute pain. Patients can live with this residual pain as
long as their dose of opioids is titrated up to a level where they can
function. This is the major benefit of
opioids in chronic pain. They allow the
patient to function in spite of the pain. This relieves suffering.
Death
and Opioids – Deaths caused by opioids, among patients
who take opioids as prescribed are virtually unheard of.
General experience
suggests a death rate among chronic pain patients on opioid therapy of
approximately one death per hundred patients per year from all causes. This
means that patients taking opioids often die, but does not mean that opioids
killed them.
Patients relying on
insurance reimbursement of medication expenses are subject to denial of
coverage based on allegations that the treatment is not medically necessary, or
that it is unconventional (not supported by the scientific medical literature)
and experimental).
Chronic pain and opioid
therapy may lead to family disagreement regarding the propriety or economic
value of treatment, possibly resulting in divorce or estrangement from family
members.
Employers or regulatory
authorities may view opioid therapy as a disqualification for certain kinds of
work.
Pharmacists and other health
care workers may stigmatize patients on opioid therapy as addicts. Possession of opioid medications may make
patients a target for robbery or police investigation.
I understand that Dr.
__________ 's practice operates at the discretion of the regulatory authorities
and that his licenses to practice medicine and to prescribe controlled
substances may be yanked without warning.
Under such circumstances, there may be no medical facility willing to
continue treatment as prescribed by Dr. __________, and patients may then be
subject to the risk of acute opioid withdrawal.
I am aware that opioids have some potential to be
addictive and am willing to take that risk, as long as the benefits of
treatment in my situation outweigh the risks.
I understand that if I do become addicted, this is a treatable condition,
and I have the right to request and be referred for treatment. I am aware that addiction is defined as the continuing use
of a drug or activity in spite of harm, cravings, and a decreased quality of
life. I am aware that the chance of becoming addicted to my pain medicine is
very low. I agree to tell my doctor my
complete and honest personal drug history and that of my family to the best of
my knowledge.
I agree to immediately report any psychological
cravings I may experience for the substances with which I am being treated, as
well as to report any adverse consequences or side effects of their use. I agree to report to Dr. ___________ any use
or desire to use controlled substances for other than their intended
purpose. This could include recreation,
relief of stress, or getting high.
I understand that physical dependence is an expected
consequence of using opioids, and is not a sign of addiction. I understand that
physical dependence on opioids means that I may have a flu-like withdrawal
reaction if the medication is abruptly discontinued and that while this is
seldom life threatening, it may be uncomfortable. This withdrawal reaction is preventable by tapering the dose of
medication gradually, should it become necessary or desirable to discontinue
treatment.
Abrupt opioid withdrawal means that I
may suffer from any or all of the following: increased pain,
depression, muscle cramps, irritability, nausea, vomiting, sweats, chills, runny nose,
yawning, large pupils, goose bumps, abdominal pain and cramping, diarrhea,
irritability, aches throughout my body and a flu-like feeling. I am aware that
opioid withdrawal is uncomfortable but not usually life threatening. In
some individuals, severe withdrawal reactions may be life threatening.
I understand that these
medications may be safely discontinued, when tapered slowly and that even
gradual discontinuation may lead to increased sensitivity to pain. I understand
that if I am pregnant or become pregnant while taking opioid medications, my
child would be physically dependent on opioids at the time of birth, and
withdrawal could be life threatening for the baby, if not properly managed
medically.
I understand that opioid
medications may cause a variety of side effects, including, but not limited to,
nausea, vomiting, itching, dizziness, constipation, sedation, dry
mouth, fluid retention, weight gain, weight loss, suppression of the immune
system, suppression of thyroid function, suppression of menstrual cycle,
suppression of male hormone, itching, and allergic reactions. High dose
methadone is suspected of causing irregular heart beat, which can be life
threatening.
I understand that with gradual titration and
continued use I may develop a tolerance, which will allow me to take dosages of
opioids that would most likely kill an opioid naïve individual, and that these
large dosages are safe, as long as they are not combined with overdoses of
alcohol or tranquilizers.
I
understand that if I do not take opioids for a period of time, possibly as short
as a few days, this tolerance can be lost, and returning directly to my
previous dose can be lethal. Another gradual titration may be required.
I am aware that tolerance to analgesia
means that I may require more medicine to get the same amount of pain
relief. If tolerance occurs, increasing
doses may or may not be effective, and may cause unacceptable side effects. On
the other hand, titration is very often effective in controlling pain. The most
common reason for needing a higher dose is increased physical activity. Greater
pain may signal progression of an underlying disease.
I understand that certain
chronic medical or psychiatric conditions, such as insulin-dependent diabetes,
inflammatory bowel disease, sleep apnea, epilepsy, depression, and panic
disorder, among others, may increase the risk of opioid therapy and complicate
the process of opioid withdrawal.
I am aware that certain other medicines
such as nalbuphine (Nubain™), pentazocine (Talwin™), buprenorphine (Buprenex™),
and butorphanol (Stadol™), may reverse the action of the medicine I am using
for pain control. Taking any of these other medicines while I am taking my pain
medicines can cause symptoms like a bad flu, called a withdrawal syndrome. I
agree not to take any of these medicines, and to tell any other doctors that I
am taking an opioid as my pain medicine and can't take any of the medicines
listed above.
I understand that opioids
may be prescribed alone or in combination and that they may be supplemented
with other classes of medications, such as stimulants, tranquilizers, muscle
relaxants, laxatives, anti-histamines, anti-nausea medications, or
anti-depressants.
I understand that the
effects of sedatives, muscle relaxants, and mind-altering medications or
chemicals may be dangerously increased when administered to a patient on opioid
medications. I agree to inform other physicians as to which medications I am
taking and to request that they consult with Dr. _____________ or his
associates, regarding the co-administration of medications that may affect
alertness or consciousness.
I
will check with Dr. _____________ before taking any over the counter
medications. Some are known to have
adverse interactions with the medications I may be taking.
I agree to bring any medication I will not be using,
in for destruction under observation by Dr. ___________ or his staff and that
this event will be noted in my chart. Medications will neveer actually be
returned to the doctor.
I
am aware that there may be a risk of liver and possibly kidney damage
associated with the use of Tylenol (acetaminophen), and I understand that the
risk is small except in individuals who deliberately overdose. Periodic liver
function testing (GGTP) will determine if there is a potential problem, in
patients using Tylenol regularly.
I agree not to drink alcohol to excess, with the
understanding that the majority of deaths caused by so called opioid overdoses
actually occur in combination with overdoses of alcohol and other central
nervous system depressants such as Valium, Xanax, and barbiturates.
Marijuana (In the
states where this applies)
I agree not to use marijuana without the approval or
recommendation of a licensed physician, and then only for medicinal purposes.
I agree to fill all my prescriptions at only one
pharmacy, whenever this is possible, because this promotes a better quality of
care.
I agree to report any contact with other health care
providers to Dr. ____________, including visits to the emergency room and
encounters with mental health care providers.
I
agree to keep my medication in a safe, except for what I may carry to be used
throughout the day. I will provide proof of this in the form of a receipt for
the purchase of a safe, or a picture of the safe itself. This provision is to
keep medication from falling into the wrong hands, where it can be dangerous.
With the understanding that opioid treatment for
chronic pain remains controversial, I agree to represent the issue well by
being a good and productive citizen. If
I remain too disabled to maintain or return to full time employment I will at
least engage in some socially productive activity, such as volunteer work.
I have been informed as a patient with chronic
intractable pain, in accordance with California law, that if Dr. __________
chooses not to treat me with opioid pain medication, there may be other doctors
who will.
(Females
Only)
If I plan to become pregnant or believe
that I have become pregnant while taking this pain medicine, I will immediately
call my obstetric doctor and this office to inform them. I am aware that,
should I carry a baby to term while taking these medicines, the baby will be
physically dependent upon opioids. I am aware that the use of opioids is not
generally associated with a risk of birth defects. However, birth defects can
occur whether or not a mother is on medications.
(Males
only)
I am aware that chronic opioid use has
been associated with low testosterone levels. This may affect my mood, stamina,
sexual desire and physical and sexual performance. I understand that my doctor
may check my blood to see if my testosterone level is normal.
I
agree not to participate in the use of, or any activity involving illegal drugs
and to inform Dr. ____________ if I become aware that any of his other patients
are involved in these activities. If I
happen to use illegal drugs or abuse any substance I will inform Dr.
________________ immediately so that appropriate treatment can be arranged.
I agree to random drug screening. I
authorize this clinic to test my blood, urine, or hair, for the presence of
illicit substances and non-prescribed medications, without prior notice, and
agree to submit to psychiatric or drug abuse evaluation should the clinic staff
request it.
I agree not to sell, give, trade, or otherwise
transfer any controlled substance to any other individual, as this activity
constitutes a sale of drugs, and is a felony.
I further understand that if someone were to die as the result of such a
transaction I could be charged with manslaughter or even murder, as well as
drug dealing.
I am aware that the government routinely engages
patients to testify against pain doctors and others whom they suspect of being
drug "kingpins". I agree to immediately disclose any concerns to Dr.
___________, if I feel that he is simply prescribing drugs for profit, or doing
anything else improper, and to leave his practice immediately if I am not
satisfied that he is engaged in the good faith practice of medicine. In agreeing to this, I am making it clear that
if I attempt to make such assertions at a later date, I have simply been set up
to do this because of other trouble I have gotten myself into, and that
whatever I say along these lines is likely to be entirely contrived and self
serving.
I
agree to comply with all orders for lab testing, xrays, and treatment, and to
notify Dr. __________ if there is some reason I cannot follow through with any
aspect of my care in a timely fashion.
I agree to unannounced counts of my medication.
I agree to report any arrests, convictions, or other
contact with law enforcement to Dr. ____________.
I agree not to lie to Dr. ____________ or to
withhold any information, which might impact my treatment or his practice.
It is illegal to operate a motor vehicle while the
ability to drive is impaired by medication, and I agree to comply with such
prohibition.
I give my consent for Dr. ____________ to discuss my
care with other practitioners and pharmacists who are, or who have been
involved in my treatment. This consent will be in force until revoked in
writing.
With the understanding that pain and its treatment
are issues that involve entire families, I give consent for Dr. ____________ to
discuss my treatment with my family members.
This consent will be in force until revoked in writing.
Nature
of the Treatment Alliance
I agree not to obtain pain medications from any
provider other than Dr. ________ except on an emergency basis, and if this
occurs, I will notify Dr. ____________ at the first opportunity.
I understand that the above clause conversely
entitles me to pain management sufficient to assure my optimum functioning, and
that I will be expected to report accurately on the effects of my treatment,.
This will include level of functioning, side effects, and whether or not I am
receiving enough pain medication to reach treatment goals.
I have read this form or have had it
read to me, and I understand all of it. I have had all of my questions
regarding this treatment answered to my satisfaction.
This agreement may be terminated by either party at
any time and for any reason.
I have suffered from chronic pain for ____ years.
The decision to attempt this form of treatment was made because my
condition is serious, and other approaches have not cured my pain. These
include:
Surgery __, Physical Therapy
__, TENS __, Biofeedback __, Pain Clinic __, Implantable Device __, Relaxation
Techniques __, Other Modalities________________________________________________
___________________________________________________________________________________.
I understand that opioid treatment for chronic pain is
the subject of social controversy. There is significant disagreement regarding
the propriety and morality of this treatment, in spite of the fact that the
scientific literature on this subject makes it clear that there is a subset of
patients suffering from chronic pain who appear to do quite well on this
treatment, but no other. I believe that I am among those who can benefit from
this treatment.
I understand that the doses of medication prescribed
are likely to be significantly higher than doses customarily prescribed for
short-term pain management, and that other physicians, pharmacists, and medical
facilities unaccustomed to this treatment may object, and refuse to continue
this treatment, should I choose or need seek it elsewhere.
By signing this agreement, I voluntarily give my informed consent
for the treatment of chronic pain with opioid pain medications.
_______________________ ___________________
(Patient) (Date)
_______________________ ___________________
(Doctor) (Date)
1.
I have read and
understood the above information concerning treatment of chronic pain with
opioid analgesic medication.
2.
I am in agreement with
of the conditions of treatment listed above, and further agree to inform Dr.
____________ immediately if I become aware that any of them are being
violated.
3.
I specifically
understand that chronic pain is a disease of the nervous system, which carries
serious and progressive adverse health consequences for the victim, when
allowed to progress unchecked.
4.
I understand that
addiction is a psycho-behavioral disorder, involving cravings for a substance
or activity along with self-destructive behavioral manifestations including
repeated use of the substance or activity in spite of adverse consequences. I
am particularly aware of the low incidence of addiction to opioid medications
in pain patients, and I understand the difference between dependence and
addiction.
5.
I am also aware of the
low incidence of respiratory depression in pain patients who use opioids, and
aware of the facts that patients are protected against this occurrence by their
pain, which stimulates respiration, as well as by tolerance developed through
regular use of opioids. I understand
that if a patient combines their opioid medication with overdoses of alcohol or
tranquilizers, there is significant risk of respiratory depression and death,
and that the vast majority of opioid related deaths occur in this fashion, in
non-patients.
6.
I am aware that Dr.
_____________ is available to answer any questions or concerns not fully
explained by the above information, and I have availed myself of that
opportunity to my own satisfaction prior to signing this document.
7.
I agree to notify Dr.
__________________ immediately if any problems occur or if I develop any
reservations or questions about this treatment in the future.
8.
With the above facts and
conditions in mind, I comfortable with the idea of ________________________
participating in a comprehensive pain management program which may include the
use of opioids, as well as a variety of other medications and treatment
modalities.
9.
This document is
accompanied by a copy of my photo ID.
Relationship to Patient:
_______________________
Printed Name: _______________________
Age: ____
DOB: ____
____ ____
SS#: ______
____ ________
Address: _________________________
_________________________
_________________________
Telephone: ______ ______ ________
Signatures: __________________________ _________________
(Family Member)
(Date)
__________________________ _________________
(Doctor)
(Date)
Comments/Opinions
Frank B. Fisher, MD
[email protected]
510-233-3490
Or
[email protected]
