INFORMED CONSENT AND AGREEMENT FOR CONTROLLED DANGEROUS SUBSTANCES
Purpose of Informed Consent and Agreement
Dr. _____________________________________ is prescribing controlled dangerous substances
(including opioid medicines), sometimes called narcotic analgesics, to me for a diagnosis of
____________________________________________________________________________________.
Pain relief is an important goal for your care. Controlled dangerous substances (CDS) and opioid
medications may be a helpful part of pain treatment for some people. However, misuse may result in
serious harm to patients prescribed them and, when these medications are diverted, to the public at
large. As opioid use for pain management has increased in recent years, injury, addiction, and death
due to misuse of opioids have also increased.
Patients and healthcare providers both have responsibilities for the safe use of CDS and opioid
medications when they are prescribed for pain. This agreement provides important information on the
potential benefits and risks of CDS/opioid medications and serves to document that both you and your
provider agree on a care plan that is safe and effective in treating your pain.
Expected Benefits or Goals of CDS/Opioid Treatment
Common goals in using opioids to treat pain include:
 Improved pain
 Improved ability to engage in work, social, recreational, and/or physical activities
 Improved quality of life
Your provider may discuss more specific goals for pain treatment with you as well. Goals:
_____________________________________________________________________________________
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Potential Risks or Side Effects of CDS/Opioid Treatment
 Physical Side Effects – These may include but not be limited to: mood changes, drowsiness,
nausea, constipation, urination difficulties, depressed breathing, skin rash, itching, sleep
abnormalities, possibility of impaired mental status and/or motor ability, bone thinning, and
sexual difficulties due to lowering of male hormone in men and cessation of menstrual periods
in women.
 Physical Dependence – If the CDS/opioid medication(s) is abruptly stopped or not taken as
directed, a withdrawal symptom(s) can occur. This is a normal physiological response, and could
include but not be limited to: sweating, nervousness, abdominal cramps, diarrhea, goose
bumps, and alterations in one’s mood.
 Tolerance - The dose of a CDS/opioid may become less effective over time, even though there is
no change in your physical condition. The dose of the medication(s) may need to be changed,
adjusted or discontinued.
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Addiction – This is a disease with genetic, psychosocial and environmental factors influencing its
development. It is more common in people with personal or family history of addiction, but can
occur in anyone. It is characterized by one or more of the following: drug craving, impaired
control over drug use, compulsive use, continued use despite harm, and decreased quality of
life.
Hyperalgesia – This is increased sensitivity to and/or increased experience of pain caused by use
of opioids and may require change or discontinuation of medication.
Overdose – Taking more than the prescribed amount of medication or using with alcohol or
other drugs can cause you to stop breathing, resulting in coma, brain damage, or even death.
Sleep Apnea – CDS/opioids can make periods of not breathing while asleep worse. If it is severe
enough, it can even cause you to stop breathing, resulting in death.
Risk to Unborn Child – This may include but not be limited to: physical dependence at birth,
possible alterations in pain perception, increased risk for development of addiction, and birth
defects.
Victimization – You or your household may be subject to theft, deceit, assault or abuse by
persons seeking to obtain your medications for purposes of misuse.
Life Threatening Irregular Heartbeat – This can especially occur with methadone.
Responsibilities during CDS/Opioid Therapy
Your provider’s responsibilities include: listening carefully to your concerns, treating you with care and
due respect, and making clinical decisions based on what he/she believes is in your best interest. If you
develop complications from CDS/opioid use, such as addiction, your provider will assist you in finding
treatment. Please be aware that your provider must cooperate fully with law enforcement and other
agencies in the investigation of opioid-related crimes including sharing, selling, trading or other potential
harmful uses of these powerful medications. Your provider must also obey all local, state, and national
statutes, laws, and regulations related to prescribing CDS/opioid medications.
You agree that your responsibilities include:
 You will be honest with your provider(s) about your medications or drug abuse. The success of
treatment depends on mutual trust and honesty in the physician/patient relationship.
 You will use one physician to prescribe and monitor all CDS/opioid medications and adjunctive
therapy.
 You will use one pharmacy to obtain all opioid prescriptions and adjunctive analgesics
prescribed by your physician. You will inform your provider(s) within 24 hours if you must use a
pharmacy different from your usual one.
 You will inform your physician about all medications you are taking, including herbal remedies
and over-the counter medications, since these could interact with your CDS/opioid medications.
 You will be seen on a regular basis and given prescriptions for enough medication to last from
appointment to appointment. No early refills will be given without an office visit so that your
provider may evaluate any changes to your condition and effectiveness of the medications.
Early request(s) for refills my result in termination of the physician/patient relationship.
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No refills of any medications will be given during evenings or weekends. Prescriptions for pain
medicine or any other prescriptions will be done only during an office visit or during regular
office ours.
Any evidence of drug hoarding, unauthorized dose increases or decreases, acquisition of any
opioid medication or adjunctive analgesia from other physicians (including emergency rooms),
loss of prescriptions, or failure to follow the agreement may result in termination of the
provider/patient relationship.
You will not share, sell, trade or in any way provide your medications to others.
You will not use alcohol or illegal substances (such as cocaine, marijuana, etc.), while taking
these medications. This may result in a change to your treatment plan, including safe
discontinuation of your CDS/opioid medications or complete termination of the
provider/patient relationship.
You will submit to all random drug tests as requested by your provider.
You will keep your medications locked up and in a safe place to avoid intentional or
unintentional use or diversion by others. Discard all unused medications.
You will keep all your appointments scheduled for your care and participate in other pain
treatments agreed to with your provider.
You will bring your CDS/opioid medications to all appointments, when requested.
You will communicate fully to your provider about your pain level and functional ability at
each visit.
You will permit the provider(s) to communicate with other care providers and/or your
significant others as needed to assure CDS/opioids are being used appropriately and are
beneficial to your health and well-being.
Your medications may be continued if they improve your pain, help you in your daily activities, and/or
enhance your quality of life, and if you adhere to the above responsibilities. They may be discontinued if
your goals for treatment are not met, you experience negative effects, or you do not adhere to this
agreement. Non-compliance to any of your responsibilities may result in termination of the
provider/patient relationship.
Consent to Treatment and Agreement to Responsibilities Outlined Above
I have reviewed this document and been given the opportunity to have any questions answered. The
risks and benefits of alternative treatments have also been explained to me. I understand the possible
benefits and risks of CDS/opioid medications, and I accept the responsibilities described above.
Patient Name (Print): ___________________________________________________________________
Signature: ___________________________________________ Date: ___________________________
Relationship to Patient (Parent, Legal Guardian/Representative): ________________________________
Witness Signature: ____________________________________ Date: ____________________________