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DSI Newsletters, Issue 37:
Medication Contract

As a patient/research subject volunteer of The Jupiter Preventive Medicine Center/Drug Study Institute I understand that I may be prescribed medications of the opioid narcotic class and/or benzodiazepine tranquilizer/muscle relaxant class that are considered "addictive." Such medications include the opioid narcotics like: Oxycodone (Oxycontin, Oxy IR, and Percocet), Morphine (Avinza, MS Contin), Codeine (Tylenol #3), Propoxyphene (Darvocet), Hydrocodone (Vicodin, Lortab, Lorcet), Fentanyl (Duragesic Patch), Hydromorphone (Dilaudid), Levorphanol (Levodromoran) and others. They also include the tranquilizer/muscle relaxants like: Valium, Robaxin, Xanax, Ativan and Klonopin. All medications and treatments have risks, benefits and alternative procedures. It is the purpose of this medication contract to inform you of these in an effort to maximize benefits and minimize adverse events (side effects) including: somulence, urinary retention, blurry night time vision, facial flushing, excessive abnormal sweating, abnormal unexplained mood changes, nausea and vomiting. Towards this goal, responsibilities I bear include:
  1. Dr. Saponaro will be the only physician that will be writing for these medications and I will not seek these medications from other physicians, including emergency room physicians.
  2. That I will take the medications as prescribed and not take more on a daily basis unless approved by Dr. Saponaro.
  3. That I will be compliant and faithful in keeping my follow up appointments and treatment plans.
  4. That I understand that all prescriptions must be obtained in person and will not be called into the pharmacy.
  5. That I will keep these medications in a safe place and I will not give these medications to any other person.
  6. That pharmacy miscounts (the druggist shorted me pills) are my responsibility to find out and deal with the pharmacist in a timely manner.
  7. That if a prescription is stolen, a police report will be required before any additional medications will be written.
  8. That I will consent to random blood and urine toxicology screens to test for all types of drugs to determine my compliance and to document that I am not using street drugs of abuse like marijuana, heroin or cocaine and others.
  9. That I will seek psychiatric services if requested to do so.
  10. That our office may call local pharmacies for confirmation of prescriptions and to check to see that you are not receiving any other prescriptions from another doctor.
If any of the above requirements are not met by myself, I understand that no additional medications will be prescribed and that all of my treating physicians and pharmacies will be notified of my non-compliance. Additionally, I may be summarily discharged from this medical practice and be discontinued from an experimental protocol and asked to seek future pain treatment from another physician and/or undergo detoxification in a drug rehabilitation center.

Medication renewal requests will be taken Monday through Friday from 9:00 am till 3:00 pm. There may be a 48-hour processing time for prescriptions renewals. It is the policy of the practice not to renew or prescribe pain medications after hours, on weekends or without the patient's medical record at hand. Your signature below attests that we discussed the issues (risks, benefits and alternative procedures) in relation to opioid narcotic therapy, including but not limited to:
  1. The potential for:
    1. Sedation (Sleepy)
    2. Constipation
    3. Impaired Mentation (Feeling groggy to the point it is difficult to think straight)
    4. Mood Alteration (Excessive happy or sad)
    5. Respiratory Depression (stop breathing) especially in an overuse/overdose situation.
  2. The patient (research subject volunteer) was advised to avoid driving if they feel sedated or impaired especially after first beginning or increasing their narcotic dose.
  3. We also discussed the addiction issues related to chronic opioid narcotic therapy including:
    1. Tolerance (The need for more narcotic to have the same effect)
    2. Physical Dependence (Stopping the drug abruptly especially from a high dose can cause a withdrawal reaction associated with: shaking, vomiting, etc...)
    3. Psychological Dependence (The sensation you want more and more of the drug even though you are aware it is hurting you as it "calls to you.")
  4. In the adult population of patients with chronic pain, the addiction potential is about 2%. It is usually over rated by legitimate pain patients while hidden and lied about in those who are "drug seekers." In practice, it is rare to give a patient a narcotic and then have difficulties with addiction. Although, for medical-legal reasons we discuss it in detail.
  5. After a long discussion on the relevant medical issues, the patient: verbalized understanding; agreed to abide by the tenants of our narcotic agreement; and, signed the contract as attested by their signature below.
Today, we discussed the general issues in relation to opioid therapy, including but not limited to: the potential for sedation; impaired mentation; mood alteration; constipation and respiratory depression especially when the dose is abruptly increased. The patient was advised to avoid driving especially after a medication change if any sedation or impaired function is suspected to be present. It was stressed that these effects are most likely with the first dose and when the dose of the opioid narcotic is first increased. We also discussed tolerance, physical dependence, and psychological dependence related to chronic opioid therapy. In addition we discussed that random drug testing will occur to ensure compliance and safety.

Sincerely:

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCRI, CCRC, CCRP
Board Certified Internist, JPMC
Principal Investigator, DSI
Diplomat American Board of Internal Medicine
Fellow American College of Physicians
Certified Physician Investigator by the AAPP
Certified Clinical Investigator by the DIA
Certified Clinical Research Investigator by the ACRP
Certified Clinical Research Coordinator by the ACRP
Certified Clinical Research Professional by SoCRA
Member: The American College of Preventive Medicine


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Patient's Name


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Signature


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Date

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