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Dr. Lobel’s Opioid, Narcotic, & Controlled Substance Prescription Guidelines

1) In order for me to see you, you must be referred by a physician.

2) If a doctor is currently writing prescriptions for opioids, narcotics, or controlled substances, we may ask you to get a letter documenting that they will no longer be writing such prescriptions.

3) If you have been a patient at another pain management clinic, I may require a letter from your treating physician explaining the circumstances that led to your discontinuation from care.

4) Please bring a copy of your medical records, including MRI and CT reports, operative reports, as well as a list of your current medications, to the office, so we can review it. Please DO NOT assume your physician has sent such records, but rather, bring them with you. If you have the imaging on CD, BRING IT.

5) I do not just write for medication. If that is all you want, I may not be the right doctor for you.

a. My approach includes physical therapy, modalities, and interventions (things like epidural steroid injections in the neck or the back, facet injections in the neck or the back, etc).

b. Please understand that, if you are unwilling to undergo such procedures when they are recommended, I may not be able to continue treating you.

6) No opioids, narcotics, or controlled substances will be prescribed on the first visit. Please make sure your referring doctor has written enough medication for you.

7) No other doctor can write for controlled substances without my permission. That includes your primary care physician, the emergency room doctor, your dentist, or another doctor who is going to operate or do a procedure.

8) There are certain drugs I do not write prescriptions for: Methadone, Soma, Demerol, Ativan, Valium, Klonopin, or Xanax. These medications are also not to be taken when I prescribe opiates. If currently being prescribed by your Psychiatrist or PCP, a wean may be necessary or opiates may not be an option.

9) There are drugs that, while I am willing to prescribe them, I do not write more than recommended in Guidelines. The CDC released Opioid Guidelines March 15, 2016. This includes dose limitations, addition of rescue medications, and frequent visits. Maximum dosing of pain medication has been established in these guidelines and this must be adhered to. For patients that are on more medication than the guidelines suggests, a gradual taper to the maximum will be performed over the next several months.

10) If you have been prescribed Suboxone, I assume it was for a history of abuse. I will require a letter from your addiction specialist documenting that re-starting you on opioids, narcotics, or controlled substances is reasonable and safe.

11) Fibromyalgia/chronic pain is a condition best treated with exercise and non-narcotic medication. I will be happy to take you on as a new patient if, in addition to generalized pain, you also have localized neck, low back, extremity, or knee pain (documented on MRI or CT).

12) If you are on blood thinners (Warfarin (Coumadin), Clopidogrel (Plavix), Ticlodipine (Ticlid), Rivaroxaban (Xarelto), Apixiban (Eliquis), Prasugrel (Effient), Dabigatran (Pradaxa), Ticagrelor (Brilinta)), you will need to get a letter from the prescribing physician clearing you to come off the medication for potential procedures.

13) If you or your friends or relatives are rude, ugly, disrespectful, yell, raise your voice, curse, or threaten my staff, I will have to stop writing for opioids, narcotics, or controlled substances.

14) The staff may potentially drug test you every visit.

a. If you test positive for marijuana, I will not be able to write for opioids, narcotics, or controlled substances.

b. If you test positive for any other illegal substances (like cocaine, ecstasy, methamphetamine, etc), I will not be able to write for opioids, narcotics, or controlled substances until you complete a drug treatment program.

15) The staff may call you without warning, and ask you to bring the pills I prescribe into the office. If you can’t bring them in within a couple of hours, I won’t be able to write for any more opioids, narcotics, or controlled substances.

16) Prescriptions will only be issued at time of appointments. Do not call the office to request prescriptions if they are misplaced or stolen. You are responsible for scheduling an appointment in a timely manner to ensure that your prescriptions do not run out before your next appointment.

17) Breaking my rules will result in discontinuation of opioids or possibly dismissal from my care.

Please understand that these are my practices. They will not be negotiated. If you are willing to work with me, and try alternative medications, I am happy to address your pain with all the available options, methods, and techniques.

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Informed Consent and Agreement for Treatment

I understand and agree to follow the policies of Medical Associates of North Georgia (MANG) as set forth below. I understand that MANG is under no obligation to prescribe these medications for me. I also understand that there may be other, more reasonable treatment options available for my condition that my doctor may recommend instead of or in addition to the use of these medications.

DEFINITIONS OF OPIOIDS, BENZODIAZEPINES, AND OTHER CONTROLLED SUBSTANCES

I understand the definitions of these medications to be:

1. Opioid - An opioid medication is a derivative of morphine or similar compound and thus has strong pain relieving properties.

2. Benzodiazepine - A benzodiazepine is a sedative-hypnotic. Its primary role is for the treatment of anxiety.

3. Other related drugs - For the purposes of this agreement, “other related drugs” includes medications such as muscle relaxants (e.g., Flexeril), membrane stabilizers (e.g., Lyrica), and non-narcotic analgesics (e.g., Ultram). These medications may cause sedation, altered mental status, occasionally dangerous withdrawal effects when stopped abruptly, and may have medication interactions similar to or different from opioids or benzodiazepines.

RISKS OF OPIOIDS, BENZODIAZEPINES, AND OTHER RELATED MEDICATIONS (“CONTROLLED SUBSTANCES”)

I understand that these medications have potential risks with the most significant being:

1. Physical Dependence—Physical dependence is a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence, by itself, does not equate with addiction.

2. Addiction—Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.

3. Overdose- Taking too much of one or more medications may lead to respiratory arrest and death.

4. Altered Mental Status- These classes of medications may cause confusion, sedation, drowsiness, problems with coordination, and changes in thinking ability. This may make it unsafe for you to drive a motor vehicle, operate hazardous equipment and machinery, or perform dangerous activities. Other side effects may include but are not limited to, the following: nausea, constipation, unsteadiness, decreased appetite, difficulty urinating, depression, and loss of sexual drive with testicular atrophy (in males).

CONDITIONS OF AGREEMENT

1. I understand that Controlled Substances may be prescribed by my physician only if he determines that such treatment has a reasonable chance of improving my quality of life, ability to participate in work activities, and social activities.

2. I do not currently have problems with substance abuse (drugs and/or alcohol).

3. I am not involved in the use, possession, diversion, or transport of illegally obtained controlled substances.

4. I agree to use these medications only as prescribed to me and will not take more of these medications than instructed. I agree to not allow other individuals to take my medication nor will I take medication prescribed to another person.

5. I understand the risk of controlled substances to unborn children and will notify MANG if I am or become pregnant.

6. I will obtain pain medications only from MANG and not from any other source unless a true medical emergency exists. I will notify MANG in advance of any anticipated acute needs (dental work or surgery).

7. I agree to accept generic brands of my controlled substances if available.

8. If it appears to my physician that the use of controlled substances is not providing a demonstrable therapeutic benefit such as improvement in daily function or improved ability to participate in the treatment program, if the controlled substances being prescribed are expected to be the mainstay of pain treatment when other medical options exist and are practical, or that addiction, rapid loss of effect, or significant side effects are developing, I agree to taper my medication as directed. If a substance abuse problem is suspected, I understand that I may be referred for evaluation and management of the problem.

9. I agree to keep my scheduled appointments prepared to provide a urine sample. Failure to provide a sample may result in withdrawal of treatment using controlled substances and possibly discharge from MANG.

10. I agree to bring my medications to the office for random pill counts to assess compliance with treatments. Failure to provide medication for inspection may result in suspension of opiate treatment.

11. I agree to comply with my physicians’ request for additional imaging studies, lab tests, diagnostic procedures (with separate informed consent), and referrals to additional specialists as recommended by my physician.

12. I understand that MANG is a specialty consulting practice. The MANG staff will communicate with my Primary Care Provider, Specialists, Pharmacists, Therapists, Employer, and Family to assist in determining the best course for continued treatment for chronic pain. My care may be transferred back to my Primary Care Provider for continued prescriptions of controlled substances once my medical regimen has been optimized.

13. All of my controlled substance prescriptions will be filled at the same pharmacy. Should I choose to change pharmacies, I will notify MANG immediately.

14. It is recommended that patients prescribed medications by MANG not drive while taking these medications. Many of the prescribed medications can cause impairment and may lead to a DUI or at fault accident.

15. Early refills are not provided. Medications may be prescribed at office appointments only. Medical Associates of North Georgia will not prescribe any medication after hours or on weekends. Medical Associates of North Georgia will not prescribe replacement medications should they become misplaced, stolen, or destroyed. No controlled substance prescriptions will be called in to your pharmacy at any time.

Consequences for not following the treatment agreement are as follows:

I understand that any violation of this agreement may pose a health risk to myself and others and may result in a discontinuation of treatment with controlled substances if deemed medically prudent. Violation of this agreement may result in dismissal from the care of Medical Associates of North Georgia as well as reporting any illegal activities to appropriate law enforcement agencies. All patients who demonstrate difficulties managing their controlled substance medications will be referred to an Addiction Psychiatrist and/or a Clinical Psychologist or Counselor for further evaluation.

I have read this document, understand it, have had all questions regarding risks and conditions of the agreement answered satisfactorily, and I agree to all of its elements.

Patient Signature:____________________________________ Date _________________

Opioid Risk Tool

1. Family History of Substance Abuse: Female Male

Alcohol ( (

Illegal Drugs ( (

Prescription Drugs ( (

2. Personal History of Substance Abuse:

Alcohol
 ( (

Illegal Drugs ( (

Prescription Drugs ( (

3. Age (mark box if between 16-45) ( (

4. History of Preadolescent Sexual Abuse ( (

5. Psychological Disease

ADD/ADHD, OCD, Bipolar, Schizophrenia ( (

Depression ( (

Revision Date: 4/16

NOTICE TO ALL PATIENTS IN THE PRACTICE TAKING OVER 90mg MED PER DAY

A growing body of medical literature demonstrates-

1. Patients receiving over 90 MED per day have a much higher incidence of overdose deaths by 4 to 10 times or more, (average 9 fold increased risk of death)

2. A growing number of medical studies showing high dose opioids actually worsen pain, result in serious significant side effects, and that reduction of high doses lowers pain levels

3. CDC Guidelines are now calling for a maximum dosage of 90 MED for non-cancer pain

Physicians can only prescribe opiates for a “legitimate medical purpose” according to federal and state law. However after a 2 week review of the published literature on opioids conducted in March of 2015, it is apparent there is almost no literature to support safety or efficacy of long term high dose opioid prescribing for non-cancer pain, yet there are several publications that attest to the drastically increased risks and lack of safety from high dose opioid prescribing. A legitimate medical purpose must be supported by research and the available literature, but clearly high dose opioid prescribing is not.

There have been actions taken against many physicians for high dose prescribing initiated by the state attorney general and medical board, and there have been litigation and threats of litigation by patients or their families against pain physicians across the state for poor outcomes when high doses opioids are being prescribed. Those injured by patients while driving with opioids in the bloodstream, may now sue the physician who prescribed the medications according to our state supreme court.

Up to half of the prescription opioid overdose deaths in the state are caused by sharing of medications by pain patients with others that do not have a prescription for the medications that cause their deaths. This suggests there is an overall excess of medication prescribing to the degree pain patients can give away enough meds that they actually result in the deaths of others.

DUE TO THESE ISSUES:

Our medical practice will begin lowering dosages to a maximum of 90 MED (90 morphine equivalent doses per day) over a several month period. We will provide you with non-narcotic medications that will help to ease the side effects of this dosage reduction. During this time, you have the option of locating another pain physician on your own, or continuing with our practice. We are unaware of other pain practices that prescribe routinely more than 90 MED, therefore cannot provide you with the name or generate a referral to any other physician prescribing high dose opioids. It is possible to add non-narcotic medications or utilize injection therapies, physical therapy, and psychological measures to help with pain relief from now on.

TO DETERMINE MED: Multiply the number of milligrams of your medicine by the conversion factors below, then add together if you are taking more than one opioid narcotic.

Each milligram tapentadol (Nucynta) = 0.4 mg MED MAX 400mg per day

Each milligram morphine or hydrocodone= 1 MED MAX 90mg per day

Each milligram of oxycodone (Oxycontin, Roxicodone) = 1.5 MED MAX 60mg per day

Each 25mcg patch of fentanyl (Duragesic) = 60 MED MAX 37.5mcg dose

Each milligram of oxymorphone (Opana) = 3 MED  MAX 30mg per day

Each milligram of hydromorphone (Dilaudid) = 4 MED MAX 22mg per day

CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care

Determining When to Initiate or Continue Opioids for Chronic Pain

Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.

Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. 


Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy. 


Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation

When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.

When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. 


Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed. 


Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

Assessing Risk and Addressing Harms of Opioid Use

Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.

Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

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* All recommendations are category A (apply to all patients outside of active cancer treatment, palliative care, and end-of-life care) except recommendation 10 (designated category B, with individual decision making required); see full guideline for evidence ratings.

U.S. Food and Drug Administration

Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death

[Posted 08/31/2016]


AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice

ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication (/Drugs/DrugSafety/ucm518473.htm) for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.

FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication (/Drugs/DrugSafety/ucm518473.htm) for a Data Summary). Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.

FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.

BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures.

RECOMMENDATION: Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.

Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. [pic]

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