ARE WE IN AGREEMENT?

…One Pain Specialist’s Take on the Controlled Substances Prescriber-Patient Agreement 

 me and c arm

With all of the information and misinformation about pain medicines, addiction, and prescription drug abuse, I thought it might be useful to publish a sample of what a “full-bodied” patient-prescriber agreement looks like. More and more states are requiring these for ongoing treatment with powerful medications that have a substantial potential for abuse (i.e. “controlled substances”). Although this version may not be best for everyone (some may be longer, some shorter), my pain management office uses a document similar to this.

So if you have a little time on your hands and want to know what goes into these agreements, here’s my take on what a thorough prescriber-patient agreement looks like.

 cs agree pic

 

INTRODUCTION:

I understand controlled substances medications (i.e. opioid pain medications, tranquilizers, etc.) have a potential for harm and are therefore closely controlled by the local, state and federal governments. I understand that any medical treatment is initially a trial, with the goal of treatment being to improve my quality of life and my ability to function and/or work. My progress will be assessed periodically to determine the benefits of continued treatment. Continued use is dependent on whether my prescribing provider and I believe that the medication usage benefits me. These drugs can be useful, but have high potential for misuse and are therefore closely regulated. This agreement will help my healthcare provider and me and comply with controlled substance regulations. I agree to use opioids (morphine-like drugs) as part of my treatment plan. The success of my treatment depends on trust, honesty and understanding of how opioids are used. I understand that violation of any part of this agreement may result in this medication being discontinued, as well as termination of my relationship with my provider. I agree to the following conditions:

safe

SECURITY OF THE MEDICATIONS:

I am responsible for keeping my pain medications in a safe and secure place, such as a locked cabinet or safe. I am expected to protect my medications. If my medication is stolen, I will report this to my local police department and obtain a stolen item report. I will also report the stolen medication to my physician. I agree that if my medications are lost, misplaced, stolen, or if I use them up sooner than prescribed, my physician may choose not to replace my medications.  I understand that this opioid medication is strictly for me. I will never give away my medications or sell them to others, because it may endanger that person’s health and is against the law.

FOLLOWING DIRECTIONS:

Unless directed to by my prescriber, I will not alter my medication in any way, and I will take my medication whole. My medication will not be broken, chewed, crushed, injected, or snorted. I am responsible for my opioid medications. I will not allow my medications to be damaged.  I will take my medication exactly as instructed and prescribed. I know that any change in dosage or directions must be approved by my licensed provider. I am responsible for taking the medication in the doses prescribed and for keeping track of the amount remaining. I will not take more than is prescribed.

TIME-LIMITED USE FOR ACUTE CONDITIONS:

I understand that a controlled substance used to treat an acute medical complaint is for time-limited use. I will discontinue the use of the controlled substance when the condition requiring the controlled substance use has resolved.

WHEN OTHER CONDITIONS OR SYMPTOMS ARISE:

I will notify my healthcare provider of side effects that continue or are severe or impair me in any way. I will notify Pain Center by the next business day if I need to visit another physician or need to visit an emergency room due to pain or if I become pregnant.

I agree to not request or accept a controlled substance medication from any other prescriber or individual while I am a patient at Pain Center. However, if another licensed provider, after being made aware of my Pain Center Agreement, still feels it is in my best interest to administer or prescribe a controlled substance for me, I will notify Pain Center by phone by the next business day. I will inform all of my healthcare providers of all medications I am taking, including herbal remedies. I understand that medications, including over-the-counter non-prescription medications can interact with opioid medications and be dangerous.

no_drugs-1331px

NO ILLICIT SUBSTANCES:

I will not use any illicit substances such as cocaine, marijuana, etc. I understand that the use of alcohol together with opioid medications is dangerous and can lead to death. I will promptly inform my Pain Center prescriber if I use or intend to use any of these substances, including alcohol.

KEEPING APPOINTMENTS:

It is my responsibility to schedule appointments for the next refill. I will communicate fully and honestly with my prescriber about my pain level and my activities. I understand that in order to more thoroughly evaluate my plan of care as it pertains to the use of controlled substances, I may have additional visit scheduled at my provider’s discretion. I will keep all my Pain Center appointments.  If I must reschedule, I will notify Pain Center prior to my scheduled time.  If an appointment for a prescription refill is missed, I will request another appointment as soon as possible. I know that immediate or emergency appointments to address medication issues may not be available. However, I understand that I am allowed to seek the services of another healthcare provider in the event of an emergency or acute situation.

REFILLS:

Refills will not be made as an “emergency.” They will be made at planned clinic visits, during regular business hours. I will not expect any medications will be prescribed during the evening or on weekends. I do not expect prescriptions to be written in advance due to vacations, meetings or other commitments. I do not expect my prescriptions to be mailed. I expect that a government issued picture ID will be required to pick up prescriptions.

friendly-pharmacist1

ONE DESIGNATED PHARMACY:

I will designate and use only one pharmacy for all of my controlled substance medications and give the Pain Center full permission to communicate with the pharmacist about my medical care and medications.  Unless I have been given authorization by Pain Center, controlled substance prescriptions can only be filled by a pharmacy in the same state as the Pain Center, even if I am a resident of another state. I will allow my prescriber and his or her associates to send a copy of this agreement to my other healthcare providers and/or to the pharmacy where I obtain my prescriptions.

Urine Sample

DRUG TESTING: 

My prescriber may perform drug testing on me. I agree that I may be called at any time to come in to the clinic for a count of all my remaining medications and/or a drug screen and I agree to come that day. I agree to be responsible for any costs this may incur. If requested to provide a urine sample or other type of sample if necessary. If I decide not to provide a urine sample, I understand that my prescriber may change my treatment plan. This might include discontinuation of my opioid medications or complete termination of our patient-prescriber relationship. The presence of a non-prescribed drug or illicit drug in my urine may be cause for termination of our relationship.

SHARING INFORMATION:

I agree to allow my healthcare provider to contact any healthcare professional, family member, pharmacy, legal authority, or regulatory agency to obtain or provide information about my care or actions if the he or she feels it is necessary. I will allow my prescriber and his or her associates to receive information from any health care provider or pharmacist about use or possible misuse of alcohol and other drugs. I will allow my prescriber and and his or her associates to contact my family and friends to monitor my conditions.  Furthermore, I consent to a criminal background check.

PRIMARY CARE PROVIDER RELATIONSHIP:

I have and will maintain at all times a relationship with a primary care provider and keep him or her informed of all medications I am taking. I agree to and understand the requirement that I have an annual preventive health screening and physical exam by my primary care provider. If recommended, I will see a specialist and/or complete a screening exam to help determine whether I am developing an addiction or psychological illness.  I agree to be responsible for any costs this may incur.

FUNCTIONAL GOALS:

I understand that the main treatment goal is to improve my ability to function. I understand that in general, it is unrealistic for patients to expect complete resolution of their chronic pain with any specific treatment or combination of therapies. I understand that it is important to have a conversation with my provider about my treatment plan and set realistic goals for improvement. I pledge to work together with my provider towards improving my pain control and achieving specific functional goals. I understand that functional goals might include increasing physical activity level, resuming a job/hobby or improving the quality of sleep.

exit-sign

AN “EXIT STRATEGY”:

I understand the concept of an “exit strategy” regarding these medications. I agree that if any of the following goals are not attained this may be evidence of a failure of opioid therapy and discontinuation of some or all of my medications could be the most appropriate plan: (1) meaningful pain control; or (2) acceptable level of function; or (3) tolerable side-effects; or (4) stable and acceptable mental health and behavior: or (5) compliance the plan of care, laws, and regulations.

PATIENT EDUCATION:

I acknowledge that I have been educated on the following matters through verbal or written counseling: (1) proper use; (2) impact on driving and work safety; (3) effect of use during pregnancy; (4) potential for overdose and appropriate response to overdose; (5) safe storage of controlled substances; and (6) proper disposal.

OFF-LABEL USE OF MEDICATION:

All prescription drugs in the US have a label approved by the FDA.  This label provides an indication and dosage for the drug, but neither physician nor patient is legally bound to follow them.  Studies cannot reliably evaluate all the combination treatments in complicated, difficult-to-treat conditions. I understand that my treatment may include “off label” use of medications. 

DISCONTINUATION OF CARE:

I understand that my violation of any of the above conditions may result in re-evaluation of my treatment plan and discontinuation of my medication. I could be gradually taken off these medications or even discharged from the clinic. If my violation involves obtaining controlled substances from another individual, as described above, I may also be reported to my physician, medical facilities and other authorities, including the police.

handshake_between_doctor_and_patient_with_the_sky_background_1341168865

I HEREBY AGREE:

I have read this agreement or it has been explained to me by the Pain Center practitioners and/or staff. If I am not currently receiving controlled substances from Pain Center, this agreement does not apply.  However, I understand that this agreement immediately becomes effective if in the future I do receive controlled substances.  I fully understand the consequences of violating this agreement.  I have been explained the risks and potential benefits of these therapies, including, but not limited to, psychological addiction, physical dependence, withdrawal and over dosage. All of my questions regarding the treatment of pain with opioids have been answered to my satisfaction. I hereby agree to participate in the opioid medication therapy and acknowledge that I have received this document.

Disclaimer: This is not legal advice.  This is not medical advice.  This is my personal opinion and has not been endorsed by any individual or entity.  All persons should consult his or her own legal counsel and/or health care providers for advice and guidance.

job-reference-check

First Do No Harm: The Indiana Healthcare Providers Guide to the Safe, Effective Management of Chronic Non-Terminal Pain, Version1.0  http://www.in.gov/bitterpill/docs/First_Do_No_Harm_V_1_0.pdf

Sample Controlled Substance Agreement Developed by The Greater Louisville Medical Society http://kbml.ky.gov/substance-abuse/Pages/default.aspx

Kentucky Board of Medical Licensure, House Bill 1 Ordinary Regulations Effective March 4, 2013 http://kbml.ky.gov/hb1/Pages/House-Bill-1-Ordinary-Regulations.aspx

Medical Licensing Board of Indiana, Emergency Rule (Pain Medications) http://www.in.gov/pla/files/Emergency_Rules_Adopted_10.24.2013.pdf

Indiana Pain FINAL RULE (Effective November 1, 2014):
http://www.in.gov/legislative/iac/20141105-IR-844140289FRA.xml.html

 

me close up

James Patrick Murphy, MD, MMM attended medical school at the University of Louisville, interned in Psychiatry at the San Diego Naval Hospital, studied at the Naval Aerospace Medical Institute, and later served as a Naval Flight Surgeon onboard the aircraft carrier U.S.S. Enterprise.  He returned to Louisville for residency training in Anesthesiology after which he completed a Pain Medicine Fellowship at the Mayo Clinic in Rochester, MN. Dr. Murphy is board-certified in Anesthesiology, Pain Medicine, and Addiction Medicine. He is President of the Greater Louisville Medical Society, Medical Director of Murphy Pain Center, Assistant Clinical Professor at the University of Louisville School of Medicine, and serves on the board of the International Association for Pain and Chemical Dependency. In May 2013 Dr. Murphy earned a Master of Medical Management degree from the University of Southern California Marshall School of Business.

Dr. Murphy’s blog is The Painful Truth. He can be found on TWITTER by searching @jamespmurphymd. His President’s eVoice and other communications & videos can be accessed at the Greater Louisville Medical Society website.

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3 thoughts on “ARE WE IN AGREEMENT?

  1. Pain Center Patient Education Points

    Reference:
    http://kbml.ky.gov/hb1/Pages/Considerations-For-Patient-Education.aspx

    Proper Use
    1. The patient must carefully following instructions for use, including timing of doses, whether to take the medication with or without food, and any foods or other medications to avoid while taking the medication;
    2. Patients with low or impaired vision are advised to wear glasses when taking the medication and not take the medication in the dark;
    3. The patient should read the prescription container label each time to confirm the dosage;
    4. The patient should never use the medication after the expiration date;
    5. The patient must never share the medication with others;
    6. The patient must not take the medication with alcohol or other sedatives;
    7. The patient should not take the medication to help them sleep;
    8. The patient should never break, crush or chew the medication;
    9. If appropriate, external heat, fever and exertion can increase the absorption of transdermal products, leading to potentially fatal overdose;
    10. The patient should immediately contact the physician’s office to report any adverse reaction; and,
    11. It is illegal to share, sell or give away controlled substances.

    Driving and Work Safety
    1. Controlled substances may cause sleepiness, clouded thinking, decreased concentration, slower reflexes, or incoordination, all of which may create a danger to the patient and others when driving or operating certain type of machinery;
    2. You are encouraged to avoid, if possible, driving or engaging in other potentially dangerous work or other activities, for a specific period of time until the initial effects of the controlled substances no longer create such dangers; and,
    3. You are cautioned the patient that ingesting other substances, such as alcohol, benzodiazepines or some cold remedies, at the same time you are taking the controlled substances prescribed or dispensed may increase cognitive and motor impairment.

    Pregnancy
    If you are a female patient between the ages of 14 to 55 year of age with child bearing potential:
    1. Understand that there are potential risks and benefits of controlled substance use during pregnancy. Do not use controlled substances or only use controlled substances on a minimal basis during pregnancy, unless the benefits of such use outweigh the risks;
    2. If pregnant or planning to become pregnant on in the likelihood that you may become pregnant, you and your obstetrician must make an individualized and deliberate determination that the benefits of prescribing or dispensing controlled substances sufficiently outweigh the risks for you and your baby, before accepting a prescription for controlled substances or taking these medications;
    3. If there are any signs of adverse reaction or side effects, or conditions creating risk of danger to the patient or fetus, discontinue the medications immediately, contact your physician immediately, go to the emergency room, or call 911.

    Potential for Overdose and Response
    The use of controlled substances creates a risk of respiratory depression, which may result in serious harm or death and that the patient and others should be watchful for the following warning signs of overmedication:
    1. intoxicated behavior, such as confusion, slurred speech, or stumbling;
    2. feeling dizzy or faint;
    3. acting very drowsy or groggy;
    4. unusual snoring, gasping, or snorting during sleep; and/or
    5. difficulty waking up from sleep or difficulty in staying awake.

    Immediately call “911” or an emergency service upon observing or experiencing any of the following conditions:
    1. patient cannot be aroused or awakened, or patient is unable to talk after being awakened;
    2. patient has shortness of breath, slow or light breathing, or stopped breathing;
    3. gurgling noises coming from the patient’s mouth or throat;
    4. patient’s body is limp, seems lifeless;
    5. patient’s face is pale or clammy;
    6. patient’s fingernails or lips are turning purple or blue; and/or
    7. patient’s heartbeat is slow, unusual or stopped.

    Safe Storage of Controlled Substances
    There is always the potential for partners, family members or others to improperly obtain the patient’s controlled substances if those substances are not stored in a safe manner. Maintain the controlled substances prescribed or dispensed in the original container. Store controlled substances in a locked cabinet or other secure storage unit, that is cool, dry and out of direct sunlight, such as:
    1. an existing safe;
    2. a cut-proof travel bag;
    3. a portable lock box designed for travel; or,
    4. a locking medical box.

    You are discouraged from storing controlled substances in: an unlocked medicine cabinet; in your car; or in a refrigerator or freezer unless specifically recommended by the prescriber or pharmacist.

    Immediately notify the physician if any controlled substances prescribed or dispensed by the physician are stolen or improperly taken by another individual.

    Proper Disposal
    1. It is important to safely and appropriately dispose of unused controlled substances that had been prescribed or dispensed;
    2. You should promptly dispose of unused controlled substances after the expiration date of the prescription or after the patient no longer requires the controlled substances to treat the medical condition;
    3. In order to safely dispose of controlled substances, the patient should turn in the unused controlled substances as part of an approved governmental drug take-back program. There are some medications that may be flushed controlled substances down the toilet; and most may be placed in a sealed plastic bag with coffee grounds or kitty litter and thrown in the trash (preferably when no one is there to observe – to minimize scavenging and pilfering by those seeking the leftover medications).
    4. Personally remove any identifying information, including the prescription number, from an empty controlled substance container and then properly dispose of the empty container.

  2. Sample Informed Consent for Controlled Substances Therapy for Chronic Pain

    PURPOSE
    I understand that the purpose of this form is to document our discussion and my understanding of potential risks, benefits, and alternatives associated with my treatment with controlled substances (including opioids), as well as certain expectations related to proper medication use.

    INTRODUCTION
    I understand that licensed providers at Pain Center are prescribing DEA controlled medicine for me. Opioids (morphine-like drugs) are an example of these medicines. I acknowledge that we have had a discussion about the alternative therapies to controlled substances for managing pain that may exist for me. I understand this therapy was offered to me because my condition is serious and other treatments have not helped my pain to an acceptable level. I understand that my treatment with these medications is always subject to review and revision. I also am aware of the possible risks and benefits of other types of treatments that do not involve the use of opioids and controlled substances. I have been provided a simple and clear explanation of the key elements of my treatment plan. I have been encouraged to ask questions and all of my questions have been answered to my satisfaction, understanding, and educational level.

    PREGNANCY
    If I am a woman between the ages of 14 and 55 with child bearing potential, I acknowledge that I have been counseled about the risks to the fetus when the mother has been taking opioids while pregnant – including the risk of fetal opioid dependency and neonatal abstinence syndrome (NAS). I understand if I am planning to become pregnant, if I become pregnant, or if I am suspicious that I am pregnant, I will notify my prescriber immediately. If I plan to become pregnant or believe that I have become pregnant while taking pain medicine, I will immediately contact my obstetric doctor and this Pain Center to inform. I am aware that should I carry a baby to delivery while taking these medicines the baby will likely be physically dependent. I understand birth defects can occur whether or not the mother is on medicines, and there is always the possibility that my child will have a birth defect while I am taking pain medications. I understand that I may be on other medications, such as sedatives, that carry a higher risk of birth defects than opioids. I further accept that any medication may cause harm to my embryo/fetus/baby and hold the prescriber and all staff harmless for injuries to the embryo/fetus/baby.

    SIDE-EFFECTS
    I am aware that the use of these medicines has certain side-effects and risks, including but not limited to: sleepiness, drowsiness, severe constipation, sexual dysfunction, hormonal abnormalities, nausea, sweating, itching, rashes, vomiting, dizziness, allergic reactions, dangerous slowing of breathing rate, worsening of sleep apnea, blood pressure problems, irregular heart rate, slowing of reflexes or reaction time, impaired immunity, seizures, physical dependence, addiction, tolerance to pain medications, inadequate pain relief, worsening of pain, accidental overdose, and cardiac arrest. I understand that dangerous reactions can occur when my medications are used along with some legal drugs (even over-the-counter drugs), illegal drugs, and alcohol. I understand that use of opioids and other DEA controlled substances can cause death by a number of means.

    RESPONSIBILY TO AVOID CERTAIN ACTIVITES
    I understand that even if I do not notice it, my reflexes and reaction time might still be slowed. I pledge to not be involved in any activity that may be dangerous to me or someone else if I feel drowsy or may not be thinking clearly. Examples of such activities include, but are not limited to: using heavy equipment or a motor vehicle, working in unprotected heights, or being responsible for another individual who is unable to care for himself or herself.

    SECURITY
    I understand that there are people willing to risk there own lives or even kill me in order to steal these medications from me. I understand that most unlawfully diverted medications come from family, “friends,” and acquaintances, and I will keep my medications locked and under my control at all times.

    ADDED RISK OF HIGHER DOSES
    I understand that the use of high-dose or chronic opioid therapy is controversial and is not recommended without a demonstrated need and a plan for appropriate monitoring and only if the potential benefits are greater than the potential risks. I understand that many respected clinicians do not believe long-term use of these medications is beneficial for chronic pain. The need for progressively higher opioid doses may be a result of progression of the underlying condition, the development of tolerance, a psychiatric condition, or may indicate a substance use disorder or unlawful diversion. I understand what the term “morphine equivalent dose” means. And I understand that if my prescribing clinician elects to provide or to continue providing opioid therapy at a morphine equivalent dose of more than sixty (60) milligrams per day, my risks associated with opioid therapy – including my risk of dying – are substantially increased.

    ALCOHOL
    I am aware that I must not consume alcoholic beverages while taking these medications. Additionally, I understand that I must not use prescription or non-prescription medications containing alcohol while taking these pain medications. This is especially true if I am taking extended-release opioid (morphine-like) drugs. Consumption of alcohol while taking these medications may result in the rapid release and absorption of a potentially fatal dose of medication.

    ADDICTION
    I am aware that addiction can be defined as the use of a medicine even if it causes harm, having cravings for a drug, feeling the need to use a drug for non-medical purposes, and preoccupation with obtaining the drug. I understand that addiction is a life-threatening condition that may have no cure. I am aware that the development of addiction has been reported in medical journals as more common in a person who has a family or personal history of addiction and drug abuse. I agree to tell my doctor my complete and honest personal drug history and that of my family to the best of my knowledge.

    PHYSICAL DEPENDENCE
    I understand that physical dependence is an expected result of using these medicines. I understand that physical dependence is not the same as addiction. I am aware physical dependence means that if my pain medicine dose is markedly decreased, stopped or reversed by some other drug, I will likely experience a withdrawal syndrome. In the case of opioid withdrawal my symptoms could include any or all of the following: runny nose, yawning, large pupils, goose bumps, abdominal pain and cramping, diarrhea, irritability, aches throughout my body, a flu-like feeling, and worsening of my usual pain. I am aware that opioid withdrawal is uncomfortable and possibly life threatening. I also understand that withdrawal from other drugs such as sedatives and anticonvulsants can be extremely dangerous and life threatening.

    TOLERANCE
    I am aware that tolerance to analgesia means that I may require more medicine to get the same amount of pain relief. If this occurs increasing doses may not always help and may cause unacceptable side effects. Tolerance or failure to respond well to opioids may cause my doctor to choose another form of treatment.

    REVERSAL ANTIDOTES
    I am aware that certain other medicines – such as: nalbuphine (Nubain ™), pentazocine (Talwin™), buprenorphine (Buprenex™, Suboxone™), butorphanol (Stadol™), naloxone (Narcan), and naltrexone (Revia) -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 unless directed by healthcare provider and only after I have disclosed that I am taking an opioid as my pain medicine.

    UNDERSTANDING
    I have read this entire form or it has been read to me. I understand all of it. I have had a chance to have all of my questions regarding this treatment answered to my satisfaction. I know I may have a copy of this form. By signing this form voluntarily, I give my consent for the treatment of my pain with opioids and other controlled substances.

    Disclaimer: This is not legal advice. This is not medical advice. This is my personal opinion and has not been endorsed by any individual or entity. All persons should consult his or her own legal counsel and/or health care providers for advice and guidance.

    REFERENCES:
    First Do No Harm: The Indiana Healthcare Providers Guide to the Safe, Effective Management of Chronic Non-Terminal Pain, Version1.0 http://www.in.gov/bitterpill/docs/First_Do_No_Harm_V_1_0.pdf

    Sample Controlled Substance Agreement Developed by The Greater Louisville Medical Society http://kbml.ky.gov/substance-abuse/Pages/default.aspx

    KENTUCKY BOARD OF MEDICAL LICENSURE, HOUSE BILL 1 ORDINARY REGULATIONS EFFECTIVE MARCH 4, 2013 http://KBML.KY.GOV/HB1/PAGES/HOUSE-BILL-1-ORDINARY-REGULATIONS.ASPX

    Medical Licensing Board of Indiana, Emergency Rule (Pain Medications) http://www.in.gov/pla/files/Emergency_Rules_Adopted_10.24.2013.pdf

  3. REMS

    Updated REMS@FDA website (June 2015)
    http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?REMS=17&event=RemsDetails.page&source=govdelivery&utm_medium=email&utm_source=govdelivery

    The informed consent, patient agreement, and educational points together serve as a foundation for a medical practice’s effective “Risk Evaluation and Mitigation Strategy” (REMS) program.

    From the FDA website:

    What is a Risk Evaluation and Mitigation Strategy? http://goo.gl/frbvx7

    A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product (e.g. extended release opioids)

    A REMS can include:

    (1) A Medication Guide,
    (2) Patient Package Insert,
    (3) A communication plan,
    (4) Elements to assure safe use,
    (5) An implementation system,
    (6) A timetable for assessment of the REMS.

    What are “elements to assure safe use”?
    1. Health care providers who prescribe the drug have particular training or experience, or are specially certified;
    2. Pharmacies, practitioners, or health care settings that dispense the drug are specially certified;
    3. The drug is dispensed to patients only in certain health care settings;
    4. The drug is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory test results;
    5. Each patient using the drug is subject to certain monitoring; or
    6. Each patient using the drug is enrolled in a registry.

    Reference:
    Questions and Answers on the Federal Register Notice on Drugs and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies
    http://goo.gl/frbvx7
    http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095439.htm

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