OPIOID PAIN MEDICATION Agreement and Informed Consent I. Introduction Research and clinical experience show that opioid (narcotic) pain medications are helpful for some patients with chronic pain. The amount of pain relief any one patient will have is hard to predict, and a trial of opioid medication is the only way to find out. In this agreement there is information about how we will together judge if your medication is effective and safe to continue. Opioid is only a part of pain treatment there may be physical rehabilitation and/or behavioral pain medicine treatment that is as important or more important than the opioid treatment. Opioid medications can have side effects and there are special problems to watch out for. Occasionally the side effects are severe enough that the medication is not worth the side effects and has to be discontinued. The main side effects and risks are spelled out in this agreement/informed consent. We also address some of the special circumstances related to these medicines. For example, opioids are different from other medicines because they have street value and because they are medicines to which people can become addicted although becoming addicted to the pain medication is not a common problem among IPCA patients. There is a statement of the IPCA position on medical marijuana at the end of this agreement which all patients must review, understand, and acknowledge. Patients are encouraged to ask questions! I,, as a patient of, have received a copy of this Agreement and Consent and agree to the following: 1) I understand that opioids/narcotics are often part of a treatment plan that may include other essential treatments such as physical rehab, behavioral pain medicine, weight loss, diet changes, smoking cessation, exercise, and treatment of mental health conditions, and that receiving prescriptions for opioids may be stopped if I am unable or unwilling to participate in other essential therapies. 2) I understand that opioids/narcotics are Very unlikely to eliminate all my pain. Reasonable expectations include improved comfort, increased activity tolerance, and improved sleep. 3) I understand that opioids/narcotics may not work at all for my pain. II. Managing the Medication 4) With the exception of opioid medication provided to me by emergency rooms, urgent care clinics, ambulatory surgery centers, dental clinics, or when I am sent home from a hospital or nursing facility: I will accept prescriptions for opioid pain medications from no other medical provider besides my IPCA provider or his/her designee. I will make sure that any health provider who provides me with pain medication is aware of my current IPCA medication regimen before they prescribe. I understand that this is critical for my safety. If an opioid prescription is provided to me as part of a visit to another medical provider in an office setting (such as a dentist), a visit to an emergency room or urgent care clinic, or after an outpatient procedure, I will notify IPCA within one (1) business day of the visit/procedure. If an opioid prescription is provided to me at discharge from a hospital, nursing facility, or other inpatient care facility, I will notify IPCA within one (1) business day of the day of my discharge from the inpatient facility. The method of notification is by leaving a voice message for the IPCA medication coordinator (520-797- 7246 ext.126).
Page 2 of 6 5) I will have all medications prescribed by this office filled at one (1) pharmacy (or pharmacy chain) if possible. If for whatever reasons (i.e., medication not stocked by pharmacy, financial or insurance purposes) I have some or all prescriptions filled at a pharmacy other than the one submitted to this clinic, it is my responsibility to advise the IPCA staff no later than my next office visit. 6) I will manage my medications responsibly: 6.1) it is my responsibility to not run short of my prescriptions. I will verify the number of pills dispensed prior to leaving the pharmacy when I pick up my prescription. 6.2) I will secure my medications in a safe, locked area at home where they cannot be lost, destroyed, stolen or ingested by other adults, children, or pets. (Please read the warning on this subject at the end of this document). 6.3) I will take my medication exactly as prescribed and not in excess of my provider s instruction. If my pain is not adequately controlled, I agree to call my IPCA provider prior to taking any extra medicine. I understand that if I take more medication than prescribed I will not receive a new prescription until the next routine fill date. This may mean that I will experience physical withdrawal symptoms. 6.4) I understand that my prescription is meant to last for the number of days written on the prescription (usually 30 days). I understand what this means for any as needed medication I take: I will run out before the number of days the prescription is to last if I take the maximum daily amount of medicine permitted, every day. I understand that I must monitor my medication use so that I do not run out early. 6.5) I understand that if I lose or misplace the hard- copy prescription, or my medications are lost or stolen, or if I run out early, it is IPCA s policy to not issue replacement prescriptions. I understand that if this happens, I will not receive a new prescription until the next routine fill date. This may mean that I will experience physical withdrawal symptoms. 6.6) I am responsible for learning and remembering what my IPCA provider tells me. I will use whatever means necessary (notebook, tape recorder) to record and remember my IPCA provider s instruction and warnings related to opioids at clinic visits. I will ask for clarification when I do not understand 6.7) I agree to provide a written explanation for my medical record if I ask for early refills, if I lose hard- copy prescriptions or medications, if they have been stolen, or if I obtain medications from a source other than IPCA. 6.8) I will not take illegal drugs, nor will I use any opioid pain medications that are not prescribed to me by IPCA (with the exceptions described in #4).
Page 3 of 6 III. Side Effects and Risks 7) I have read and understand the following about side effects of opioids. They include but may not be limited to: mental side effects impaired judgment dizziness poor concentration poor coordination mental slowness feeling drunk drowsiness shakiness increased tiredness tolerance nausea Itching rash flushing sweating dry mouth poor sex drive difficult urination constipation increased joint pain new headache new or increased leg or foot swelling interactions with other drugs hormonal changes which may lead to osteoporosis, irregular menstruation, infertility, decreased muscle mass, sleep disturbance, fatigue and worsening or new depression palpitations (feeling of rapid heart beating) and dizziness may occur, especially with methadone skin irritation at the site of medication patches Dry mouth is a common side effect that may lead to increased dental problems such as cavities. I have reviewed the National Institutes of Health dry mouth patient education handout provided with this agreement. I understand that side effects may require my provider to stop or switch medications and that if my provider thinks that I am mentally impaired, I give my consent that he/she may contact whomever necessary (family, friends, employer, other healthcare providers, etc.) to protect me or others. 8) I have read and understand the following about the mental effects of opioids: 8.1) Alcohol, sleeping aids, sedatives and some anti- anxiety medications, anti- depressants, antihistamines, anti- seizure medicines, and muscle relaxants are some of the medicines that can multiply and increase the mental side effects of opioids, and I must be extra vigilant for mental impairment if I take these substances along with opioids. I will ask my provider if I am unsure if it is safe to combine opioids with any of the other medicines that I take. I will make sure to let my provider know about all other medications that I am taking, especially any new medicines. 8.2) I agree not to drive, carry or use a firearm, operate dangerous machinery, or serve, in any capacity related to personal and public safety, if I feel impaired, tired, or mentally foggy. 8.3) I understand that it is possible to be cited for DUI if a law enforcement officer finds on a field test that I am operating a motor vehicle while mentally impaired by my medication.
Page 4 of 6 9) I understand that I will develop the capacity to experience physical withdrawal symptoms (headache, nausea, vomiting, chills, diarrhea, muscle aches, and malaise) if I take opioid medications for more than a few months. This is NOT addiction. I understand that I can always stop opioids without withdrawal symptoms if I taper the medicine slowly under a provider s care. I understand that serious dehydration and chemical imbalance can occur if I go through withdrawal and cannot eat or drink for a prolonged period, and that I should seek help in an emergency room or urgent care center for rehydration if this should ever occur. 10) I understand that it is possible to develop addiction (psychological dependence) to opioids, but that this is fairly uncommon. My IPCA provider will be monitoring for this and will take appropriate action should the warning signs start to appear. 11) Concerning women: I will do everything I can to avoid getting pregnant while taking these medications, which could bring harm to a fetus and require the newborn to go through detoxification. To the best of my knowledge, I am presently not pregnant. Opioids are classified as category C in pregnancy (there is unknown safety, animal studies have shown an adverse effect, and there are no human studies). IV. Monitoring Use of the Medication 12) I understand that opioid medication, or any pain medication, is intended to reduce pain and improve activity tolerance without significant side effects or concerning ( aberrant ) patient behaviors in relation to the medication. I understand that at follow- up clinic visits, the IPCA care coordinators and providers will assess the benefit of my pain medication by having me fill out a brief questionnaire and asking about the Four A s: a. Analgesia how much pain relief does it provide? b. Activity does the medicine permit an increase in any activity? c. Adverse effects are there any side effects, and how bad are they? d. Aberrant behaviors lost prescriptions, early refills, multi- sourcing, etc.? I understand that it is my responsibility to be prepared to discuss these issues at each visit. 13) I give consent to allow my provider or his/her designee to consult with any physician or pharmacist, or family member or friends in this or any other state, about my use or possible abuse of medications, alcohol and/or illicit drugs. I understand IPCA staff may have to reveal details of my medical history to family members and to others who do not have a legal obligation to protect this information. 14) I will submit to a random urine specimen and/or alcohol breath test whenever my provider requests, to test for illegal or illicit drugs, alcohol consumption, and/or compliance. I will bring all my medication with me to the clinic if asked to do so. If I refuse urine screening or alcohol breath testing on the day it is requested, if a urine specimen is tampered with, if illegal drugs or narcotics/sedatives that my IPCA provider is not prescribing are detected by urinalysis, if I fall short on a pill count, or if substances that are expected to be in my urine are not present, I understand that my provider may discharge me from care for being in violation of this agreement, and will notify my primary care physician, my referring physician, and my pharmacist of the reasons for the discharge.
Page 5 of 6 OPIOID AGREEMENT and INFORMED CONSENT 15) I understand and give my consent that my provider, at his or her discretion, may discontinue opioid therapy if I do not follow the above plan, if I do not treat the IPCA staff with reasonable respect, or if he/she believes that my being on opioid pain medications is either harming me or not helping me. 16) I agree to attend all medication follow- up visits according to my treatment plan. I understand that I will be required to attend medication follow- up visits monthly. I understand that if I miss an appointment for any reason, I may not get my prescriptions that are due until I am seen again, and that my IPCA Provider may discharge me from care if I miss appointments. VI. Regarding Medical Marijuana (MM) We understand that people report experiencing pain relief and nausea relief, as well as appetite stimulation with the use of medical marijuana (MM), and that human and animal research also shows that the chemicals in marijuana are often goof for pain relief, for control of severe nausea, for control of anxiety, and to combat loss of appetite. However, the Integrative Pain Center of Arizona (IPCA) will not be recommending the use of MM for pain control. We have two reasons for taking this stance: a. The first reason relates to your safety. We do not have enough information on MM to advise you on how to use it. MM is a Schedule I (one) controlled substance, meaning that the Federal Government classifies it as a drug with no legitimate medical use. Because MM is listed on Schedule I (one) there is minimal quality medical research on MM safety. Consequently we cannot adequately advise you on safety concerns. We know that marijuana can impair judgment and motor skills similar to alcohol and perhaps more; but beyond this we do not have sufficient medical evidence to adequately advise you what the risks are, especially the risks of long term use. Furthermore, there is no FDA prescribing information on drug- to- drug interactions. Consequently, your IPCA providers cannot adequately advise you regarding potential interactions between MM and other drugs prescribed to you, including pain relieving and other drugs prescribed by our providers. b. The second reason has to do with our duty to serve the best interests of our nation s public health. While the FDA drug development system is far from perfect, we do not believe that it is in the best interests of our nation s public health for therapeutic drug development to proceed outside the established FDA process. Yet that is exactly what has happened with MM. This is a drug that has been approved for use outside the FDA system, through popular referendum and/or legislative action. We will not support the use of a drug developed in this manner. For patients using medical marijuana: I have read and understand the information above and all of my questions have been adequately answered. a. I understand that if I use MM, this is against the advice of IPCA providers. b. I understand that it is my responsibility to provide a current list of my medications, including the medications prescribed by my IPCA provider c. If I do use MM, I understand that IPCA providers may not prescribe opioids or other pain medications; and, I understand that I must address questions regarding compatibility of MM with my other medications and safety issues with the provider(s) recommending/dispensing medical marijuana to me. d. I understand that any failure to disclose use of MM to my IPCA care team may create an unsafe situation for me and those around me, is a breach of the provider- patient relationship, is a breach of this opioid agreement, and may lead to termination of my care at IPCA. _
Page 6 of 6 PATIENT NAME DATE OF BIRTH PATIENT SIGNATURE DATE Reviewed with patient by (IPCA Staff s) The warning is found on methadone manufacturer s labeling, but this warning applies to all opioid/narcotic medications: Keep opioids/narcotics in a secure place out of the reach of children and other household members. Accidental or deliberate ingestion by a child may cause respiratory depression that can result in death. Patients and their caregivers are strongly advised to discard unused medication in such a way that individuals other than the patients for whom it was originally prescribed will not come in contact with the drug.