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Please read this agreement carefully before reading the education resources on this website. This includes but not limited to Chronic Pain Education and Prvention Program, MyPainTools and the Opioid Safety Program. Here on these resources will be referred to as: the “Website”. By accessing or using the Website, you agree that you are at least 18 years old and competent to enter into this Agreement and to be bound by the Terms and Conditions below. If you do not wish to be bound by these terms and conditions, you should not access or use the Website. Terms and Conditions The Website is not intended for rendering medical diagnoses, advice or recommendations. IT IS NOT INTENDED TO PROVIDE MEDICAL ADVICE. The contents of the Website, including any and all articles, comments, or correspondence is provided for informational purposes only. 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First it is important that we understand some important terminology as we go forward with this program:

The last point that I want to make is the most important point when it comes to the treatment of chronic pain and the use of opioid therapy. Self-management of pain is an important part of your treatment plan. Active self-management techniques must be included in your treatment plan. Active techniques in the form of mastered self-initiated skills such as pacing your activities, selfmassage and self-relaxation therapy for example are important. These techniques when combined with treatments such as psychology, cognitive therapy, acupuncture and interventional injections can have both synergistic and medication-sparing effects. This will allow you to obtain the function and pain relief you desire while minimizing the amount of opioid medications needed to achieve those goals. As stated before it is important to have a well-rounded treatment plan that incorporates multiple different modalities to help control and manage your pain as this will allow a better quality of life and the need for fewer medications, such as opioids. You should think of your treatment plan like a “Bowl Of Soup” and think of the different treatments as ingredients in your soup. You want to use as many healthy “ingredients” such as acupuncture, exercise, biofeedback, etc. in addition to other treatments such as opioid therapy. Life style modifications are also one of these additional modalities that need to be considered. If you have time and wish to learn more please read the optional section on additional information about opioid therapy.

There are three classifications of chronic pain: intermittent, persistent and breakthrough pain. There are also two different forms of pain medications: short acting and long acting opioid medications. Persistent or constant pain is characterized by pain that lasts for 12 or more hours every day. The pain is usually treated with medicines that last around the clock, such as long acting opioids, adjuvant medications and with non-drug therapies. This form of pain is common with chronic pain. For patients with chronic pain, the classic approach is to convert the patient from shortacting opioids to long-acting/sustained release opioids, because long-acting opioids provide less fluctuation in analgesic blood levels, fewer adverse effects, and require less frequent dosing. Intermittent pain is characterized as episodic and may occur in waves or patterns. Intermittent pain is typically treated with non-drug therapies and a short course of adjuvant medications such as NSAIDs, however intermittent moderate to severe pain may be treated with short-acting opioids. Intermittent pain is usually not persistent. It is possible to have both persistent pains, such as chronic low back pain, in additional to intermittent pain, such as acute migraines. Breakthrough or sudden pain is characterized by a flare-up or a break through the relief provided by an around the clock pain medicine regime used to treat persistent pain. Non-drug therapies, adjuvant medications and occasionally short-acting opioid medications can be used to treat breakthrough pain. The CDC recommends that when starting opioid therapy for chronic pain, clinicians should first start by prescribing immediate-release opioids instead of extendedrelease/long-acting (ER/LA) opioids. Historically when using a combination of long acting and short acting medications many physicians recommend only one type of long acting opioid medication and one type short acting medication be used. Some recent studies have challenged this idea and have shown that lower doses of two different types of long acting or short acting medications may decrease the risk of tolerance and medication side effects compared to high doses of one type of medication. This is however a controversial topic. Each individual and their pain are unique and your pain specialist will determine the best treatment plan for you. Whichever medications your doctor chooses, they will start you on the lowest doses and slowly titrate these medications till the needed effect is reached. Keep in mind that it is very important to take advantage of the opportunity that pain relief brings to make your life better. For most people, this means resuming activities that were stopped by the pain or illness. When opioids are used to eliminate pain without improving lifestyle or function, the medicine becomes the focus of your life and this can do more harm than good.

State and federal departments are working together to also develop increased education and training for patients taking opioid medications to improve safety and reduce the risk of abuse, one of those programs which you may be required to comply with is known as the REMS program. Effective March 25, 2008, the Food and Drug Administration Amendments Act of 2007 (FDAAA) reserved the right for the U.S. Food and Drug Administration (FDA) to order Risk Evaluation & Mitigation Strategies (REMS) for drugs or biologics with significant toxicity levels and/or demonstrable risk factors. A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for extended-release and long-acting (ER/LA) opioid analgesics. Under the conditions specified in the REMS, patients who take analgesics are strongly encouraged to do all of the following: 1) Be educated on the safe use, serious risk, storage and disposal of opioid medication, which this course has covered. 2) Obtain more specific information about the particular opioid medications you take by clicking on Patient Counseling Document (PCD). 3) Once on the PCD website click on Medication Guides and read the medication guide for the opioid medications you are taking. You should always be reading the Medication Guide that you will receive from your pharmacist every time an ER/LA opioid is dispensed to you, if you have not done so in the past. Patient Counseling Document on Extended Release / Long-Acting Opioid Analgesics The DOs and DON’Ts of Extended-Release / Long - Acting Opioid Analgesics Call 911 Or Your Local Emergency Service Right Away If: • You take too much medicine • You have trouble breathing, or shortness of breath • A child has taken this medicine Tell Your Healthcare Provider: • Your complete medical and family history, including any history of substance abuse or mental illness • The cause, severity, and nature of your pain • If the dose you are taking does not control your pain • About any side effects you may be having • About all the medicines you take, including over-the-counter medicines, vitamins, and dietary supplements • Your treatment goals Another part of the REMS program deals with guidelines and recommendations that your physician may refer to when prescribing opioid medications, and this document is known as the: FDA BLUEPRINTS.

Pregnancy If you are pregnant or planning to get pregnant you should talk to your physician with regards to the safety of opioid therapy during your pregnancy. These guidelines also include reproductiveaged women who are not planning a pregnancy but might be at risk of an unintended pregnancy. If you have been taking an opioid for a long time you should not just stop suddenly. This could cause you to go into withdrawal which could be harmful to you and may cause harm to your pregnancy. Talk with your health care provider about the risks and benefits of continuing or stopping your medication. Any reduction in your medication needs to be done very gradually, and carefully monitored by your health care provider. There is inadequate data on human pregnancy exposure to opioids to rule out teratogenic risks completely, although the limited data available do not indicate substantial teratogenic effects. Indiscriminate use should be avoided. According to the Centers for Disease Control and Prevention (CDC) the effects of opioids on a pregnant woman and her unborn baby are not well understood. Previous research has shown that opioid analgesic use and abuse have been increasing in recent years but their effects on the developing fetus are poorly understood. According to an ongoing, population-based study conducted by the CDC, women receiving opioid analgesic treatment in early pregnancy had a 2- to 3-fold increased risk of delivering infants with ventricular septal defects, atrioventricular septal defects; hypoplastic left heart syndrome, spina bifida, or gastroschisis. Although the absolute risk for any individual woman is relatively modest, caution should be used while pregnant. Some studies have suggested that opioid exposure in the first trimester may be associated with heart defects and other birth defects. Based on these studies the risk appears to be small. Several other studies have not supported an increased risk for heart defects or birth defects in general. Opioids are not known to decrease the likelihood of you becoming pregnant. At this time the only Category B opioid is oxycodone. You should avoid benzodiazepine use at all times during pregnancy due to its risk on the development of the fetus. Other fetal adverse events with the use of opioid therapy during pregnancy include miscarriage, premature birth, fetal growth restriction, low birth weight, and birth defects such as heart defects and spina bifida. You and your physician must weigh the benefits of these medications along with their potential risks when discussing analgesic treatment options with you, if you are or may become pregnant. Uncontrolled pain during pregnancy itself can endanger the mother as well as the fetus due to for example severe hypertension among other things. One of the biggest concerns with the use of opioids during pregnancy is the development of neonatal withdrawal syndrome in the baby after delivery. This is due to the fact that the fetus is exposed to opioids through the placenta during pregnancy and after delivery the baby is no longer exposed to the medication. If you are taking opioid therapy your OB/GYN doctor will discuss the possibility of your baby needing to stay a few nights in the NICU for close monitoring. The degree of fetus exposure to opioid medications will often determine the intensity of the withdrawal severity post-delivery. Always inform your doctor if you are taking any amounts of opioids during pregnancy. It is best that you inform all of your doctors of all your medications when pregnant. The length of time and the amount of medication you have been taking can influence the likelihood of withdrawal in the newborn. Withdrawal usually begins within the first 24 hours after birth, but can occur up to 2-3 weeks later. It is important that you are aware of the signs of withdrawal which include: irritability, sneezing, runny nose, tremors, vomiting, difficulty breathing, extreme drowsiness, poor feeding, sweating, diarrhea and occasionally seizures. Cases of untreated withdrawal can lead to seizures and death. With proper treatment most babies can be supported through the withdrawal process. Withdrawal in the newborn does not appear to be associated with any long-term complications. There is no information to suggest that opioids taken by the father would adversely affect a pregnancy, however there may be an effect on a male’s sperm count and sexual function due to testosterone lowering effects of opioids. BREASTFEEDING Breastfeeding during opioid therapy is also an important topic to discuss with your physician. Many consider breast milk to be the best food for their baby, and some argue that if one stops breastfeeding they risk losing their milk supply. Always check with your baby’s pediatrician with regards to the safety of breastfeeding while on opioid therapy as individual considerations need to be addressed. Always use the lowest dose of opioids needed to treat your pain. Consult your pharmacist or physician with regards to additional recommendations. All opioids are known to be found in breast milk, mostly in very small amounts. If you need to take an opioid while breastfeeding you should take as low a dose as possible and for as brief a period of time as necessary. If at all possible, breastfeeding should be timed to avoid the peak amount of the drug in your system. An alternative to breastfeeding is the use of formula, which is a personal choice. If you pump, you may want to consider pumping in the morning and taking your medications after you pump and avoiding night time doses. Opioid medications are at their highest concentration in the body during the first 1 to 2 hours after taking them. You should consider avoiding breastfeeding during this time. Breastfed infants whose mothers are taking an opioid should ALWAYS be very carefully and watch for any signs of drowsiness. Concerning signs to watch for include: the baby being sleepier than normal, breastfeeding pattern changes, you notice constipation in your baby, baby becomes difficult to arouse for feeding, and the baby’s ability or effort to suck effectively decreases. If any of these side effects are noticed, either the opioid or the breastfeeding should be stopped and the child should be seen by a pediatrician immediately and if necessary call 911. All opioids are category C, except for Oxycodone which is category B. In animal studies on pregnancy and oxycodone, the medication did not seem to increase the risk of birth defects or other problems. However, as a narcotic, oxycodone can cause withdrawal symptoms in the infant after delivery. Please note that Oxycontin® which is a long acting form of Oxycodone is category C. Please also note that oxycodone often is in combination for example with other medications such as NSAIDs are not recommended during pregnancy. Please note alcohol and/or benzodiazepine use are absolutely contraindicated during pregnancy. United States FDA Pharmaceutical Pregnancy Categories

A very important topic with regards to opioid therapy is the special considerations that must be taken into account in patients who develop liver and renal (i.e. kidney) dysfunction. Although chronic opioid therapy has minimal long-term effects on organs, organ dysfunction can have a dramatic effect on side effects from these medications. As in any clinical setting, the ‘right dose’ of an opioid analgesic medication is that which provides adequate pain relief in conjunction with an acceptable side effect profile. It is important to monitor renal and liver function in patients taking chronic opioids and before starting opioid therapy. Renal or hepatic impairments can lead to toxicity as most opioids are metabolized in the liver and excreted through the renal system. We recommend that you get annual liver and renal function tests from your primary care doctor and inform all your physicians if there are any abnormal results. HEPATIC In hepatic failure, opioid clearance is reduced and drug bioavailability is increased. These changes can be secondary to reduced hepatic blood flow (limiting first-pass metabolism) and/or decreased CYP450 enzyme levels in these patients. It is recommended that if used, opioid dosing should be reduced to 50% of the recommended starting doses in these patients. Morphine, oxycodone, hydromorphone and tramadol can usually be used cautiously in hepatic failure by means of downward adjustment of the dose and/or upward adjustment of the interval between doses. Methadone, codeine and meperidine should be avoided in patients with liver failure. Codeine is a prodrug that is hepatically converted to morphine by the liver. In patients with liver dysfunction, pain control can be compromised if codeine is not metabolized. Meperidine is metabolized by liver to normeperidine. In hepatic disease, meperidine clearance is reduced and its half-life is prolonged. Seizures, a major side effect of meperidine and normeperidine, can occur at reduced doses in patients with hepatic failure. Methadone should not be used in the presence of significant hepatic failure unless absolutely no alternative exists. This is simply because the risk of excessive blood levels of methadone developing will be greater, and more unpredictable. Combination drugs that include opioid medications (such as oxycodone and hydrocodone) with acetaminophen and NSAIDs (i.e. Norco®, Vicodin®, Percocet®) are limited by the non-opioid component, and overconsumption of acetaminophen containing products is hepatotoxic, and overconsumption of NSAID containing products can be toxic to the kidneys. Fentanyl’s pharmacokinetics are considered to be unchanged by liver failure, however its halflife is prolonged in liver failure with repeated dosing or high dose therapy. Transdermal fentanyl has not been adequately studied in liver failure. Hepatic failure can alter skin permeability and drug absorption; the clinical relevance of this, if any, has not been determined. Some experts suggest fentanyl is a preferred opioid in liver failure as it is for patients with renal failure as well, although this judgment appears to be entirely empiric. Buprenorphine is metabolized in the liver, and its metabolites are excreted into the bile. (They are also, to a lesser extent, excreted by the kidneys.) There are some reports of acute liver toxicity associated with buprenorphine in the presence of liver disease, but information about its use in this situation is otherwise quite sparse. The liver plays an important role in the presystemic clearance of orally administered oxymorphone, thus should be used with caution or avoided in liver dysfunction. RENAL The absorption, metabolism, and renal clearance of opioids are complex in renal failure. However, with the appropriate selection and titration of opioids, patients with renal failure can achieve analgesia with minimal risk of adverse effects. Codeine and meperidine are not recommended for use in people with renal disease, because of the toxicity of their metabolites. Also not recommended is propoxyphene which has been taken off the USA market due to cardiac toxicity. There is debate as to the safety of morphine in patients with renal dysfunction due to buildup of active and toxic metabolites. If used, as with all opioids, we recommend close monitoring for sedation and other signs of toxicity. Safer choices for patient with renal disease, but that still should be used with caution include hydromorphone, oxycodone, oxymorphone and hydrocodone. The safest opioids to consider in patients with renal dysfunction include fentanyl and methadone. Fentanyl is considered relatively safe in renal failure as it has no active metabolites. Methadone is considered relatively safe in renal failure. It has no active metabolites and limited plasma accumulation in renal failure due to enhanced elimination in the feces. However, precautions regarding the use of methadone exist. It does not appear to be removed by dialysis. Buprenorphine mainly undergoes hepatic elimination; there is minimal risk of accumulation in patients with renal impairment. Buprenorphine can be administered at normal doses in patients with renal dysfunction because it is mainly excreted through the liver. Buprenorphine are unchanged in hemodialysis patients, which means that there is no need for dose-reduction with this drug. Thus, in patients with reduced renal function, chronic renal insufficiency and hemodialysis, buprenorphine appears to be a safe choice when opioid treatment is initiated. Tramadol should be used with caution or avoided in patients with renal disease as tramadol’s active metabolite is excreted renally and can accumulate with renal dysfunction. The following guidelines have been proposed for the initial dosing of the safer opioids in renal failure. Creatinine Clearance > 50 mL/min: normal dosing. Creatinine Clearance of 10-50 mL/min: 75% of normal. Creatining Clearance < 10 mL/min: 50% of normal. In summary for most patients with renal or hepatic dysfunction always start at the lowest dose possible and caution should always be followed while monitoring closely for side effects. USE OF OPIOIDS IN PATIENTS WITH LIVER DYSFUNCTION USE OF OPIOIDS IN PATIENTS WITH RENAL DYSFUNCTION

Adjuvant medications and therapies are medications and treatments used to help treat pain that are often used alone or in conjunction with opioid therapy. It is important to understand that these medications and treatments exist and talk to your doctor about adding these therapies, if they are not part of your pain regimen. When used in conjunction with opioid therapy they have shown to reduce the amount of opioid medications needed and decrease the risk of tolerance. Only you and your doctor together can determine which medications and other treatment therapies are appropriate for you to help treat your medical condition. You should empower yourself by educating yourself not only about your medical condition but also about your medications and treatment options available to manage your condition. When it comes to pain management there is a wide variety of medication categories in addition to opioids used to treat pain. These include but not limited to: NSAIDS Oral Steroids Acetaminophen Anticonvulsants Muscle Relaxants Antidepressants Anti-Rheumatics Migraine Medications Dopamine Stimulants Gout Medications Medications to treat side effects such as: Constipation and Nausea Not all of the above medications are appropriate for everyone, and they too come with their own risk and side effects. In the MyPainTools tutorial you learned that there are many different types of underlying pains such as nociceptive and neuropathic pain. Neuropathic pain often is treated best with medications that target that particular pain mechanism such as with anticonvulsants and antidepressants, often referred to as “neuropathic” medications. Acute and/or inflammatory pain, that is often nociceptive, can often be managed with short term anti-inflammatory medications. Often interventional procedures you might receive to help you manage your pain may include a steroid epidural injection which is a strong anti-inflammatory medication. It is important to include in your treatment plan interventional treatment options as well as alternative and integrated medicine such as acupuncture. By now you already know that opioid medications have the known risk of tolerance and we recommend rather than increasing your opioid medications when you have a pain flare, you strongly consider the use of adjuvant medications or therapies discussed above. These therapies can help decrease your pain back and avoid the need for increasing doses of opioid medications

Like all medications opioids can have side effects. You should always read the Medication Guide you receive from your pharmacist each time a medication is dispensed to you. Report any side effects or changes in your health to your physician so they can make appropriate changes as needed. Likewise, report any change in your health or any comorbid diseases you have or develop as this can affect your doctor’s decision when determining your treatment plan. Failure to do so can lead to unexpected side effects including overdose and death. There are 4 absolute contraindications to the use of opioid therapy: 1) Significant respiratory depression 2) Acute or severe chronic bronchial asthma 3) Known or suspected paralytic ileus 4) Hypersensitivity to the medication Use caution in patients with: 1) Biliary Colic 2) Head Injury 3) Reduced Blood Volume 4) Severe Hepatic Insufficiency 5) Convulsion states Some important opioid-related adverse effects to report to your physician include things such as constipation, nausea, worsening pulmonary disease, sedation, and cognitive impairment. Inform your provider immediately if you develop pneumonia or other lung diseases as it may be necessary to lower your opioid doses during this time due to risk of overdose even if you are taking your normal doses as prescribed. Recent research indicates that chronic opioid therapy is associated with a high frequency of sleep-disordered breathing, suggesting cautious use in patients with sleep apnea. If you suspect that your have sleep apnea, have day time tiredness or have excessive snoring you should ask your doctor for a sleep study. If you know you have sleep apnea please inform your doctor and consider treatment such as with a CPAP machine. Failure to take the necessary steps such as the use of a CPAP if you have sleep apnea can increase your risk of overdose and death. In patients with underlying cognitive impairment, chronic opioid therapy may increase the risk of falls or delirium. Opioid-related constipation is likely to be particularly problematic in patients with pre-existing constipation. Among opioids, fentanyl is probably least likely to cause constipation, but there is considerable variation among patients; therefore, opioid rotation may be considered for refractory constipation. Some of the side effects of opioids are secondary to histamine release from mast cells, such as itching and facial flushing. Common adverse reactions in patients taking opioids for pain relief include: nausea and vomiting, drowsiness, itching, dry mouth, miosis, and constipation. Note dry mouth can lead to cavities and other dental issues, so it is important that if you are on chronic opioid therapy that you see a dentist regularly. Some opioids medications contain sugar and increase this risk if used chronically. Other adverse reactions in patients taking opioids for pain relief include: dose-related respiratory depression, confusion, hallucinations, delirium, urticaria, hypothermia, bradycardia/tachycardia, orthostatic hypotension, dizziness, headache, urinary retention, ureteric or biliary spasm, muscle rigidity, myoclonus (with high doses), flushing (due to histamine release), mood swings, weight gain, depression, osteoporosis, chronic fatigue, sexual dysfunction. Both therapeutic and chronic use of opioids can compromise the function of the immune system. However the relevance of this in the context of pain relief is not known. Men who are taking moderate to high doses of an opioid analgesic long-term are likely to have subnormal testosterone levels, which can lead to osteoporosis and decreased muscle strength if left untreated. Serum levels of testosterone and estradiol are associated with an increased risk of osteoporosis. If you are on opioid therapy you should discuss with your primary care physician if testing your testosterone level during your annual physical is reasonable and if treatment if appropriate. Patients getting testosterone replacement therapy should have prostate-specific antigen levels monitored as there is a risk of prostate cancer with this therapy and you should consult with your primary care physician before starting testosterone replacement therapy. OPIOID AFFECTS ON THE BODIES ORGAN SYSTEMS CENTRAL NERVOUS SYSTEM 1) Analgesia 2) Sedation 3) Euphoria/Hallucinations 4) Mental Clouding 5) Respiratory Depression 6) Nausea and Vomiting 7) Suppresses Cough Reflex 8) Miosis (small pupils) GASTROINTESTINAL TRACT 1) Decrease GI Motility 2) Increase GI Tone 3) Constipation 4) GI Spasms 5) Biliary Tract Spasms CARDIOVASCULAR 1) Bradycardia at high doses 2) Orthostatic Hypotension 3) Peripheral Vasodilation (Histamine Effect) 4) Itching (Histamine Effect) URINARY TRACT 1) Urinary Retention 2) Increased Urinary Sphincter 3) Decrease Urine Production UTERUS 1) Prolongs Duration of Labor BRONCHIAL SMOOTH MUSCLE 1) Bronchoconstriction (Histamine Effect) ENDOCRINE SYSTEM 1) Decrease Release of ACTH, Prolactin, and Gonadotrophic Hormones (Testosterone) MUSCULOSKELETAL SYSTEM 1) Muscle Rigidity (High Doses) IMMUNE SYSTEM 1) Suppression of Immune System (chronic use) PREGNACY (see opioids and pregnancy section below) 1) All Opioids cross the placenta 2) Neonatal Withdrawal Syndrome (MANAGING ADVERSE EFFECTS) Nausea and Vomiting: tolerance occurs within 7–10 days, during which anti-emetics can be very effective. The following are the most commonly used anti-emetics: 1) Zofran® 2) Reglan® 3) Compazine® 4) Phenergan® 5) Hydroxyzine 6) Benadryl® Drowsiness: tolerance usually develops over 5–7 days, but if troublesome, switching to an alternative opioid often helps. Certain opioids such as fentanyl, morphine and diamorphine tend to be particularly sedating, while others such as oxycodone, and meperidine (Demerol®) tend to produce comparatively less sedation, but individual patients responses can vary markedly and some degree of trial and error may be needed to find the most suitable drug for a particular patient. Although in some case CNS stimulants can be helpful we recommend avoiding the use of stimulants due to cardiovascular adverse events. Increased aerobic exercises to your daily routine will also help with reducing the level of drowsiness. Itching: Does not tend to be a severe problem when opioids are used for pain relief, but when required, antihistamines are useful. Non-sedating antihistamines such as Allegra® are preferable so as to avoid increasing opioid induced drowsiness. Other drugs that can be used to treat the side effects of itching include: 1) Allegra® 2) Norflex® 3) Claritin® 4) Phenergan® 5) Cyclizine® 6) Benadryl® Constipation: develops in many people on opioids and since tolerance to this problem does not develop readily, most patients on long-term opioids will need specific treatment. Mild/Moderate Constipation: 1) For mild cases, increase water intake (around 1.5 L/day), use fiber and colace and consider drinking prune juice. 2) If needed the addition to the laxative and stool-softeners can be considered (e.g. Docusate® in combination with Bisacodyl® or Senna®)(many question the benefit of stool-softeners long term) 3) Peripherally-acting opioid antagonists (e.g. methylnaltrexone) effectively prevent constipation while not affecting centrally mediated analgesia or provoking withdrawal syndrome, however these can still potentially reduce the efficacy of opioid analgesics in the treatment of conditions where much of the pain relief comes from action at peripherally situated opioid receptors, such as in inflammatory conditions like arthritis or post-surgical pain. Severe Constipation/Chronic Cases: For more severe and/or chronic cases, the drugs that are used work by not increasing peristalsis, but by preventing water uptake in the intestine, leading to a softer stool with a larger component of water, and, additionally, by acidifying the environment inside the intestine, which both decreases water uptake and enhances peristalsis (e.g. lactulose, which is controversially noted as a possible probiotic). The following drugs are generally efficacious: 1) Polyethylene glycol 3350 (MiraLax®, GlycoLax®). 2) Lactulose® syrup Always consult your doctor as long term use of laxatives is not recommended and can have its own side effects. Other Options: One combination, oxycodone/naloxone, aims to reduce systemic side effects by combining oxycodone with an opioid suppressor, naloxone, in a form which does not pass through the blood–brain barrier. Thus, the constipation effect is suppressed, but not the pain reduction. Peripherally acting opioid antagonists such as methylnaltrexone (Relistor®) have been found to effectively relieve opioid induced constipation without triggering withdrawal symptoms. There are many advertised natural alternatives and recipes available on the internet to treat constipation. Some have a good long term track record, but other may not. So if you explore these options be sure to consult with your doctor as to the safety issues with these alternative therapies. Respiratory depression: although this is the most serious adverse reaction associated with opioid use it usually is seen with the use of a single, intravenous dose in an opioid-naïve patient. In patients taking opioids regularly for pain relief, tolerance to respiratory depression occurs rapidly. Respiratory depression is not a clinical problem normally when medications are only taken as prescribed and not mixed with other sedative drugs. Several drugs have been developed which can partially block respiratory depression, although the only respiratory stimulant currently approved for this purpose is doxapram, which has only limited efficacy in this application. Please note opioid therapy is contraindicated for patient with severe respiratory depression. If you have any concerns or issues with respiratory depression call your physician immediately or dial 911.

The Medical Board of California (MBC) has created guidelines and recommendations to help patients and providers safely prescribe and use opioid therapy to improve the quality of life of patients., while preventing drug diversion and abuse. You will also be responsible to abide by the MBC guidelines and all DEA, state and federal regulations. Before prescribing you medications your physician will perform a complete medical history and physical examination. This will include an assessment of your pain; your physical and psychological function; a substance abuse history; history of prior pain treatment; an assessment of underlying or coexisting diseases or conditions; and documentation of the presence of a recognized medical indication for the use of a controlled substance. It is important that you be honest and provide as much information as possible to your physician. You must have a reasonable medical need and indication to be prescribed opioid therapy to manage your pain. As stated before at your initial visit it is your responsibility to bring to your doctor’s appointment your past medication records, including any lab or imaging studies and a list of your current and past medications as well as the original bottles. During your follow up visits your physician will be looking for objectives by which the treatment plan can be evaluated, such as pain relief and/or improved physical and psychosocial function, and indicate if any further diagnostic evaluations or other treatments are needed. Your physician will tailor pharmacological therapy to your individual medical needs. Multiple treatment modalities and/or a rehabilitation program may be necessary if your pain is complex or is associated with physical and psychosocial impairment. It is important that you not only focus on your “pain scores” but also on your improvement in physical and psychosocial function when discussing your care with your physician. Your physician will also review the risks and benefits of the use of controlled substances and other treatment modalities with you (most of which is provided in this tutorial). It is your responsibility to ask questions and ask for this information as well. The physician will periodically review the course of your pain treatment and any new information about the etiology of your pain and the state of your health. If your progress is unsatisfactory, your physician may assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities. Your physician may consider referring you to other specialist as necessary for additional evaluation and treatment in order to achieve treatment objectives. To comply with DEA, state and federal recommendations your physician will require certain additional safe guards when prescribing controlled substances such as opioid medications. These guidelines and recommendations were developed to provide increased safety when using opioids as part of your treatment plan. Failure or refusal to comply with these recommendations can be a reason why your physician may determine that opioid therapy is not an appropriate option as part of your treatment plan. To overcome the critical challenge of eliminating or significantly curtailing abuse of controlled prescription drugs and at the same time assuring the appropriate treatment for patients who can be helped by these medications, you may be required to comply with opioid therapy monitoring programs. One of these safe guards used to monitor opioid therapy is routine urine drug screening known as UDS testing. Urine drug testing is a widely used and familiar method for monitoring opioid use in chronic pain patients. Urine drug testing can help track patient compliance and help decrease the risk of drug misuse and abuse, thus increasing safety with the use of opioid therapy. Another monitoring tool during opioid therapy that your physician may use includes a state specific Prescription Monitoring Program. For example this program is California is called: Controlled Substance Utilization Review and Evaluation System (CURES), which is part of the California Prescription Drug Monitoring Program (PDMP). As of 2013 there is no federal database so most states have developed their own prescription monitoring program. Each State Department of Justice, has a Prescription Drug Monitoring Program (PDMP) system which allows pre-registered users including licensed healthcare prescribers eligible to prescribe controlled substances, pharmacists authorized to dispense controlled substances, law enforcement, and regulatory boards to access timely patient controlled substance history information By having access to controlled substance history information at the point of care it will help your physician make better prescribing decisions and cut down on prescription drug abuse. It allows physicians to see all the controlled prescriptions you have been prescribed and by whom to ensure you are only getting opioid therapy from one provider/clinic. The online PDMP system will make it much easier for physicians and pharmacists to quickly review controlled substance information via the automated Patient Activity Report (PAR) in an effort to identify and deter drug abuse and diversion through accurate and rapid tracking of Schedule II through IV controlled substances. This is an important added safety measure to help assure the safe use of these medications as part of your treatment plan. To ensure your safety and compliance with opioid therapy your physician may also perform random pill counts. It is important that you comply with these random pill counts. Some physician will require patient to bring with them their pain medications in their original bottles to each office visit. Another part of ongoing therapy and monitoring is routine blood work. If you take chronic opioid medications you should ask your primary care physician to include in your annual checkup liver and renal function test. You should also report to your provider if you develop any heart or lunch disease or worsening of organ function as this can have an adverse effect on your health. Your doctor may also ask for annual EKGs. For example if you take methadone you should also include annual EKGs due to risk of QTc prolongation and cardiac arrhythmias. (MEDICATION SAFE STORAGE AND DISPOSAL) The majority of people abusing prescription opioids for non-medical reasons often obtain them from friends or family members, often without their consent. It is important and your responsibility to keep your opioid medication stored in a safe, secure, dry place, where a pet, child, teenager, family member, or stranger cannot get to them. Do not store your opioids medications in several different locations around the home. You should keep the tablets in a bottle with a child-resistant lid, and keep the bottle in a secure lockbox that is approved by your doctor. Only you, and if needed your caregiver, should have access to the lockbox. If you suspect another person may be stealing your medications please inform your physician, this includes family member and/or your caregiver. When disposing of opioid therapies there are certain guidelines you should follow. Remember expired and unused opioid medication should never be saved. If you receive prescriptions for a different dose of your current medications or you receive prescriptions for new medications, you must safely dispose of the leftover old medications. You should never take old opioid medications or medications that have been discontinued as part of your treatment. You should consult the medication guide that accompanied your prescriptions for tips on safe disposal specific to your medication, and also follow the instructions given to you by your physician or pharmacist. As far as actual physical disposal of your unused meds, some opioid medications can be flushed down the toilet; other kinds should be broken up and mixed with coffee grounds or cat litter prior to being thrown away (this makes the medication less tempting to children or pets and unrecognizable to people who may intentionally search through your trash). Before flushing your medications (for those that can safely be disposed of in this manner), you should contact your local water treatment or sanitation department to see if your community has restrictions regarding flushing medicines down the toilet and to find out how to safely dispose of medicines in your community. Before discarding empty pill bottles, you should also remove all labeling to protect your identity. The FDA offers several good resources that offer detailed information and instructions about how to properly dispose of prescription pain medications,. You can obtain this information by clicking on: “Disposal of Unused Medicines: What You Should Know”. This website features a list of medications recommended for disposal by flushing. The Drug Take-Back Network website offers information about “strategies already underway to reduce drug abuse and accidental poisonings, and to improve water quality by offering consumers a safe option for disposing of their unused drugs. Visitors to the site will find links to information about permanent and/or regularly recurring programs to collect and dispose of unused medications in 22 states. The site also includes a link to a national directory (searchable by ZIP code) of “one-time, occasional, or on-going take back programs. Click here for more information: The Drug Take-Back Network. Speak to your prescribing physician or pharmacist with regards to their medication take back policies as well.