CDC Guidelines for Prescribing Opioids for Chronic Pain

Acute pain is defined as, “Pain that has an abrupt onset and offers a warning of a disease process or a threat to the body.”²⁸ Management of acute pain may include opioids. While good pain control is important in patient care, the use of opioids for acute pain increases the risk of long-term opioid use. Use of caution is imperative because long-term opioid use often begins with the treatment of acute, self-limiting afflictions. Ideally, opioids should be prescribed only when necessary, with the lowest effective dose and for the shortest duration possible.

Acute painful conditions may include post-operative pain and other conditions commonly encountered in the primary care setting or emergency department. Recent guidelines have considered this and have re-examined the best way to manage acute pain.

The Center for Disease Control suggests that opioids should only be used when necessary and at the lowest effective dose. Less than three days of opioid medication is appropriate for nontraumatic nonsurgical pain.¹⁹ Immediate-release opioids are recommended for short term use, although in some instances of acute pain may require more than three days.

New York City published guidelines for the use of opioids. They recommend that most patients require three or fewer days of therapy, giving patients short-acting medication, patients should be evaluated for addiction or misuse, avoid administered benzodiazepines and opiates together, and use extreme caution with stolen, lost, or destroyed prescriptions.²⁰

When too many pills are prescribed, there are “left-over pills.” These left-over pills may have use for diversion or abuse. Nonetheless, it is often difficult to predict how much acute pain each patient will have and how many pills to prescribe.

One study showed that persistent opioid use occurred after surgery between 5.9 and 6.5% of the time.²¹ Some factors increase the risk of persistent opioid use. These risks include the history of alcohol or drug abuse, lower socioeconomic status, multiple medical comorbidities, depression, use of benzodiazepines or antidepressants, and preoperative pain.

Chronic pain affects approximately 76.2 million Americans.²² Pain is a common problem seen in primary care, with about 20% of outpatient visits being for pain issues. Chronic pain affects about one in two long-term care residents.²⁴

Persistent pain is often associated with anxiety, depression, functional impairment, sleep disturbances, disability, and impairment in activities of daily living. Every year, chronic pain leads to more than 50 million lost workdays in the United States and costs the American taxpayer over 100 billion dollars.²⁵

Chronic pain is defined as pain lasting more than three months and may affect any part of the body. Chronic pain is most frequently caused by back pain (10%), leg/foot pain (7%), arm/hand pain (4.1%), headache (3.5%), and widespread pain (3.6%). Many individuals affected by chronic pain have more than one type of pain.²⁶

The definition reads, “An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.”²⁷

The definition of chronic reads, “Pain that lasts beyond the usual duration of time that an insult or injury to the body needs to heal.”²⁸ Chronic pain can also be viewed as pain without apparent biologic value that has lasted beyond the usual tissue healing time (typically at least three months). Some define chronic pain as pain that continues for at least six months.²⁷

An expert panel concluded that chronic opioid therapy might be effective for some individuals with chronic non-cancer pain that have been thoughtfully selected.²⁸ The use of high dose long-acting opioids are used only in specific circumstances with severe, intractable pain that has not responded to short-acting or moderate doses of long-acting opioids. No evidence exists as to who responds better between long-acting and short-acting opioids concerning pain relief and side effects.²⁹

A recent survey showed that individuals might go to extreme lengths to obtain certain prescription medications. Opioids were the most obtained medications, followed by the sedative-hypnotics and amphetamines. Individuals who seek these medications are more likely to use more than one physician and more than one pharmacy. This survey showed that seventy-five patients feigned symptoms to get prescriptions, two of thirty-six used falsified MRI images, three patients paid the prescribers, and three harmed themselves to get the prescriptions.³⁰

An important role of the practitioner is prescribing controlled substances. Establishing treatment goals is an important aspect of opioid therapy. Goals should focus on pain relief and improvement in functioning. Prescribing controlled substances is laced with risks, and it is important for the prescriber to realize that a primary goal of prescribing opioids should be to maintain patient safety. A responsible prescriber should follow multiple steps to ensure the safe and effective care of their patients.

Therapeutic goals should be established regarding pain control and improvement in function. Pain goals typically involve a reduction in pain, not necessarily an elimination of pain. Functional goals may include improved sleeping, increased ability to perform activities of daily living, progress in physical therapy, increased social interactions, returning to work, and improved regular exercise. In addition, goals should also include limiting side effects and minimizing adverse drug events.

Pain typically classifies as nociceptive, neuropathic, or other. Nociceptive pain comes from tissue damage or inflammation and may originate from the muscles, joints, skin, organs, bones, or tendons. It may include burns, tumors, muscle strain, joint pain, arthritic pain, or post-surgical pain.

Neuropathic pain comes from damage to the nervous system. It may result from anything that damages neurons. The damage may include pinching of the sciatic nerve, damage from chemotherapy, phantom limb pain, multiple sclerosis, diabetic neuropathy, postherpetic neuralgia, or post-stroke central pain. This pain usually describes as burning, tingling, stabbing, or electrical. The pain type of neuropathic pain is more likely to lead to chronic pain as nerves do not heal as well.

Examples of other pain that cannot classify into these two categories include fibromyalgia, complex regional pain syndrome, or nonspecific chronic low back pain.

The management of pain may include medications, behavioral interventions, physical medicine, neuromodulation, medical interventions, or surgery. The use of a multidisciplinary approach is typically used in the management of chronic pain.

The first recommendation suggests that chronic pain should be managed primarily with nonpharmacologic therapies and nonopioid pharmacologic therapies. Opioid therapy should be considered only when consideration given to both the potential benefit in pain control and functional improvement versus the risks. When opiates are used, they should be combined with nonopioid and nonpharmacological therapy.

Appropriate non-pharmacological therapies include weight loss, physical therapy, exercise, psychological therapies, and selected intervention procedures (joint injections). Nonopioid pharmacotherapy may include NSAIDs, acetaminophen, cyclo-oxygenase (COX)-2 Inhibitors, some anticonvulsants, and some antidepressants. The use of nonopioid pharmacotherapy is associated with a significantly reduced risk of overdose.

The second recommendation suggests that before initiating opioid therapy in chronic pain patients, it is important to establish realistic goals for pain and function. Also, patient education given that opioid therapy would discontinue if risks of therapy deemed greater than the benefits. Opioid prescriptions should only continue when there is a meaningful improvement in function and pain, and the benefit outweighs the risk to patient safety.

Research suggests that long-term use of opioids is associated with serious risks, and that risk is dose-dependent. Research shows weak evidence that opioid therapy beyond six months results in clinically significant pain relief or clinically significant improvements in quality of life.³⁵ Many patients who use long-term opiate therapy discontinue therapy due to adverse effects or inadequate pain control. Because of these facts, it is hard to predict which patient will have benefits greater than harm when receiving chronic opiate therapy.

When opioid therapy initiated, the prescriber should determine the assessment protocol of the effectiveness of therapy. Also, treatment goals should be established with the patient before starting therapy. Goals should include relief in both pain and improvement in function. Conditions that lead to progressive functional impairment or injuries such as spinal cord trauma may have a primary goal of pain relief as opposed to improvements in physical function. In addition, the consideration of the social and emotional well-being of patients should impact that assessment as well.

Functional goals may include returning to work, attending specific recreational activities, walking around the block, or taking the dog for a walk. Assessing for depression and anxiety as well as other psychological conditions is an important aspect of managing the whole patient. Generally, if pain and function are not improved on opioid therapy, tapering or discontinuing the opioid should be strongly considered.

A written agreement should also be used that discusses how opioids will be prescribed and monitored and how they will be tapered or discontinued. Situations, where opioids should be tapered or discontinued, including when opioids are not needed, side effects become too severe, or treatment goals not being met.²

The third recommendation suggests that providers should discuss the risks and benefits of opioid therapy both before and during treatment. Also, the responsibilities of both patient and clinician merit mandatory discussion before and during therapy.

Key teaching points:

• Functionally improvement is the main goal, even if pain still is present.
• The use of opioids generally does not improve pain and function in the long-term, but opioids may reduce pain in the short-term.
• Discuss common side effects include nausea, vomiting, mental status changes, constipation, dry mouth, drowsiness, tolerance, physical and psychologic dependence, and withdrawal symptoms upon ceasing opioids.
• Discuss potentially fatal respiratory depression, especially with higher doses or when used with other depressants such as benzodiazepines.
• Chronic opioid use may lead to a lifelong opioid use disorder.
• Increase fluid intake and fiber to reduce the risk of constipation.
• Opioids reduce the ability to operate motor vehicles safely.
• Discuss that the need for periodic review with consideration given to reducing or discontinuing the opioid.
• Discuss the importance of not sharing prescriptions among family or friends.
• Discuss safe storage, such as in a locked location.
• Discuss safe disposal of controlled substances.
• Discuss monitoring that will include the use of urine drug testing and the use of the prescription drug monitoring program.
• Consider discussing the use of naloxone.

Recommendation number 4 suggests that when starting opiates for chronic pain, immediate-release opioids are recommended over longer-acting medications. Longer-acting opioids are associated with a higher risk of overdose when compared to immediate acting opioids.

The Food and Drug Administration (FDA) reported in 2014 that extended-release or long-acting opioid pain medications should be used when pain is severe enough to necessitate daily, around the clock long-term opiate treatment when other options are not effective, not tolerated or would not offer adequate pain management. They should not have use on an as needed basis.

Other key points under this recommendation include:

• Certain medications are only appropriate for opioid-tolerant patients. An opioid-tolerant patient is defined as someone who has taken 60 mg daily of oral morphine, 30 mg daily of oral oxycodone, or equianalgesic dosages of other opioids for at minimum one week.³⁶
• There is not enough evidence to determine if taking immediate-release opioids for breakthrough pain when using ER/LA opioids is safe outside of palliative care, end of life care, and active cancer.²
• The use of abuse-deterrent technologies makes it more difficult and less rewarding to manipulate the opioids. While they still can be abused, it is more difficult to do so. The abuse-deterrent technology does not prevent unintentional overdose, and the document from the Center for Disease Control does not make recommendations regarding abuse-deterrent formulations.
• Research suggests Methadone having the highest number of overdose deaths when compared to other opioids when prescribed for chronic pain. Methadone also has cardiac complications such as QT prolongation and cardiac arrhythmias. In addition, methadone has a variable and long half-life, which can complicate when peak respiratory depression occurs. There is more interindividual variability in the pharmacodynamics of methadone when compared to other opioids. Methadone should only be used by prescribers that are very familiar with the unique pharmacodynamics and are willing to monitor patients on it closely.
• The pharmacodynamics of transdermal fentanyl is also complex. A gradual increase in serum concentration can occur over the first 72 hours. Absorption can be variable based on factors such as external heat.
• Initiation of Opioid treatment should not occur with ER/LA dosing, and this type of medication should not be used for intermittent use. They should be considered only in those who have severe pain and have used intermediate release opioids daily for at least seven days.

Recommendation five suggests that when starting opiates, the lowest effective dosage should take precedence. Extreme caution should be used when prescribing opiates. The risks versus benefits should be reevaluated with dosages above 50 morphine milligram equivalents (MME)/day used. If dosages above 90 MME/day used careful documentation of its justification should be accomplished.

Benefits of high dose opioids are not well established, and higher doses are associated with more harm such as opioid use disorder, overdose, and motor vehicle accidents.

While lower doses of opiates reduce the risk, there is no dose threshold eliminating the risk of overdose. Dosage above 90 MME/day is linked to a high risk of overdose with lower dosages associated with less risk. According to the CDC document², when dosages pushed to over 50 MME/day, the risk of overdose increases without improving pain control or functional benefit.

When increasing the dosages of opioids, the increase should occur in the smallest amount possible to reduce the risk of overdose. There is no firm evidence on how long to wait before increasing dosages, but waiting at least five half-lives before increasing the dosage has been recommended.² In addition, extreme caution should be used in individuals over the age of 65 or those with kidney or liver insufficiency.

When dosages are increased above 50 MME/day, the prescriber should:

• Assess if the opiate is helping to meet the treatment goals
• Increase the frequency of follow-ups
• Consider providing naloxone
• Provide overdose education

Even patients who have been on high doses for many years, the offer to wean their dosage should occur. The patient should have education regarding recent clinical evidence suggesting that patients on high doses of opiates are at higher risk for overdose, and the provider should offer the patient an opportunity to wean dosage slowly if indicated.

Recommendation 6 suggests that when using an opioid for acute pain, the provider should use the lowest dose of immediate-release opioids and provide a quantity that is no more than the expected duration that the patient needs. Three days or less is often enough, and more than seven days rarely indicated.

Some research suggests that for back pain managed in a primary care setting, the use of opioid medications results in a large reduction in pain until the fourth day of treatment, and after that, smaller pain reductions are noted. Opioids should not be prescribed “just in case.”²

Recommendation number 7 suggests that patients using opioids for chronic pain should have the benefits and harms evaluated within one to four weeks of beginning therapy or when there is a dose increase. After that, the benefits and harms should be evaluated at least every three months. If benefits do not outweigh the harms, the provider should consider tapering opioids to a lower dosage or discontinuing opioids.

Individuals who continue opioid therapy for three months or more are at increased risk of developing opioid use disorder.² Therefore, frequent follow-up in the first three months may help reduce the risk of opioid use disorder. Another argument for close follow-up is that the risk of overdose is high during the first two weeks of treatment with ER/LA opioid use. The risk is especially high with methadone or fentanyl.

Research suggests that individuals who do not have pain relief from opioids at one month will likely not have pain relief at six months. Therefore, assessment within the first month is important to determine who will likely benefit from opioid therapy. Frequent assessments should reduce the risk of complications of long-term opioid use such as overdose, opioid use disorder, and other injuries.

Certain individuals are at higher risk for opioid use disorder or overdose, and this includes individuals with a history of a substance use disorder, individuals with depression or another mental health condition, patients taking greater than 50 MME/day, those with a history of overdose, and those taking other central nervous system depressant medications. These individuals should be evaluated more frequently. If found to be without benefit from the opiate, strong consideration should occur in reducing the dose or discontinuing the opiate.

When tapering opioids, the dose should be reduced weekly by 10-50%. In individuals who had a severe adverse event, such as an overdose, rapid discontinuation of 2-3 weeks could be utilized.² For individuals who have utilized opioids for extended periods reducing dosages slowly may be appropriate. Reducing as slowly as 10% a month may be utilized in individuals who have been taking opioids for years.

A slow reduction in opioid doses reduces the signs of opioid withdrawal such as anxiety, nausea, vomiting, diarrhea, tremor, increased heart rate, insomnia, drug craving, and abdominal pain.

Recommendation number 8 suggests that risk factors for opioid-related harms should be assessed before starting therapy and during opioid therapy. In addition, clinicians should implement strategies to reduce risk in individuals at high risk. The strategies would include individuals on greater than 50 MME per day, those with a history of an overdose, a history of a substance use disorder, or those on concurrent benzodiazepines.

One strategy to reduce the risk of overdose death includes prescribing naloxone. Naloxone can reverse the opioid when there is severe respiratory depression. Naloxone has the potential to bring on acute withdrawal symptoms in patients who are physically dependent on opioids.

Other factors that place patients at high risk for overdose including those with sleep-related breathing disorders such as sleep apnea or congestive heart failure, pregnancy, mental health issues, those with renal or liver insufficiency, and those greater than age 65.

Pregnancy puts both mother and fetus at risk because it can increase the risk of poor fetal growth, congenital disabilities, stillbirth, and preterm delivery. It can also lead to neonatal opioid withdrawal. When prescribing opioids for anyone of childbearing age, it is important to discuss a possible consequence of opioids during pregnancy.

Prescribing medication, including opioids, can be challenging in older adults. Some of the concerns include reduced renal or hepatic function, higher risk of respiratory depression, increased risk of side effects including cognitive impairment, more comorbid medical problems, polypharmacy, higher risk of falls, and constipation.

Extra caution should be utilized in individuals with mental health problems when prescribing opioids. This group of individuals is at higher risk for opioid use disorder and increased risk for drug overdose (especially in those with depression).² For individuals with significant psychiatric instability or high suicide risk, opioid therapy should not be initiated. Also, individuals who have been prescribed benzodiazepines should very cautiously be prescribed opiates, if at all.

The Patient should be asked about drug and alcohol use. In addition, the prescriber should use the prescription drug monitoring program (PDMP) database before prescribing. For individuals with a substance use disorder obtaining outside consultation with a substance use disorder specialist or pain specialist regarding the management of pain is recommended.

Recommendation number 9 suggests that the clinician should review the PDMP database to determine previous/current opioid prescriptions as well as other medications that may interact and place the patient at higher risk for overdose. The clinician should review this data at a minimum of every three months, but as often as every prescription written.

Research is limited on the benefits of PDMPs, but evidence suggests that individuals who received opioid prescriptions from multiple prescribers and at high doses are at the highest risk for overdose. The PDMP can help detect these situations.

Providers should not dismiss patients from their practice based on data received from these databases. Doing so has the potential to have negative health outcomes. The PDMP provides the provider and opportunity to intervene to reduce the risk of overdose by providing interventions as providing education, considering alternative therapies, or prescribing naloxone.

Recommendation number 10 suggests that when prescribing opioids for chronic pain, the use of urine drug testing should be used before the start of therapy, and at least once a year. The use of urine drug testing will ensure the patient is taking the medications as prescribed and that there are no illicit drugs in the patient’s system.

The use of other controlled substances increases the risk of overdose. Urine drug testing has the potential to identify these patients and reduce risk. Urine drug testing also can determine when patients are not utilizing prescriptions as prescribed, which may point to diversion or side effects that limit compliance.

While urine drug testing should be done before starting opioid therapy, there is disagreement with how frequently testing should be done during long-term therapy. It should be done at least once a year. In high-risk individuals, more frequent testing should ensue.

Patients should have educated regarding the purpose of drug testing; to improve patient safety. Before testing, the provider should ask about the use of other drugs or other medications, and if there might be any unexpected results. The clinician should be prepared for any unanticipated results and should have a plan for dealing with them. Unexpected results should be discussed with the patient to determine if there is a logical explanation. If the unexpected results (for example, negative for a prescribed drug or positive for an unexpected drug) are not explained, then confirmatory testing should occur.

Confirmed unexpected results can lead to one of the following outcomes.

• Modification of the pain management strategy
• More frequent evaluations
• Tapering/stopping the opioids. When testing for expected medications is repeatedly negative, then abrupt discontinuation is appropriate (as the patient is not taking the medication)
• More frequent re-evaluation
• Giving naloxone
• Referral for substance use disorder treatment
• Clinicians should not remove the patient from care due to an unexpected urine drug test. The abrupt removal from treatment is a safety measure as the patient could have withdrawal or obtain medication from another source or even start heroin. It could also be construed as patient abandonment. Lastly, it may miss a chance to get the patient into treatment for substance abuse disorder.

Recommendation 11 suggests avoiding prescribing an opioid and benzodiazepine together. This combination reduces respiratory drive and significantly increases the risk of overdose. The recommendation is not an ultimatum to never prescribe these two agents together but should be done rarely and with extreme consideration. For example, a patient who has been on a long-term, low dose benzodiazepine and develops severe acute pain may be a candidate for a low dose opiate medication.

Other medications that suppress the central nervous system should be avoided in those on opiates. These may include sedatives, hypnotics, muscle relaxants, some antidepressants, and sedating antihistamines.

Recommendation number 12 recommends using an evidence-based treatment in those with opioid use disorder, which may include medication-assisted treatment (MAT) with behavioral therapy.

Points discussed under this recommendation include:

• Opioid dependence is estimated to be present in between 3-26 percent of primary care patients on opioids for chronic pain. The use of MAT is effective in preventing relapse in those with opioid use disorder.²
• MAT can occur with buprenorphine or methadone and, in some cases, naltrexone. Naltrexone blocks opioids effects and can be given as daily oral therapy or as monthly injections.
• Providers should be aware of community resources available to help patients get treatment for opioid use disorder.
• The use of MAT in pregnant women with opioid use disorder improves maternal outcomes. Treatment should be with buprenorphine or methadone, not naltrexone.

The CDC guideline aims to enhance the communication between patient and provider regarding the risks and benefits of opioid treatment in chronic pain. It also looks to reduce the risks of long-term opioid therapy and improve effectiveness and safety.

To prevent prescription drug abuse, the clinician needs to assure:

• Patients are assessed and reassessed
• Treatment agreements in use
• Prescription monitoring occurs
• The practice of safe prescription methods

Patients' risk should be assessed, with contraindications immediately identified. Contraindications to opioid treatment include those who have erratic follow up, suffer from current untreated addiction, or have poorly controlled mental illness.⁴¹

When taking a patient history document, the opioid currently prescribed, its dose, the frequency of use, and the duration of use. It is important to query the state prescription drug monitoring program to confirm the patient’s report of prescription use. In addition, it is important to contact past providers to obtain medical records.

A history of illegal substances use, alcohol use, tobacco use, prescription drugs use, psychiatric history, family history of substance abuse and psychiatric disorders, history of sexual abuse, legal history, behavioral problems, employment history, marital history, social network, and cultural background should be assessed in all patients who are being considered for controlled substances. History of substance abuse does not prohibit treatment with opioids but may necessitate more intensive monitoring or referral to an addiction specialist.

Multiple tools are available to evaluate opioid risk. The Opioid Risk Tool is a tool that is used in primary care to screen adults for the risk of aberrant behaviors when prescribed opioids for chronic pain. It is a copyrighted tool, encompasses five questions, and takes about one minute to use. It classifies a patient as low, moderate, or high risk to abuse opioids. Those who are high risk have a high likelihood of aberrant drug-related behavior. The five questions include asking about family and personal history of substance abuse (alcohol, prescription drugs or illegal drugs), age (risk is 16-45 years old), psychological disease, and history of preadolescence sexual abuse. The questions are scored with different points assigned for each question, which is variable between men and women, and a total score is tallied. The patient is placed in low, moderate, or high risk.

Regular follow up is important and should occur at a minimum of every three months. When assessing the pain patient, include the five A’s, which are: analgesia, addiction, activities of daily living, adherence, and adverse effects. Part of follow up should be urine drug testing to detect medication adherence as well as illicit and non-prescription drug use. It is critical the clinician adequately document any and all interactions with patients, assessments, results of testing, and treatment plans.

Written treatment agreements, which should be used between prescribers and patients when controlled substances prescribed. The agreement helps guide the conversation between the patient and the prescriber. It discusses expectations, the risks, and the monitoring that will occur to limit the complications of controlled substances (Table 2).

How should the clinician respond when abuse or misuse detected? If it is a singular, minor deviation, then counseling, along with more intensive monitoring may suffice. Tapering controlled substances to reduce the risk of withdrawal is appropriate in more severe or persistent cases of misuse. When diversion is the cause of misuse, immediate removal of the prescription is likely the best course. If a substance abuse disorder is suspected, recommend a referral to an addiction specialist.

Safe prescription methods are listed below in the section on prescribing controlled substances.

• Have an upper dosing threshold. The risk of accidental overdose increases with higher doses of opioids. Risk increases at 50 MME/day. Prescribers should generally avoid doses of morphine or morphine equivalents more than 90 - 200 MME/day.⁴³
• Use caution with certain medications. For example, methadone should only be used by a prescriber who is extremely comfortable with the medication. Fentanyl is another medication that requires extreme caution as there is unpredictable absorption – especially with the patch.
• With opioid use, respiratory depression is more likely in the older population and those who are cachectic or debilitated. Monitor patients at high risk more closely, and do give opioids in combination with other respiratory depressants. The dose of opioids should be started at one-third to one-half of the typical starting dose in at-risk patients. Titration opioids carefully. Constipation is more likely, and a bowel regime should be prescribed when opioids in use.
• The greatest risk of opioid use is respiratory arrest and death, and this risk is greatest when therapy started or the dose increased. Opioid-induced respiratory depression manifests by the reduced desire to breathe and reduced respiratory rates. The patient will be breathing shallow, and CO2 retention can exacerbate the sedating effects of opioids. If respiratory depression noted, the family should call 911.
• Opioids should not be used in those with respiratory depression. Titration must occur slowly, and when changing formulations, do not overestimate the converting dosage.
• Avoid combinations of opioids and benzodiazepines. When these two classes are combined, particularly if more than 100 mg of morphine or morphine equivalents per day is used, the risk of accidental overdose is high.
• Pay attention to drug-to-drug and drug-to-disease interactions.

Opioid overdose is a continuing public health crisis, and states have taken steps attempting to reduce the overuse of these medications in hopes of reducing overdose and other negative outcomes. Organizations, including the CDC, have made recommendations regarding the amount or duration that opioids should be prescribed.

The goal of pain management should be tolerable pain levels with good function. Here are some guidelines for how long medications are prescribed to those with acute pain.¹⁹

• Mild pain syndrome should generally be treated with acetaminophen and/or nonsteroidal anti-inflammatories along with nonpharmacological therapy.
• Individuals who suffer from moderate pain, such as after minimally invasive surgery, simple fractures, and soft tissue surgery, a 3 to 5-day course of oxycodone may be appropriate.
• For individuals who suffer from severe pain such as those from a major surgical procedure, total joint replacement, compound fracture, higher doses of opioids may be used for up to one week.
• One study looked at the number of pills prescribed after procedures for 80% of patients and showed that those after laparoscopic cholecystectomy, laparoscopic inguinal hernia repair, or an open inguinal hernia repair required 15 pills of oxycodone 5 mg. In contrast, partial mastectomy patients required five pills.⁴⁴
• Predicting the number of medications patients will need after discharge from their procedure can be ascertained from the number of pills the patient took the day before discharge. One study showed that patients who took 1 to 3 pills on the day before discharge from the hospital took a mean of 7.6 pills after discharge from the hospital. Individuals who took four pills on the day before discharge took a mean of 21.2 pills after being released from the hospital.⁴⁵

The Iowa Department of Public Health evaluates the number of prescribers enrolled in the Board of pharmacy’s prescription drug monitoring program. Factors that are evaluated by the Iowa Department of Public Health include the average MMEs prescribed per day, the total number of days for the prescription written, and the total number of opioid prescriptions written. Recent data suggests that over the last few years, the strength of the dosing is not decreasing, and the number of days of prescribing is increasing.⁴⁶

The state of Iowa has implemented administrative codes regarding opiate use. According to Iowa Administrative Code (IAC) 657-10.29(124), “[a]n individual prescriber may issue multiple prescriptions authorizing the patient to receive a total of up to a [ninety]-day supply of a Schedule II controlled substance according to the provisions and limitations of this rule.”, Refills are prohibited. IAC 657-10.25(3) states, “Each separate prescription, other than the first prescription if that prescription is intended to be filled immediately, shall contain written instructions indicating the earliest date on which a pharmacist may fill each prescription.”⁴⁷

According to IAC 657-10.29(6), “Nothing in this rule shall be construed as requiring or encouraging an individual prescriber to issue multiple prescriptions according to this rule or to see the prescriber’s patients once every 90 days when prescribing Schedule II controlled substances. An individual prescriber shall determine, based on sound medical judgment and in accordance with established medical standards, how often to see patients, and whether it is appropriate to issue multiple prescriptions under this rule.”⁴⁷

According to IAC 657—10.32(124), “No prescription for a controlled substance listed in Schedule III, IV, or V shall be filled or refilled more than six months after the date on which it was issued nor be refilled more than five times. Beginning January 1, 2020, all prescriptions for controlled substances shall be transmitted electronically to a pharmacy according to rule 657—21.6(124,155A), except as provided in rule 657—21.8(124,155A). 10.32(1).”⁴⁷

The board may discipline an ARNP for prescribing opioids in dosage amounts that exceed what would be prescribed by a reasonably prudent ARNP in a similar practice.⁴⁹

Patient education is important as it will reduce the risks associated with these medications and result in improved pain management. Patients need education in the safe use, storage, and disposal of opioid medications. Safe use of opioids requires the patient to know about adverse events, as well as risks of abuse, misuse, and addiction.

An overdose occurs when someone takes a higher dose than the body can tolerate leading to a significant adverse effect. Respiratory depression is the primary risk. This risk is highest in those who are not tolerant to opioids, take other respiratory depressants, have multiple health conditions, or have debilitated health and/or an impaired respiratory function.

Medications associated with a high risk of respiratory depression are schedule II opioids. Fentanyl, a synthetic opioid pain reliever, is 50 to 100 times more potent than morphine and has been implicated in many cases of overdose death. Medications that are altered for administration also increase the risk of overdose. Snorting, injecting, inhaling, chewing, or dissolving medications that should be swallowed whole (particularly extended-release opioids) increases the risk. Other methods that may lead to overdose include rapid titration of opioids and overestimation of the dose when converting from one opioid to another. Medication overdoses also occur when taken by someone it was not prescribed for, especially children. Therefore, safe storage and disposal are critical.

Patient education should include information on abuse. Many patients, who end up abusing opioid medications, usually got a valid initial prescription. Most patients who abuse medications get them either by buying or stealing from an acquaintance (most typically a friend or relative).⁵⁰

Patient education should also include information on misuse. Many patients will misuse medications because they are seeking to improve function, have uncontrolled pain, or are using them to manage stress or mental disease. Aberrant behavior may manifest in those who are undertreated for pain. In the absence of addiction, these behaviors cease when pain is adequately controlled.

The patient's teaching must include zero tolerance for drug diversion and that it will result in immediate termination of the prescription with referral to a substance abuse program and possible legal action.

Patients should be taught about addiction. Addiction is a chronic disease with psychological, social, genetic, and environmental factors influencing its presentation and development. Addiction presents with the drug craving, compulsive use, impaired control, and persistent use despite harm.

Drug Take-Back Programs provide a convenient way for patients to dispose of unneeded, expired, or unused controlled substances. If no program is available, the patient must use extreme caution when disposing of controlled substances. Improper disposal may lead to environmental complications or drug diversion. Controlled substances can be mixed with cat litter or coffee grounds then sealed in a non-leaking container.

Key points in patient education include:

• Goals of treatment.
• Alternative treatment options.
• Patients should be encouraged to read their medication guide and/or the package insert every time they get a new prescription.
• Teach about abuse, addiction, misuse, and diversion.
• Risks of overdose and/or death if dose not taken exactly as prescribed or someone else takes the medication.
• Pain medications may impair breathing.
• Do not give the medication to anyone else.
• If anyone else takes the medication, to contact emergency services.
• Swallow pills whole that are meant to be swallowed – do not crush, snort, chew, inhale, or take by any other means other than the method prescribed.
• Maintain contact with the prescriber for monitoring and titration.
• Teach about drug-to-drug interactions. Medications that should be avoided in combination with opioids include alcohol or any medication that the patient does not have a prescription. Medications that should only be taken after a careful review and counseling by a prescriber include sedatives, hypnotics, anxiolytics, antidepressants, and antihistamines.
• Opioids may lead to cognitive impairment and may affect driving ability or safety at work, especially if operating heavy equipment.
• Opioids should be stored safely and away from family members, acquaintances, and friends.
• Medications should be locked up in a drawer, cabinet, or safe so no one else will get them.
• Educate patients that it is illegal and dangerous to give away or sell their medications to others.
• Patients should keep track of the number of pills, capsules, etc. - so it can be determined if any are missing.
• Do not store them in a pill reminder container.
• Teach about common side effects: sedation, drowsiness, respiratory problems, dizziness, mental status changes, nausea, vomiting, constipation, anxiety, tremors, and diaphoresis.
• Monitoring will take place in the form of pill counts, urine drug screens, and the use of the prescription drug monitoring program. Unfavorable results may lead to termination of treatment or alteration in the treatment plan.

Discontinuation of opioid therapy may be considered if problematic patterns are noticed, opioid therapy is not effective, or goals are not being achieved. The prescriber and patient must agree upon reasons to terminate therapy before initially prescribing the medications and should be part of the initial agreement.

The clinician should have a method for addressing prescription drug misuse. Minor infractions may result in patient counseling and intensifying monitoring activities. More severe behaviors may require the clinician to discontinue prescribing controlled substances. If patients are found to be diverting prescription medication, immediate cessation of the prescriptions is appropriate. In most other cases, it is appropriate to taper the controlled substances to reduce the risk of inducing a withdrawal syndrome.

When stopping the medication, the patient and the prescriber must agree to stop the medication. For patients who decide to continue treatment with another prescriber, the prescriber may consider maintaining the current dose for four weeks.

When appropriate, implement a tapering schedule to avoid withdrawal. A reduction of 10% every 7 to 14 days until the patient gets to a lower dose, at which time a 5% reduction every 2-4 weeks may be done.

Offer Individuals who have shown aberrant behavior other non-opioid options. For patients who have engaged in criminal activity (such as diverting drugs or altering prescriptions), should be referred to a substance abuse treatment program and may be discharged from the practice.