92% of participants will know how to apply best practices and Ohio law in prescribing controlled substances, including awareness of drug diversion.
92% of participants will know how to apply best practices and Ohio law in prescribing controlled substances, including awareness of drug diversion.
After completing this course, the student will be able to:
Note: Many regulations refer to an exclusionary formulary. The exclusionary formulary no longer exists as a list. It has been replaced with1:
Using prescribed drugs, not as directed, describes potentially aberrant drug-taking behaviors. In a study of 202 patients, only 44.1% were screened for potential aberrant drug-taking behaviors. It was concluded that screening for abuse or misuse of opioids does not frequently occur in large family drug training programs. More training and set policies for risk evaluation and monitoring for opioid abuse are needed.2
Healthcare providers tend to under-assess patients at risk for opioid-related aberrant behaviors. One study showed that providers assessed the risk of misuse, abuse or diversion at less than 2% when in reality, 10.4% of patients had prior illicit drug use, 23.4% had abnormal urine drug tests, almost 11% reported crushing or chewing opioids in the past and 60% of patients self-reported abuse, misuse or diversion.3
Prescriber lack of training and inexperience can have a profound impact on the misuse of drugs. One study showed that resident physicians (when compared to attending physicians) more often prescribed opioids for more than three months, were more likely to have their patients report that their prescriptions were lost/stolen, were more likely to have patients who exhibited substance misuse and were more likely to have their patients get opioids prescribed by a different prescriber in addition to them.4
Prescribers receive little training in how to prescribe scheduled substances, how to screen for substance abuse, and how to refer patients who need treatment for substance abuse. Proper continuing education is one way to address this problem.5
Drug abuse occurs when drugs are not used medically or socially appropriately. Controlled substances may lead to dependence, either physical or psychological. Physical dependence transpires when there are withdrawal symptoms such as anxiety, tachycardia, hypertension, diaphoresis, a volatile mood, or dysphoria after the rapid discontinuation of the substance. Psychological dependence is the perceived need for the substance. It makes the individual feel as though they cannot function if they do not have the substance. Psychological dependence often kicks in after physical dependence wears off. Psychological dependence typically lasts much longer than physical dependence and often is a substantial contributing factor to relapse. Physical dependence is not addiction.
Addiction is psychological dependence, along with extreme behavior patterns associated with drug usage. At this point, there is typically a loss of control regarding drug use. The drug is continued despite severe medical and social consequences. Tolerance, defined as the need to increase the doses of the drug in order to produce an equivalent effect, is typically seen by the time addiction is present. Physical dependence can occur without addiction. Individuals who take chronic pain drug may be dependent on the drug but not addicted.
Addiction is a primary concern in those taking opioids. When prescribing opioids, it is essential to determine who is likely to participate in aberrant drug-related behaviors. At higher risk for aberrant drug-related behaviors are individuals with significant depression, psychotropic drug use, younger age, or those with a family or personal history of drug or alcohol misuse. Those at high risk for addiction would be better managed in concert with a specialist.6
Opioid use disorder is a use pattern of opioids that result in problems or distress. It may include tolerance, impaired social functioning, loss of control of opioid use, dangerous opioid use, and withdrawal. To meet diagnostic criteria, patients with an opioid use disorder must have at least 2 of the 11 symptoms over 12 months.7 These symptoms include:
Aberrant drug-related behaviors may include abuse, misuse, diversion, or addiction. Examples of aberrant drug-related behaviors include:
Opioids have the potential to provide analgesia and improve function. These benefits must be weighed against the potential risks, including misuse, addiction, physical dependence, tolerance, overdose, abuse by others, and drug-to-drug and drug-to-disease interactions.
Opioid dependence costs the United States healthcare system one billion dollars annually.15 Also, opioid dependence leads to decreased work productivity, increased legal costs, and lasting psychological effects experienced by the victims of the crimes caused by opioid abuse. Also, opioid misuse may lead to other diseases such as HIV, hepatitis, and sexually transmitted diseases.
|According to the fifth edition of the Diagnostic and Statistical Manual from the American Psychiatric Association, the essence of a substance use problem may be summed up by the phrase8:|
“…cognitive, behavioral, and physiological symptoms indicating the individual continues using the substance despite significant substance-related problems.”
In this course, the term APRN includes clinical nurse specialists and certified nurse-midwife.
In Ohio, the nurse practice act (NPA) recognizes that nurses can be found everywhere, doing many different tasks at all levels of care. For that reason, it has specifically addressed the standards it expects from advance practice registered nurses16:
Before beginning practice, a standard care arrangement shall be entered into with each physician or podiatrist with whom the specialist collaborates. The standard care arrangement can be revised to add or delete a physician or podiatrist within that employment setting instead of making a new arrangement. A new standard care arrangement is needed when the nurse is employed in a different setting and engages in practice with different collaborators. The collaborating physician's or podiatrist's practice must be the same or similar to the nurse's practice.16
A standard care arrangement includes at least16, 17:
Quality assurance provisions16:
The most current copy of the standard care arrangement, and any legal authorization signed by a physician, must be retained by the nurse’s employer, and available by request, but may be maintained elsewhere. Upon request of the board, the nurse must provide a copy of the standard care arrangement to the board. Retain copies of previously effective standard care arrangements for three years. The copies may be retrained longer since the statute of limitations on many legal cases is seven years.
When a hospital negotiates a standard care arrangement, the review and approval of the standard care arrangement must be following the policies and procedures of the hospital governing body and the bylaws, policies, and procedures of the hospital medical staff.
An APRN cannot practice without a standard care arrangement executed. A nurse must notify the board of the identity of a collaborating physician or podiatrist any change in the name and business address of a collaborating physician or podiatrist within 30 days of the change.16
ARNP may prescribe any drug or therapeutic device in any form or route of administration if16:
Below is a Prescribing Process Flow chart recommended by the Ohio Board of Nursing. An error on the flowchart is that the previous exclusionary formulary is no longer in effect. ARNP must prescribe according to the standard care agreement with their collaborating physician, consistent with national certification and state and federal laws.16
PDF available here
Ohio Board of Nursing Prescribing Resources are available at nursing.ohio.gov/practice-resources/prescribing-resources/
An APRN may delegate the administration of a drug to an unlicensed person if the following conditions are met18:
Before delegating this authority, the APRNs with prescriptive authority is required to assess the patient, determine that the drug is appropriate for the patient, and determine that the person to whom the authority will be delegated has met the conditions.17
An APRN with prescriptive authority has many requirements and limitations. These include16:
Morphine equivalent daily dose (MED) means a conversion of various opioid analgesics to a morphine equivalent dose by the use of accepted conversion tables provided by the state board of pharmacy at www.ohiopmp.gov/MED_Calculator.aspx.
The formulary for APRNs is found at codes.ohio.gov/oac/4723-9-10. The exclusionary formulary no longer exists as a list. It has been replaced with1:
Acute pain fades with healing, is related to tissue damage, alters a patient's function, and is time-limited usually not more than six weeks.20
Chronic pain persists after efforts have been made to relieve it and continues for twelve or more weeks. Chronic pain may be intermittent or continuous. The term chronic pain is not used with a terminal condition or with a progressive disease that is expected to result in a terminal condition.
Extended-release or long-acting opioid analgesics means an opioid analgesic that is administered via a transdermal route or contains methadone.
Extended-release or long-acting opioid analgesics means an opioid analgesic that is FDA approved and labeled as extended-release or long-acting opioid, administered via a transdermal route or contains methadone.
Sub-acute pain persists after treatment for more than six weeks but less than twelve weeks. Sub-acute pain may be intermittent or continuous.
If the patient is a family member, the ARNP cannot prescribe to a family member unless:
To prescribe drugs that are a controlled substance, the following apply20:
An APRN can prescribe schedule II controlled substances and gabapentin only in situations where all of the following apply20:
An APRN can prescribe a schedule II control substance if the prescription is issued from any of the following2o:
An APRN cannot prescribe a schedule II controlled substance from a convenience care clinic even if the clinic is owned or operated by an entity specified above.20
For the treatment of acute pain, an APRN must comply with the following20:
In all circumstances where opioid analgesics are prescribed for acute pain, an ARNP can prescribe2o:
If a patient is intolerant of or allergic to an opioid medication initially prescribed, a prescription for a different opioid medication may be issued at any time during the initial seven-day or five-day dosing period.
The patient, or a minor's parent or guardian, must be advised of the benefits and risks of the opioid analgesic, including the potential for addiction, and counseling must be documented.
The total morphine equivalent dose (MED) of a prescription for opioid analgesics for the treatment of acute pain shall not exceed an average of thirty MED per day, except when the patient's treating physician has entered a standard care arrangement with the APRN that arrangement must state the understanding of the physician as to when the APRN can exceed the thirty MED average and when the APRN must consult with the physician before exceeding the thirty MED average. Document the reason for exceeding the thirty MED average and the reason it is the lowest dose consistent with the patient's medical condition.
The above rules apply to the treatment of acute pain only and do not apply when an opioid analgesic is prescribed to a patient in the following situations20:
For sub-acute and chronic pain, first consider and document non-drug options.
The APRN shall prescribe the minimum quantity and potency needed to treat the expected duration of pain and improve the patient's ability to function.
Before prescribing an opioid analgesic for sub-acute or chronic pain, complete or update patient record assessment. Complete an OARRS review. Offer the patient a prescription for naloxone if the following circumstances exist20:
Consider offering a prescription for naloxone if the dosage exceeds fifty MED. During treatment with an opioid at doses below the average of fifty MED per day, provide periodic follow-up assessment and documentation of the patient's20:
Drugs approved by the FDA but not yet reviewed and approved by the committee on prescriptive governance may be prescribed, unless later disapproved by the committee on prescriptive governance, if the collaborating physician has agreed in the standard care arrangement that the APRN may prescribe these drugs.20
An APRN shall not prescribe any drug or device to perform or induce an abortion.20
An APRN may issue a prescription for or personally furnish a complete or partial supply of a drug to treat chlamydia, gonorrhea, or trichomoniasis, without having examined the individual for whom the drug is intended if all of the following conditions are met21:
An APRN may prescribe or personally furnish a drug for not more than a total of two individuals who are sexual partners of the nurse's patient. For each drug prescribed or personally furnished under this situation, the nurse shall do all of the following21:
If the APRN contacts the individual21:
An APRN who in good faith prescribes or personally furnishes a drug under this situation is not liable for or subject to any of the following21:
OARRS is a database that tracks the dispensing and personal furnishing of controlled prescriptions to patients. The state board of Pharmacy manages that database. The system is available at ohiopmp.gov/.
The accepted and prevailing standards of care require that when prescribing or personally furnishing a controlled substance schedules II, III, IV, V, an APRN shall consider22:
When considering these circumstances in the course of determining whether to prescribe or personally furnish a controlled substance to a patient, the APRN shall use sound clinical judgment and consider obtaining and reviewing an OARRS report, consistent with the requirements of this rule.
The APRN must obtain and review an OARRS report when a patient shows any of the following red flags22:
Obtain and review an OARRS report, covering at least the last 12 months, when prescribing opioid analgesics and benzodiazepines in the following situations22:
If the patient continues to receive opioid analgesics or benzodiazepines after the initial prescription, review an OARRS report at least every 90 days. If your county is adjacent to another state, request a drug database report from that state.22
OARRS reports may be requested by the APRN's delegate but must be personally reviewed by the APRN. Document your evaluation of the OARRS report. Also, document any actions you take because of your evaluation of the use of an OARRS report. Also, document if a drug database report cannot be obtained, why, and efforts to obtain a report.
An OARRS report is not required if the patient is22:
If an OARRS report indicates red flags, consult with a physician before prescribing or furnishing the drug. The consultation should include the review and document17:
Results of the consultation could include22:
When abuse/misuse is detected, how should the clinician respond? If it is a single, minor deviation, then counseling, along with more intensive monitoring, might be all that is needed. 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, a referral to an addiction specialist is recommended.
Medication-assisted treatment is alcohol or drug addiction services that are accompanied by medication for the treatment of substance use disorder, prevention of relapse of a substance use disorder, or both. The induction phase is the part of opioid treatment when maintenance medication dosage levels are adjusted until a patient is stable. The stabilization phase is the medical and psychosocial process of assisting the patient through acute intoxication and withdrawal management to the attainment of a medically stable, fully supported substance-free state, which may include the use of medications.23
Office-based opioid treatment (OBOT) is medication-assisted treatment of opioid dependence or addiction using controlled substances, in a private office or public sector clinic. Also, the office or clinic is not otherwise regulated by practitioners who are authorized to prescribe outpatient supplies of medications for the treatment of opioid addiction or prevention of relapse.
OBOT includes treatment with all controlled substance medications approved by the FDA for such treatment. OBOT does not include treatment that occurs in the following settings23:
A qualified APRN for medication-assisted treatment must have one of the following23:
Eight hours of continuing education in substance abuse and addiction during each renewal period is required.
A qualified ARNP may provide OBOT under the following circumstances23:
Consider screening for tuberculosis and sexually-transmitted diseases in patients with known risk factors. For other than the toxicology tests for drugs and alcohol, appropriate history, substance abuse history, and pregnancy test, the APRN may satisfy the assessment requirements by reviewing records from a physical examination and laboratory testing of the patient that was conducted within a reasonable time before the visit. If any part of the assessment cannot be completed before the initiation of OBOT, the advanced practice registered nurse shall document the reasons in the medical record.
A documented treatment plan should include all of the following23:
OBOT should be provided an acceptable treatment protocol for assessment, induction, stabilization, maintenance, and tapering. Acceptable protocols are any of the following23:
A different protocol can be used if a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider determines the optimal type and intensity of psychosocial treatment. The treatment shall, at a minimum, include a psychosocial needs assessment, supportive counseling, links to existing family supports, and referral to community services. The treatment shall include at least one of the following interventions23:
If the patient refuses the recommended plan, the APRN shall ensure that the OBOT treatment plan requires the patient to participate in a twelve-step program or appropriate self-help recovery program. Documentation of on-going participation is required. If the APRN refers the patient to another provider, the APRN's meaningful interactions with the provider must be documented.
The patient should be offered a prescription for a naloxone kit. Patient education includes the use of the kit, recognizing signs and symptoms of an overdose, and calling 911. If the patient refuses the prescription, the APRN shall provide the patient with information on where to obtain a kit without a prescription.
If the OBOT is using buprenorphine products, apply the Risk Evaluation and Mitigation Strategy for buprenorphine products, available at the FDA website at the following address: www.accessdata.fda.gov/scripts/cder/rems/index.cfm.
Buprenorphine without naloxone (buprenorphine mono-product) can only be prescribed in the following situations23:
Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative-hypnotics, carisoprodol, and tramadol, the APRN shall only co-prescribe these substances when it is medically necessary, and only if the following happens23,25:
During the induction phase, do not prescribe a dosage that exceeds FDA recommendations except for medically indicated circumstances, as documented. See the patient at least once per week.
During the stabilization phase, when using an oral formulation of buprenorphine, increase the daily dosage in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving.
During the first ninety days of treatment, prescribe no more than a two-week supply of the buprenorphine product containing naloxone. Starting with the 91st day of treatment and until the completion of twelve months of treatment, prescribe no more than a thirty-day supply.
Take steps to reduce the chances of buprenorphine diversion by using the lowest effective dose, appropriate frequency of office visits, pill counts, and checks of OARRS. Require urine drug screens, serum medication levels, or oral fluid testing at least twice per quarter for the first year of treatment and at least once per quarter after that.
When using an oral formulation of buprenorphine, document the rationale for prescribed doses exceeding sixteen milligrams of buprenorphine per day. Do not prescribe a dose of buprenorphine exceeding twenty-four milligrams per day.
Incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.
The APRN may treat a patient using the administration of extended-release, injectable, or implanted buprenorphine under the following circumstances23:
If using naltrexone to treat opioid use disorder, comply with the following additional requirements23:
Use oral naltrexone only for the treatment of patients who can be closely supervised and who are highly motivated. Comply with the FDA approved labeling for naltrexone hydrochloride tablets.
Encourage the patient to have a support person to assist with the administration and supervision of the medication. Require urine drug screens, serum medication levels or oral fluid testing at least every three months for the first year of treatment and at least every six months thereafter.23
Incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare or mental health services provider. Treat a patient with extended-release naltrexone for opioid dependence or concurrent opioid and alcohol use disorders. Consider treatment with extended-release naltrexone for patients who have issues with treatment adherence.
An APRN can personally furnish to a patient a drug or therapeutic device, only if the following requirements are met26 :
An APRN with prescriptive authority can furnish a sample drug if27:
An APRN with prescriptive authority can supply naloxone and a complete or partial supply of a drug to treat chlamydia, gonorrhea, or trichomoniasis.27
In 2011, the White House Office of National Drug Control Policy was introduced with the intent of addressing prescription drug abuse. It provided support to states to expand prescription drug monitoring programs, worked to eliminate “pill mills” and educated healthcare providers and patients.
Hospitals and pharmacies are essential players in assuring the safe use of controlled substances. The Food and Drug Administration (FDA) is responsible for assuring the safety of the drug supply in the United States. They require the pharmacy to confirm that prescribers and organizations they work with are licensed and registered with the FDA. Under the FDA, the hospital must investigate and handle any suspicious or known illegitimate prescriptions.
The Drug Enforcement Agency (DEA) regulates the distribution of controlled substances. The DEA is responsible for enforcing laws and regulations related to controlled substances. They also have the authority to bring about criminal or civil charges to individuals or organizations that are involved in illicit traffic of controlled substances.
The Environmental Protection Agency (EPA) helps ensures that there is proper disposal of pharmaceutical waste. This prevents pharmaceutical waste in the environment, such as the ground and drinking water. The EPA has regulations that the pharmacy must follow.28
Every legislator and government agency seems to be presenting their unique plan on how to combat the opioid epidemic. Below are some of the concepts that have either been already implemented or stand a good chance of being seen by healthcare professionals across the nation.
In a March 19, 2018, public address on the current opioid crisis, President Donald Trump outlined an initiative to confront the driving forces behind the opioid crisis. President Trump’s plan contains three core focus points, each with progressive actions under them29,30
The U.S. Department of Health and Human Services (HHS) has pushed forward with plans for a five-fold approach to containing the Opioid Crisis31
NIH, the National Institute of Health, through a branch agency of the massive HHS system, has already been meeting with academic researchers and the big pharmaceutical companies who bear a goodly portion of the blame for the current opioid flood pushing the crisis forward.31
The plans NIH is busy implementing include:
The Joint Commission (JC) recognizes that pain control is an important part of quality healthcare. They acknowledge that pain is considered the fifth vital sign and should be assessed with other vital signs. According to the JC, patients have the right to assessment and treatment of pain. Additional beliefs of the JC include:
Say what you will about the pharmaceutical industry’s actions relating to this generation’s opioid epidemic, some of the large corporations are stepping up with initiatives to slow the growth of addiction. Pharmacy chain CVS Caremark, for example, began implementing a filling restriction for new pain drug patients prescribed opioids, limiting them to a seven-day supply of drugs. Other drug dispensaries are considering coming on board with this self-limitation, and some legislative plans are advocating this throttled down introduction to opioids become the law of the land.31
The Center for Disease Control (CDC) and Prevention developed guidelines for prescribing opioids in chronic pain. It offers guidance to the clinician regarding safe and effective prescribing of opioids and assistance in the management of chronic pain. This guideline focuses on patients over the age of 18 who seen in the primary care setting. The guideline focuses on chronic pain that does not involve end-of-life care, active cancer treatment, or palliative care.
This guideline is meant to help primary care clinicians deal with the 11% of adult patients that deal with daily pain.32 It was developed because primary care clinicians reported insufficient training in opioid prescribing and concern regarding addiction. The guideline focuses on three main areas32:
It discusses the use of urine drug testing, the prescription drug monitoring program (PDMP), treatment of opioid use disorder, and precautions regarding co-prescriptions of benzodiazepines.
The first recommendation suggests that chronic pain should be managed primarily with nonpharmacologic therapies and nonopioid pharmacologic therapies.32 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.32
The second recommendation suggests that before initiating opioid therapy in chronic pain patients, it is essential to establish realistic goals for pain and function.32 Also, patient education given that opioid therapy would discontinue if risks of therapy are deemed more significant 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 severe risks.32 Research shows weak evidence that opioid therapy beyond six months results in clinically significant pain relief or clinically significant improvements in quality of life. 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.32 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. Also, 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.32 Situations, where opioids should be tapered or discontinued, include when opioids are not needed, side effects become too severe, or treatment goals not being met.
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.32
Key teaching points32:
Recommendation four suggests that when starting opiates for chronic pain, immediate-release opioids are recommended over longer-acting drugs. 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 drugs 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.32 Extended-release and long-acting opioids drugs should not be used on an as needed basis.
Certain drugs 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.32
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.32
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 challenging 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. Also, 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 carefully.
The pharmacodynamics of transdermal fentanyl is also complicated. A gradual increase in serum concentration can occur over the first 72 hours.32 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 drug 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.32 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.32 According to the CDC document, 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 for at least five half-lives before increasing the dosage has been recommended. Also, 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 should32:
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 six 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 drugs 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.32”
Recommendation number seven 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.32 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.
Specific 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 drugs.32These 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.32 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 eight suggests that risk factors for opioid-related harms should be assessed before starting therapy and during opioid therapy. Also, 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 65.32
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 essential to discuss a possible consequence of opioids during pregnancy.
Prescribing drugs, 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.32 This group of individuals is at higher risk for opioid use disorder and increased risk for drug overdose (especially in those with depression). 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. Also, 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 nine suggests that the clinician should review the PDMP database to determine previous/current opioid prescriptions as well as other drugs that may interact and place the patient at higher risk for overdose.32 The clinician should review this data at a minimum of every three months, but as often as every prescription is written.
Research is limited on the benefits of PDMPs. However, 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 adverse 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 ten 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 drugs as prescribed and that there are no illicit drugs in the patient’s system.32
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 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 outcomes32:
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 drugs 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 eleven 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.32
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 drug.
Other drugs 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 twelve recommends using an evidence-based treatment in those with opioid use disorder, which may include drug-assisted treatment (MAT) with behavioral therapy.
Points discussed under this recommendation include32:
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.
In 1970, section 812 of the Controlled Substance Act was enacted, which lists substances that are controlled. The list describes chemicals that may be classified as controlled substances. The Controlled Substance Act divides the drugs and other substances into five schedules, which is updated annually at www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm.
Schedule I controlled substances have no accepted medical use in the United States, have a high potential for abuse, and lack safety data. Substances in this class include heroin, marijuana, 3,4-methylenedioxymethamphetamine ("Ecstasy"), and lysergic acid diethylamide (LSD).
Schedule II and IIN substances may potentially be abused and may lead to severe physical or psychological dependence. Schedule II narcotics include oxycodone (OxyContin®, Percocet®), hydrocodone (Vicodin®, Zohydro ER®), fentanyl (Sublimaze®, Duragesic®), methadone (Dolophine®), hydromorphone (Dilaudid®), morphine, opium, and codeine. Examples of Schedule IIN stimulants include methylphenidate (Ritalin®) and amphetamine (Dexedrine®, Adderall®).30
Schedule III or IIIN substances have less abuse potential than those substances that are Schedule I or II. They are at high risk for psychological dependence and low to moderate risk of physical dependence. Examples of drugs in this class include buprenorphine (Suboxone®) and products that have less than 90 milligrams of codeine per dosage unit, such as Tylenol® with Codeine. Drugs that are considered Schedule IIIN include: anabolic steroids such as Depo-Testosterone and ketamine.
Schedule IV controlled substances have a lower potential for abuse when compared to Schedule III controlled substances. Examples of drugs in this class include benzodiazepines, midazolam (Versed®), modafinil (Provigil®), tramadol (Ultram®), and carisoprodol (Soma®).33
Schedule V controlled substances have a low abuse potential relative to Schedule IV substances. Examples of drugs in this class include cough preparations that contain less than 200 milligrams of codeine per 100 milliliters or per 100 grams such as Robitussin® AC, lacosamide (Vimpat®), and pregabalin (Lyrica®).33
The Controlled Substance Act regulates five classes of drugs: anabolic steroids, depressants, hallucinogens, narcotics, and stimulants. Each class has different properties and substances in each class typically produce similar effects. Most controlled substances alter mood, feeling, or thought due to their effect on the central nervous system. Drugs likely to produce euphoria are more likely to be abused, but drugs may be abused to aid in sleep, reduce pain, reduce anxiety, reduce depression, and improve energy.
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 programs, OARR, to confirm the patient’s report of prescription use. Also, it is important to contact past providers to obtain medical records.
Before controlled substances are prescribed, a history of illegal substance use, alcohol use, tobacco use, prescription drug use, family history of substance abuse and psychiatric disorders, history of sexual abuse, legal trouble history, behavioral problems, employment history, marital history, social network, and cultural background should be assessed. History of substance abuse does not prohibit treatment with opioids but may necessitate more intensive monitoring or referral to an addiction specialist.
Multiple tools to evaluate for opioid addiction risk are available. The Opioid Risk Tool is a tool that is used in primary care to screen adults for the risk of aberrant behaviors when they are prescribed opioids for chronic pain. It is a copyrighted tool, encompasses five questions, and takes about one minute to administer. It classifies a patient as low, moderate, or high risk for opioid abuse. Those who are at high risk have a higher likelihood of aberrant drug-related behavior.
This tool is not validated in individuals without pain. 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 at low, moderate, or high risk.
Educating clinicians has been the primary focus of the medical community over the last number of years. This has led to increased awareness and safer prescribing of controlled substances. Practice guidelines disseminated among the emergency providers in Ohio was linked to a 12% reduction in opioid prescriptions per month.27 This guideline included multiple positive steps, including assuring the clinician reviewed the prescription drug monitoring database, the patient was referred for further evaluation, reduced quantities of the drug was prescribed, and education was provided about the risks versus benefits of the opioid.
A comprehensive medical history is the first step in the workup of an individual experiencing chronic pain. Many healthcare providers believe that pain is the fifth vital sign. A comprehensive medical history should include an evaluation of the patient’s medical and surgical history and a review of the drug list.
The comprehensive medical history must include a detailed description of the pain. The pneumonic: OLD CARTS is sometimes used to evaluate pain.
Document the impact the pain is having on the patient’s quality of life. Ask:
Measuring the intensity of pain is often done on scales and are meant to compare the intensity of the patient’s pain at different points in time, not to compare one person’s pain to another. The use of pain scales helps the prescriber assess the effectiveness of pain treatment.
The best scales are brief, valid, require minimal training to use, and use both behavioral and descriptive measures of pain.34 A scale commonly used rates pain from 0 to 10. Another scale allows the patient to rate their pain as no pain, mild pain, moderate pain, severe pain, or unbearable pain. Other scales have the patient select the degree of pain on a pictorial scale with facial expressions. Pain maps are helpful in individuals who have a difficult time speaking. Pain maps have a front and rear view of the body on a piece of paper, and the patient marks the location of the pain and rates the severity of the pain.
The patient’s perception of the pain should be reviewed:
Psychological factors that contribute to the pain should also be assessed. Patients need to have reasonable expectations about the pain and its management.
All patients with chronic pain should have a complete physical examination. It is crucial to have a baseline physical examination, so ensuing evaluations will permit the healthcare team to establish progress in how well the pain is being managed.
Other key features that should be assessed before treatment include:
The physical examination should include:
Diagnostic testing is often part of the workup of painful conditions. It is essential to realize that an abnormal diagnostic test does not necessarily diagnose the source of the pain. Blood tests may be helpful in certain diseases that cause pain. For example, an elevated C-reactive protein or an elevated erythrocyte sedimentation rate is often present in individuals with polymyalgia rheumatica, infection, or rheumatoid arthritis.
Imaging can be useful in some cases of chronic pain. X-rays, computed tomography, and magnetic resonance imaging can help determine the cause of the pain. Remember, diagnostic testing needs to be interpreted carefully as some abnormalities may be incidental and not the source of the pain.
Caution should be used when evaluating patients as overuse of imaging, or other diagnostic modalities may lead to increased use of opioids, activity restriction, and increased fear.
An electromyogram (EMG) or a nerve condition study (NCS) assesses the cause of pain. The EMG measures the electrical activity of the muscle and can help find damaged muscle, nerves, or neuromuscular abnormalities such as herniated disc or myasthenia gravis. The NCS measures the capacity of the nerves to transmit electrical signals and assists in the diagnosis of multiple types of neuropathies.
Acute pain normally fades with healing, is related to tissue damage, and significantly alters a patient’s typical function. Acute pain is expected to resolve within days to weeks. Pain that continues 12 weeks is considered chronic. This guideline may not apply to acute pain resulting from exacerbations of underlying chronic conditions.
Assessment, documentation and Diagnosis of Patient Presenting with Pain For assessing patients presenting with acute pain includes6:
A specific diagnosis should be made to facilitate the use of an evidence-based approach to treatment. Develop and document a plan together with the patient that includes7:
The goal is to improve function to baseline as opposed to complete resolution of pain.
Examples of non-pharmacological therapy are6:
Non-opioid medications should be used with non-pharmacologic therapy. When initiating pharmacologic therapy, educate patients on the proper use of medication, the importance of maintaining other therapies and expectations for the duration, and degree of symptom improvement.
Treatment options, by the quality of pain6:
Reserve opioids for acute pain resulting from severe injuries or medical conditions, surgical procedures, or when non-opioid options are ineffective or contraindicated. Short-term opioids may be first-line therapy in specific circumstances, like immediately post-operative. Opioids should usually be used as adjuncts to additional therapies, rather than alone.6
Healthcare providers need to communicate with one another if the patient receives an opiate prescription from more than one provider.
Recommendations for the general use of opioids to manage acute pain6:
Reevaluate patients who receive opioid therapy for acute pain if opioid therapy exceeds 14 days and again at six weeks.
If pain persists, reevaluate and document the initial diagnosis and consider the following6:
Chronic pain affects approximately 76.2 million Americans. Pain is a common problem seen in primary care, with about 20% of outpatient visits being for pain issues.35 Chronic pain affects about one in two long-term care residents.34
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.36
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.37
Pain is defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.38”
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.38”
Chronic pain is defined as “pain that lasts beyond the usual duration of time that an insult or injury to the body needs to heal.38” 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.6
Opioids are indicated for pain conditions. An expert panel concluded that chronic opioid therapy might be effective for some individuals with chronic non-cancer pain that have been thoughtfully selected.38 When deciding to prescribe opioids, the risks versus benefits must be considered.
The use of high dose long-acting opioids is 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 the effect and side effects.39
A recent survey showed that individuals would go to extreme lengths to obtain specific prescription drugs. Opioids were the most commonly obtained drugs, followed by the sedative-hypnotics and amphetamines. Individuals who seek these drugs 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.37
Regular follow-up and documentation is essential and should occur at a minimum of every three months and more frequently in individuals who are at high risk for abuse or during periods of drug adjustment. Baseline evaluation of the nature and intensity of the pain and the underlying effects pain is having on a patient's physical and psychological function will help in assessing the effectiveness of the treatment.
When assessing the patient experiencing pain, the six A’s should be assessed: analgesia, addiction, activities of daily living, adherence, aberrant behaviors, and adverse effects. Part of the follow-up should include urine drug testing, which can be used to detect drug adherence, as well as illicit and non-prescription drug use. The prescriber should adequately document any interactions with patients, assessments, results of testing, and treatment plans.
Documentation should include the amount of pain relief experienced, as indicated by the patient’s improved ability to function physically or psychologically. It should include what goals are recommended (e.g., improved level of function and improved quality of life). It should also include the plan of care and methods to help patients meet their goals.
Treatment should not be continued if the patient is not making adequate progress toward their goals. In this case, modification of treatment should be considered.
Written treatment agreements, between prescribers and patients when controlled substances are used, help guide the conversation between patient and prescriber. It discusses expectations, the risks, and the monitoring that will occur to limit the complications of controlled substances (Table 3).
Prescription monitoring programs are available in 49 states. They provide an online database that lists all prescriptions of controlled substances dispensed for each patient by pharmacies. The prescriber should check the database before prescribing controlled substances. If a patient has an undisclosed prescription for controlled substances, it can be considered prescription drug misuse.
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 on reasons to terminate therapy before initially prescribing the drugs. This 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 drugs, 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 drug, the patient and the prescriber must agree. For patients who decide to continue treatment with another prescriber, the prescriber may consider maintaining the current dose for four weeks.
When appropriate, a tapering schedule should be implemented 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 made.
|Daily MED (mg)||Weaning Period (Days)|
|Drug Type||Generic Drug Name||Brand Name (Example)||Daily Dose||Weaning Period for BWC Orders (Based on Daily Dose)||Maximum Weaning Period (Days)|
|Short-Acting||Alprazolam||Xanax®||>4mg||90 days plus 30 day for every 1mg above 4mg|
|2-4 mg||30 days plus 30 days for every 1mg above 2 mg|
|</=1mg||No weaning period|
|Lorazepam||Ativan®||>8mg||90 days plus 30 days for every 1mg above 8mg|
|4-8mg||30 days plus 30 days for every 1mg above 4mg|
|</=2mg||No weaning period|
|Oxazepam||Serax®||>120mg||90 days plus 30 days for every 30mg above 120|
|60-120mg||30 days plus 30 days for every 30mg above 60mg|
|Diazepam||Valium®||>40mg||90 days plus 30 days for every 10mg above 40mg|
|20-40mg||30 days plus 30 days for every 10mg 20mg|
|No weaning period|
|Chlordiazepoxide||Librium®||>100mg||90 days plus 30 days for every 25mg above 100mg|
|50-100mg||30 days plus 30 days for every 25mg above 50mg|
|Clonazepam||Klonopin®||>4mg||90 days plus 30 days for every 1mg above 4mg|
|30 days plus 30 days for every 1mg above 2mg|
|>/=1mg||No weaning period|
|Tranxene®||>30mg||90 days plus30 days for every 7.5mg above 30mg|
|15-30mg||30 days plus 30 days for every 7.5mg above 15mg|
|</=7.5mg||No weaning period|
Individuals who have shown aberrant behavior should be offered 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 discharged from the practice.
The management of pain may include drugs, behavioral interventions, physical drugs, neuromodulation, medical interventions, or surgery. A multidisciplinary approach is typically used in the management of chronic pain.
Current treatments in the management of chronic pain result in approximately a 30% reduction in pain.40 One of the problems encountered is that general practitioners have limited training in the management of chronic pain.41 The use of a pain management specialist is often needed to manage pain properly.
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 function. Controlled substances are laced with risks, and the prescriber needs 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 patient.
Therapeutic goals should be established and documented 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.
The treatment plan should be established before initiating treatment. In this plan, the patient and the provider should discuss and document the benefits, risks, and alternatives before starting treatment. Also, the clinician needs to discuss how the patient will be monitored, including how the patient will be evaluated for potential misuse of the prescribed drug. The use of written documents is often included in the plan. This may include agreements, treatment plans, and informed consent. The clinician must document that decision making was implemented, including informed consent; goal setting was discussed, and a monitoring plan was defined.42
When high doses of opioid prescriptions are given, there is an increased risk of overdose death. Therefore, the clinician must discuss, document and limit the number of opioids prescribed. The CDC recommends that providers prescribed no more than 90 morphine milliequivalents per day.43
The World Health Organization (WHO) analgesic ladder was created for the management of cancer pain and published in the 1980s.44 Key points of the analgesic ladder include:
This approach is 80-90% effective.
Adjunctive drugs are used to enhance the analgesic effect, reduce side effects, and assist with co-existent symptoms. Different patients will respond distinctively to different treatments regarding efficacy and side effects. Trial and error are often used in the treatment of chronic pain.
When starting therapy, the dose should be initiated at a low dose and titrated to obtain pain control and minimize side effects. Tolerance often develops as a patient gets used to the drug.
Treatment is typically started with a short-acting drug, and the drug is then titrated upwards to control pain while side effects are monitored. After determining the dose of the drug required to provide adequate pain relief with minimal side effects, the drug can then be converted to a sustained release form and be administered once or twice a day. When a long-acting drug is used, a breakthrough drug can be given.
A periodic review and documentation of the patient’s pain and clinical status is essential to assure that opioids need to be continued or should be discontinued. Any change in the patient’s state of health, degree or nature of pain, mental health, and overall function should be noted. The clinician and patient should review the proper dosage and schedule of the drug. Decisions on the benefits of pain management should focus on previously decided upon goals. Positive response to treatment can include a reduction in pain, improvement in the quality of life, or improved function.
An important role of the practitioner is prescribing controlled substances. Controlled substances have inherent risks, so the prescriber needs 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 the patient.
Have an upper dosing threshold. The risk of accidental overdose increases with higher doses of opioids. Prescribers should generally avoid doses of morphine or morphine equivalents more than 90 - 200 mg/day.40
Use caution with certain drugs. For example, methadone should only be used by a prescriber who is exceptionally comfortable with the drug. Fentanyl is another drug 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. Patients at high risk should be monitored more closely, and opioids should not be given 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 should be done carefully. Constipation is likely, and a bowel regime should be prescribed when opioids are used.
When starting opioid therapy, it should be initially started as a therapeutic trial that may last from several weeks to several months. The decision to continue the therapy must be carefully considered based on the outcomes of the trial, such as progress toward meeting goals, side effects, changes in the underlying condition causing pain, and any concern for drug misuse and addiction.
The most significant risk of opioid use is respiratory arrest and death, and this risk is highest when therapy is started, or the dose is increased. Opioid-induced respiratory depression is manifested 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 this is noted, the family should call 911.
Opioids should not be used in those with respiratory depression. Titration must be done slowly, and when changing formulations, do not overestimate the converting dosage.
Opioid rotation – changing from one opioid regime to another to reduce adverse events and improve therapeutic outcomes - may be considered. Tolerance to one opioid can lessen the analgesic effects, and the use of a different opioid may result in an improved analgesic effect and fewer adverse effects.
When opioid rotation is done, it requires the prescriber to determine the approximate equianalgesic dose. This is the ratio used to get about the equivalent analgesic effect. When switching from one opioid to another, the dose should be reduced by 25 – 50% to prevent adverse effects. Multiple computer programs or applications for mobile devices are available to help with this conversion.
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.
To prevent prescription drug abuse, the prescriber needs to assure:
Patient risks should be assessed, and contraindications should be immediately identified. Contraindications to opioid treatment include those who have erratic follow up, suffer from current untreated addiction, or have poorly controlled mental illness.40
Informed consent provides written documentation regarding the benefits and risks of the therapy and discusses the legal responsibilities of both the patient and the prescriber. Informed consent improves adherence, improves the effectiveness of a treatment plan, reduces the risk of inadvertent drug misuse, lays out the potential adverse effects including side effects and addiction, discusses how refills will happen as well as the policy of early refills and lost prescriptions/drugs and discuss reasons for discontinuing therapy.
Not all patients on chronic opioid therapy need to have a referral, but some do. Consider a referral to psychology, psychiatry, or an addiction expert for those at high risk for or those who engage in aberrant drug-related behaviors. Those with a substance abuse disorder are also candidates for referral. A pain management consultation may be helpful for those on high dose opioids. Goals should also include limiting side effects and minimizing adverse drug events.
Non-steroidal anti-inflammatory drugs (NSAIDs) are laced with risks, and some patients are unable to tolerate NSAIDs due to side effects and pre-existing co-morbid conditions. The risks associated with NSAIDs is one reason many prescribers choose an opioid to manage pain. Opioid therapy is useful in the management of many chronic pain conditions, including cancer, osteoarthritis, low back pain, neuropathic pain, and postherpetic neuralgia.
In recent times, opioid therapy has fallen out of favor as a commonly prescribed drug. In the distant past, it was only used for severe acute pain and cancer pain. In the early 2000s, opioids were one of the most commonly prescribed drugs, but now only hydrocodone with acetaminophen falls in the top ten drugs that are prescribed.45
A position paper from the American Academy of Neurology suggested that there is evidence for good short-term pain relief with opioids, but no good evidence exists for continuation of pain relief or improved function for an extended time without sustaining serious risks of dependence, overdose, or addiction.46
When non-opioid therapy is ineffective, or there is severe nociceptive pain, opioid therapy is often used. In chronic back pain, opioids do not improve pain scores any more than non-opioid therapy.47 Opioid therapy is often used to manage neuropathic pain but is commonly thought to be the second line to antidepressants and anticonvulsants.
There are many known risk factors of opioid abuse, misuse, diversion, addiction, and overdoses.25 Evaluating these risk factors is an essential aspect in the evaluation of a patient. Factors that increase the risk of problematic opioid use include:
Opioid drugs are associated with multiple side effects, including constipation, nausea, vomiting, pruritus, abdominal cramping, sedation, and mental status changes. Multiple interventions are available to reduce or eliminate the side effects of opioids.
Constipation is a frequent issue for those who use opioids. Risk factors for constipation include older age, those with intra-abdominal pathology, and those who eat a low fiber diet. Patients on opiates should be encouraged to increase fiber intake, drink plenty of fluids, and exercise. Stool softeners (e.g., docusate sodium) and stimulants (e.g., bisacodyl) may be needed to manage constipation. An osmotic laxative such as polyethylene glycol or lactulose may also be considered and may be added to stools softeners/stimulants for resistant constipation.
Antiemetic drugs can help treat nausea. Antihistamines can relieve or lessen pruritus.
Opioids are associated with somnolence and other mental status changes. Patients do develop tolerance to these symptoms over weeks. Reducing the dose of opioids may lessen the mental status changes. An adjunctive drug may be added to the lower dose of opioid to help manage the pain. Rarely, the use of a stimulant can be used to manage sedation due to opioid use.
Respiratory depression may occur, but it is uncommon when the drug is used carefully. Starting with a low dose and slowly titrating the dose higher will reduce the risk of respiratory depression. Problems arise with rapid titration, the addition of another drug that may depress the respiratory drive (benzodiazepines, alcohol, or a barbiturate) or the patient overdoses. Sedation precedes respiratory depression, so when starting a patient on opioid therapy, the patient should be encouraged to take the first dose in the office to be monitored or in the presence of a responsible adult who can help monitor the patient.
The level of consciousness should be assessed at least every 30-60 minutes after the opioid is given. The next dose should be held, and the prescriber should be contacted immediately if a reduced level of consciousness occurs, hypoxia develops, or the respiratory rate is less than 10 per minute.
Drug interactions have the potential to lead to significant health concerns in those taking opioids. Many individuals with chronic pain have co-morbid conditions that necessitate the use of other drugs. A study showed that drug-to-drug interactions in those with chronic low back pain on long-term opioid analgesics had a prevalence of 27%.25
Drug-to-drug interactions are variable among products. Drugs that depress the central nervous system, such as alcohol, benzodiazepines, and tricyclic antidepressants, may potentiate the respiratory depression and sedative effects of opioids. Some extended-release formulations of opioids may rapidly release the opioids when given with alcohol. Methadone and buprenorphine may prolong the QT interval.
Many drugs can affect various cytochrome P450 enzymes. Codeine, oxycodone, hydrocodone, and tramadol levels may be increased when given with selective serotonin reuptake inhibitors (SSRIs), protease inhibitors, diltiazem, verapamil, diazepam, clarithromycin, fluoroquinolones, and diphenhydramine. Levels may be decreased with carbamazepine and phenytoin. Fentanyl levels may be increased by SSRIs, protease inhibitors, diltiazem, verapamil, diazepam, and clarithromycin. Some opioids used with anticholinergic drugs may increase the risk of constipation and urinary retention.
Grapefruit juice has the potential to increase levels of multiple opioids such as fentanyl, codeine, hydrocodone, and methadone. Ginkgo Biloba, Valerian Root, and St. John’s Wort have the potential to reduce levels of multiple opioids. Some individuals have an allelic variant in CYP-2D6, making them inefficient at converting codeine to its active metabolite morphine, thus resulting in a less analgesic effect to codeine.
Patient education is essential as it will reduce the risks associated with these drugs and result in improved pain management. Patients need education in the safe use, storage, and disposal of opioid drugs. 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 an impaired respiratory function.
Drugs 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. Drugs that are altered for administration also increase the risk of overdose. Snorting, injecting, inhaling, chewing, or dissolving drugs 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. Overdoses also occur when the drug is taken by someone it was not prescribed for, especially children. Therefore, safe storage and disposal are critical.
Information on abuse should be taught to the patient. Many patients, who end up abusing opioid drugs, usually got a valid initial prescription.49
Patients should also be taught about misuse. Many patients will misuse drugs because they are seeking to improve function, have uncontrolled pain, or are using them to manage stress or mental disease. Aberrant behavior may be seen in those who are undertreated for pain. In the absence of addiction, these behaviors cease when pain is adequately controlled.
Patients should also be taught that drug diversion will not be tolerated. It will result in immediate termination of the prescription with a 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 a 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:
All benzodiazepines are schedule IV controlled substances. As controlled substances, all benzodiazepines have the potential for abuse, addiction, and diversion. It is not safe to drive, operate machinery, or perform other hazardous tasks while taking a benzodiazepine. Alcohol may potentiate these effects. Patients who are co-prescribed benzodiazepines and opioids are at higher risk of overdose.50
Benzodiazepine should be prescribed for a short course of treatment, no more than two to four weeks. Expectations of clinical benefits must be clear. Do not escalate the dosage without a clear clinical benefit.50
|Generic Name||Brand Name||Common Uses|
|alprazolam||Niravam®, Xanax®, Xanax XR®||anxiety, panic disorders|
|chlordiazepoxide||Librax||anxiety, alcohol withdrawal|
|clobazam||Onfi®||Lennox-Gastaut syndrome, adjunct (seizures)|
|clonazepam||Klonopin®||seizure disorder, panic disorder, neuralgia (nerve pain)|
|clorazepate||Tranxene T-Tab®||anxiety, alcohol withdrawal, partial seizures|
|diazepam||Valium®||anxiety, sedation, alcohol withdrawal, muscle spasm, seizure disorders|
|estazolam||ProSom®||insomnia (short-term use)|
|flurazepam||Dalmane®||insomnia (short-term use)|
|lorazepam||Ativan®||anxiety, insomnia (short-term use), seizures, sedation|
|midazolam||Versed®||sedation, preoperative; general anesthesia induction; seizures|
|oxazepam||Serax®||anxiety, alcohol withdrawal|
|temazepam||Restoril®||insomnia (short-term use)|
|triazolam||Halcion®||insomnia (short-term use)|
Side effects of benzodiazepines57:
Stop the drug if side effects are not tolerable. Benzodiazepine should be tapered, not abruptly stopped. Withdrawal symptoms may occur with abrupt discontinuation. These symptoms may include convulsions, cramps, insomnia, sweating, tremors, and vomiting.
Some people develop a paradoxical reaction to benzodiazepines. This is the opposite reaction to what would be expected, including57:
Multiple ethical issues surround pain and its management. Healthcare providers should attempt to minimize pain and suffering while maintaining a balance between adequate pain management and minimizing harm from the treatment of pain. The healthcare provider has to do no harm and must guard against overmedicating the patient. The healthcare provider has to be aware of the negative consequences of pharmacotherapy, including physical dependence, tolerance, and abuse.
Some think that pain management is a human right. Medical organizations do not consider pain management an explicit duty of the prescriber, except for a part of proper medical care. If pain is considered a human right, it will force the government in the middle of the patient-physician relationship.
Access to healthcare is not equitable and brings up questions of justice. Specific populations are at a disadvantage when it comes to access to pain management. Individuals who do not have insurance may lack the means to receiving medical care and pain management. Individuals who are more likely to have access to care include those who are older, those who live in a suburb, those who have insurance, a college degree or have a high income. Those with less access to care include those with financial problems and those of Hispanic ethnicity.
Ethical issues surround the end of life care. The management of pain at the end of life is a moral duty for the provider caring for a terminal patient. While opioid use may suppress respiration and may even hasten death, the treatment of pain is an important part of care for intractable pain as death nears. The goal of giving pain management is to relieve suffering, not accelerate death. The use of palliative sedation may be considered to manage refractory pain at the end of life.
Drug diversion is the use of legal drugs for illegal purposes or the use of prescription drugs for recreational purposes and is a key concern in the use of controlled substances. Removing prescription drugs from legitimate channels is drug diversion and can occur in many ways. Diversion may occur on any level from the patient, prescriber, other healthcare providers, or pharmacist.
Slightly more than 40% of patients who abuse prescription pain drugs got it from a relative or friend without having to pay for the drugs.57 36.4% of abusers of prescription drugs got them through their healthcare provider either by prescription or by stealing.26 Ten percent stole drugs from a relative or friend.57
Methods that patients use to obtain drugs for illicit use include influencing or forcing prescribers to write the prescription, changing the prescription, getting multiple prescriptions for the same drug, or writing their prescription.
Some patients get drugs through doctor shopping, but the majority of patients receive their drugs through one doctor.57 Fraudulent prescriptions are another method of obtaining prescription drugs. This can occur in many ways. Methods include altering an already written prescription, stealing a prescription pad, or creating falsified computer prescriptions.
The prescriber can be engaged in drug trafficking or selling drugs for money or sexual favors. Healthcare providers who are abusing drugs may be irritable, defensive, or isolated. Other signs or symptoms suggestive of prescription drug abuse or misuse problem include frequent bathroom trips, coming into the office when not scheduled, working overtime, multiple drug errors, incorrect counts of controlled substances, poor judgment, neglect of patients, long sleeves in warm weather, and strange behavior.
The pharmacist may be the source of diversion. The pharmacist may dispense drugs based on incomplete information on the prescription, not catch obvious fraudulent attempts by the patient, or not check the accuracy of the physician’s DEA number.
Other methods of diversion include theft, losses during transportation, or internet pharmacies.
Techniques to reduce drug diversion are:
It is very difficult to deal with the patient who has a chief complaint of severe pain and wants opioid therapy. It is essential to understand the motivations of patients who seek drugs. Do the patients have pain, or are they looking for controlled substances for non-medical purposes?
Prescribers often want to trust their patients, or they do not want to confront the patient about his/her drug habits. Prescribers want their patients to be happy. Also, time is often a factor, and taking time to assess the patient, including their physical, psychological, and social state, takes much more time than just writing a prescription.
Good communication is essential to help deal with drug-seeking patients. Prescribers must be empathetic and acknowledge that the patient is suffering. Providers must maintain confidentiality and privacy to ensure that the patient is comfortable.
Communicating with the patient is most successful when the provider confidently presents information, question patients using open-ended questions to promote honesty and documents well, including the patient’s assessment and any agreements.
Having firm office policies is essential in the management of patients being prescribed opioids. Generally, prescribing opioids at the first visit should be avoided. The policies should include the frequency and timing of refills. It should be documented that patients are aware of these policies.
The use of a pain management contract should be utilized. Providing the patient with an understanding of how long the drug will be prescribed should be done. This is particularly true for an acute injury or a surgical procedure where pain typically gets better.
Prescribers must be aware of problematic behaviors. Behaviors highly suggestive of a substance abuse disorder include legal problems, using drugs not as prescribed, getting drugs through nonmedical channels, reduced function at work or home, and concurrent abuse of other drugs or alcohol. Behaviors that may suggest addiction include requesting specific drugs, increased dosage need, missed appointments, and requesting more drugs.
Chris T. is a 58-year-old widowed male. He presents to the Emergency Department upon being found on the couch by his son in an unresponsive state. His son was able to wake him, but his speech was incoherent.
Mr. T’s past medical history is positive for hypertension, hyperlipidemia, Stage III CKD, anxiety/depression, and osteoarthritis of his knees and low back pain. He is currently on daily aspirin, amlodipine, citalopram, atorvastatin, and hydrocodone/acetaminophen.
Mr. T. has been taking the hydrocodone /acetaminophen 1 - 2 times a day for over three years. About three months ago, he presented to the Emergency Department with a similar presentation and was discharged after six hours with no definitive diagnosis but was given a prescription for more hydrocodone /acetaminophen for pain.
Mr. T’s son reports that Mr. T. has not been coming to as many social events over the last month because his pain level has increased. The Emergency Department nurse practitioner notes that the vital signs (including oxygen saturation) are stable, but the patient is somnolent. He does wake when stimulated and answers only yes/no questions. His blood work, including liver/kidney function tests, glucose, and metabolic profile, are high, except he is shown to have Stage III CKD (but at baseline for the patient). His drug screen is positive for opioids.
Mr. T. reports that his pain has been worse and that he has been taking more than his prescribed dose of oxycodone/acetaminophen.
The patient’s symptoms are thought to be caused by sedation due to the opioids and his impaired kidney function, leading to a buildup of metabolites. He is discharged from the hospital and is seen by his primary care provider the next day.
His primary care provider recognizes that his pain is poorly controlled, leading to him overdosing on opioids. Due to his CKD, NSAIDs are not appropriate options. Managing his depression/anxiety, along with closely monitored opioid therapy, with extensive counseling on safe use, is implemented.
The patient is given a treatment plan that includes:
The patient returns to his primary care provider after two weeks. He reports that he has started therapy is sleeping better. He is only using one hydrocodone/acetaminophen a day – typically after exercise. After four more weeks, he reports that he is using about 3 - 4 doses of hydrocodone/acetaminophen per week, feels less anxious and depressed, and is sleeping “just fine.” After another four weeks, he says he no longer uses his opioid drug, has gotten a part-time job, and is regularly exercising.
Sara is a 42-year-old physical therapy assistant with chronic back pain due to a herniated disc and spinal stenosis, which was first diagnosed after lifting a patient four years ago. She currently rates the severity of her back pain as an 8/10 and has been unable to work due to her pain. The pain is described as dull and constant, with occasional sharp exacerbation in the low back with the pain increasing with bending, prolonged standing, and walking. The patient denies any loss or change of bowel/bladder control, history of IV drug use, recent infection, progressive neurological complaints, night pain, night sweats, weight loss, or fever. The pain occasionally radiates into the right buttock. The patient can do all of her ADLs but does report poor sleep at night.
She has no significant past medical or surgical history.
She has had multiple rounds of physical therapy, chiropractic treatment, and numerous drugs. She tried to control the back pain on acetaminophen, naproxen, ibuprofen, the lidocaine patch, and topical NSAIDs without relief. The patient experienced a possible seizure while on tramadol. Epidural injections did not help. Surgery was discussed, but the patient refused this option.
Sara is single, and now that she is not working, she has limited financial means. She reports having a problem with drinking in her twenties but has not had a drink in three years. She currently smokes. She denies any history of substance abuse, and there is no family history of alcohol or substance abuse.
Physical examination showed a patient with a slow, deliberate gait, a limited range of motion in the spine with no obvious deformity, swelling, or erythema. There is mild tenderness on the right side of the spine from the area of L4 to S1, as well as tenderness in the right sacroiliac joint. Normal reflexes, normal sensation, ordinary strength, and no atrophy is noted in the lower extremities. The straight leg raise test is normal.
An MRI was done one year ago that was significant for a herniated disc at the L5/S1 level and mild spinal stenosis.
The Opioid Risk Tool was administered, and it was determined that the patient is at low risk for opioid abuse. She signed a written opioid treatment agreement that outlines the conditions of opioid therapy. The state prescription drug monitoring program was queried and showed no suspicious activity.
The patient is prescribed hydrocodone/acetaminophen 5 mg/500 mg; two tablets every six hours as needed (56 tablets) for one week.
Five days later, she calls for an early refill and reports that the drug is not helping her pain, and she just lies around all day.
She comes back into the office for re-evaluation and reports she needed to take more pain drugs than prescribed. It was reviewed with the patient that she violated the opioid agreement. A urine sample was obtained that showed no illicit substances or drugs that would not be expected in the urine. The prescription drug monitoring program did not show that she got any other prescriptions in the interim.
She was referred to a psychiatrist and a pain specialist. She was agreeable to both. She was able to get into the psychiatrist within one week, but the pain specialist appointment was three weeks out. The patient saw the psychiatrist, and he diagnosed the patient with depression and started her on duloxetine (which may also help with pain). The psychiatrist was unable to make an assessment related to opioid abuse.
With the help of the pain specialist, oxymorphone ER 5 mg was ordered every 12 hours. The patient was told to follow-up in one week to assess effectiveness. After one week, the patient reports she is more functional but still in a lot of pain. The dose of oxymorphone ER was increased to 10 mg every 12 hours. After one more week, she was given oxymorphone IR 5 mg to be used one hour before exercise. This allowed the patient not only to function well but begin participating in an exercise program. The patient was ordered a bowel stimulant (Senna) with a stool softener (Colace) to prevent constipation.
The patient is prescribed fourteen pills oxymorphone ER 10 mg (to be taken twice a day) and seven pills of oxymorphone IR 5 mg (to be taken once a day before exercise) once a week.
The use of controlled substances is laced with risks for the prescriber and the patient. Abuse, misuse, drug diversion, and overdose are all potential complications of opioid use.
Prescribers must be knowledgeable in pain assessment, knowledge of addiction, and the appropriate management of pain. Multiple techniques are important to implement to reduce the risks associated with opioid therapy, including informed consent, controlled substance agreements, screening for drug abuse, patient education, teaching patients about proper storage and disposal of drugs and monitoring patients using controlled substance monitoring programs.