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Opioid use and abuse for acute and chronic pain is a significant problem in the United States as well as Kentucky.[1][2][3] The rate of overdose-related to the use of illicit opioids has drastically increased in the United States and in Kentucky. Over one-quarter of United States citizens suffer from chronic pain.[4] It is among the most common complaints seen in an outpatient clinic and in the emergency department. The failure to manage acute and chronic pain appropriately, as well as the possible complication of opioid dependence related to treatment, can result in significant morbidity and mortality. One in five patient complaints in an outpatient clinic is related to pain, with over half of all patients seeing their primary care provider for one pain complaint or another. It is paramount that providers have a firm grasp on the management of patients with chronic pain. As a country, the United States spends well over 100 billion dollars a year on healthcare costs related to pain management and opioid dependence.[5] Pain-related expenses exceed those for the costs of cancer, diabetes, and heart disease combined.[6] How a patient's chronic pain gets managed can have profound and long-lasting effects on a patient's quality of life. The International Association for the Study of Pain defines chronic pain as any pain lasting longer than three months.[7] There are multiple sources of chronic pain. Combination therapy for pain includes both pharmacological therapies and nonpharmacological treatment options. There is a more significant reduction in pain with combination therapy compared to a single treatment alone. Escalation of pharmacological therapy is in a stepwise approach. Comorbid depression and anxiety are widespread in patients with chronic pain. Patients with chronic pain are also at increased risk for suicide. Chronic pain can impact every facet of a patient's life. Thus learning to diagnose and appropriately manage patients experiencing chronic pain is critical.[8]

In the past, the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders defined "addiction," "substance abuse," and "substance dependence" separately. The result was provider confusion contributed to the under-treatment of pain. Over time, the manual has eliminated these terms and now uses "substance use disorder," ranging from mild to severe. Unfortunately, there are numerous challenges in pain management, such as both underprescribing and overprescribing opioids. The concerns are particularly prominent in patients with chronic pain and have resulted in patients suffering from inadequately treated pain while at the same time there has been a development of concomitant opioid abuse, addiction, diversion, and overdose. As a result, providers are often negatively influenced and fail to deliver appropriate, effective, and safe opioids to patients with chronic pain. Providers have, in the past, been poorly trained and ill-informed in their opioid prescribing. To make the challenges even worse, chronic pain patients often develop opioid tolerance, significant psychological, behavioral, and emotional problems, including anxiety and depression related to under or overprescribing opioids. Clinicians that prescribe opioids face challenges that involve medical negligence in either failure to provide adequate pain control or risk of licensure or even criminal charges if it is perceived they are involved in drug diversion or misuse. All providers that prescribe opioids need additional education and training to provide the best patient outcomes and avoid the social and legal entanglements associated with over and under-prescribing opioids. Provider Opioid Knowledge Deficit There are substantial knowledge gaps around appropriate and inappropriate opioid prescribing, including deficits in understanding current research, legislation, and appropriate prescribing practices. Providers often have knowledge deficits that include: Understanding of addiction At-risk opioid addiction populations Prescription vs. non-prescription opioid addiction The belief that addiction and dependence on opioids is synonymous The belief that opioid addiction is a psychological problem instead related to a chronic painful disease

There are substantial knowledge gaps around appropriate and inappropriate opioid prescribing, including deficits in understanding current research, legislation, and appropriate prescribing practices. Providers often have knowledge deficits that include: Understanding of addiction At-risk opioid addiction populations Prescription vs. non-prescription opioid addiction The belief that addiction and dependence on opioids is synonymous The belief that opioid addiction is a psychological problem instead related to a chronic painful disease With a long history of misunderstanding, poor society, provider education, and inconsistent laws, the prescription of opioids has resulted in significant societal challenges that will only resolve with significant education and training. Definitions  [9] [10] [11] Abuse - Maladaptive pattern of opioid use for a purpose other than pain relief Addiction - Compulsive pursuit of a chemical substance to find relief or reward Dependence - Use of a drug that causes a withdrawal syndrome with cessation or reduction in the amount administered Diversion - Transfering a controlled substance from an authorized person's use to an unauthorized person's use for distribution or possession Misuse - Use of a medication in a manner different than how it was prescribed Pseudo-addiction - Aberrant drug-seeking behavior similar to opioid use disorder driven by a need for relief of pain, resolves with pain control Tolerance - Adaption to the effect of a drug

Causes of Pain Most patients who suffer from chronic pain complain of more than one type of pain.[12] For example, a patient with chronic back pain may also have fibromyalgia. A significant percentage of patients suffer from major depressive and generalized anxiety disorder. Over 67% of patients with chronic pain suffer from a comorbid psychiatric disorder.[13] There are multiple categories and etiologies of types of pain, which include neuropathic, nociceptive, musculoskeletal, inflammatory, psychogenic, and mechanical.[8][14] Neuropathic Pain Peripheral neuropathic pain, as in the case of post-herpetic neuralgia or diabetic neuropathy Central neuropathic pain - cerebral vascular accident sequella Nociceptive Pain Pain due to actual tissue injuries such as burns, bruises, sprains, or fractures. Musculoskeletal Pain Back pain Myofascial pain Inflammatory Pain Autoimmune disorders (rheumatoid arthritis) Infection Psychogenic Pain Pain caused by psychological factors such as headaches or abdominal pain caused by emotional, psychological, or behavioral factors Mechanical Pain Expanding malignancy Causes of Opioid Abuse and Associated Morbidity and Mortality Unfortunately, the cure for pain is associated with morbidity, mortality, and abuse of opioid therapy often used to alleviate the pain. Causes of opioid abuse include medical, social, and economic problems. Medical and Social Twenty years ago a national shift occurred where clinicians were encouraged to treat pain more aggressively. Pain was considered to be the 5th vital sign and clinicians that undertreated noncancer pain potentially incurred liability, patient complaints, and licensing board complaints. At the same time oxycodone was introduced and touted to have low addiction potential. Further, patients and clinicians concluded that it was better and safer to take prescription opioids, rather than street drugs. The end result was more than a decade of growth in prescription opioid use.[15][16] Economic Opioid use has increased as a result of direct marketing to consumers; promotion to physicians and pharmacists from sales forces; and illicit production and distribution of opioids. Due to the opportunity for enormous profits, "pill mills" developed where unscrupulous providers provided prescriptions for opioids that required little or no documentation. As these sources have gradually diminished, heroin use has made a resurgence.[17][18][19]

Opioid use has increased as a result of direct marketing to consumers; promotion to physicians and pharmacists from sales forces; and illicit production and distribution of opioids. Due to the opportunity for enormous profits, "pill mills" developed where unscrupulous providers provided prescriptions for opioids that required little or no documentation. As these sources have gradually diminished, heroin use has made a resurgence.[17][18][19] Opioid Manufacturer Role Individuals and governments, including federal, state, and local municipalities, have successfully sued opioid manufacturers for their role in promoting the use of opioids. Purdue Pharma specifically has been found liable for the promotion of its sustained-release form of oxycodone.[20] Prescribers Prescribers who prescribe for chronic noncancer pain, exceeding practice guidelines, higher than normal doses, long-acting formulations, large volume prescriptions with limited follow-up, and using methadone for pain relief have increased opioid abuse and associated morbidity and mortality. Dispensers Unfortunately, some prescribers challenge pharmacists who question prescriptions that seem unreasonable. Pharmacists can use noninvasive means such as checking state opioid use databases and then contact prescribers with patients that are concerning. Interprofessional collaboration, often mandated by states, encourages optional and safe patient care.[21][22]

Opioids are the most used therapeutic agent for chronic pain and are derived synthetically from generally unrelated compounds. Opiates are derived from the liquid of the opium poppy either by direct refinement or by relatively minor chemical modifications. Both opioids and opiates act on three major classes of opioid receptors: mu, kappa, delta, and several minor classes of opioid receptors like nociceptin and zeta. Simplifying significantly, the mu receptors are thought to provide analgesia, respiratory suppression, bradycardia, physical dependence, gastrointestinal dysmotility, and euphoria. The kappa agonism can yield hallucinations, miosis, and dysphoria. The delta receptor likely has pain control and mood modulation effects, but some have suggested that mu agonism is necessary for the delta receptor to function strongly for analgesia.[26][27] The nociceptin receptor modulates brain dopamine levels and has clinical effects like analgesia and anxiolysis. The zeta receptor, also known as the opioid growth factor receptor, can modulate certain types of cell proliferation, such as skin growths, and are not thought to have many functions in modulating pain or emotion.[28][29] In the past, providers in the United States rarely prescribed opioids for any condition except chronic cancer pain. This approach began to change in the 1990s.  Dr. James Campbell addressed the American Pain Society (now bankrupt) in 1995 and urged healthcare providers to treat pain as the fifth vital sign.[30] The prescription of opioids for treating all chronic pain conditions has grown to the point that opioid sales have reached over 7 billion dollars. The United States currently consumes more than 80% of all opioids produced worldwide. With increased use, concomitant problems have developed, and the number of individuals abusing opioid analgesics has increased dramatically.[31][32] Kentucky

In the past, providers in the United States rarely prescribed opioids for any condition except chronic cancer pain. This approach began to change in the 1990s.  Dr. James Campbell addressed the American Pain Society (now bankrupt) in 1995 and urged healthcare providers to treat pain as the fifth vital sign.[30] The prescription of opioids for treating all chronic pain conditions has grown to the point that opioid sales have reached over 7 billion dollars. The United States currently consumes more than 80% of all opioids produced worldwide. With increased use, concomitant problems have developed, and the number of individuals abusing opioid analgesics has increased dramatically.[31][32] Kentucky Kentucky has been substantially affected by the diversion of prescription drugs, particularly hydrocodone and oxycodone. Hydrocodone and oxycodone are the most abused prescription drugs in Kentucky. With the education of providers on inappropriate prescribing of opioids and a slowing of diversion, individuals dependent on opioids have unfortunately shifted to the use of heroin and fentanyl. The death rate of overdose death due to prescription drugs has decreased while overdose deaths to non-prescription opioids have climbed rapidly. According to the Kentucky Office of Drug Control Policy: Approximately 2,000 die each year due to overdose Kentucky is in the top 10 states with opioid-related overdose deaths and near the top with a very high opioid overuse problem Opioids are prescribed at an alarmingly high rate There is a surge in the use of methamphetamine, heroin, and other street opioids Fentanyl and carfentanil abuse is up substantially, with fentanyl responsible for almost half of the overdose deaths Total prescription opiate usage is down with changes in controlled substance prescribing laws while drugs of abuse usage are up

History History should include the onset of pain, description, mechanism of injury if applicable, location, radiation of pain, quality, severity, factors contributing to relief or worsening of the pain, frequency of the pain, and any breakthrough pain. A verbal numeric rating scale (VNRS) or number scale for pain is a common measure to determine the severity of pain, numbered from 0 to 10. This tool is commonly used for pain intensity. Furthermore, associated symptoms should be assessed, such as muscle spasms or aches, temperature changes, restrictions to range of motion, morning stiffness, weakness, changes in muscle strength, changes in sensation, and hair, skin, or nail changes. In addition to the patient's symptoms, the significance of the impact of the pain in day-to-day function should be discussed, and a review of daily living activities. It is important to understand how chronic pain affects the patient’s quality of life. Is pain impacting relationships or hobbies? Does the patient find themselves becoming depressed? Is the patient able to sleep throughout the night or exercise regularly? Can the patient go to work without limitations? Are activities of daily living affected, such as toileting, dressing, bathing, walking, or eating limited or restricted? Older adults are a specific population that often identifies as suffering from chronic pain. The self-reporting of pain can be difficult in this population. Self-reporting of pain is essential for the identification and treatment of pain, while the inability to describe or communicate pain leads to undertreatment. Often elderly patients describe pain differently than the average population complicating diagnosis.[38][23] Instead of pain, an elderly patient may complain of soreness or discomfort.[39] There are multiple acronyms used to obtain the history of a patient's pain. Some of the most commonly used abbreviations are "COLDERAS" and "OLDCARTS. These acronyms summarize the character, onset, location, duration exacerbating symptoms, relieving symptoms, radiation of pain, associated symptoms, and severity of illness.  "PQRST" stands for provocation or palliation, quality, radiation or region, severity, and timing.[40]

There are multiple acronyms used to obtain the history of a patient's pain. Some of the most commonly used abbreviations are "COLDERAS" and "OLDCARTS. These acronyms summarize the character, onset, location, duration exacerbating symptoms, relieving symptoms, radiation of pain, associated symptoms, and severity of illness.  "PQRST" stands for provocation or palliation, quality, radiation or region, severity, and timing.[40] A multidimensional assessment of a patient's pain and the severity of their pain can be completed. A Pain, Enjoyment, General Activity (PEG) tool can aid the multidimensional assessment of patients in pain.[41] The PEG score focuses on function and quality of life. A chronic pain patient who experiences daily 7/10 pain is treated with both pharmacological and nonpharmacological therapies. Following treatment, their pain is 5/10. A few points might not seem like a significant difference, but if their enjoyment and quality of life and function are improving, treatment may have had a profound impact on the patient's life. The PEG tool is scored 0 to 10 for each category. The higher the score, the worse the function and uncontrolled pain. The Four-item Patient Health Questionnaire or PHQ-4 is a combination of the PHQ9 and GAD7 assessment tools used to evaluate depression and anxiety, respectively.[42] The PHQ-4 should be used as a screening tool for all cases of chronic pain. If the score of the PHQ-4 is more significant than five, then a full GAD-7, PHQ-9, and the Primary Care PTSD screening tools are recommended.[43] The Defense and Veterans Pain Rating Scale (DVRPS) is a five-item tool with a 0 to 10 out pain scale, as well as an assessment of the impact of pain on sleep, mood, stress, and activity levels.[44] In children's self-reporting, behavioral observation scales are used to assess pain.[45] Age-based rating scales of pain can be used. Visual analogs are also often implemented. Typically visual analogs are done with pictures of faces in various degrees of distress.  By adolescence, children usually can rate their pain on a numerical scale, similar to adults.[46] The Pediatric Pain Questionnaire and the Adolescent and Pediatric Pain Tool are used to assess the location of a patient's pain as well. The patient is asked to draw on the body map where they feel pain.[47] The ideal age for these tools is age 10 years.

In children's self-reporting, behavioral observation scales are used to assess pain.[45] Age-based rating scales of pain can be used. Visual analogs are also often implemented. Typically visual analogs are done with pictures of faces in various degrees of distress.  By adolescence, children usually can rate their pain on a numerical scale, similar to adults.[46] The Pediatric Pain Questionnaire and the Adolescent and Pediatric Pain Tool are used to assess the location of a patient's pain as well. The patient is asked to draw on the body map where they feel pain.[47] The ideal age for these tools is age 10 years. Observational pain assessment tools are used in populations who cannot self-report. The facial expression, fussiness, distractibility, ability to be consoled, verbal responsiveness, and motor control are observational findings used in such an assessment tool. Observational pain assessment in infants or young children can use the (r-FLACC) tool.[45][48] The tool is an acronym for Revised Face, Legs, Activity, Cry, Consolability.[49][50] Multiple other validated tools can be used, the one that is better than another is the NAPI tool. However, multiple tools have been used and are validated.[51][52][53][48] Nonverbal children with neurologic impairment (NI) is a challenging population to assess pain. Caregivers are often needed to help determine changes in the patient's behavior. Grimacing, moaning, increased muscle tone, crying, arching, atypical behavior such as aggressive behavior are a few symptoms to monitor in this population. Nonverbal children with NI include the Revised Face, Legs, Activity, Cry, Consolability (r-FLACC) scale, and the Individualized Numeric Rating Scale (INRS). The assessment adds specific behavior for atypical presentations.[49][52] The Brief Pain Inventory (BPI) can be used to assess patients' beliefs on pain and the impact of pain on their lives.[54][55] Separately, the McGill Pain Questionnaire (SF-MPQ-2) includes a drawing for the location of pain on the human body, a questionnaire regarding previous pain medication use, and past experiences with pain.[56] Neuropathic pain is assessable using the Neuropathic Pain Scale to follow responses to therapy. Physical A detailed physical, including musculoskeletal, neurologic, and psychiatric exam, should be completed, as well as a focused examination of the area of pain.

Chronic Pain Assessment Standard blood work and imaging are not indicated for chronic pain, but the clinician can order it when specific causes of pain are suspected. This can be on a case-by-case basis. In some cases, urine toxicology is ordered to monitor compliance and to exclude the use of nonprescription drugs. Psychiatric disorders can amplify pain signaling making symptoms of pain worse.[57] Furthermore, comorbid psychiatric disorders, such as major depressive disorder, can significantly delay the diagnosis of pain disorders.[58] Major depressive disorder and generalized anxiety disorder are the most common comorbid conditions related to chronic pain. There are twice as many prescriptions for opioids prescribed each year to patients with underlying pain and a comorbid psychiatric disorder compared to patients without such comorbidity.[39] Intuitively, this makes sense. For example, a patient suffering from depression often complains of fatigue, sleep changes, loss of appetite, and decreased activity. These symptoms can make their pain worse over time. It is also crucial to realize patients with chronic pain are at an increased risk for suicide and suicidal ideation.[24][25] Simultaneously screening for depression is recommended for patients with chronic pain. The Minnesota Multiphasic Personality Inventory-II (MMPI-2) or Beck's Depression Scale are the two most commonly used tools. The MMPI-2 has been used more frequently for patients with chronic pain.[59][60] Addiction Risk Assessment  [31] [61] [62] The clinician should consider information from the history and physical, family members, the state prescription monitoring program, and screening tools to assess the risk of developing an untoward behavioral response to opioids. Patients can be stratified to three risk levels: Low-risk: standard monitoring, vigilance, and care Objective signs and symptoms, localizable physical pathology Confirmatory testing such as physical exam findings, CT, MRI, etc. No individual or family history of substance abuse At most, mild medical or psychologic comorbidity Age < 45 High pain tolerance Active coping strategies Willingness to participate in multimodal therapy Attempting to function at normal levels Moderate-risk: additional level of monitoring and more frequent provider contact Significant pain Defined pathology with objective signs and symptoms

At most, mild medical or psychologic comorbidity Age < 45 High pain tolerance Active coping strategies Willingness to participate in multimodal therapy Attempting to function at normal levels Moderate-risk: additional level of monitoring and more frequent provider contact Significant pain Defined pathology with objective signs and symptoms Confirmatory testing such as physical exam findings, CT, MRI, etc. Moderate psychologic problems controlled by therapy Moderate comorbidities well controlled by medical therapy and are not affected by opioids Mild opioid tolerance but not hyperalgesia without addiction or physical dependence Individual or family history of substance abuse Pain involving more than three regions of the body Moderate levels of pain acceptance Active coping strategies Willing to participate in multimodal therapy Attempting to function at normal levels High-risk: intensive and structured monitoring, frequent follow-up contact, consultation with addiction psychiatrist, and limited monthly prescription of short-acting opioids Significant widespread pain No objective signs and symptoms Pain involves more than 3 body regions Divergent drug-related behavior Individual or family history of addiction, dependency, diversion, hyperalgesia, substance abuse, or tolerance Major psychologic problems Age >45 HIV-related pain High levels of pain exacerbation Poor coping strategies Unwilling to participate in multimodal therapy Not functioning at a normal lifestyle Prescribing Opioids Before prescribing opioids, complete a detailed patient history that includes: Indication requested for pain relief Location, nature, and intensity of pain Prior pain treatments and response Comorbid conditions Potential physical and psychologic pain impact on function Family support, employment, and housing Leisure activities, mood, sleep, substance use, and work Emotional, physical, or sexual abuse When considering opioids, weigh the risks of abuse, addiction, adverse drug reactions, overdose, and physical dependence. If there are any special concerns, such as a history of substance abuse, consult a psychiatrist or addiction specialist. If current substance abuse, withhold prescribing until the patient is involved in an addiction treatment and monitoring program. Assessment Tools  [62]

When considering opioids, weigh the risks of abuse, addiction, adverse drug reactions, overdose, and physical dependence. If there are any special concerns, such as a history of substance abuse, consult a psychiatrist or addiction specialist. If current substance abuse, withhold prescribing until the patient is involved in an addiction treatment and monitoring program. Assessment Tools  [62] Screening tools assist in determining risk level, and degree of monitoring and structure required for a treatment plan; however, their validity is not yet supported in the literature. Some examples of opioid tools include: Brief Intervention Tool Brief Intervention Tool is a 26-item "yes-no" questionnaire used to identify signs of opioid addiction or abuse. The items assess for problems related to drug use-related functional impairment. CAGE, CAGE-AID, and CAGE-Opioid CAGE (Cut down, Annoyed, Guilty, and Eye-opener) Questionnaire consists of four questions designed to assess alcohol abuse. CAGE-AID and CAGE-OPIOID are revised versions to assess the likelihood of current substance abuse.[63] Current Opioid Misuse Measure (COMM) The Current Opioid Misuse Measure is a 17-item patient self-report assessment designed to identify abuse in chronic pain patients. It identifies aberrant behaviors associated with opioid misuse in patients already receiving long-term opioid therapy. Diagnosis, Intractability, Risk, and Efficacy (DIRE) Tool The Diagnosis, Intractability, Risk, and Efficacy is a clinician-rated questionnaire used to predict patient compliance with long-term opioid therapy. Patients scoring low are poor candidates for long-term opioids. Mental Health Screening Tool The Mental Health Screening Tool is a five-item screen that evaluates feelings of calmness, depression, happiness, peacefulness, and nervousness in the past month. A low is an indicator that the patient should be referred to a pain management specialist. Opioid Risk Tool The Opioid Risk Tool is a five-item assessment to evaluate for aberrant drug-related behavior. It categorizes the patient into low, medium, or high levels of risk for aberrant drug-related behaviors based on question responses concerning previous alcohol, drug abuse, psychologic disorders, and other risk factors. Pain Assessment and Documentation Tool (PADT)

The Opioid Risk Tool is a five-item assessment to evaluate for aberrant drug-related behavior. It categorizes the patient into low, medium, or high levels of risk for aberrant drug-related behaviors based on question responses concerning previous alcohol, drug abuse, psychologic disorders, and other risk factors. Pain Assessment and Documentation Tool (PADT) Guidelines by the CDC, the Federation of State Medical Boards, and Joint Commission stress documentation from both a quality and medicolegal perspective. The Pain Assessment and Documentation Tool (PADT) was designed to help the clinician document appropriate information. Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a screen with questions addressing the history of alcohol or substance use, cravings, mood psychologic status, and stress. The SOAPP-R helps assess the risk level of aberrant drug-related behaviors and the monitoring level needed. Urine Drug Tests (UDT) Urine drug tests evaluate the use of the medication prescribed and detect unsanctioned drug use. The CDC recommends drug testing before starting opioid therapy and at least annually. On study suggests monitoring frequency based on risk level.[64] Table Testing is usually done with class-specific immunoassay drug panels; however, this may be followed with gas chromatography/mass spectrometry for specific metabolite detection. The test should identify the specific drug. If urine test results suggest aberrant opioid use, discuss the issue in a positive, supportive approach, and document the discussion. Checklists For Prescribers and Dispensers Prescribing/Dispensing Dose, frequency, and length prescribed consistent with the indication - avoid long-acting opioids for acute pain Age, weight, height, and sex considered Evaluate for potential drug interactions Evaluate for potential allergic reactions Patient informed and understands risks and benefits - warnings addiction, abruptly halting, use power equipment, side-effects, respiratory depression, avoid sharing, storage, theft protection Medication use agreement in place Instructions for storage and disposal of unused opioids VIGIL Verification: Is this a responsible opioid user? Identification: Is the identity of this patient verifiable? Generalization: Do we agree on mutual responsibilities and expectations?

Patient informed and understands risks and benefits - warnings addiction, abruptly halting, use power equipment, side-effects, respiratory depression, avoid sharing, storage, theft protection Medication use agreement in place Instructions for storage and disposal of unused opioids VIGIL Verification: Is this a responsible opioid user? Identification: Is the identity of this patient verifiable? Generalization: Do we agree on mutual responsibilities and expectations? Interpretation: Do I feel comfortable allowing this person to have controlled substances? Legalization: Am I acting legally and responsibly? Patient Validation and Red Flags Check government-issued photo ID Only drugs prescribed are controlled substances Early refills Insurance present but pays cash Lost prescriptions Remote address Multiple prescribers Unrealistic expectations PDMP concerning results Prescriber Validation and Red Flags Prescriber writes the same drug, dose, frequency, and length despite differences in age, height, sex, and weight Prescriber outside the geographic area Prescriber write outside scope of practice Combination of opioids, benzodiazepine, or muscle relaxant Excessive drug quantities Multiple prescriptions from the same provider The provider does not take insurance Prescription Validation and Red Flags Eraser marks Handwriting irregularities Late night and weekend prescription drop-offs Prescription irregularities Federal and state-controlled substance number irregularities Evidence turned away by another pharmacy Misspellings How to Handle Not Prescribing or Dispensing Provide news to the patient in a calm manner Do not accuse of wrongdoing Report concerning prescription to the authorities Prescription Drug Monitoring Programs (PDMPs) Prescription drug monitor programs or PDMPs are now in place in various degrees in all states and most territories. They assist prescribers and dispensers in working together to decrease drug abusers and diverter's access to prescription opioids. The PDMP regulations are state-based and as such vary in application. The key benefits are as follows: Assists in monitoring outpatient prescriptions National decrease in multiple providers providing prescriptions (avoids "doctor shopping") Encourages prescribers and pharmacists to work together as an interprofessional team Assists regulatory boards, Medicaid, medical examiners, law enforcement, and research organizations in gathering data on the effectiveness and enforcement of provisions

National decrease in multiple providers providing prescriptions (avoids "doctor shopping") Encourages prescribers and pharmacists to work together as an interprofessional team Assists regulatory boards, Medicaid, medical examiners, law enforcement, and research organizations in gathering data on the effectiveness and enforcement of provisions Some states are participating in PMP Interconnect, which allows the sharing of prescription information across state lines Weaknesses In PDMP System System is not interlinked among all states Many states only require clinicians and pharmacists to consult the PDMP if they have a reasonable belief there is drug-seeking Database may be out of date by several days as they are often not updated in real-time Future PDMP System In the future, it is expected that PDMP requirements will expand to mandatory checking of the database by both prescribers and dispensers, real-time reporting, easier use, more active management, and flagging by government agencies. PDMP Systems Success States with aggressive PDMPs in place are seeing as much as an 80% decrease in opioid prescribing. [65][66][67]

Healthcare professionals who treat patients with chronic pain should understand best practices in opioid prescribing, approaches to pain assessment, pain management modalities, and appropriate use of opioids for pain control. Pharmacologic and nonpharmacologic approaches should be evaluated. Patients with moderate-to-severe chronic pain who have been assessed and treated with non-opioid therapy without adequate pain relief are candidates for opioid therapy. Initial treatment should be a trial of therapy, not a definitive course of treatment. The CDC has issued updated guidance on the prescription of opioids for chronic pain. These guidelines address when to initiate or continue opioids for chronic pain; opioid selection, dosage, duration, follow-up, and discontinuation; and assessing risk and addressing opioid use harm. Pain Management Referral Recommendations are to refer a patient to pain management in the case of debilitating pain, which is unresponsive to initial therapy. The pain may be located at multiple locations, requiring multimodal treatment or increases in dosages for adequate pain control or invasive procedures to control pain. Treatment of both pain and a comorbid psychiatric disorder leads to a more significant reduction of both pain and symptoms of the psychiatric disorder.[68] Pain may also worsen concurrent depression; thus, the treatment of pain has demonstrated to improve the responses to the treatments for depression.[69] There are multiple pharmacological, adjunct, nonpharmacological, and interventional treatments for chronic, severe, and persistent pain. Pharmacologic Options and Risks/Benefits The list of pharmacological options for chronic pain is extensive. This list includes nonopioid analgesics such as nonsteroidal anti-inflammatories (NSAIDs), acetaminophen, and aspirin. Additionally, medications such as tramadol, opioids, antiepileptic drugs (gabapentin or pregabalin) can be useful. Furthermore, antidepressants such as tricyclic antidepressants and SNRI’s, topical analgesics, muscle relaxers, N-methyl-d-aspartate (NMDA) receptor antagonists, and alpha 2 adrenergic agonists are also possible pharmacological therapies.

The list of pharmacological options for chronic pain is extensive. This list includes nonopioid analgesics such as nonsteroidal anti-inflammatories (NSAIDs), acetaminophen, and aspirin. Additionally, medications such as tramadol, opioids, antiepileptic drugs (gabapentin or pregabalin) can be useful. Furthermore, antidepressants such as tricyclic antidepressants and SNRI’s, topical analgesics, muscle relaxers, N-methyl-d-aspartate (NMDA) receptor antagonists, and alpha 2 adrenergic agonists are also possible pharmacological therapies. Treatment response can differ between individuals, but treatment is typically done in a stepwise fashion to reduce the duration and dosage of opioid analgesics. However, there is no singular approach appropriate for the treatment of pain in all patients.[70] Chronic musculoskeletal pain is nociceptive pain. The treatment of such pain is in a stepwise approach but includes a combination of nonopioid analgesics, opioids, and nonpharmacological therapies. First-line therapy would be acetaminophen or NSAIDs. Both are effective for osteoarthritis and chronic back pain.[71][72][73] However, NSAIDs are relatively contraindicated in patients with a history of heart disease or myocardial infarction, renal disease, or patients on anticoagulation or with a history of ulcers.[74][75] There is limited evidence of which NSAID to use over another. One nonsteroidal antiinflammatory pharmacological agent may have a limited effect on a patient's pain while another may provide adequate pain relief. The recommendations are to try different agents before moving on to opioid analgesics.[76] Failure to achieve appropriate pain relief with either acetaminophen or NSAIDs can lead to considering opioid analgesic treatment.

Chronic musculoskeletal pain is nociceptive pain. The treatment of such pain is in a stepwise approach but includes a combination of nonopioid analgesics, opioids, and nonpharmacological therapies. First-line therapy would be acetaminophen or NSAIDs. Both are effective for osteoarthritis and chronic back pain.[71][72][73] However, NSAIDs are relatively contraindicated in patients with a history of heart disease or myocardial infarction, renal disease, or patients on anticoagulation or with a history of ulcers.[74][75] There is limited evidence of which NSAID to use over another. One nonsteroidal antiinflammatory pharmacological agent may have a limited effect on a patient's pain while another may provide adequate pain relief. The recommendations are to try different agents before moving on to opioid analgesics.[76] Failure to achieve appropriate pain relief with either acetaminophen or NSAIDs can lead to considering opioid analgesic treatment. Opioids are considered a second-line option; however, they may be warranted for pain management for patients with severe persistent pain or neuropathic pain secondary to malignancy.[77] There have been conflicting results on the use of opioids in neuropathic pain. However, for both short term and intermediate use, opioids are often used to treat neuropathic pain.[78] Opioid therapy should only start with extreme caution for patients with chronic musculoskeletal pain.[79] Side effects of opioids are significant and frequent and may include opioid-induced hyperalgesia, constipation, dependence, and sedation. For chronic musculoskeletal pain, they are not superior to nonopioid analgesics.[80][81]

There is an estimated 78 percent risk of an adverse reaction to opioids such as constipation or nausea, while there is a 7.5 percent risk of developing a severe adverse reaction ranging from immunosuppression to respiratory depression.[87] Patients with chronic pain who meet the criteria for the diagnosis of opioid use disorder should receive the option of buprenorphine to treat their chronic pain. Buprenorphine is a considerably better alternative for patients with very high daily morphine equivalents who have failed to achieve adequate analgesia. Different types of pain also warrant different treatments. For example, chronic musculoskeletal back pain would be treated differently from severe diabetic neuropathy. A combination of multiple pharmacological therapies is often necessary to treat neuropathic pain. Less than 50% of patients with neuropathic pain will achieve adequate pain relief with a single agent.[88] Adjunctive topical therapy, such as lidocaine or capsaicin cream, can be utilized as well.[89][90] The initial treatment of neuropathic is often with gabapentin or pregabalin. These are calcium channel alpha 2-delta ligands. They are indicated for postherpetic neuralgia, diabetic neuropathy, and mixed neuropathy.[91] There is limited evidence in the use of other antiepileptic medications to treat chronic pain, where many of these, such as lamotrigine, have a more significant side effect profile. The exception is carbamazepine in the treatment of trigeminal neuralgia and other types of chronic neuropathic pain.[92][93] Alternatively, antidepressants such as dual reuptake inhibitors of serotonin and norepinephrine (SNRI) or tricyclic antidepressants (TCA) can is an option. Antidepressants are beneficial in the treatment of neuropathic pain, central pain syndromes, and chronic musculoskeletal pain. For neuropathic pain, antidepressants have demonstrated a 50 percent reduction of pain. Fifty percent is a significant reduction, considering the average decrease in pain from various pain treatments is 30%.[94][95]

Alternatively, antidepressants such as dual reuptake inhibitors of serotonin and norepinephrine (SNRI) or tricyclic antidepressants (TCA) can is an option. Antidepressants are beneficial in the treatment of neuropathic pain, central pain syndromes, and chronic musculoskeletal pain. For neuropathic pain, antidepressants have demonstrated a 50 percent reduction of pain. Fifty percent is a significant reduction, considering the average decrease in pain from various pain treatments is 30%.[94][95] The serotonin-norepinephrine reuptake inhibitor (SNRI) duloxetine is a useful treatment for treating chronic pain, osteoarthritis, and the treatment of fibromyalgia.[96] Furthermore, the efficacy of duloxetine in the treatment of comorbid depression is comparable to other antidepressants.[97][94] Venlafaxine is an effective treatment for neuropathic pain, as well.[98] A TCA can also be utilized, such as nortriptyline. TCA medications may require six to eight weeks to achieve its desired effect.[77] Adjunctive topical agents such as topical lidocaine are a useful treatment for neuropathic pain and allodynia as in postherpetic neuralgia.[99][100] Topical NSAIDs have been shown to improve acute musculoskeletal pain, such as a strain, but are less effective in chronic pain. Yet, topical NSAIDs are more effective than controls in the treatment of pain related to knee osteoarthritis.[101][102] Separately, topical capsaicin cream is an option for chronic neuropathic or musculoskeletal pain unresponsive to other treatments.[103] Botulinum toxin has also demonstrated effectiveness in the treatment of postherpetic neuralgia.[104] The use of cannabis is also an area of interest in pain research. There is some evidence that medical marijuana can be an effective treatment of neuropathic pain, while the evidence is currently limited in treating other types of chronic pain.[105]

Adjunctive topical agents such as topical lidocaine are a useful treatment for neuropathic pain and allodynia as in postherpetic neuralgia.[99][100] Topical NSAIDs have been shown to improve acute musculoskeletal pain, such as a strain, but are less effective in chronic pain. Yet, topical NSAIDs are more effective than controls in the treatment of pain related to knee osteoarthritis.[101][102] Separately, topical capsaicin cream is an option for chronic neuropathic or musculoskeletal pain unresponsive to other treatments.[103] Botulinum toxin has also demonstrated effectiveness in the treatment of postherpetic neuralgia.[104] The use of cannabis is also an area of interest in pain research. There is some evidence that medical marijuana can be an effective treatment of neuropathic pain, while the evidence is currently limited in treating other types of chronic pain.[105] The list of nonpharmacological therapies for chronic pain is extensive. Nonpharmacological options include heat and cold therapy, cognitive behavioral therapy, relaxation therapy, biofeedback, group counseling, ultrasound stimulation, acupuncture, aerobic exercise, chiropractic, physical therapy, osteopathic manipulative medicine, occupational therapy, and TENS units. Interventional techniques can also be utilized in the treatment of chronic pain. Spinal cord stimulation, epidural steroid injections, radiofrequency nerve ablations, botulinum toxin injections, nerve blocks, trigger point injections, and intrathecal pain pumps are some of the procedures and techniques commonly used to combat chronic pain. TENS units' efficacy has been variable, and the results of TENS units for chronic pain management are inconclusive.[106] Deep brain stimulation is for post-stroke and facial pain as well as severe, intractable pain where other treatments have failed.[107] There is limited evidence of interventional approaches to pain management. For refractory pain, implantable intrathecal delivery systems are an option for patients who have exhausted all other options. Non-Pharmacologic Options

Pain is a symptom, not a diagnosis. Developing a differential diagnosis for a patient's chronic pain is based on assessing the possible underlying etiologies of the patient's pain. It is essential to determine what underlying injury or disease processes are responsible for the patient's pain since this requires the identification of effective treatment. For instance, it is crucial to determine if a patient's neuropathic pain is peripheral or central. In another example, if a patient suffers from severe knee pain, it is essential to consider whether or not the knee pain is secondary to severe osteoarthritis since the patient may benefit from an injection or possibly from a knee replacement. In contrast, if the knee pain were instead related to a different condition such as rheumatoid arthritis, infection, gout, pseudogout, or meniscal injury, very different treatments would be necessary. The differential diagnosis for generalized chronic pain would include patients who develop allodynia from chronic opioids as well as patients suffering from a major depressive disorder, as well as other psychiatric or sleep disorders, including insomnia. Furthermore, autoimmune diseases such as lupus or psoriatic arthritis, fibromyalgia as well as central pain syndromes, should be considered in states involving widespread, generalized chronic pain states. The four main categories of pain are neuropathic, musculoskeletal, mechanical, and inflammatory. Persistent and under-treated painful conditions can lead to chronic pain. Thus chronic pain is often a symptom of one or multiple diagnoses and can become its diagnosis as it becomes persistent and the body's neurochemistry changes. It is critical to treat acute and subacute pain before chronic pain develops.

Current chronic pain treatments can result in an estimated 30% decrease in a patient's pain scores.[70] A thirty percent reduction in a patient's pain can have significant improvements to patients' function and quality of life.[114] However, the long-term prognosis for patients with chronic pain demonstrates reduced function and quality of life. Improved outcomes are possible in patients with chronic pain improves with the treatment of comorbid psychiatric illness. Chronic pain increases patient morbidity and mortality, as well as increases rates of chronic disease and obesity. Patients with chronic pain are also at a significantly increased risk for suicide compared to the regular population. Spinal cord stimulation results in inadequate pain relief in about 50% of patients. Tolerance can also occur in up to 20 to 40 percent of patients. The effectiveness of the spinal cord stimulation decreases over time.[115] Similarly, patients who develop chronic pain and are dependent on opioids often build tolerance over time. As the amount of morphine milligram equivalents increases, the patient's morbidity and mortality also increase. Ultimately, prevention is critical in the treatment of chronic pain. If acute and subacute pain receives appropriate treatment, and chronic pain can be avoided, the patient will have limited impacts on their quality of life.

Chronic pain leads to significantly decreased quality of life, reduced productivity, lost wages, worsening of chronic disease, and psychiatric disorders such as depression, anxiety, and substance abuse disorders. Patients with chronic pain are also at a significantly increased risk for suicide and suicidal ideation. Many medications often used to treat chronic pain have potential risks and side effects and possible complications associated with their use. Acetaminophen is a standard pharmacological therapy for patients with chronic pain. It is taken either as a single agent or in combination with an opioid. The hepatotoxicity occurs with acetaminophen when exceeding four grams per day.[116] It is the most common cause of acute liver failure in the United States.[117] Furthermore, hepatotoxicity can occur at therapeutic doses for patients with chronic liver disease.[118] Frequently used adjunct medications such as gabapentin or pregabalin can cause sedation, swelling, mood changes, confusion, and respiratory depression in older patients who require additional analgesics.[119] These agents require caution in elderly patients with painful diabetic neuropathy. Also, gabapentin or pregabalin, in combination with opioid analgesics, has been shown to increase the rate of patient mortality.[120] Duloxetine can cause mood changes, headaches, nausea as well as other possible side effects, and should be avoided in patients with a history of kidney or liver disease. Feared complications of opioid therapy include addiction as well as overdose resulting in respiratory compromise. However, opioid-induced hyperalgesia is also a significant concern. Patients become more sensitive to painful stimuli while on chronic opioids.[121] The long-term risks and side effects of opioids include constipation, tolerance, dependence, nausea, dyspepsia, arrhythmia (methadone treatment QT prolongation), and opioid-induced endocrine dysfunction, which can result in amenorrhea, impotence, gynecomastia, and decreased energy and libido. Also, there appears to be a dose-dependent risk of opioid overdose with increasing daily milligram morphine equivalents.

Involvement of Patient and Family The patient and family can assist in making informed decision-making regarding continuing or discontinuing opioid therapy. Family members are often aware of when a patient is depressed and less functional. Questions to ask the family include: Is the patient's day focused on taking opioid pain medication? What is the frequency of pain medication? Does the patient have any other alcohol or drug problems? Does the patient avoid activity? Is the patient depressed? Is the patient able to function? What To Teach A Patient Taking Opioids Avoid driving or operating power equipment Avoid stoping opioids suddenly Avoid taking other drugs that depress the respiratory system as alcohol, sedatives, and anxiolytics Contact prescribing if pain medication is not adequate for relief Destroy opioids based on product-specific disposal information (usually flushing down the toilet or mixing with cat litter or coffee grounds) Do not chew tables Do not share opioids with friends or family Follow prescribed dosing regimen Provide product-specific information Take opioids only as prescribed Set appropriate expectations Interprofessional Approach To Prevent Opioid Abuse Clinicians, pharmacists, and allied health professionals must work together as an interprofessional team to provide safe and appropriate opioid medication use. While clinicians initially evaluate and prescribe, pharmacists play a crucial role by evaluating the appropriateness and legitimacy of prescriptions received and make the final determination of what prescriptions should be filled. Failure to assess possible abuse, misuse, or diversion results in patient and society problems while an overzealous effort denies patients with legitimate pain-appropriate therapy. A team approach of prescribers and dispensers is likely to produce the best outcome.

Maintain Accurate Medical Records Regarding Opiate Prescriptions All clinicians should maintain accurate, complete, and current medical records, including: Records of prescriptions for controlled substances Record instructions provided Detailed history, physical, monitoring, and reasons prescribed Federal and State Laws [136] Several regulations and programs at the federal and state level to reduce prescription opioid abuse, diversion, and overdose. These laws require: Immunity from prosecution for individuals seeking assistance during an overdose Pain clinic oversight Patient identification prior to dispencing A physical examination prior to prescribing opioids Prescription limits Prohibition from obtaining controlled substance prescriptions Tamper-resistant prescriptions Federal Laws The U.S. Drug Enforcement Administration (DEA) sets national standards for controlled substances. Drug scheduling was mandated under The Federal Comprehensive Drug Abuse Prevention and Control Act of 1970. The law addresses controlled substances within Title II. The DEA maintains a list of controlled medications and illicit substances that are categorized from scheduled I to V. The five categories have their basis on the medication’s proper and beneficial medical use and the medication’s potential for dependency and abuse. The purpose of the law is to provide government oversight over the manufacturing and distribution of these types of substances. Prescribers and dispensers are required to have a DEA license to supply these drugs. The licensing provides links to users, prescribers, and distributors.[137][138][139] The schedules range from Schedule I to V. Schedule I drugs are considered to have the highest risk of abuse while Schedule V drugs have the lowest potential for abuse. Other factors considered by the DEA include pharmacological effect, evidenced-based knowledge of the drug, risk to public health, trends in the use of the drug, and whether or not the drug has the potential to be made more dangerous with minor chemical modifications. Table "High abuse potential with no accepted medical use; medications within this schedule may not be prescribed, dispensed, or administered"   Examples of include marijuana (cannabis), heroin, mescaline (peyote), lysergic acid diethylamide (more...)

The schedules range from Schedule I to V. Schedule I drugs are considered to have the highest risk of abuse while Schedule V drugs have the lowest potential for abuse. Other factors considered by the DEA include pharmacological effect, evidenced-based knowledge of the drug, risk to public health, trends in the use of the drug, and whether or not the drug has the potential to be made more dangerous with minor chemical modifications. Table "High abuse potential with no accepted medical use; medications within this schedule may not be prescribed, dispensed, or administered"   Examples of include marijuana (cannabis), heroin, mescaline (peyote), lysergic acid diethylamide (more...) It is essential to understand the DEA controlled-substance scheduling both to ensure adequate caution when prescribing medications with high abuse potential and also to ensure against prescribing outside of one's authority.[140][141] The Controlled Substances Act has great potential to improve patient safety by providing federal oversight for drugs with a high potential for abuse. Providers of scheduled substances (physicians, dentists, podiatrists, advanced practitioners) may have links to the distribution of these substances. They are required to have a DEA license and record prescription of scheduled drugs. This licensing prevents overprescribing and obligates providers to be wary of potential drug-seeking patients. The dispenser must also be aware of a patient's medication history and be mindful of the potential for polypharmacy if a patient seeks multiple providers. The current opioid epidemic is a time where federal oversight and interdisciplinary coordination have the potential to reduce harm to patients prescribed scheduled drugs drastically. It will, however, take further time and evaluation to know if drug scheduling actually reduces abuse, addiction, and overdose.[142][143][144][145][146] See Table 1 for information regarding registration, records, prescriptions, refills, distribution, security, and theft or significant loss of controlled substances. See Table 2 for information regarding DEA forms 106, 222, 224, and 224a. Summary of Kentucky Laws on Opioid and Controlled Substance Prescribing KASPAR (Kentucky All Schedule Prescription Reporting)

See Table 1 for information regarding registration, records, prescriptions, refills, distribution, security, and theft or significant loss of controlled substances. See Table 2 for information regarding DEA forms 106, 222, 224, and 224a. Summary of Kentucky Laws on Opioid and Controlled Substance Prescribing KASPAR (Kentucky All Schedule Prescription Reporting) KASPER is a controlled substance prescription monitoring system designed to assist practitioners and pharmacists with providing medical and pharmaceutical patient care using controlled substance medications. KASPER provides an investigative tool for law enforcement and regulatory agencies to assist with authorized reviews and investigations. KASPER is not intended to prevent patients from receiving needed controlled substance medications. Who requests KASPAR reports? Practitioners and pharmacists for medical or pharmaceutical treatment of their patient, and for reviewing data on controlled substances administered or dispensed to the birth mother of an infant being treated for neonatal abstinence syndrome or prenatal drug exposure. Law enforcement officers for drug-related investigation. Commonwealth's attorneys. Licensure boards for an investigation of a licensee. A Medicaid program for utilization review on a recipient. A grand jury by subpoena. A judge or probation or parole officer administering a drug diversion or probation program. A medical examiner engaged in a death investigation. Who is required to upload controlled substance information to KASPAR? Pharmacies and dispensing practitioners within one business day of administering or dispensing a controlled substance (KRS 218A.202 and 902 KAR 55:110) How do you set up a KASPAR account? Go to the Kentucky Online Gateway website or call KOG Help Desk at 502-564-0104) What does a KASPER report show? Schedule II through V controlled substance prescriptions a patient has received and a list of prescribers who prescribed them and dispensers who dispensed them. What can be done with a KASPAR report? Practitioners, pharmacists, or employees may share the report with the patient or authorized representative and include it in the medical record; discuss it with other health professionals treating the patient, or with law enforcement, if there is just cause. Unauthorized disclosure is beyond that allowed in KRS 218A.202 is a class B misdemeanor. When are KASPER reports available?

Practitioners, pharmacists, or employees may share the report with the patient or authorized representative and include it in the medical record; discuss it with other health professionals treating the patient, or with law enforcement, if there is just cause. Unauthorized disclosure is beyond that allowed in KRS 218A.202 is a class B misdemeanor. When are KASPER reports available? 24/7, however, Kentucky dispensers have one business day from date of dispersion to report to KASPAR. What should a health provider do if they suspect controlled substance diversion after review of KASPAR? Report to the proper law enforcement authorities Prescriber and Dispenser Communication When may a clinician order and pharmacist dispense a Schedule II controlled substance oral prescription? (902 KAR 55:095 Sections 1 and 2) Hospice or long-term care facility for immediate administration Limited to minimum quantity need to immediately treat the patient Must be communicated by the prescriber Contains all elements of a written prescription except a signature Within 7 days, the prescriber must send a written prescription for the emergency quantity verbally authorized When may a clinician order and a pharmacist dispense a Schedule II Controlled Substance faxed prescription? (902 KAR 55:095 Section 3) Compounded Schedule II narcotic for the direct administration via parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion Hospice or long-term care facility The facsimile serves as the original prescription and a written follow-up prescription is not required When may a clinician order and a pharmacist dispense a Schedule III-V Controlled Substances oral prescription? (KRS 218A.180(6)) All oral, verbally authorized prescriptions for Schedule III-V controlled substances shall be immediately reduced to writing, dated, and signed by the pharmacist. When may a clinician order and pharmacist dispense Schedule III-V Controlled Substance faxed prescriptions? (902 KAR 55:105, Section 4(4)) Written on a green security prescription blank “FAXED” written or stamped on the face of the original prescription with the date and the person’s name or initials responsible for faxing The practitioner must file the original prescription in the patient’s chart What if a faxed Schedule III-V controlled substance prescription does not meet the requirements? (902 KAR 55:105)

“FAXED” written or stamped on the face of the original prescription with the date and the person’s name or initials responsible for faxing The practitioner must file the original prescription in the patient’s chart What if a faxed Schedule III-V controlled substance prescription does not meet the requirements? (902 KAR 55:105) The pharmacist must exercise due diligence to verify the prescription such as telephoning the prescriber’s office and taking the prescription as a verbal authorization from the prescriber or their agent. What E-prescribing of Controlled Substances is allowed? (KRS 218A.171, KRS 218A.182) All controlled substance prescriptions, Schedule II-V, are allowed to be e-prescribed as long as the e-prescribing software system meets DEA requirements All controlled substance prescriptions must be e-prescribed with few statutory exceptions What are the telehealth rules for prescribing Controlled Substances during the current state of emergency? If in the opinion of the physician they are unable to fulfill the professional standards, it should be documented thoroughly. Controlled Substance Regulation What is the restriction of dispensing Schedule II and Schedule III Controlled Substances containing hydrocodone? (201 KAR 9:220) Clinicians may only dispense up to a 48 hour supply unless it is done as part of a licensed narcotic treatment program. What documentation is required for prescribing or dispensing a Controlled Substance? (201 KAR 9:260) Document relevant information in the patient’s medical record in a legible manner and in detail. If unable to conform to the prescribing and dispensing standards document justification for non-conformance in the patient’s record. What patient education is required of a patient receiving a Controlled Substance? (201 KAR 9:260) Educate on dangers such as overdose and addiction potential. When does the Controlled Substance prescribing and dispensing regulations not apply to patients? (201 KAR 9:260, KRS 216.510) Hospice, end-of-life, cancer treatment, disaster, mass casualties, or if a single dose for a procedure. If classified as a Schedule V controlled substance.

Educate on dangers such as overdose and addiction potential. When does the Controlled Substance prescribing and dispensing regulations not apply to patients? (201 KAR 9:260, KRS 216.510) Hospice, end-of-life, cancer treatment, disaster, mass casualties, or if a single dose for a procedure. If classified as a Schedule V controlled substance. Hospitalized inpatient, outpatient, or observation patient (If prescribing or dispensing of Schedule II Controlled Substances and Schedule III Controlled Substances containingHydrocodone, the hospital or clinician must query KASPER within 12 hours of admission and place a copy of the KASPER report in the patient’s chart. Long-term-care facility (If prescribing or dispensing of Schedule II Controlled Substances and Schedule III Controlled Substances containing hydrocodone, the long-term care facility or clinician must query KASPER within 12 hours of admission and place a copy of the KASPER report in the resident’s chart. Prescribing or administering no more than a 14-day supply following an operative or invasive procedure or delivery Prescribing or dispensing a substitute prescription within 7 days of the initial prescription (refills to the initial prescription should be canceled and the patient is required to dispose of any unused medication) Prescribing or dispensing to the same patient for the same condition by a partner in a practice with (initial prescriber or other coverage arrangement) within 90 days of the initial prescription Prescribing or dispensing to a research subject enrolled in an IRB-approved drug study a study that covered by the National Institutes of Health certificate of confidentiality What are the requirements for an initial prescribing or dispensing of a controlled substance for pain or associated with the same primary complaint? (201 KAR 9:260 Section 3) Appropriate medical history and physical exam Obtain KASPER report for the previous 12 month periodPrescribe or dispense only what is medically appropriate Do not prescribe or dispense long-acting or controlled-release controlled substances for acute pain not directly related to or close in time to surgery Explain that the medication is being prescribed to treat an acute medical complaint for time-limited use, and that is should be discontinued when the condition has resolved Explain how to safely/properly dispose of the medicine

Do not prescribe or dispense long-acting or controlled-release controlled substances for acute pain not directly related to or close in time to surgery Explain that the medication is being prescribed to treat an acute medical complaint for time-limited use, and that is should be discontinued when the condition has resolved Explain how to safely/properly dispose of the medicine If Schedule II Controlled Substance or Schedule III Controlled Substances with hydrocodone: 1. Make a written plan stating the objectives of the treatment and further diagnostic examinations required; Discuss the risks and benefits of controlled substance use; and 3. Obtain written consent for treatment What are the requirements for commencing long-term treatment (>3 months) for pain associated with a medical complaint for patients 16 years old or older? (201 KAR 9:260 Section 4) Appropriate history and physical, past medical history including substance use and prior treatment, family history of substance use, and psychosocial history Baseline assessment to evaluate progress over time Obtain written informed consent If a reasonable likelihood of substance abuse, psychiatric, or psychologic condition, refers to a treatment program or specialist If a risk of diversion, enter into a Prescribing Agreement Obtain baseline drug screen If evidence controlled substance will be or likely used for a non-therapeutic purpose, do not prescribe Document attempt of a trail of noncontrolled modalities or lower doses by a clinician before prescribing long-term controlled substance Standards may be met by multiple prescribers in a group if: 1. Each has lawful access to the medical record; 2. Compliance with all applicable standards; and 3. Acting within their legal scope of practice What are the requirements for maintaining long-term treatment (>3 months) for pain associated with a medical complaint for patients 16 years old or older? (201 KAR 9:260 Section 5) Annual preventive health history and physical Monthly evaluation until the controlled substance is titrated, without unacceptable side effects, and sufficient monitoring to minimize the likelihood of improper use or diversion History and physical at regular intervals and document measurable examinations Interval evaluation and modification of diagnosis and treatment plan to determine if improved functionality or any change in baseline measures

Monthly evaluation until the controlled substance is titrated, without unacceptable side effects, and sufficient monitoring to minimize the likelihood of improper use or diversion History and physical at regular intervals and document measurable examinations Interval evaluation and modification of diagnosis and treatment plan to determine if improved functionality or any change in baseline measures Consult specialists as needed, particularly if poor response If a risk of diversion or improper use of controlled substance discontinue prescribing or justify continued use in the record If no significant improvement in function despite treatment obtain consultative assistance If mood, anxiety, psychiatric or psychological symptoms, obtain a psychiatric consult If “breakthrough” pain, identify triggers and preferable treat with non-controlled substances only prescribe additional controlled substances in the minimal amount needed taking steps to minimizeimproper/illegal use KASPER review every 3 months, or immediately if any concern not taking prescriptions as directed, diverting, or improper use; if more than one prescriber, notify co-prescribers Conduct random pill counts and random drug screens (if noncompliant controlled taper, stop dispensing/prescribing, refer to addiction, mental health, or drug treatment program) Stop prescribing and refer to an addiction specialist, if no response or lack of improvement where medically expected, significant adverse effects, or inappropriate drug-seeking or diversion Standards may be met by multiple prescribers in a group if: 1. Each has lawful access to the medical record; 2. Compliance with all applicable standards; and 3. Acting within their legal scope of practice What are the standards for prescribing Controlled Substances in the emergency department? (201 KAR 9:260 Section 6) Comply with Sections 3 and 8 If prescribing more than a 7 day supply, document rationale Shall not Administer an IV controlled substance for acute exacerbations of chronic pain, unless only appropriate route Provide replacement prescriptions for those that are destroyed, lost, or stolen Provide replacement doses of methadone, buprenorphine, and naloxone Prescribe or administer long-acting or controlled-release medications, or meperidine Prescribe or dispense more than the minimum amount necessary until follow-up by primary treating or other physician

Provide replacement prescriptions for those that are destroyed, lost, or stolen Provide replacement doses of methadone, buprenorphine, and naloxone Prescribe or administer long-acting or controlled-release medications, or meperidine Prescribe or dispense more than the minimum amount necessary until follow-up by primary treating or other physician What other conditions should prescribers and dispensers be aware of in providing Controlled Substances? (201 KAR 9:260 Section 7) Prior to the initial prescription of any controlled substance for conditions other than pain: Perform a history and physical exam, if appropriate a psychiatrist or other mental health exam Obtain and review KASPER report Medically appropriate decision to prescribe or dispense Only prescribe what is medically necessary Explain medication is for a time-limited use, to discontinue when the condition has resolved, and how to properly dispose of the medicine Discuss risks and benefits If ongoing prescribing or dispensing, comply with the accepted and prevailing standards of medical practice for the treatment of that medical complaint and use of Schedule II Controlled Substances and Schedule III Controlled Substances with hydrocodone, also: Make a written plan stating objectives of the treatment and required further diagnostic examinations Obtain written consent for the treatment from the patient If requests from established patients to prescribe or dispense a controlled substance to treat a single event/nonrecurring episode of anxiety/depression: Obtain KASPER report for prior 12 months Make a deliberate decision to prescribe or dispense that is medically appropriate the minimum amount of controlled substance to treat the situational anxiety or depression What happens if a health professional fails to follow the KBML controlled substance prescribing and dispensing professional standards? [KRS 311.595(9)(12)] Disciplinary sanctions by the KBML.

Chronic pain is a significant condition that affects many millions of people and is an important public health concern with considerable morbidity and mortality and associated opiate drug diversion and misuse. Thus chronic pain is best managed with an interprofessional approach. Managing chronic pain requires an interprofessional team of healthcare professionals that includes a primary care physician, nursing team, pharmacist, and pain medicine specialists. Without proper management, the patient's quality of life can have a deleterious impact.  The evaluation and treatment of such patients are paramount but in order to avoid drug diversion and misuse, health professionals must work as a team. Chronic pain correlates with several severe complications, including severe depression and suicide attempts, and ideation. The lifetime prevalence for chronic pain patients attempting suicide attempts was shown to be between 5% and 14%; suicidal ideation was approximately 20%[24] These complications often require psychiatric intervention and advanced pharmacological or interventional therapies. Severe symptoms must receive treatment immediately, leading to an increase in healthcare costs. It is of the utmost importance to identify the risk factors and perform a thorough assessment of the patient with chronic pain as well as monitor for progression of symptoms. A team approach is an ideal way to limit the effects of chronic pain and its complications. Evaluation of a patient with acute pain by the primary care provider to prevent the progression of chronic pain is the recommended first step. Conservative management of chronic pain should commence when symptoms are mild or moderate, including physical therapy, cognitive-behavioral therapy, and pharmacological management. A pharmacist or other expert knowledgeable in the medications frequently utilized to treat chronic pain should evaluate the medication regimen to include medication reconciliation to preclude any drug-drug interactions, and alert the healthcare team regarding any concerns. The patient should follow up with a primary care provider as well as pain specialists as necessary regularly to assess and effectively treat the patient's pain. Clinicians must address comorbid psychiatric disorders. This action may require the involvement of a psychiatrist, depending on the severity of the patient's symptoms.

The patient should follow up with a primary care provider as well as pain specialists as necessary regularly to assess and effectively treat the patient's pain. Clinicians must address comorbid psychiatric disorders. This action may require the involvement of a psychiatrist, depending on the severity of the patient's symptoms. If symptoms worsen on follow up or if there is a concerning escalation of pharmacological therapy such as with opioids, a referral to a pain medicine specialist merits consideration. If the patient has exhausted various pharmacological and nonpharmacological treatment options, interventional procedures can be a consideration. If at any time the patient expresses concern for suicidal ideation or plan, an emergent psychiatric team should evaluate the patient immediately. Patients who have developed opioid dependence secondary to pharmacological therapy should be offered treatment, possibly referral for addiction treatment or detoxification if indicated. The patient should be put on a medication weaning schedule or possibly medications for the treatment for opioid dependence. Based on CDC recommendations, patients on high-dose opioid medications or patients with risk factors for opioid overdose (e.g., obesity, sleep apnea, concurrent benzodiazepine use, etc.) should receive naloxone at home for the emergent treatment of an unintentional overdose. The interprofessional team should openly discuss and communicate clearly about the management of each patient so that the patient receives optimal care delivery. This area is where nurses and pharmacists can play a crucial role by helping verify patient compliance with the treatment plan and monitor for progress (or lack of) with the present treatment plan. Nurses and pharmacists can help monitor for adverse medication side effects, concerns regarding diversion or misuse of opioids, and communicate any areas of concern to the treating clinicians. Effective, open interprofessional communication is crucial in the optimal management of chronic pain [Level 2] and in minimizing the negative effects of chronic pain in the patient. Interprofessional Team Case Study #1 CC: Syncope and Confusion

The interprofessional team should openly discuss and communicate clearly about the management of each patient so that the patient receives optimal care delivery. This area is where nurses and pharmacists can play a crucial role by helping verify patient compliance with the treatment plan and monitor for progress (or lack of) with the present treatment plan. Nurses and pharmacists can help monitor for adverse medication side effects, concerns regarding diversion or misuse of opioids, and communicate any areas of concern to the treating clinicians. Effective, open interprofessional communication is crucial in the optimal management of chronic pain [Level 2] and in minimizing the negative effects of chronic pain in the patient. Interprofessional Team Case Study #1 CC: Syncope and Confusion HPI: A 70-year-old confused female arrives in the trauma after she was found passed on the bathroom floor near the toilet. The husband reports a past history of morbid obesity, diabetes, kidney disease, and chronic right hip pain, for which she has been scheduled for prosthetic hip surgery replacement that has been delayed to get her weight under control. She has been prescribed a combination of hydrocodone and acetaminophen to allow control of the pain enough for ambulation and daily pool exercises. Lately, the pain has been getting worse, and the husband mentions that occasionally she takes more medicine than prescribed. PE: Vital signs T 98.7 degrees F, Bp 100/70, HR 110, RR 14, and O2 Saturation 92%. Physical exam reveals a somnolent and female that arouses to a painful stimulus. The heart, lung, and extremity exam is normal. There are no focal neurologic deficits. Work-up Laboratory studies including a CBC, chemistry, and urinalysis are normal except for a moderate elevation of the blood urea nitrogen and creatinine. A chest x-ray and pelvic film are negative for fracture. The ECG was normal. The drug screen is positive for opioids and cannabinoids. The patient is given naloxone and becomes awake and conversant. She admits that she was sitting on the toilet urinating, and the last thing she remembers is feeling faint. She indicates that she has difficulty sleeping and walking due to chronic hip pain, and she has severe pain with exercise in their home pool. She denies suicidal ideation. She admits to taking an extra pain pill and “smoking a joint” prior to the episode.

The patient is given naloxone and becomes awake and conversant. She admits that she was sitting on the toilet urinating, and the last thing she remembers is feeling faint. She indicates that she has difficulty sleeping and walking due to chronic hip pain, and she has severe pain with exercise in their home pool. She denies suicidal ideation. She admits to taking an extra pain pill and “smoking a joint” prior to the episode. Checking KASPAR reveals she has been on a three times a day dose of her oxycodone and acetaminophen for the last six weeks prescribed by her orthopedic surgeon. Treatment The patient is admitted to the hospital, and orthopedic surgery, pain management, pharmacy, physical therapy, and dietician are consulted. Subsequent workup by the interprofessional team concludes the incident was caused by an accidental overdose of her opioid medication combined with her comorbid conditions. The family and husband were informed that due to age, diabetes, and kidney disease, the opioid she is taking was cleared less efficiently. With the doubling of her dose, she developed an acute toxic encephalopathy. The family and patient have a limited understanding of the potential side effects of opioids in treating pain, a poor understanding of exercise, and dieting for weight control.The interprofessional team recommends to the family continuing opioids at the prescribed dose without any additional doses, rare NSAIDs for breakthrough pain, monitored physical therapy and exercise, a planned diet, temporary placement of a TENS unit, pain monitored by a pain specialist, and surgical intervention as soon as possible. At discharge, a written treatment and management plan is presented to the family and patient for discussion and consent. The goals include relief of pain, increased exercise and weight loss, and surgical intervention as soon as possible. The patient is scheduled for outpatient pain management, physical therapy, and weight management. Before discharge, the pharmacist counsels the family and patient regarding the safe use, dosage regulation, side effects, and proper disposal of opioid medication. An emergency naloxone kit is prescribed, and the family is educated on its use. Follow-up

The patient is scheduled for outpatient pain management, physical therapy, and weight management. Before discharge, the pharmacist counsels the family and patient regarding the safe use, dosage regulation, side effects, and proper disposal of opioid medication. An emergency naloxone kit is prescribed, and the family is educated on its use. Follow-up Three months after discharge, the patient has successfully lost 40 pounds (18 kg) and was cleared for surgery. Following hip replacement, the patient's pain has dramatically diminished, and she is gradually tapered off of her pain medications. She continues to maintain regular exercise and dieting until she is noticeably improved. She reports that she feels better, is enjoying life, and is encouraged by her progress. An interprofessional approach to diagnosis, treatment, and dispensing provides a positive outcome. Interprofessional Case Study #2 CC: Request For Increased Pain Medicine A 76-year-old patient presents to the pharmacy to fill a prescription for acetaminophen and codeine. The pharmacist asks if this is a new prescription. The patient says she has been on it for months ever since she tripped over her hungry cat between her legs and broke her back. The patient says she recently moved from her own home to live with her daughter just down the street from the pharmacy. The pharmacist asks if the patient has been having any problems and she states she “has the runs”, “sleeps as much as her cat”, and she “hurts all over”. She also indicates she would like to return to her volunteer job as a librarian but due to her ongoing pain and feeling unhappy all the time, she has not felt she could bend over to put books on the shelves and does not have the energy or drive to do the work. The pharmacist notes she is a bit agitated. The pharmacist accesses PDMP and confirms this is the only narcotic the patient has been prescribed for the last six months with a recent drop in frequency from QID to BID. The pharmacist is concerned about chronic pain and long-term treatment with an opioid is a risk factor for opioid use disorder. The pharmacist calls the orthopedic surgeon prescriber and presents the signs and symptoms and concerns regarding the development of opioid use disorder. The clinician concurs. The dose is increased to TID and the clinician agrees to see the patient in the office the next day. Work-up/Treatment

The pharmacist accesses PDMP and confirms this is the only narcotic the patient has been prescribed for the last six months with a recent drop in frequency from QID to BID. The pharmacist is concerned about chronic pain and long-term treatment with an opioid is a risk factor for opioid use disorder. The pharmacist calls the orthopedic surgeon prescriber and presents the signs and symptoms and concerns regarding the development of opioid use disorder. The clinician concurs. The dose is increased to TID and the clinician agrees to see the patient in the office the next day. Work-up/Treatment In the visit, the orthopedic surgeon obtains a follow-up x-ray and is reassured the hairline lower vertebral fracture has healed. She maintains the TID dose of the opioid, adds a low-dose NSAID for another 30-days, and refers the patient for physical therapy. She also instructs the patient to apply hot and cold ice packs to her lower back, get a weekly massage, and start gentle stretching exercises. The patient is instructed to follow-up in 2-weeks with the clinician's nurse practitioner. Follow-up The patient sees the nurse practitioner 14-days later. The patient's pain is under control and her signs and symptoms of opioid use disorder have resolved. The patient is instructed to continue the opioid at a BID dose and is placed on a long-term NSAID with a higher safety profile. She is instructed to return in 14 days. The orthopedic surgeon sees the patient on the next visit and reviews the report of the physical therapist. The patient feels much better and the opioid is decreased to once per day. For 14-days and then she is instructed to stop the medication and return for a follow-up visit 2-days later. On this visit, the patient is in minimal pain and has no symptoms of opioid withdrawal or use disorder. She is kept on the NSAID at a once-daily dose and continues to see the physical therapist for another month. The patient follows up with the nurse practitioner who prescribes a low dose, high-safety profile NSAID. She sees the pharmacist who refills the NSAID and she reports she is back to work at the library, she is feeling much better, and she now feeds the cat on the counter to avoid tripping over it during feeding. An interprofessional approach to diagnosis, treatment, and dispensing provides a positive outcome. Interprofessional Case Study #3 CC: Chronic Leg Pain

The patient follows up with the nurse practitioner who prescribes a low dose, high-safety profile NSAID. She sees the pharmacist who refills the NSAID and she reports she is back to work at the library, she is feeling much better, and she now feeds the cat on the counter to avoid tripping over it during feeding. An interprofessional approach to diagnosis, treatment, and dispensing provides a positive outcome. Interprofessional Case Study #3 CC: Chronic Leg Pain HPI: 60-year-old male presents with a history of progressive neuropathic leg pain with an unclear etiology. Physical therapy, relaxation therapy, massage therapy, and acupuncture have been tried without relief. Gabapentin, SSRIs, NSAIDs, and tramadol controlled the pain for the last year but the pain is now worse and is inhibiting the patient's mobility. The clinician tried a short-acting opiate for the last 2-weeks and the pain was relieved. PE: Vital signs T 98.8 degrees F, Bp 120/80, HR 90, RR 16, and O2 Saturation 98%. Physical exam reveals a female in no apparent distress. The heart, lung, and extremity exam is normal. A neurologic exam revealed hyperalgesia and hyperpathia of the lower legs. Work-up Prior EMG studies were consistent with severe neuropathy. Laboratory blood tests reveal no vitamin deficits or toxicities. Treatment: The clinician, a neurologist, decides to transition the patient from short-acting to long-acting opioids and discusses the risks and benefits. The nurse provides a hand-out and discusses monitoring, understanding and signing required documentation, safe opioid use, safe storage, expectations, addiction risks, and required regular follow-ups. The nurse also discusses the signs and symptoms of opioid overdose and the use of naloxone. The clinicians write a prescription for a long-acting narcotic at a low dose and for naloxone. The patient is asked to follow-up in 7-days. The pharmacist is familiar with the patient. The pharmacist accesses KASPAR and confirms the prior narcotic order, the new long-acting order, and that no other potentially interactive medications have been prescribed. The pharmacist educates the patient on narcotic and naloxone use. Follow-up The patient follows up at 7-days and the pain is now under control with no complications. The prescriber completes appropriate documentation and provides for a 30-day course with monthly follow-ups.