Prescribing Controlled Substances, Drug Diversion, and Best Practices, 1 hour West Virginia, (FL INITIAL-AP-Pharmacology)

Opioid and other controlled substance addiction, diversion, and overdose continue to be problematic for patients, healthcare providers, and law enforcement and is a complex medicolegal issue. Attempting to control the epidemic of overdose deaths, increasing addiction, and diversion of controlled substances prescribed, many states require individual providers to receive specific training in different areas of prescribing controlled substances. These areas include diversion, patient use monitoring, and abuse risk assessment.

• Substance Abuse is the “Intentional use of an opioid for a non-medical purpose, such as euphoria or altering one’s state of consciousness” (Kalkmana et al., 2022).
• Addiction is a “Pattern of continued use with experience of, or demonstrated potential for, harm” (Kalkmana et al., 2022).
• Appropriate opioid analgesic prescribing involves providing pain control while minimizing toxicity, use disorder, or the risk of use disorder and implementing safeguards to reduce drug diversion (Preuss et al., 2022).
• Alcohol use disorder (AUD) is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences (DSM V-5, 2022).
• Cannabinoids-products are used either as the natural marijuana plant or isolated from the constituents of the marijuana/hemp plant.
• Controlled substance is a drug or other substance the government tightly controls because it may be abused or cause addiction.
• The Drug Abuse Screening Test (DAST10) is a 10-question screening tool administered by a clinician or self-administered.
• DAST-20 A 10-item, yes/no self-report instrument designed to provide a short tool for clinical screening and treatment evaluation can be used with adults and older youth.
• Iatrogenic harm is unintentionally induced by a physician or surgeon, medical treatment, or diagnostic procedures (Merriam-Webster, n.d.).
• Opioid-tolerant patients are those taking, for at least one week, ≥ 60 mg oral morphine a day, ≥ 25 mcg transdermal fentanyl per hour, ≥ 30 mg oral oxycodone a day, ≥ 8 mg oral hydromorphone a day, ≥ 25 mg oral oxymorphone a day, ≥ 60 mg oral hydrocodone a day, or an equivalent dose of another opioid (PDR, n.d.).
• Inappropriate opioid analgesic prescribing is non-prescribing, inadequate, excessive, or continued prescribing despite evidence of the lack of effective opioid analgesic treatment (Preuss et al., 2022).
• Misuse is “Opioid use contrary to the directed or prescribed pattern of use, regardless of the presence or absence of harm or adverse effects” (Kalkmana. et al.,2022).
• Medical morphine equivalent (MME).
• Naloxone, Narcan®, and Kloxxado® are an opioid antagonist that can quickly reverse an overdose of opioid drugs (NIDA, 2022).
• The opioid Risk Assessment Tool (ORT) is over 20 years old.
• Pain neuroscience education (PNE) teaches about pain mechanisms, causing the brain to stop overreacting and becoming constantly hyper-stimulated at the cerebral cortex level. This, in turn, reduces cerebral threat perception, which decreases the activation of pain systems in the brain. This is for pain like fibromyalgia.
• Pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage (Raja et al., 2022).
• Acute pain duration less than 1 month.
• Sub-acute pain duration 4-12 weeks.
• Chronic pain duration greater than three months.
• Acute, chronic pain is when a “flare-up” of “old” pain is usually due to a new insult to an old injury.
• Neuropathic pain- sometimes called nerve pain. This is caused by the somatosensory nervous system's primary lesion(s).
• Visceral pain is induced by organs, such as the gallbladder, stomach, or bladder (a deep aching).
• Nociceptive pain is normally expected from an injury to tissues and Inflammatory pain. Activation and sensitization of the nociceptive pain pathway by the body’s inflammation mediators released at the injury site, such as bradykinins (usually sharp, caused by movement or intermittent to constant sharp aching).
• Computerized statewide pharmaceutical monitoring database programs (PDMP) differ in each state and country.
• Prescription diversion is giving or selling, or loss due to theft of all or part of a prescription for controlled medications to anyone other than for whom it is prescribed.
• Urine drug test (UDT).
• Screener and Opioid Assessment for Patients with Pain (SOAPP).
• Substance use disorder (SUD) DSM-5 criteria are a maladaptive pattern of substance use leading to clinically significant impairment or distress. (Hartney,2022).
• West Virginia Controlled Substance Monitoring Program (WVCSMP).
• Opioid intoxication, per the DSM-5:
  • Opioids are often taken in more significant amounts or longer than intended. There is a persistent desire or unsuccessful efforts to reduce or control opioid use. A great deal of time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects, craving, or a strong desire to use opioids. Recurrent opioid users fails to fulfill major role obligations at work, school, or home. Continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids. Important social, occupational, or recreational activities are given up or reduced because of opioid use. Recurrent opioid use in situations in which it is physically hazardous Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by opioids (DSM-5 2022).
• Tolerance is either one of the following:
  • a need for markedly increased amounts of opioids to achieve intoxication or desired effect
  • markedly diminished effect with continued use of the same amount of an opioid (DSM-5 2022)
• Either of the following manifests withdrawal:
  • the characteristic opioid withdrawal syndrome
  • the same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms (DSM-5 2022)

Understanding the diversion of drugs helps to see the bigger picture in the epidemic of opioid and other controlled substance prescribing environments. There is a greater likelihood that providers will ameliorate it at the primary care level if they know the facts and follow the FDA, CDC, and the VA’s recommendations with a higher degree of care and discernment.

With any patient, there can be a risk of addiction (even with pain present), diversion, abuse, or misuse of controlled substances. While unfortunate, the actions of the bad actors and the epidemic of complex medico-legal disasters have outweighed the patients’ needs due to legitimate pain and mental health. Stringent guidelines and laws have been implemented to stem the tide of illicit activities. This has been successful, but in a limited way (Manchikanti et al., 2022).

Providers willing to comply with all the detailed rules and regulations involved must avoid seeming untrusting or suspicious as they fulfill their obligation to “Do no harm.”  According to Goldstick et al. (2022), providers have reacted to the extreme in the face of very restrictive guidelines published by the CDC in 2016. The CDC did not intend this reaction, and thus they wrote new guidelines in 2019, which include the warning not to overreact and thereby harm patients (iatrogenic harm) who are justifiably in need (Dowell et al., 2022; Salvatore et al.,2022).

According to Manchikanti et al. (2022):

• The 2016 CDC opioid guidelines were aimed at primary care providers. However, many state boards mandated them by law, resulting in tremendous needless suffering and exacerbating the illicit opioid epidemic with the causation of needless deaths. These guidelines not only restrict opioid prescriptions but also have restricted all interventional techniques to reduce access and send patients to the streets for illicit opioids. 

Providers were concerned about being on the right side of the law and were attempting to protect their hard-earned licenses. Providers already have the situation of trying to discern “real need” from manipulation attempts to gain controlled substances for diversion (Preuss, 2022). Provider trust may continue to be an issue when a provider requires a patient to sign a patient responsibility contract allowing urine drug testing (UDT) and pill counting. UDT is put in place to identify the need to work with a patient who is using other (illegal) drugs and, at the same time to find that the patient is indeed consuming at least some of the prescribed medications. Patients may be “self-medicating” other illegal controlled substances, such as street drugs, which may be dangerous. These patients will need help to discern this, and a medication change to eliminate the need to self-medicate. Pill counting is a time-consuming measure that may be a relatively accurate way to discern whether a patient has been diverting medications. Still, it is not a perfect way to assess risks alone (Gill et al., 2022).

Studies are needed to design newer tools, and many computer-assisted tools were in development as late as 2022 but are not available to the providers at the clinic or community level (Wei-Hsuan et al., 2022). Hospitals are equipping themselves against diversion perpetrated by staff providers using computer-driven algorithm software, which can be built into the medication dispensing workstations (Shaw, 2022).

Regarding the prescribing, monitoring, and finally discontinuing controlled medications, communication and education with the patients must be performed and documented to maintain strict conformation to states’ requirements. During your initial patient-provider communications, you should touch on the kind of pain your patient is describing and which medications are best for reducing and relieving that type of pain.

Education should include the side effects, dosage, safety information (such as safe, locked storage), and signs of overdose. CDC encourages that naloxone be prescribed with dosage instructions when opioids are prescribed. Overdose of naloxone is rare, but depending on the level of opioid dose, repeated consecutive doses could be uncomfortable for the habituated patient (Dowell et al., 2022). The patient and family members or caregiver should be warned to call 911 immediately after a naloxone dose, as the dose should be managed moment-by-moment by a medical professional as soon as possible.

After the clinician determines that a controlled substance will be prescribed, there is yet more work for the provider to do. Due to the unintended tragic situation caused by the industry’s overreaction to the CDC 2016 guidelines, Manchkanti et al. (2022) reported increased illegal drugs for pain and (presumably) mental health issues. There was a concurrent increase in suicides among people with severe chronic pain issues when providers discontinued chronic controlled substances. Many tapering or weaning-off plans were either unsupported or not implemented (2022). Provider-to-patient trust became an issue.

First, discovering the patient’s personal, religious, social, and cultural pain constructs are legitimate assessments for pain management. Assessing the patient’s cognitive ability as it relates to expressing pain and understanding issues to avoid is also particularly important. With a nonverbal patient, the provider must look for signs and question family members about the patient’s pain history. All these things are part of patient-provider communication.

The patient sets pain goals to discover a place to begin tapering off the medications without leaving the patient in severe pain or with severe mental health issues. Pain goals may include:

• Getting the most pain relief with the least amount of side effects.
• Improving the quality of life in the long term as well as the short term.
• Safely returning to work without side effects of pain medications.

The provider should also be alert to psychological improvements and quality of life changes. It is also a tool that the clinician can use to teach that it may not be possible to eliminate all pain (as a goal) in a patient’s body. Sometimes, especially in subacute or chronic pain, the best a patient and provider can hope for is to keep pain to a reasonable level (a goal chosen by the patient) and remediate it with non-pharmacological means. Decisions between the patient and the provider must be made about whether weaning off the drug is the goal or if specialized medical or mental healthcare is the goal. Prescriptions can be written for temporary relief while the patient gets established with a specialist in the field they require. The patient must be taught about medication safety and keeping controlled substances at home. The danger of child overdose cannot be stressed strongly enough. In a retrospective study by Champagne-Langabeer et al. (2022), during the three years ending in 2017, almost 60,000 children were in emergency departments (ED in the US for opioid use and overdoses. The mean age was 11.3, the greater part of the girls. In addition, most of the children were from the South. Sadly, 68.5 percent of these visits were from opioid overdoses. Overall, infants were in the second-largest opioid accident group to appear in EDs across the United States during this period. Over 9000 children have died since the turn of the century because of opioid accidents (Champagne-Langabeer et al., 2022). The rate of prescription opioid overdose among adolescents has also been increasing in recent years. In 2022, there were an estimated 1,800 deaths from prescription opioid overdoses among adolescents. This number is more than double the number of deaths from prescription opioid overdoses among adolescents in 2002. This is evidence that locked, safe and out-of-reach controlled substance storage in the home is critical. These statistics also indicate the need for naloxone prescriptions with opioid medications for patient and family safety (NIDA, 2022).

In West Virginia in the 1st quarter of 2023, there were 2006 visits to the ER for overdoses, with the greater number of these patients being male between 30-39 years of age. Approximately 73% of these were discharged. Of the rest, 1.5% died. Unfortunately, 3% died at the scene despite 71.5% being treated with Naloxone. (DHHR, 2023). W.VA. had more overdoses per capita than any other state (90.9 out of every 100,000 residents) in 2021, a ten-year increase of over 50 percent (KFF, 2023).

Theft of opioids and other controlled substances is a major way drugs are diverted from the intended use. Hence a locked cabinet is the best solution. Parents are not often willing to believe their minor children or other family members in an extended family household would steal medications, however; 50 percent of 12 to 17-year-olds have reported they stole medications from family members, in the previous 12 months before the study (2021 National, 2022). According to the National Institute on Drug Abuse (NIDA), an estimated 2.5 million adolescents aged 12 to 17 used prescription opioids for nonmedical purposes in 2022. This number has been steadily increasing in recent years, and it is now more than double the number of adolescents who used prescription opioids for nonmedical purposes in 2002 (SAMHSA, 2022).

A 2017 Substance Abuse and Mental Health Services Administration (SAMHSA) study found that 10.6% of adults aged 18-25 reported using a prescription pain reliever without a prescription in the past year. Of these, an estimated 2.1 million adults reported having obtained their prescription pain relievers from a friend or family member, and an estimated 500,000 adults reported having obtained their prescription stimulants from a friend or family member. Theft occurred by parents of children prescribed controlled substances for various conditions, from ADHD to pain (SAMHSA, 2017). Pharmacy misappropriation, robbery of legitimate drug transport from manufacturers, stealing prescription ordering supplies from medical offices, and stealing from hospitals and other health facilities by healthcare workers and others, including hospices occur. The patients from all the facilities mentioned above are part of the diversion picture. Since diversion may also come from inadequate disposal of “leftover drugs,” there are ways to prevent this. We must not overprescribe to satisfy the “as needed” quantities. Our patients react to leftover, labor, time, and financially intensive medications by “saving” them for the future. This becomes problematic if used without supervising the overall health picture shared with others. Now the patient is an illicit provider and an illegal pharmacy. A child or a pet could ingest that medication or be stolen, used, and sold. Proper disposal of these leftover medications becomes imperative. DEA Drug Take Back boxes are at pharmacies nationwide. 

Using the criteria set for substance abuse disorder in the DSMV 5-TR, providers are expected to determine whether a patient will likely abuse, divert, or get addicted to a controlled substance prescription. Multiple screening tools are available for identifying drug or alcohol abusers, such as ORT and SOAAP. DAST10 and DAST20 are designed to identify drug or alcohol abuse in adults and adolescent abusers, respectively.

•  
• DAST-10
• DAST-20
• SOAPP is attachment A (see Resources section)
• ORT is attachment B (see Resources section)

These tools are primarily patient self-screening tests that can also be administered by trained nurses and are intended to be used in concert with the providers’ advanced education and intrinsic good judgment. It is unclear why the substance abuser or the drug dealer would be honest and forthcoming while filling out one of these tools. That is why there are several red flags you can watch for that will be covered later.

A prescription drug monitoring program (PDMP) is an electronic database that tracks controlled substance prescriptions in a state. They can provide health and legal authorities with timely information about providers’ prescribing and patient behaviors that contribute to the epidemic and facilitate a nimble and targeted response (CDC, 2021). PDMPs track controlled substance prescriptions from physicians, nurse practitioners, and physician assistants. They also track pharmacists who fill controlled substance prescriptions.

The West Virginia Controlled Substances Monitoring Program (WVCSMP) requires all prescribers must be registered within 30 days of receiving the DEA number. There are fines associated with proven guilt of not registering, fraudulent use, and disclosing private information from the database. When a prescription is written, the provider provides a DEA and Provider identification number. Along with this, a patient’s current legal identification form, including current residence address is required. It is electronically transmitted to the pharmacy, where the pharmacist fills the prescription and files a report (within 24 hours) to the WVCSPM. The person who picks up the medication must provide a legal form of identification and sign for the medication. The patient must have an up-to-date legal form of identification. Records of this transaction must be maintained for one year. A facility that does not have internet access is not required to transmit this report electronically (West Virginia, 2021).

According to Niculescu et al. (2019), pain is so real that there are genetic serum biomarkers for its presence and severity. Sadly, they report that suicidality shares some markers with severe pain. Pain has been described throughout human history as an enemy, a threat to sanity, and a lover. There are many ways to accept pain occurring in our bodies, but accepting pain in others is much more difficult. We tend to minimize other people’s pain, and according to studies, we are minimizing based on our subjective criteria, with little thought for the patient’s subjective report. Depending upon our biases, we may even judge pain in others by their age, gender, apparent financial status, and racial appearance (Keister et al., 2021). As each patient's pain is different and specific to them, there is no one-size-fits-all dosage of pain medication. Pain tolerance is not only different for different people, but it also changes throughout the lifespan (Mullins et al., 2022).

There is a syndrome in patient management called opioid-induced hyperalgesia (OHI), where the medication causes more pain than it relieves. Hyperalgesia is the body feeling a heightened level of pain. Allodynia is the sensation of pain related to a stimulus that ordinarily does not cause pain, such as a light touch or a cool breeze. Allodynia and hyperalgesia can also be leftovers of OIH. The best thing you can do for OIH is reduce the level of pain medication and titrate it to a similar morphine milligram equivalent (MME) in another opioid. The treatment for hyperalgesia is an NMDA receptor agonist such as methadone or ketamine, and for allodynia, pregabalin, or another nerve pain medication. People at high risk for allodynia are migraine sufferers, with women at greater risk than men. The culprit for allodynia for both men and women is nerve damage.

It is reported in several studies that there is a bias toward prescribing opioid pain relievers to people who are married, white, and of a mature (50-65 years) age as a preference (Keister, 2021). Dr. Carmen Green reports that women of color are improbable to have their pain treated or even assessed properly (Healthy Women, 2020). Even in the case of Sickle Cell Disease (SCD), a widely understood disease process that causes pain by its very mechanism, it is undertreated and given less than sterling care. With greater than 90% of SCD patients in America being of African descent, it is an easy-to-study bias phenomenon (Marr, 2022). Boring et al. (2022) report that there is a bias that women and people of color overrate their pain. Still, their study shows that this is not true, showing that women and people of color often minimize their pain due to fears of not being believed and that we all discount or minimize the pain of others. This is a complex issue psychologically, but it may be sufficient to be aware of our biases and do our best to realize that other people are more likely to be telling the subjective truth about their pain and treat it to effect (Boring et al., 2022).

You will encounter two common situations at least once and probably much more often in primary care.

The selected medications below are listed for your information. However, controlled pain medications are not the chosen treatments according to the CDC, the FDA, and the VA. These agencies recommend that nonopioid and non-pharmacological therapies be used for sub-acute (flare-ups) and chronic pain treatment (Dowell et al.,2022; US Department of Veterans Affairs, 2022). Nonpharmacological treatments could be said to fall into five groups:

• Metabolic: dietary supplements, herbs, vitamins, and minerals, weight loss.
• Stress Reduction: Yoga, Meditation, Acupressure, Massage.
• Device Assisted: Acupuncture, Transcranial or direct magnetic stimulation, neurofeedback, chiropractor.
• Exercise: Tai Chi, Qigong, stretching, physical therapy, PNE with physical therapy.
• Psychosocial: PNE, support groups, volunteering.

Some of these non-pharmacological areas overlap and are used in combination with each other and with non-controlled and controlled pain relief medications. Patients should be strongly encouraged to participate in one or more as this is more effective for increasing the quality of life and decreasing awareness of pain and discomfort than medications alone (CDC, 2022; VA, 2022).

Pain is assessed the same in every case. It is the details that matter here. Ask where it hurts and mark the pain map meticulously as a baseline. Document further using a pain assessment tool like the PQRST model, PEG, or 1-10 scale. The Baker-Wong scale has only five faces and is often used for children. The benefits of this scale are that it works no matter the patient’s age or language. Be sure to provide a patient-friendly professional interpreter and tools if the patient speaks a different language at home. The following are website examples of a pain map, assessment tools, and scales.

• Pain Map
• PQRST Pain Assessment
• 1-10 pain scale
• Wong-Baker Scale
• The PEG Scale is Attachment C (see Resources section)

Get a complete social, family, and health history, including diseases or co-morbidities. Find out if they have seen other providers for this pain, what was tried, did that help, and has the pain changed. Knowledge is power. The more you know about this patient and the past, present, and future, the better you will help them and yourself.

Modified PEG tool

If the pain is not specifically trauma related, is it a product of diseases such as Sickle Cell disease (SCD), MS, or Diabetes? Imaging studies are in order once you have eliminated obvious physiologic reasons for pain: injury, trauma, metabolic, or polypharmacy. Insurance companies require a certain order of imaging tests, or the patient must pay out of pocket. Usually, radiographs are followed by CT scans, and finally, MRIs can be done. Insurance companies are poor decision-makers regarding what should be done and when. You will help your patient by preauthorizing tests. While different pains can all be assessed in about the same manner and treated differently, eventually, we can use pharmacogenetics as a more personalized prescription.

Doctors and scientists have already discovered DNA useful to determine whether some drugs might be metabolized better by some people due to genetic expression and enzymes that either promote or inhibit metabolism. The CYP 450 and the CYP 46B4 are enzymes responsible for many pharmaceutical metabolic actions, including opioids and other pain-alleviating drugs. These are expressed well, moderately, or not, in different people.

Many patients have a combination of types of pain. A severe injury or trauma patient might experience soft tissue and visceral and nerve pain. Bone fractures, burns, and crushing injuries are similarly complex to treat. Then there are the most common patient complaints of disease-related pain, headaches, back pain, orthopedic sprains, and tears. Soft tissue pain is considered inflammatory pain that benefits from NSAIDS. For nerve pain, Consider TCAs or antiseizure medication such as Neurontin. Are there labs or imaging needed to discern the cause of visceral pain? Treating the source of the pain is always the desirable answer if etiology can be identified. Consider over-the-counter anti-inflammatories such as Naprosyn Sodium or Ibuprofen, non-anti-inflammatory acetaminophen, or a combination product.

Non-cancer disease pain like sickle cell disease is chronic with acute or chronic flares. This pain may require opioids such as MS Contin, with an immediate release “backup” such as Oxy IR. For diseases and disorders such as arthritis, irritable bowel disease, ulcerative colitis, sciatica, migraines, fibromyalgia, and rheumatoid arthritis, to list a few, NSAIDs with non-pharmacological adjuncts are just as successful (V.A. 2022). Cancer pain is often treated with long-acting or extended-release opioids.

The CDC and Goldstick et al. (2022) have made mention of the previous 2016 controlled substance guidelines being followed so strictly that patients were harmed by being tapered too quickly off opioid pain medications and not being given adequate support during the process (Dowell et al.,2022; Goldstick et al., 2022).

Tapering is the deliberate reduction of controlled substance dosage and lengthening intervals between doses. You can use tapering algorithms to help your patients stop taking these problematic medications. No perfect tapering algorithm fits every unique physical and psychological situation because every patient's mind, spirit, and body are unique. Research shows that out of almost 14,000 patients who tapered off opioids over one year, they continued to have pain, overdose, and increased mental health crisis issues, even suicide up to two years after the tapering started (Fenton et al., 2022). The United States Department of Veteran’s Affairs (VA) has given provider advice for tapering: reducing opioid medications in the chronic opioid user taking more than 50 MMEs per day should not exceed 5-20% of the total daily dose per month (VA, 2019). This amount may help a patient to reduce or discontinue the opioid drug, keeping in mind that the patient must be educated that they cannot suddenly return to the original dose as they will no longer have the tolerance for it. It will precipitate an overdose (Fenton et al., 2022).

According to Fenton et al. (2022), 15.3% of patients in their meta-review successfully discontinued opioid use and had fewer mental health issues. According to the same study, however, the other 74% of the patients continued to need opioid pain medications at a reduced rate, and a few eventually increased the dosage they were taking (Fenton et al., 2022). This complex study led to several conclusions over and above these. The main gist of the study is that the dangers of opioids do not end with tapering the medications, and the patient should be followed and supported up to two years after initialization of the tapering efforts. The provider may need to consider keeping the pain goals fluid.

In today’s medical practices, most providers lack consistent electronic calendar reminders and the time to achieve these needs. Providers must keep this at the forefront of their communications with the patient at every visit. Educating the patient regarding the need for extra follow-up, rotating medications, and starting non-pharmacological therapies early may help to alleviate or reduce these mental health crises. Unfortunately, not all patients can be discontinued from pain medications and maintain a decent quality of life.

Per the CDC:

• You can refer specifically to DSM-5 Criteria A and B for opioid withdrawal syndrome:
  • Either of the following:
    • cessation of or reduction in opioid use that has been heavy and prolonged for several weeks or longer; or
    • administration of an opioid antagonist after a period of opioid use.
  • Three or more of the following, developing within minutes to several days after Criterion A: dysphoric mood; nausea or vomiting; muscle aches; lacrimation or rhinorrhea; pupillary dilation, piloerection, or sweating; diarrhea; yawning; fever; or insomnia (2022).

Pain in hospice patients varies from patient to patient. Pain in this population is treated in ways that could not be employed for non-terminal disease pain. In the past, methadone, morphine, oxycodone, and fentanyl have all been used in nearly every formulation, from oral and sublingual tablets, capsules, lollipops, injections, automatic pumps, oral films, and transdermal patches. The medication dosages are titrated up to the level of effect, which will keep the dying patient from suffering from symptoms of uncontrolled pain while dying. The dosages are often extraordinarily high compared to a patient who is expected to live longer than six months.

In this situation, there is no need for limits concerning addiction or the need to taper the patient from the medications in the future. There is still the possibility of overdose as the metabolism slows at the end of life, and there is a need to be cognizant of that. Also, there is a certain amount of drug diversion by family, visitors, and medical personnel (Cagle, 2020). Again safe, locked storage of these medications should be in place, regardless of the inconvenience to the patient, providers, and caregivers. Pain medication in terminal cancers and other life-ending disease processes is multilayered and ever-changing due to the complexities of physiological changes.

Billing codes for this do exist. For Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule, go here.

Medicare is using the following codes, Pain Management bundle codes effective January 01, 2023:

• Required initial face-to-face visit at least 30 minutes provided by a physician or other qualified health professional; first 30 minutes personally provided by a physician or other qualified healthcare professional, per calendar month.
• When using G3002, 30 minutes must be met or exceeded. In other words, the code includes assessment, diagnosis, and monitoring of the patient’s pain, including working with other clinicians to manage treatment and lead to better outcomes. However, this code only describes the first 30 minutes of chronic pain management care.
• Providers who spend more than 30 minutes with the patient can report the new add-on code: G3003: Each additional 15 minutes of chronic pain management and treatment by a physician or other qualified healthcare professional per calendar month, listed separately in addition to code for G3002. When using G3003, 15 minutes must be met or exceeded. Because G3003 is considered an add-on code, providers can only report it if they spend more than 30 minutes on chronic pain management (Kim, 2023).

Billing codes designed for the AMA: Evaluation and Management (E&M) codes are ever-changing. For a complete sheet, go here. For the complete document with accompanying grids and in-depth instructions, go this website here.

This is a complex medical-legal issue. West Virginia has tried to establish a system to combat the diversion, abuse, and misuse of prescribed controlled substances at the primary level. There are some things as a provider you should know about when you prescribe controlled substances. The following is the website.

First, as a potential prescriber of controlled substances, you must obtain a DEA registration number and report it to the Board of Pharmacy within 30 days. The West Virginia controlled substances monitoring program can record all your controlled substance prescription writing. The board can report to multiple law enforcement agencies and other state entities any inappropriate seeming prescribing or filling of prescriptions for controlled substances. Several entities can access the database in specific cases for legal investigations and checking on employees, such as at hospitals, long-term care, rehab facilities, medical-themed schools, and colleges. Scientists and researchers can also access the information if it is first de-identified for study.

Doctors, nurse practitioners, physician assistants, and dentists must report all controlled substance prescriptions to the West Virginia Controlled Substance Monitoring Program (WVACSMP) within 24 hours. Only veterinarians are not required to report to the WVACSMP. All records of patients, prescribers, and pharmacists involved with controlled substances are kept for five years.

Secondly, to prescribe controlled substances, you must first have three continuing education credits of training such as this one and a one-hour course yearly after that. If you want to prescribe marijuana, another 4-hour training is required yearly.

Providers are expected to access the WVACSMP before prescribing controlled substances and during the treatment regimen to discover people using more than one pharmacy or prescriber to obtain controlled substances for nefarious uses. This protects you from writing controlled substance prescriptions for a patient attempting to use the prescription for abuse or diversion. It also protects you from being fined for not checking for criminal behaviors that you can check for.

Hospitals, EMS, and other providers must also report overdoses and overdoses that result in death, along with any ancillary evidence of what may have been used and how it was obtained if known. This makes criminal investigation easier, and of course, if illicit prescribing or filling of prescriptions for controlled substances is involved in an overdose death, that prescriber or pharmacist can be prosecuted if investigated and found guilty.

If anyone is found to have accessed the database for use other than intended by the law, such as looking up a colleague or neighbor, they may be prosecuted, fined, and or jailed if found guilty.

If you are a dispenser of these medications directly to the patients, without the patient going to an outside pharmacy, you must search the database and report each time with your name, DEA, and provider number, also supplying the patient’s complete ID information and the medication information numbers. You may only dispense a quantity sufficient to last 72 hours of controlled substances, no more than twice in 15 days.

(§60A-9-6b). “The information obtained from accessing the WVACSMP database for the patient shall be documented in the patient’s chart maintained by a private prescriber or any inpatient facility (West Virginia Code,2022).” If the provider does not access the system as they should when prescribing, they will be fined $100 for each event by their licensing board. There is no civil liability for required reporting. These fines are put into the fight substance abuse fund. This interest-earning account in the state treasury is used to fight substance abuse via public training and information. Leftover money rolls over each year to continue funding.

Providers who are required to report to the State Board of Pharmacy, that do not, can be fined from $100.00 to $500.00 per instance, whereas if found to be knowingly and willfully refusing to report, they can be fined a maximum of $1000.00 and confined in jail for a maximum of six months. The fine goes up to $5000 if fraudulent information is reported, and the jail time increases to one year.

Authorized fraudulent use of the accessed materials is punished by a jail stay of up to six months and a fine of not more than $1000. Unauthorized fraudulent access is a felony. A conviction carries a fine of $3000.00 to $10,000.00 and prison time of not less than one year, and up to a maximum of five years. All of this applies to out-of-state prescribers and pharmacists if the patient is a current resident of West Virginia. Thankfully, according to §55-7B-2b of this code, you cannot be prosecuted for refusing to prescribe controlled substances to someone you believe is abusing or diverting that drug.

According to §55-7B-2e, f of this code Registered Nurses and Registered Pharmacists will not be prosecuted for administering or dispensing (respectively) a controlled substance when acting on a physician’s order. According to §60A-4-410 b, Patients asking for that prescription while withholding the information that they are already receiving care for the issue are prosecutable with jail for not more than nine months or fined not more than $2,500, or both. Some of the drug treatment programs available at their website.

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• Attachment A
• Attachment B
• Attachment C

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Additional Resources:

Areso-Bóveda, P.B., Mambrillas-Varela, J., García-Gómez, B. et al. (2022). Effectiveness of a group intervention using pain neuroscience education and exercise in women with fibromyalgia: a pragmatic controlled study in primary care. BMC Musculoskelet Disord 23, 323 (2022). 

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