Responsible Controlled Substance and Opioid Prescribing

What is Responsible Controlled Substance and Opioid Prescribing?

The Drug Enforcement Administration (DEA) in the United States classifies drugs and substances used in making drugs into 5 categories. This is based on whether the drug has a medical use and its potential for misuse or dependency. The law considers factors like its potential for abuse, its known effects, scientific understanding of the substance, its historical and current patterns of abuse, the extent and duration of the abuse, potential risk to public health, the drug’s potential to cause dependence, and if it is a precursor to another controlled substance.

Controlled substances include painkillers known as opioids, sleeping pills, hypnotics, and stimulants. There are strict federal regulations on how and when these substances can be prescribed to minimize their potential for abuse. In 2020, there were 91,799 drug overdose deaths in the US, with opioids responsible for about 75% of these deaths. Synthetic opioids were involved in 82.3% of opioid-related deaths. The rate of overdose deaths rose by 31% from 2019 to 2020. Opioid abuse is a significant problem and causes much of the drug abuse in the community.

Furthermore, about 2.7 million people in the US over the age of 12 had an opioid use disorder in 2020, with 2.3 million of them having a prescription opioid use disorder. These startling figures emphasize how important it is for people who prescribe, dispense, and manufacture these drugs to take measures such as reducing the amount of opioids dispensed, disposing of unused medications correctly, prescribing opioid reversal agents to those at risk of addiction, and strictly following federal guidelines for prescribing controlled substances and opioids. All this is to help control the opioid crisis and reduce the rise in substance misuse disorders in the US.

According to studies, leftover or unused prescription opioids can lead to substance misuse disorders, and have contributed to the ongoing opioid crisis in the US. These medications are critical for managing acute and chronic pain, and over a quarter of the US population struggle with chronic pain. The US spends over 100 billion dollars every year on healthcare costs related to pain management and opioid dependence, which is more than the combined costs of cancer, diabetes, and heart disease.

Chronic pain management is crucial for maintaining a patient’s quality of life. This highlights the importance of best practices when prescribing opioids. The impact of decisions made in pain management can have long-term effects. Professionals should focus on ensuring that they prescribe the right amount of opioid medication for sufficient pain control while minimizing the risks of addiction, abuse, overdose, and misuse. It’s also important to understand that inappropriate opioid prescribing includes under-prescribing, overprescribing, or continuing to prescribe opioids when they no longer work, especially in patients with chronic pain.

There are significant knowledge gaps among healthcare providers about the right and wrong ways to prescribe controlled substances. Education on substance use disorders in medical school curricula hasn’t been fully effective in closing these gaps and ensuring that these conditions are managed appropriately. Defining and understanding commonly used terms associated with addiction and substance use disorders like addiction, substance use disorder, abuse, dependence, diversion, misuse, pseudoaddiction, and tolerance can help in understanding diagnoses and identifying those needing treatment.

What Causes Responsible Controlled Substance and Opioid Prescribing?

Substance use disorders, especially related to prescription drugs, manifest due to a variety of reasons based on the type of drug involved. It’s vital for healthcare providers to familiarize themselves with the classification system that the Drug Enforcement Administration (DEA) uses for controlled substances. Particularly, they need this knowledge when working with patients who are at a higher risk of addiction. The DEA separates these substances into five categories, as follows:

Schedule I: These include drugs that can be misused frequently and have no recognized medical use in the U.S. Some examples are heroin, LSD, cannabis, ecstasy, methaqualone, and peyote.

Schedule II: This category also contains drugs with a high misuse potential, but they have acknowledged medical uses in the U.S. Examples here are cocaine, morphine, methamphetamine, methadone, oxycodone, fentanyl, and amphetamines.

Schedule III: This covers drugs less likely to be misused compared to those in Schedules I and II, and they have accepted medical uses in the U.S. Some examples are codeine combined with acetaminophen or aspirin, ketamine, anabolic corticosteroids, and testosterone.

Schedule IV: This class involves substances with a lower misuse potential relative to Schedule III drugs, and they also have accepted medical uses in the U.S. It includes benzodiazepines (like alprazolam, clonazepam, lorazepam), zolpidem, and tramadol. One important note is that flunitrazepam, despite being in this category, carries penalties same as Schedule I drugs due to its link with drug-aided sexual assaults.

Schedule V: These substances have even lower misuse potential compared to Schedule IV drugs, and they do have acknowledged medical uses in the U.S. Examples are cough syrup with codeine, pregabalin, and attapulgite.

Now, let’s discuss some important risk factors for prescription drug misuse. The primary risk comes from the amount or number of controlled substances a person is prescribed for legitimate medical reasons. Research shows that an increase in the use of certain medications, such as for attention deficit hyperactivity disorder (ADHD), can result in higher misuse rates. The same goes for opiates used for various conditions, and the increased use of benzodiazepines has also seen a spike in related overdose deaths.

Having a past history of substance misuse, including nicotine, can raise the risk of prescription drug misuse. Mental health problems, particularly those related to pain or post-traumatic stress disorder, can also increase misuse risk. Notably, a family history of substance misuse can similarly make a patient more likely to misuse prescription drugs.

Prescription opiate misuse is often linked to chronic pain. When a person with chronic pain also has a substance use disorder or mental health condition, their risk of prescription drug misuse goes up significantly. It’s also worth noting that adults with ADHD, who often have concurrent substance use disorders, can face more severe substance use disorder symptoms.

Risk Factors and Frequency for Responsible Controlled Substance and Opioid Prescribing

Chronic pain patients have been found to misuse opiate prescriptions at rates of 21% to 29%, and they develop addiction at rates of 8% to 12%. According to the 2021 National Survey on Drug Use and Health (NSDUH) by the US Department of Health and Human Services, substance use disorders and the misuse of prescriptions are quite prevalent in the US.

• Over 40 million people, which is more than 1 in 10 Americans (14.3%), were reported to use illicit drugs.
• Prescription pain medication misuse was second only to marijuana in terms of illicit drug use.
• 9.2 million people misused opioids in the previous year, including 8.7 million using prescription pain medications and 1.1 million using heroin.
• 46.3 million people aged 12 and older reported having a substance use disorder.
• This includes 8.6 million adults aged 18 to 25 (25.6%), 35.5 million adults aged 26 and older (16.1%), and 2.2 million adolescents aged 12 to 17 (8.5%).

Historically, opioid prescriptions in the US were mainly for chronic cancer pain. In the 90s, there was a shift in this approach when healthcare providers were urged to consider pain as the fifth vital sign. Drug companies also aggressively marketed these drugs while downplaying the risks of addiction. As a result, by 2004, the most commonly abused drug was the extended-release form of oxycodone. Currently, the US consumes over 80% of all opioids produced globally. With this increase in use, there has been a significant increase in the number of individuals abusing opioid analgesics.

Signs and Symptoms of Responsible Controlled Substance and Opioid Prescribing

According to the United States Preventive Services Task Force (USPSTF), all adults should be screened for unhealthy alcohol and substance use. Such screenings are crucial for prescribing controlled substances responsibly, even though they may not necessarily reduce drug use.

Screening can be done using any validated tool. The Structured Clinical Interview for DSM-5 (SCID-5), provided by the American Psychiatric Association, is often used to diagnose. It’s considered the gold-standard assessment according to the USPSTF report.

When assessing the risk of negative behavioral responses to prescription opioids and other controlled substances, healthcare providers should consider a range of factors. This could include the patient’s medical history, family feedback, prescription monitoring programs, and screening tools.

• Low risk: Standard monitoring and vigilance are necessary.
• Moderate risk: More frequent contact with healthcare providers and additional monitoring is needed.
• High risk: Regular follow-ups, consultation with an addiction psychiatrist, and limited prescription of short-acting opioids are recommended.

Another approach is a single-item screening, which asks patients about their use of illegal drugs or prescription medication for nonmedical reasons in the past year. This method is easy to administer and not time-consuming.

The 10-item Drug Abuse Screening Test (DAST) is a well-validated tool for identifying drug use. It consists of simple yes-or-no questions that assess the impact and severity of drug use over the past year.

The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) is another commonly used screening tool. It can identify people who use multiple psychoactive substances and provide insights into the severity of their use. However, the downside is that it can be time-consuming if the person uses multiple substances, potentially requiring to answer over 80 items.

Before prescribing any controlled substances, doctors should also consider family history of substance use, the patient’s social support system, their environment, and any untreated mental health issues. These factors can help to reduce the risk of prescription drug misuse.

People diagnosed with Substance Use Disorders (SUDs) must receive proper treatment. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) offers a diagnostic checklist for SUDs:

• The substance is used in larger amounts or for a longer period than intended.
• There’s a strong desire or unsuccessful attempts to reduce use.
• A lot of time is spent obtaining, using, or recovering from the substance.
• A strong desire or craving for the substance is present.
• The persistent use causes difficulties in work, school, or home.
• Usage continues despite causing recurrent social or interpersonal problems.
• Social, occupational, or recreational activities are given up due to use.
• Usage persists despite harmful physical effects.
• Usage continues despite causing or worsening physical or psychological issues.
• Tolerance to the substance develops.
• There are withdrawal symptoms.

The DSM-5-TR further classifies SUDs by severity based on the number of these criteria met. It’s considered mild if 2-3 criteria are met, moderate if 4-5 are met, and severe if 6 or more criteria are met.

Testing for Responsible Controlled Substance and Opioid Prescribing

Before prescribing controlled substances, such as medications that might be addictive or have serious side effects, doctors need to carry out a thorough evaluation. This process includes an in-depth physical exam and history taking, with a focus on any untreated mental health issues or substance misuse. Doctors also use drug testing to make sure that the patient is taking their medication as prescribed. The best way to do this is through random drug testing, which can help spot any underlying substance misuse issues. Before any testing is done, the patient must give their permission. This often forms part of a treatment contract when prescribing controlled substances.

The most common method for drug testing is a urine sample. Other samples, like blood, hair, sweat, and oral fluids, can also be used. These alternative methods have some advantages, such as being harder to tamper with and giving a longer history of drug use. However, they often require more sensitive testing methods as the drug levels can be very low. Urine testing is thus the most commonly used method. It’s simple and typically delivers accurate results.

Urine tests can detect drugs for a longer period than blood tests. However, the levels of drugs in the urine don’t mirror those in your blood. Instead, they show the breakdown products of the drug and how quickly your body gets rid of them. This means that your hydration status – how much you’ve had to drink – can drastically affect the results.

Point-of-care testing is another option. This type of testing is simple and delivers quick results. However, it needs to be performed carefully, especially by non-lab staff, to avoid incorrect results. Training is needed to make sure point-of-care test results are reliable and correctly interpreted.

Doctors frequently order urine tests for common drugs like amphetamines, cocaine, and oxycodone. The timeframe for the drug’s detection in urine varies. For instance, short-acting benzodiazepines, a type of sedative, can be detected for 3 to 5 days, while the long-acting type can appear in tests for up to 30 days. Heavy marijuana use can be detected for up to 12 weeks.

It’s important to remember that positive results can sometimes result from the use of other medications. For example, the presence of morphine in a drug test can indicate the use of morphine, codeine, or heroin. If a patient has a negative drug test, it could mean that they’re not taking the drug or that their body metabolized the drug so quickly it’s undetectable. Specialized testing could differentiate between these possibilities, but it’s not readily available in most labs.

Sometimes a positive result may come from a medication or substance that can cause a similar reaction in the test as the drug being tested for. These are called ‘false positives.’ For instance, some medications like amantadine and ranitidine, could cause a false positive for amphetamines. Similarly, dronabinol and certain heartburn medications could cause a false positive for cannabinoids (components of marijuana). It’s important to keep these false positives in mind when interpreting test results.

Treatment Options for Responsible Controlled Substance and Opioid Prescribing

Before starting a patient on pain medication for chronic pain, especially opioids (strong painkillers), the doctor and patient need to settle on some realistic targets. Those include how much the patient’s pain levels should drop, how much their daily life could improve, and how co-occurring conditions like anxiety and depression could be managed. The doctor will go over the type of treatment to use, how progress will be measured, and details on when to work with other healthcare providers if needed.

When using opioids as part of a pain treatment plan, the doctor should:

* Begin with the lowest possible dosage, then slowly increase it if necessary.
* Only use short-acting painkillers to start with.
* Ensure that the patient is aware of the risks and possible benefits of their treatment, with regular check-ins.
* Educate the patient (and their family, if possible) about the warning signs of breathing problems, a side effect of opioids.
* Keep revising the need for the treatment every time the dosage is changed.

Precautions are crucial; for instance, being careful and being able to explain why a daily dosage of 50 or more “morphine milligram equivalents” (a unit used to compare the power of opioids) is needed.

Being clear about the rules for prescribing medication is also necessary, such as how often prescriptions can be refilled and what precautions to take if they’re lost or stolen.

Before starting opioid therapy, the patient should give their informed consent, which necessitates an understanding of their diagnosis, the purpose of their treatment, and the possible risks and benefits. They should also know the pros and cons of alternative treatments, or even choosing not to get treated. The potential risks of taking opioids should be explained too, including physical side effects, dependence, potential addiction, and so on.

While there’s no standard contract for using opioids, such an agreement should outline that the patient will not seek opioids from multiple doctors and will agree to drug tests. The doctor will be responsible for listening to the patient’s treatment-related concerns and scheduling routine visits to gauge the success of the treatment.

Reasons for changing or stopping opioid therapy should be clearly stated in the treatment agreement. Ideas for how to store and dispose of unused medicines safely can be included, too. If a patient’s pain levels decrease significantly or vanish, if they experience side effects, if the painkillers aren’t sufficiently reducing their pain, if their life quality hasn’t improved, or if they’re misusing their medication, then it may be time to stop taking opioids. In such cases, the dosage should be lowered slowly over time to avoid withdrawal symptoms.

The US Centers for Disease Control and Prevention (CDC) has published guidelines on safely prescribing opioids for pain management. These guidelines include maximizing non-opioid-based therapies whenever possible, carefully discussing benefits and risks before starting opioid therapy, recommending non-opioid treatments for chronic pain, and gradually decreasing opioid use when discontinuing, among others.

In managing patients with chronic pain, non-drug strategies should be prioritized. These include exercise, physical therapy, psychological treatment, spinal manipulation, laser therapy, massage therapy, acupuncture, and yoga. If the pain persists despite these treatments, nonsteroidal anti-inflammatory drugs (NSAIDs) or duloxetine should be considered first.

When prescribing benzodiazepines (medications frequently used to treat anxiety and insomnia), shorter durations of treatment (no longer than four weeks) are recommended. The doctor and patient should keep detailed records of discussions of the risks of dependence on benzodiazepines.

Prescriptions for controlled substances must meet specific requirements. For example, they need to include the patient’s name and address, the date, the doctor’s name, address, and registration number, the medication details, the dosage, and the doctor’s signature. Follow-up visits and education about the risk of drug overdoses are also critical components of these opioid prescribing guidelines.

What else can Responsible Controlled Substance and Opioid Prescribing be?

When a patient has chronic (long-term) pain, it’s important for doctors to figure out what might be causing it. This is crucial for deciding what treatment would be the most effective. For instance, if a patient has ongoing hip and leg pain, it could be due to different reasons such as arthritis in the hip, a nerve problem originating from the lower back, or an issue with the part of the spine that connects to the hip (the sacroiliac joint). Each of these issues might need a different type of treatment.

Some conditions might be more effectively treated with anti-inflammatories, whereas others may respond better to drugs made specifically for nerve pain. The doctor also needs to think about other potential treatments for the specific diagnosis, these could include surgery, steroid injections into joints or the spine, blocking nerves to stop pain, or procedures using heat to control pain.

Doctors also need to be aware that some patients might have more than one problem causing their pain. Someone might be taking strong painkillers (opiates) long-term and their body might start to react by becoming extra sensitive to pain. This can happen alongside the original pain problem they had.

Chronic pain often occurs along with other health problems such as major depression and issues with sleeping. Recognizing these additional problems can help the doctor decide on the most suitable combination of medications. For example, certain antidepressants can help both nerve pain and depression symptoms. Lastly, in cases where a patient is experiencing pain in many areas of their bodies, conditions such as autoimmune diseases (like Lupus or psoriasis), fibromyalgia, and disorders where the brain misinterprets pain signals should be considered. Hence, it’s important for doctors to remember that chronic pain might be associated with one or several health concerns.

What to expect with Responsible Controlled Substance and Opioid Prescribing

The 2016 CDC report indicated a significant increase in harm and death rates in the US due to the escalating use of opioid analgesics for managing pain. In just one year, 2016, over 63,600 deaths occurred in the US due to drug overdose. About two-thirds of these deaths were directly linked to opioids, while almost 30% resulted from using opioids and benzodiazepines together.

Fast forward to 2021, data from the National Institute on Drug Abuse (NIDA) revealed that the number of deaths related to overdose had risen to more than 106,000. Synthetic opioids were involved in over 70,000 of these deaths, with prescription opioids accounting for over 16,000. One major indicator of future heroin use was found to be prescription drug use and unauthorized oral opioid use.

Due to these increasing trends over the last two decades, the FDA mandated a label change in 2016. The goal was to educate healthcare providers and patients about the risk of opioid medications misuse, addiction, and overdose, particularly when paired with benzodiazepines. To help curb the opioid crisis, the FDA also warned the public and healthcare professionals about the severe risk of respiratory depression, coma, and death when these medicines are used together or with alcohol.

In 2020, the FDA further addressed concerns about benzodiazepines by issuing a black box warning which highlighted the lack of sufficient prescribing information and guidelines for these drugs. The warning also detailed the serious risks of physical dependency associated with these medications, especially when used for extended periods and at high daily doses.

Possible Complications When Diagnosed with Responsible Controlled Substance and Opioid Prescribing

Prescription drug misuse, addiction, and overdose are serious potential complications related to the use of controlled substances. It’s critical to identify those who show signs of substance use disorder early so that they can get the help they need. As per SAMHSA, about 16.5% of over 12-year-olds have been diagnosed with a substance use disorder. In 2021, the CDC reported 106,699 overdose deaths in the United States.

The US government introduced the Mainstreaming Addiction Treatment (MAT) Act of 2021 to expand the availability of treatment options and address the opioid crisis. Before the act was passed, healthcare providers needed specific waivers to prescribe drugs for detoxification and maintenance treatments. The MAT Act allows providers to prescribe buprenorphine, a common treatment for opioid use disorder, without needing additional permissions. This is an effort to normalize the treatment of such disorders and spread this type of care across different healthcare settings.

Since December 2022, healthcare professionals don’t need a special waiver to prescribe buprenorphine. The Act provides such permissions to all DEA-registered practitioners with Schedule III authority. Another important step away from old regulations is that there are no longer limits on the number of patients a practitioner can treat with buprenorphine, and separate tracking of these patients is no longer required.

The MAT Act also places emphasis on education for healthcare practitioners about treating opioid use disorder and encourages them to integrate substance use disorder treatment into their practices.

Treating opioid use disorder is a long-term process that requires medical intervention. Medication for opioid use disorder, or MOUD, therapy is the standard treatment for these patients. This treatment may include the use of drugs like methadone, buprenorphine, and naltrexone. Initial doses are relatively low and must be adapted to each patient’s condition. However, MOUD therapy requires patients to abstain from opioid use before it can be started.

Care providers treat benzodiazepine use disorder by gradually reducing dosage over time, often using a long-acting formulation like diazepam. It’s also often recommended that cognitive-behavioral therapy is initiated while the patient is undergoing medically supervised tapering of benzodiazepines, as it has shown to be more effective.

Preventing Responsible Controlled Substance and Opioid Prescribing

Patients and their families can play a crucial role in making informed decisions about the use of prescription medicines, like controlled substances and opioids. Family members often notice if a patient is feeling down or struggling to manage daily tasks. As long as the patient agrees, doctors might ask family members some key questions. These may include whether taking pain medication dominates the patient’s day, how often they take pain medicine, if they are using drugs or alcohol, whether they avoid certain activities, and whether they’re feeling depressed or finding it tough to go about their daily routine.

It’s particularly important for patients who are prescribed controlled substances or opioids to understand how to use these drugs safely. They should avoid driving or using heavy machinery, abstain from drinking alcohol or taking un-prescribed sedative drugs, and never suddenly stop taking these medicines. Patients should also consult the doctor if they feel the medication isn’t working, dispose of leftover opioids in a proper manner, refrain from sharing their drugs with others, stick to the recommended dosage, and set realistic expectations for the benefits of the medication.

Preventing opioid abuse is a team effort. Medical professionals such as doctors, pharmacists, and other healthcare staff need to work together to make sure that patients are receiving and using prescription medicines safely. This includes not just prescribing medicines, but also ensuring that prescriptions filled in pharmacies are appropriate and genuine. Wrong use of these controlled substances can lead to serious problems, not only for patients, but also for the society at large.