Best Practice of Opioid Prescribing PDF
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This document discusses best practices for opioid prescribing, emphasizing the importance of understanding federal and state laws surrounding controlled substances. It covers safe prescribing recommendations, who can issue prescriptions, and the required elements on controlled substance prescriptions.
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Best Practice of Opioid Prescribing Opioid medications are **controlled substances**. This means they have a high potential for abuse as their use can lead to physical and/or psychological dependence. It is therefore important to understand the federal and state laws surrounding controlled substanc...
Best Practice of Opioid Prescribing Opioid medications are **controlled substances**. This means they have a high potential for abuse as their use can lead to physical and/or psychological dependence. It is therefore important to understand the federal and state laws surrounding controlled substance prescribing and other general recommendations related to them. **General Safeguard Recommendations** Although not always inscribed in law, there are several safeguarding recommendations for opioid prescribing, which include the following: - - - - - - **Who May Issue Prescriptions for Controlled Substances?** Laws vary from state to state with regard to nurse practitioners and controlled substance prescribing. In Connecticut, for example, nurse practitioners are permitted to prescribe, dispense, administer, and procure controlled substances. However, this may not apply in every state, so it is important to be aware of the following: - - - **Required Elements on Controlled Substance Prescriptions** As with any prescription, the following are required elements for a controlled substance prescription. The major difference between a regular prescription and one for a controlled substance is the requirement of the practitioner's DEA number. - - - - - - - - - - Additional requirements include: - - - **Examine the example prescription below to review all the required elements.** A prescription for a prescription Description automatically generated with medium confidence **DEA Registration Number** A DEA number is a unique identifier for each provider or hospital as provided by the Drug Enforcement Administration in the United States, and is not publicly available. It contains two letters and six numbers, and is used to verify the authority/validity of the prescribing practitioner. Hospital DEA registration numbers must be followed by a three-digit physician's hospital code number, as demonstrated in the example below: - - **Ethical Considerations** As a prescriber, it is important that you take into account the following ethical considerations because the consequences for prescribing unethically are severe. - - - - Opioid Prescribing Laws In this section you will review the definitions of controlled substances and medications that fall into each category. **Schedule I Controlled Substances** **Schedule I** controlled substances currently have no federally accepted **medical use** for treatment in the United States, making them **illegal to prescribe** in the vast majority of cases. This is because Schedule I controlled substances are considered risky for several reasons, including: - - Examples of Schedule I substances include: - - - - **You will see marijuana listed above. At this point it is still considered Schedule I on a federal level, despite many states legalizing it.** **It is therefore important that you familiarize yourself with your state's laws regarding the prescribing of marijuana.** **Schedule II Controlled Substances** **Schedule II** controlled substances are the highest class of medications for which there is an accepted medical use. There are, however, still several safety considerations, including: - - - **State laws that are stricter than federal law supersede federal law.** Examples of Schedule II substances include: - - - - - - - - - **Schedule II Prescribing Laws (Federal)** State laws can only be more strict (not less) than federal laws. Therefore, it is important to understand the federal laws surrounding controlled substance prescribing, such as: - - - Below is the exact verbiage from **Section 1306.05** of the law regarding the issuing of prescriptions for Schedule II controlled substances: \(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner. \(d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer, and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed. Below is the exact verbiage from **Section 1306.12 **of the law regarding the refilling of prescriptions and the issuance of multiple prescriptions for Schedule II controlled substances: \(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. \(b) (1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met: \(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. \(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription. \(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse. \(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws. \(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations, as well as any additional requirements under state law. Below is an image demonstrating the limits for the duration of an opioid prescription, meaning how many days an opioid can be prescribed for at one time. **Schedule III to Schedule V Controlled Substances** **Schedule III to Schedule V **controlled substances pose a lower risk for substance abuse. These are usually prescribed medications for illnesses, injuries, mental health disorders, and other health-related issues. Some examples might include: - - - - - - - **Schedule III to Schedule V Prescribing Laws (Federal)** Schedule III to Schedule V controlled substances have slightly different prescribing laws compared to Schedule II controlled substances. These include: - - - A diagram of a number of different colored hexagons Description automatically generated *Adapted from: NCSL, StateNet, 2018. Original image retrieved from [[NCSL WebsiteLinks to an external site.]](https://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic)* **Schedule III to Schedule V Controlled Substances** **Schedule III to Schedule V **controlled substances pose a lower risk for substance abuse. These are usually prescribed medications for illnesses, injuries, mental health disorders, and other health-related issues. Some examples might include: - - - - - - - **Schedule III to Schedule V Prescribing Laws (Federal)** Schedule III to Schedule V controlled substances have slightly different prescribing laws compared to Schedule II controlled substances. These include: - - - Opioid Tolerance, Dependence, and Addiction It is important to acknowledge the high rates of opioid dependence and opioid use disorder, especially in North America. There is data to show that the longer the first prescription of opioids, the higher the probability of continuing use as demonstrated in the graph below.  **Scale of Opioid Epidemic** The opioid epidemic is considered critical because: - - - Play the video below for a summary of the epidemic. *Remember, the numbers might differ from those cited above, but the severity remains the same.* **Tolerance** **Tolerance** is when **repeated use** of the **same medication** at the **same dose** has a **reduced effect**. For opioids, this develops over two to three weeks. Patients develop tolerance to the analgesic, sedating, respiratory, cardiovascular, and emetic effects of opioids. However, this tolerance does not extend to the constipation or miosis effects of the opioids. Patients can also have **cross-tolerance** between opioids. This means that there is a diminished effect of another opioid, despite not having taken it before. **Dependence and Withdrawal** Opioid** dependence** is identified when **discontinuation** of the medication leads to **withdrawal**. The onset of withdrawal symptoms depends on the half-life of the opioid being used. The use of naloxone, discussed further on, can precipitate withdrawal. Withdrawal symptoms can present as: - - - - - - - - - - - **Overdose** Overdose, whether **intentional** or **unintentional**, can be fatal. **Respiratory depression** with **decreased tidal volume**, **decreased respiratory rate**, and **hypercarbia** are the symptoms that lead to mortality. Opioid overdose is also seen with **concomitant CNS depressants** such as benzodiazepines. Since 2012, more people have died as a result of drug overdoses than car crashes in the United States. Opioid overdose factors. +-----------------------+-----------------------+-----------------------+ | Risk Factors | Symptoms | Treatment | | ------------ | -------- | --------- | +=======================+=======================+=======================+ | - - - - - - | - - - - - | Naloxone (Narcan^®^), | | | | an opioid antagonist, | | | | is used to block the | | | | effects of opioids | | | | and reverse an opioid | | | | overdose. It can be | | | | administered in | | | | multiple different | | | | ways, usually | | | | depending on the | | | | location in which it | | | | is being | | | | administered, such as | | | | in a hospital or in | | | | the home. | | | | | | | | - - | | | | | | | | - - - - | | | | | | | | - - | | | | | | | | - - - - | | | | | | | | - - | +-----------------------+-----------------------+-----------------------+ **Preventing and Treating Addiction** ===================================== Preventing Addiction -------------------- When prescribing opioids, it's important to establish **goals of treatment** before initiating therapy. Patients should understand that the goal of therapy isn't zero pain, but rather **tolerable pain**, where a patient can still have a good quality of life. To do that, here are some things to consider: - - - - Narcotic Contracts ------------------ Narcotic contracts are used by some prescribers, especially those treating chronic pain. This can help establish a clear plan for both the prescriber and the patient. An example is shown below. fdfdadfaf Treating Addiction ------------------ Treatment for opioid addiction is critical to helping patients with opioid use disorder. Unfortunately, there are only a few medications available and there are very specific regulations on how they can be used. The Drug Addiction Treatment Act -------------------------------- The Drug Addiction Treatment Act allows for the **maintenance treatment of addiction** or **detoxification** in combination with **counseling** under qualified clinician supervision. A qualified clinician is certified in addiction medicine and has received eight hours in training provided by an approved organization. There is currently a limited number of patients allowed per qualified clinician or group. **Opioid Addiction Treatment Programs** There are multiple requirements for opioid addiction treatment programs: - - - - - - - - - - **Buprenorphine**A table of medical information Description automatically generated **Methadone** **Naltrexone** A table of information Description automatically generated Prescription Monitoring Programs (PMPs) --------------------------------------- Prescription monitoring database information is critical for providers, pharmacists, and pharmacies to identify cases of opioid misuse and possible diversion. Prescription monitoring programs (PMPs) have been established in most states and that information can be shared with other states. **Other Substances of Abuse** ============================= It is important to understand the difference between **dependence** and **addiction**. These words are sometimes used interchangeably, but they shouldn't be. **Dependence** is a **physical dependence**. The patient exhibits withdrawal symptoms when the drug is removed. This does not mean the patient has a use disorder related to the medication. **Addiction** is a **psychological dependence**. This manifests as a **compulsion** and leads to relapsing drug use despite negative consequences. We know that increases in dopamine, or the reward system, reinforces the addiction pathway. Nicotine -------- Nicotine is known to cause both **dependence** and **addiction**. Withdrawal symptoms include irritability and sleep problems. There are many treatment options that often require multiple attempts and combinations of therapy, including: - - - - - - - - When treating a patient who is trying to quit smoking, it's important for them to understand the health benefits. Benzodiazepines and Barbiturates -------------------------------- Benzodiazepines and barbiturates are often **abused in combination with other drugs** for their CNS-depressive effects. They may also be used inappropriately in combination with opioids to **reduce anxiety during opioid withdrawal.** When stopping these drugs, symptoms of withdrawal occur within days and last between one and two weeks. These symptoms manifest as irritability, insomnia, phono and photophobia, depression, and muscle cramps. Unfortunately, there are no good treatment options and tapering is required for discontinuation. Alcohol ------- Another drug of abuse is alcohol. The withdrawal symptoms in someone who has alcohol dependence is very specific over time. Immediate withdrawal of alcohol requires benzodiazepines for treatment. +-----------------+-----------------+-----------------+-----------------+ | **6-12 hours** | **12-24 hours** | **24-48 hours** | **48-72 hours** | | | | | | | **(after last | **(after last | **(after last | **(after last | | drink)** | drink)** | drink)** | drink)** | +=================+=================+=================+=================+ | - - - - | Hallucinations | Generalized | Delirium | | - | | seizures | tremens (5--15% | | | | | mortality) | +-----------------+-----------------+-----------------+-----------------+ Alcohol Dependence Treatment ---------------------------- +-----------------------+-----------------------+-----------------------+ | **Naltrexone (opioid | **Acamprosate | **Disulfiram® | | antagonist)** | (Campral) NMDA | (antabuse) - causes | | | antagonist and GABA | severe discomfort** | | | agonist** | | +=======================+=======================+=======================+ | - - - | - - - | - - - - | +-----------------------+-----------------------+-----------------------+ Non-Addictive Drugs of Abuse ---------------------------- There are drugs that are considered non-addictive as their use doesn't activate the dopaminergic pathways. These drugs primarily cause hallucinogenic effects and activate serotonin and cholinergic pathways. Examples include: - - - - ### **Study Guide: Opioid Tolerance, Dependence, and Withdrawal** #### Key Concepts 1. **Opioid Tolerance** - **Definition:** Patients require increasing doses of opioids over time to achieve the same level of pain relief. - **Important Notes:** - Tolerance is **not the same as addiction**, which involves psychological dependence. - When **switching between opioids**, dose adjustments are necessary to account for cross-tolerance, as tolerance levels may differ between agents. 2. **Opioid Dependence** - **Definition:** Physical dependence occurs when discontinuing the opioid results in withdrawal symptoms. - **Key Factors:** - The **half-life of the opioid** determines the onset of withdrawal symptoms. - **Common Withdrawal Symptoms:** - Mild: Rhinorrhea, chills, goosebumps. - Severe: Anxiety, hostility. - **Naloxone** can precipitate withdrawal by blocking opioid receptors. 3. **Naloxone** - **Purpose:** Used to reverse opioid overdose. - **Mechanism:** Blocks endogenous opioid receptors, preventing other opioid agonists from binding. - **Indications for Use:** - Patients on **high doses of opioids**. - Prolonged opioid use. - Concurrent use of **CNS depressants** (e.g., benzodiazepines, alcohol). - **Accessibility:** Patients at risk should have Naloxone readily available. #### Federal and State Opioid Prescribing Laws 1. **Federal Regulations** - **Schedule II Medications (e.g., opioids):** - Maximum of a **30-day supply**. - No refills allowed. - **State Laws:** Can be stricter but **not less strict** than federal laws. 2. **Prescription Monitoring Programs (PMPs)** - **Purpose:** Track opioid prescriptions and fillings. - **Coverage:** Includes all prescribers, pharmacies, and insurance providers. - **Benefits:** Helps identify and mitigate opioid misuse and abuse. #### Withdrawal Symptoms - Spectrum of symptoms: - **Mild:** Runny nose (rhinorrhea), chills, goosebumps. - **Severe:** Anxiety, hostility. - Withdrawal can be triggered by **Naloxone administration**. #### Practical Application: State Laws Project - Explore your state\'s specific laws regarding controlled substance prescribing. - Understand the role of state-level PMPs in opioid regulation and abuse prevention. #### Key Takeaways - Tolerance, dependence, and addiction are distinct concepts. - Naloxone is critical for opioid overdose prevention and management. - Adherence to federal and state opioid prescribing laws is essential. - PMPs are valuable tools for tracking and addressing opioid misuse. ### Answers to Questions #### 1. What is the importance of multimodal pain management? Multimodal pain management uses a combination of pharmacologic and non-pharmacologic therapies to target different pain pathways, enhancing pain relief while minimizing the risks associated with any single treatment, especially opioids. It promotes better outcomes by reducing opioid use and its associated side effects, such as dependence and tolerance. #### 2. How do you feel about using opioids in your practice? The decision to use opioids must balance the benefits of effective pain management with the risks of addiction, dependence, and overdose. It is critical to adhere to guidelines, use the lowest effective dose, and incorporate non-opioid treatments wherever possible to ensure patient safety. #### 3. What are the ethical considerations for prescribing controlled substances? Ethical considerations include: - Prescribing only for legitimate medical purposes. - Staying within the prescriber\'s scope of practice. - Avoiding unnecessary prescriptions that could lead to abuse or diversion. - Working collaboratively with pharmacists to ensure responsible use. #### 4. What are the legal standards you have discovered for prescribing controlled substances in your state? The specific legal standards may vary by state, but general federal guidelines include: - Schedule II substances require a written prescription with no refills allowed. - Schedule III-V substances can have up to five refills within six months. - Prescribers must be registered with the DEA and ensure prescriptions include all required elements, such as the DEA number. State laws may add stricter regulations, which should always be followed. #### 5. In the event that a patient of yours becomes addicted to their prescription medications, what is the appropriate form of treatment? The treatment involves: - **Detoxification**: Gradual tapering of the medication under medical supervision to minimize withdrawal symptoms. - **Medication-Assisted Treatment (MAT)**: Use of drugs like buprenorphine, methadone, or naltrexone to manage dependence. - **Counseling and Behavioral Therapy**: Addressing the psychological aspects of addiction through therapy and support groups. - Referral to specialized addiction treatment programs as needed.