Opioid Use and Indications
With a Focus on the State of Illinois
To control prescription and usage of potentially addictive drugs or drugs that might be abused, the federal law has categorized controlled substances into five schedules. The laws on dispensing the substances in these schedules vary based on how useful and prone to abuse they are. It is important, however, to understand, that controlled substances are often essential to manage pain and their usage needs to be acceptable, but undertaken with care.
Current paper studies these schedules in details, looks at the side-effects of these drugs, especially opiates and then considers the federal and state law to control prescription of these drugs. A portion refers to differentiation between acute and chronic pain and how these can be managed/treated. Further, it describes pain assessment methods used before prescribing opioids and the importance of looking at a patient’s history before prescribing controlled substances to him/her.
Schedule II-IV Drugs, Side Effects etc.
The Controlled Substances Act (CSA) divides controlled drugs under 5 “Schedules” based on the medical utility, dependency the drugs may cause and the risk of abuse. Each schedule has its own list of procedures for manufacturing, distribution, prescription and dispensing of those drugs.
Schedule I includes drugs with no accepted medical use or lack of proven clinical safety but bearing high risk of dependence and abuse. Drugs that have accepted medical use but high abuse potential are included in Schedules II to V, with the dependency level and abuse potential decreasing progressively from Schedule I to V.
In addition, the quantity of controlled drug in the formula also helps decide what schedule it should be placed under. Pure drugs like codeine fall into Schedule II, while combinations of controlled and uncontrolled drugs come under Schedule III and IV. Cough medicines and other medicines that contain very small quantities of narcotics are under Schedule V.
There are many restrictions over the prescription and dispensing of controlled drugs. Schedule I drugs cannot be prescribed or dispensed to an individual without special permission from the FDA. Schedule II drugs require a doctor’s written prescription to be dispensed or refilled. Written prescriptions are also required for Schedule III and IV drugs, but these can be refilled up to 5 times or until six months after the prescription date. Schedule V drugs require prescription . Also, Schedule II to IV drugs come with a warning label stating that it is illegal for the drugs to be transferred to anybody other than the patient to whom it is prescribed, something which does not apply to Schedule V drugs. (Johnson, Nasis, & Grittner, 2001)
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Schedule 2 (II) includes drugs like oxycodone, codeine, topical cocaine, belladonna, opium, fentanyl, hydrocodone, hydromorphone, methadone, morphine, etc. (List of Schedule II Drugs, 2014). Schedule III drugs are those that contain no more than 1.8g of codeine or dihydrocodeine, not more than 500mg of opium or 50mg of morphine per 100ml. Schedule IV drugs are those that have low potential for abuse like tramadol, dextropropoxyphene and drugs containing less than 1mg of difenoixn. Depressants like alprazolam, barbital, diazepam, etc. are also included in Schedule IV. Most of these controlled drugs are opiates, but some are stimulants and depressors as well.
Stimulants like Amphetamine, Methamphetamine and Cocaine in Schedule II cause excitation, increase blood pressure and heart rate, insomnia and alertness, unexplained euphoria and even loss of appetite. Codeine (in Schedule II, III or IV based on what it is mixed with) and Morphine are the narcotics that cause side effects including euphoria, slow-down of respiration, drowsiness, nausea and pupil constriction. Certain hallucinogens like Phencyclidine are also listed in Schedule I and II and may cause hallucinations and altered perception of time and reality.
Side effects of opioids include development of tolerance to the drug and an enhanced pleasurable effect, both of which contribute to development of addiction. Opioids cause drowsiness, low blood pressure and respiration rate, and may cause opioid-induced hyperalgesia or increased sensitivity to pain. Other negative side effects include gastrointestinal problems like constipation, nausea, vomiting, bloating; eating disorders like anorexia; change in sleeping patterns, reduction in cell immunity, inhibition of endocrine activity and reduction in secretion of ACTH, cortisol, estradiol, testosterone and insulin.
Differences between Acute and Chronic Pain
Acute pain is typically sudden onset, sharp pain. It lasts for short periods of time, varying between an instant and less than six months and usually goes away when the underlying reason has been addressed and treated. Surgery, fractures, burns, cuts, injuries and childbirth can cause acute pain. If acute pain is not relieved, it can turn into chronic pain. In case of injuries like surgery, the body fights off infections, initiates cell repair and nerve remodeling and heightens sensitivity of the nerves in the area to limit injury by making one more sensitive to pain. (Voscopoulos & Lema, 2010)
Chronic pain usually continues even after an injury has been healed, or at times may appear without any apparent injury or physical damage. It may last for weeks or even years and affects people not just physically, but also emotionally and may hinder their normal life activities. Typically, chronic pain results from modification in expression of neurotransmitters, receptors or the cell-architecture that prevents normal stimulus-response. Some kinds of chronic pain include arthritis, lower back pain, persistent headache, cancer related pain, pain due to nerve damage (neurogenic), or psychogenic pain (psychological pain without any physical precursor). Chronic pain can generally not be treated, but can only be managed and may lead to depression, anxiety, drop in energy levels and loss of appetite in addition to pain and restrictions in movement. (The Cleveland Clinic Foundation, 2009)
Signs of Opiate Addiction and Abuse. DoThey Different from Dependence?
When a person uses opiates for a prolonged period of time, the nerves in the brain suffer damaged and stop producing endorphins, which are the body natural painkillers. Since the body can’t curb pain on its own, this causes dependence on opioid drugs as external painkillers and slowly leads to addiction. Opioid addiction has been defined as a chronic, relapsing brain disease. (Alford, et al., 2011)
Long-term abuse of opiate drugs causes physical dependence on it, so that stopping usage results in withdrawal symptoms ranging from craving, nausea, stomach cramps, vomiting, to sweating, muscle pains, insomnia, shaking, pupil dilation, hallucinations and bone pain. In rare instances, withdrawal could cause seizures, high fever or even coma and could be life-threatening.
Amongst the first signs of opiate dependence is when the patient finds himself taking more medication than has been prescribed to him, that is, larger doses, extra doses or additional medicines. Next comes loss of interest in things that mattered, shirking responsibilities, and mood and personality changes. If opiate use is not controlled at this point, it will lead to addiction.
Addicts continue to use opiates even though they know that it will have an adverse impact on them, their family and society in general.
Common signs that may be associated with opiate addiction or abuse include:
- Track marks: When heroin or other opiate drugs are taken intravenously, track marks or needle marks can be found on the arms or legs.
- Long-sleeved clothing: Addicts usually wear long-sleeves or full-length pants to cover the needle marks on their limbs.
- Lethargy: Heaviness in limbs and overall lethargy can be a sign of opiate addiction.
- Change in friend circles: Opiate users will start spending more time with other people who do drugs rather than with their old friends who did not indulge in opiates.
- Ill-groomed appearance: It will be obvious by looking at them that they do not take care of themselves or their appearances.
- Drowsiness: Opiates often cause drowsiness and excessive sleep.
- Borrowing large amounts of money: Addicts will borrow large amounts of money to buy drugs without giving any explanation about why they need money. In some cases, addicts may resort to stealing or have trouble paying bills.
- Behavioral changes: Addicts commonly start shutting themselves out from people they were close to. Paranoia, depression and anxiety are common markers of addiction.
- Weight gain or loss: Come as a result of inadequate care of self, fatigue, lethargy or change in sleeping patterns. (Addictions.com)
- Doctor shopping (Hall, et al., 2008): In addition to the above symptoms, opiate addicts often visit doctors so as to get sufficient amounts of opiates to fulfill their requirement.
This is a fairly common sign of addiction
In most cases, opiate addiction begins as opiate dependence. Dependence is a condition where the body has adapted to the drug so that it results in withdrawal symptoms when the use of the drug is reduced or eliminated. Opiate addiction is a neurological disease where the brain has impaired control on the drug, where behavior around drug usage is affected and the body craves for the drug even when one knows the harmful consequences of its use. Addiction results in psychological, environmental, physical and behavioral changes. In an opiate dependent individual, as the physical need for the drug grows, usage increases to reduce the withdrawal symptoms and dependence turns into addiction.
What are the State and Federal Guidelines for Governing Prescriptive Authority in Illinois?
All state and federal guidelines for prescription of controlled substances have been developed regarding the “Balanced Pain Policy”. This policy recognizes that controlled substances have a legitimate purpose and are useful in relieving pain in patients; however, the improper or illegal use of these substances can have harmful effects on these same patients. So, it is important that a balance drawn that allows for proper care of the patients and at the same time, prevents abuse of controlled substances. Pain policies make the controlled use of these substances for pain management acceptable and a part of patient care. Illinois, however, does not have a pain policy at the state level. (Stokowski, 2008)
At the central level, the Controlled Substances Act (CSA) is a part of the federal law for regulation of controlled substances. In addition, the DEA (Drug Enforcement Administration) has published a guide for prescribers called “Practitioner’s Manual, an Informational Outline of the Controlled Substances Act”, which thoroughly explains the CSA and the federal laws for prescribing controlled substances.
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National All Schedules Prescription Electronic Reporting Act (NASPER) has been helpful in providing health care providers with access to prescription histories and identifying patients who are potential addicts, so that proper and timely care can be taken.
Federal laws for prescription regulation include:
- Prescriptions will be signed and have the issue date mentioned.
- Prescriptions will be addressed to a single individual and his/her full name and address will be mentioned.
- The practitioner’s name, address and registration number shall also be mentioned.
- Prescriptions will contain the drug name, strength, posology, quantity and method of administration.
- Schedule II drugs cannot be refilled on a prescription.
- A practitioner can partially fulfill a prescription if he mentions the amount filled on the face of the prescription and fills the remaining amount within 72 hours. If unable to complete the order in 72 hours, the patient will require a new prescription for the remaining quantity. The practitioner must also notify the prescriber if unable to fill the prescription within 72 hours.
- A dispenser may only give narcotics to a narcotic-dependent patient with a view of “detox” or “treatment” if he is separately listed as an “opioid treatment program” with the DEA.
- Sequential prescriptions of Schedule II drugs are allowed as long as the prescriber mentions “Do not fill until ____”, with a 30 or 60-day period mentioned to prevent overlap of prescription periods.
- As of 2010, Federal law allows prescribers to give electronic prescriptions in addition to signed hand-written ones, so that pharmacies can use updated technology without compromising on the control on these drugs. (Heit & Gilson, 2010)
- Along with the federal laws the states have their own laws as well. Therefore, health care personnel must comply with both federal and state laws when it comes to prescription of controlled substances. In the state of Illinois, the following guidelines apply:
- Prescribers must have a state license to prescribe controlled substances.
- A Prescription Monitoring Program is in place to monitor controlled substances.
- Salvia is listed as a Schedule I controlled drug.
- Under the Illinois Controlled Substances Act, the ‘N’ designation is not required because the narcotic and non-narcotic schedules are combined.
- Illinois Prescription Monitoring Program (PMP)
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-1957 Uniform Narcotic Drug Act (effective since 1958): Section 13 states that, “Every physician, dentist, chiropodist or veterinarian who issues a prescription shall issue it on the prescription blanks issued by the Division.” These blanks are serial numbered, in triplicate and issued in batches of 100.
-NASPER Interstate Exchange: Illinois plans to apply for a NASPER grant which will permit sharing of prescription data across states, allowing practitioners to login to the Prescription Monitoring Program website and get information about their patient’s prescription history. This move will reduce the concept of “doctor shopping” within the state and across state borders.
-PMP requires all controlled substances prescribed outside of hospitals and nursing homes to be reported weekly. This includes retail pharmacies, prescribers who dispense medicines on their own, and medicines given on discharge from hospitals.
-The Prescription Information Library (PIL) – Licensed prescribers and dispensers of controlled substances can access prescription information of their current and prospective patients.
-Electronic Medical Record (EMR) – Illinois state plans to center its EMR system around the PIL. The EMR will be updated by pharmacies and prescribers on a daily basis and will serve as a tracking system for “meth” precursor usage. (Malan, Berberet, Lane, & Tylman, 2009)
What is necessary for a comprehensive pain assessment prior to prescribing your patient opiates as an NP. Any other modalities / referrals that would be helpful for your patient?
Before a patient is prescribed opiates, it is important to conduct a comprehensive pain assessment.
For patients presenting with acute or post-operative pain, comprehensive pain assessment will include:
- Understanding the etiology and nature of pain: Find out location, intensity and quality of pain. Understanding the progression of pain will help in treating it. While a pain score is helpful, it is also important to find out about the patient’s experience with pain, his pain tolerance and limitations and also any psychological issues that might affect the pain.
- Appropriate diagnostics: Identifying the problem that is causing the pain is important for devising the right treatment plan.
- Getting a complete Medication history, including any past or present opiate usage
- Considering running a query on the prescription monitoring program to get information of the patient’s use of controlled substances – Getting a history and querying the PMP provides information about past opioid usage and alerts the physician if there are reasons for concerns in past usage.
In cases of non-traumatic pain, before resorting to opioids, non-opioid medications should be prescribed for pain management, for example, prescription analgesics, prescription combination analgesics, topical or local anesthetics, etc. Pain medication can be combined with antibiotics and anti-inflammatories if inflammation or swelling it present. If these do not bring relief, the practitioner can prescribe opioids in small doses after checking the patient’s track record in the Prescription Monitoring Program. Opioids should never be prescribed without a thorough examination and an understanding of the reason behind the pain, since opioids can mask the pain and later make diagnosis difficult or cause the patient to ignore a potentially serious problem.
Where existing chronic pain gets exacerbated, the patient’s existing pain care plan should be checked along with his PMP history. It is not recommended to give additional opiates or increasing the dosage in a patient already on opiates, so other relief options should be recommended or therapy can be prescribed. Patients on methadone for addiction management can be prescribed small doses of opiates for pain management, but patients on buprenorphine products should not be given opiates since buprenorphine will block opioid effects and cause withdrawal. In some patients, opioid withdrawal presents as acute pain and these patients should not be prescribed opiates.
When acute pain occurs that is not related to an existing chronic pain, the practitioner should discuss the case with the patient’s regular clinician and look at his care plan. Additional opioids should be avoided or prescribed with extra care. If the patient already takes opioids for relieving chronic pain, long-acting or high-dose opiates should not be prescribed. The total dosage should be the same regardless of whether the patient is already using opioids or not, since that dose is sufficient to curb acute pain.
Before prescribing opioids, the ABCDPQRS Opioid Risk Assessment should also be done.
Use of alcohol becomes more dangerous if combined with opioid use, since alcohol affects judgment and memory, lowers respiration and increases the risk of drug overdose.
Benzodiazepines and other drug use
Benzodiazepines increase the risk of overdose or over-effect of opioids leading to respiratory failure.
Clearance and Metabolism of drugs
The patient’s renal and hepatic function must be adequate in order to clear the drugs out of the system. Patients with compromised kidney or liver function will have delay in elimination of these drugs and should be prescribed lower dosages.
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Delirium, Dementia and Falls Risk
The risk of delirium and falls or accidents is higher in older patients and the family should be informed of these risks before prescribing opioids.
Psychiatric Comorbidities: Patients who are prescribed opioids for pain management are four times more likely to suffer from anxiety or depression. Patients with psychiatric issues, depression, PTSD, etc. are more likely to be at a risk of drug misuse. In addition, opioid withdrawal can enhance psychotic symptoms. Patients with mental health disorders also expose themselves to higher suicide risk.
Query the Prescription Monitoring Program
The PMP lists all prescription data for controlled substances from within the state over the past year and allows practitioners to check their patient’s past prescriptions before prescribing opioids.
Respiratory Insufficiency and Sleep Apnea
These patients are at an increased risk of congestive heart failure, respiratory arrest and chronic obstructive pulmonary disease if put on opiates.
Safe Driving, Work, Storage and Disposal
Driving under the influence of opiates in unsafe and against the law. Opiates impair concentration and coordination, hence, patients should avoid sole parenting or taking on risky work responsibilities for at least 24 hours after the last intake. (Thorson, et al., 2014).
Opiates are extremely effective painkillers, though, have many dangerous side effects, including potential dependence or addiction on the drugs. However, while their prescription and usage is controlled and properly managed, it should not be prohibited. To effectively manage prescription regulations, many federal and state laws have been formed to reduce misuse of controlled substances like opiates. Before a patient can be prescribed opiates, the underlying problem should be ascertained, his prescription and usage history should be checked and other additional risk factors like alcohol dependence, respiratory problems, kidney or liver diseases should be considered. Proper monitoring of opiate use can prevent drug abuse and save lives of those many who die of overdose.