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Safe Opioid Prescribing in Ohio

By Amol Soin, MD , Ricardo M. Buenaventura, MD

Most physicians can expect to see a patient that is suffering from pain at some point during their clinical practice. Briefly, pain is an unpleasant sensory experience with both physical and emotional components. Pain is commonly thought to be associated with tissue damage but it can also occur in situations where the tissue damage is threatened as in ischemia, not easily seen such as nerve damage of peripheral neuropathy and in situations where no tissue injury is easily identified such as fibromyalgia, chronic abdominal pain or headaches. Pain has an emotional component that can make one person’s pain unbearable while a different person with a similar affliction may have little or no pain. It is the subjective component of pain that makes pain management difficult for patients, doctors and regulators. Some patients may fake or amplify their complaints of pain in order to get attention and medical treatment, including opioid medications. Some physicians may be more lenient in prescribing medical treatment, including opioids, because they are too pliant or for their own secondary gain. These and other factors led to the wider use of opioids in an attempt to treat pain more humanely and aggressively. As pain has been treated more aggressively, more opioid drug doses were prescribed and released into society. Along with that we saw a rise in overdose injuries and death from opioids. As the opioid epidemic marches on and more people are harmed by the inappropriate use of opioids, regulators have moved to set in place rules and boundaries that we as physicians must be aware of and comply with in an effort to reduce the harm of inappropriate use of opioids and also to protect ourselves as physicians from scrutiny and the legal ramifications of inappropriate opioid prescribing. In this article we will briefly review some of the concepts and rules as they pertain to prescribing opioids exclusively in Ohio.

To compare apples to apples and oranges to oranges, a common unit for opioid potency has been adopted. The concept of morphine equivalent dose (MED) has been around for years and was originally used in clinical research to standardize opioid drug doses when assessing patient response to opioid treatment in a research setting. It has now been adopted by the State Medical Board of Ohio (SMBO) and incorporated into their rules and regulations. It is important that physicians understand this concept when prescribing opioids to their patients. Essentially the gold standard is morphine and is what every other opioid is compared to. If a drug is ten times more potent than morphine, then a one milligram dose of the drug would count as 10 units or MEDs of morphine. Hydrocodone is equal in potency to morphine so it is an easy one for one conversation of MEDs between the two drugs, i.e. a hydrocodone 10 mg tablet is equal to a 10 mg morphine tablet. Oxycodone, by contrast, is one and a half times stronger than morphine, so a 10 mg tablet of oxycodone is equal to 15 mg of morphine orally.

The Centers for Disease Control and Prevention (CDC) has published a conversion table on calculating total daily dose of opioids for safer dosage. This CDC conversion table is what the State Medical Board of Ohio and the Ohio Board of Pharmacy use in calculating MEDs in the Ohio Automated Rx Reporting System (OARRS) database, when monitoring opioid prescriptions by Ohio physicians. Familiarity with these opioid conversion tables may help you avoid scrutiny and sanctioning by these Boards in the future.

• CDC Opioid Conversion Table: https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf
• State of Ohio Board of Pharmacy Opioid Conversion Table: https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf

The OARRS website at https://www.ohiopmp.gov/ states that “The OARRS is a tool to track the dispensing and personal furnishing of controlled prescription drugs to patients. OARRS is designed to monitor this information for suspected abuse or diversion, and can give a prescriber or pharmacist critical information regarding a patient’s controlled substance prescription history. This information can help prescribers and pharmacists identify high-risk patients who would benefit from early interventions.” Essentially, when a prescription is filled for a controlled substance, or any other dangerous drugs the Board chooses to include, the information related to that prescription is collected and transmitted to OARRS. This information might include the patient’s name and other personal information, drug prescribed, quantity, refills, prescriber’s DEA number, pharmacist DEA number and method of payment. This information is collected and also statistics are collected on patients, prescribers and pharmacists. This is a great amount of data that can be mined for risky behaviors, prescribing and dispensing practices. Outliers can be identified and investigated further. Prescribing physicians are sent regular emails with their statistics and they can compare themselves to their peers and see if they are consistent with their peers or an outlier. Prescribers can use OARRS to check a patient’s controlled substance use history and use the data to make informed decisions about whether they will prescribe the controlled substance to the patient or not. If the patient has received multiple controlled substance prescriptions in a short period of time from multiple different medical practices, this may be a sign of doctor shopping and the doctor can choose not to prescribe.

If, after an appropriate evaluation, the physician decides to provide a patient with an opioid prescription, the physician should review an OARRS report pertaining to that patient before providing the prescription or dispensing the controlled substance.

OARRS is a tool that can help doctors practice better but the data is also being used to monitor the doctor’s prescribing practices and could be used against them. Every physician that prescribes medication in Ohio is expected to register in the OARRS database program and use OARRS when prescribing controlled substances to Ohio patients. The patient should review the OARRS report for that patient every ninety days. If the physician notes any red flags of aberrant behavior or opioid misuse disorder in the patient such as suffering an overdose or forging a prescription, the physician should review the OARRS report again. The physician should document in the record why he is using controlled substances such as opioids in the patient, the treatment plan, functional status of the patient, and consider using a treatment agreement or consent. In difficult cases, a substance abuse specialist may be consulted. While the patient is undergoing continuous therapy with an opioid, the OARRS report should be reviewed every ninety days. The physician should document in the record that they reviewed the OARRS report. An OARRS report is not required for patients admitted to facilities such as a hospital, nursing home or residential facility, cancer or hospice patients, for prescriptions provided for acute pain after surgery or for prescriptions written. for seven days or less of opioids. (Ohio Rule 4731-11-11, Effective September 30, 2021)

The State Medical Board of Ohio has created rules and regulations for the treatment of acute and chronic pain. Acute pain is pain of recent onset that is associated with an event or illness in the recent past that initiated the pain. An easy example is trauma such as a fall and sprained back or broken ankle. If pain is severe enough, opioids might be acceptable. A medical condition such as sickle cell disease may cause acute pain through an acute onset sickle cell crisis. Acute pain can be caused by surgery where the surgery was invasive enough to cause significant postoperative pain warranting treatment with opioids. The time frame for acute pain is less clear and could last 6 or 12 weeks, or more, depending on the situation. Chronic pain is a pain that persists beyond 6 months and has continued after initial healing from an injury or surgery has ended. There may also be an associated event or illness in the past that contributes to the chronic pain. Diabetes and exposure to chemicals such as chemotherapy agents can cause nerve damage leading to chronic neuropathic pain. Spine surgery can result in scarring and nerve damage leading to chronic back and limb pain. The SMBO has recommendations for use of opioid therapy in these settings.

An Ohio law was passed regulating the use of opioids in the acute pain setting. It is Ohio Rule 4731-11-13, Prescribing of opiate analgesics in acute pain, and became effective August 31, 2017 (https://codes.ohio.gov/ohio-administrative-code/rule-4731-11-13). It states that long-acting opioids shall not be prescribed for treatment of acute pain. Before prescribing an opioid the physician should try non-opioid treatments first. If non-opioid therapies are inadequate and the physician decides after an appropriate history and physical examination to administer opioids, the physician should use the minimum potency and quantity needed to treat the expected duration of pain. For adults, the duration of the first opioid prescription for acute pain shall not exceed more than a seven day supply with no refills. For minors, the limit is 5 days and parental consent to opioid therapy is required. Exceptions to the time limits are allowed but the physician must document in the medical record why they are deviating from the recommended time limits. The morphine equivalent dose (MED) shall not exceed 30 MED per day. If this MED is exceeded the physician must explain the reason why in the record. Exceptions are allowed when the medical conditions warrant it, such as major trauma or major surgery. These rules do not apply to cancer and hospice patients.

Ohio also passed a law regulating the use of opioids in the chronic pain setting. It is Ohio Rule 4731-11-14, Prescribing for subacute and chronic pain, and became effective October 31, 2020 (https://codes.ohio.gov/ohio-administrative-code/rule-4731-11-14). Prior to initiating or continuing opioids for chronic pain treatment, the physician should consider and document non-medication and non-opioid treatments for pain. If after an appropriate history and physical examination, the physician decides to use opioid therapy the physician shall prescribe the minimum potency and quantity needed for the expected duration of pain and to improve function in the patient. Before prescribing the opioid the physician should document in the record a thorough history and physical, a review of pertinent diagnostic tests, review of the patient’s OARRS report, a functional pain assessment, a reasonable treatment plan including reasoning for the medication choice and the expected duration of treatment  and follow up, a discussion about the benefits and risks of opioids, safe care and handling of opioids, and a discussion of and consideration of providing a prescription for naloxone to at-risk patients. This rule also sets thresholds for the MED such that if the thresholds are exceeded the doctor is required to take certain actions. If an MED of 50 is exceeded, the doctor shall review the case and treatment plan. If the treating physician is neither a specialist for the body part involved or a pain physician, they should document consideration of a consultation with a specialist for the body part involved, a consultation with a pain physician, a consultation with an addiction medicine specialist and a pharmacist for a medication management review. Naloxone should be considered again. Prior to increasing to 80 MED or higher, the physician and patient should enter into a opioid treatment contract which outlines patient and physician responsibilities, and requires drug screens, pill counts, the requirement that the patient will only receive opioids from the treating physician, and the understanding that the opioid prescription can be tapered if the patient is not compliant. Again, the doctor should offer naloxone and consider the same consults as for when the MED exceeds 50. The physician shall not prescribe a dosage that exceeds an MED of 120 per day. Prescriptions may exceed an MED of 120 when they are provided by a physician board certified in pain medicine, hospice and palliative care, hematology or oncology. A physician who has received a recommendation to do so from a physician certified by one of the above boards may also write the prescription. The physician is expected to do routine follow up, reassessment of the underlying condition,  treatment plan, the patient’s progress, and rationale for continuing the opioid medication. This rule doesn’t apply to cancer or hospice patients.

Early in the opioid pandemic, in 2011, a law was passed to regulate pain clinics in Ohio., Ohio Rule 4731-29-01, Standards and procedures for the operation of a pain management clinic, Effective 08/31/2011 (https://codes.ohio.gov/ohio-administrative-code/rule-4731-29-01). The intention was to close opioid pill mills and set standards for future pain clinics that would seek to do business in Ohio. Prior to passage of the law there existed some clinics that were perceived as opioid pill mills because the clinic doctors provided prescriptions of opioids to patients too liberally. The law set a threshold such that if a clinic treated 50% or more of its patients with chronic opioid therapy, it would be considered a pain clinic. All pain clinics, not affiliated with a hospital, would have to apply with the Ohio Board of Pharmacy to receive a terminal distributor license for dangerous drugs in order to do business, or would be subject to fines. The license is good for one year and must be renewed annually.  The law set standards that only physicians could own a pain clinic and that the physician had to have board certification in certain specialties with some relevance to pain management. It also required that all employees in the clinic be subjected to law enforcement background checks on an annual basis. The law does not limit the prescription of opioids to only pain physicians or clinics.

The treatment of pain is difficult as it often requires decision-making based on the patient’s subjective complaints of pain. This allows different interpretations of a patient’s pain experience and for wide variation in pain treatment options. This wide variance in pain treatment allows for unscrupulous characters, both patients and physicians, to take advantage of the situation to obtain opioid medications or provide service in exchange for a fee. Ohio has attempted to set rules that narrow the range of pain treatments offered, and in some cases, has also limited the number of physicians that can call themselves pain physicians. It is important to note that the law does not state that general, non-pain, physicians are not able to prescribe opioids. All physicians can see patients with pain complaints and provide opioid prescriptions, but there are rules we should be aware of so physicians can provide appropriate and safe opioid therapy to patients in need. By these mechanisms, patients’ access to pain care is maintained and physicians are encouraged to practice in a more narrow range of treatment options that will help them avoid scrutiny by regulatory boards. Hopefully, patients are happy with continued access to opioids for pain and physicians feel less threatened when they remain compliant with the rules.

Resources

1. CDC Opioid Conversion Table: https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf
2. State of Ohio Board of Pharmacy Opioid Conversion Table: https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf
3. OARRS website: https://www.ohiopmp.gov/
4. Ohio Rule 4731-11-11, Standards and procedures for review of “Ohio Automated Rx Reporting System. https://codes.ohio.gov/ohio-administrative-code/rule-4731-11-11
5. Ohio Rule 4731-11-13, Prescribing of opiate analgesics in acute pain. https://codes.ohio.gov/ohio-administrative-code/rule-4731-11-13
6. Ohio Rule 4731-11-14, Prescribing for subacute and chronic pain. https://codes.ohio.gov/ohio-administrative-code/rule-4731-11-14
7. Ohio Rule 4731-29-01, Standards and procedures for the operation of a pain management clinic. https://codes.ohio.gov/ohio-administrative