Pearls and pitfalls for prescribing opioids in a climate of increased provider scrutiny

Case report

Mr. A is a 72-year-old male with past medical history significant for pacemaker implantation and anticoagulation therapy due to history of pulmonary embolism and atrial fibrillation, chronic pain due to nephroureterolithiasis with recurrent stones, and past psychiatric history significant for polysubstance dependence and major depressive disorder. He was transferred to our inpatient psychiatric ward following a suicide attempt via intentional overdose of rivaroxaban. It was his second suicide attempt within a month. The patient was discovered by his board and care manager, who contacted emergency medical services (EMS) to transport the patient to the hospital.

On evaluation by the hospital psychiatry resident, the patient stated he felt overwhelmed by his multiple medical problems, strained relationship with his wife, chronic pain, and unsatisfactory living situation at his current board and care. He endorsed feelings of hopelessness, anhedonia, insomnia, self-blame and stated he was unhappy that despite this suicide attempt, he was still alive.

Prior to transfer to the psychiatric ward, efforts were made to ensure the patient’s medical stability in light of his recent suicide attempt. For this particular patient, such measures included evaluating for potential drug–drug interactions, especially in light of his anticoagulated state (particularly with respect to inducers and inhibitors of the cytochrome P450 system). In his case, there were no clinically significant drug–drug interactions that would impact his care. During the medical evaluation by the medicine service, the patient reported poorly controlled abdominal and right-sided flank pain and requested pharmacologic management. He is well known to both the medicine and psychiatry services for his history of drug-seeking behavior and opioid dependence. The medicine team remarked it was difficult to ascertain if his complaints were genuine, but the patient was provided as-needed acetaminophen/hydrocodone. The patient was deemed medically stable and transferred to the inpatient psychiatric unit for the treatment of his mood and prevention of self-harm.

The patient continued to report poorly controlled flank pain and abdominal pain. A CT abdomen, which had been performed prior to his transfer to the psychiatric service, revealed right-sided ureteral calculi that was not observed on previous imaging. Urology was consulted, and it was determined that there was no need for surgical intervention but recommended to continue as-needed opioids to manage this patient’s pain. The patient was provided with as-needed low-dose acetaminophen/hydrocodone, but he continued to report that his pain was poorly controlled. He also began to request this medication for pain in other areas, such as his chest and lower back.

The inpatient team wrestled with several important issues on the overall treatment plan including the need to provide adequate medical care, pain management, stabilization of mood and suicidal ideation, and devise a safe plan for post discharge care. Several of these have been at odds however. We now present some medical-legal background and the distilled recommendations for the safe treatment of such patients.

In 2012, there were 259 million prescriptions for opioid pain medications, enough for every adult in the United States to have a bottle of pills. An estimated 20% of patients presenting to their physicians with noncancer pain symptoms or pain-related diagnoses receive an opioid prescription. Opioid misuse and overdose remains a public health crisis. The NIH reported from 2001 to 2014 there was a 3.4-fold increase in the total number of deaths from prescription opioids, and altogether during this time period, more than 165,000 persons died from overdose related to opioid use.^1,2 In July 2016, the Senate passed the Comprehensive Addiction and Recovery Act, which seeks to provide a multifaceted approach to the country’s opioid epidemic. ³ Patient misuse of opioids, leading to overdose and even death, can create hesitancy on the part of healthcare providers to prescribe opioids for their patients, even when medically indicated. To further complicate this issue, many patients who are prescribed opioids are also prescribed other controlled substances, such as benzodiazepines. As of August 2016, the FDA Safety Information and Adverse Event Reporting Program has published a safety alert warning that concurrent use of benzodiazepines and opioids can result in CNS depression and death. ⁴

Physician liability may be minimized with the use of databases, such as California’s operational prescription drug monitoring program (PDMP) and the Controlled Substance Utilization Review and Evaluation System (CURES). This database contains over 100 million entries of dispensed controlled substances and allows prescribers to access real-time information on their patients’ controlled substance history. ⁵ This system is aimed at curtailing both abuse as well as diversion of controlled substances.

Despite the availability of PDMP, the current landscape naturally raises concerns for prescribers who choose to treat their patients with opioids. Opioid misuse remains a problem that both patients and providers must be held accountable to. A 2011 review published in Pain Medicine by the American Academy of Pain Medicine referenced the review of 35 medical records of patients with chronic pain who overdosed on opioids between 2005 and 2009. These medical records were originally reviewed at the request of plaintiffs and defendants involved in lawsuits related to opioid overdose. Of 20 fatal opioid overdoses, it was determined 75% of these were due to physician error. Physician error was related to practices often involving starting opioids at excessively high doses or increasing dose at an accelerated rate. ⁶ Two sets of guidelines, one released from the American Academy of Pain Medicine and another from the Centers for Disease Control (CDC), will be discussed in this article.

In July 2016, the American Academy of Pain Medicine released prescriber guidelines for pain management with regard to methadone use. In short, patients requiring opioids intermittently/“as-needed” were not considered good candidates for methadone therapy. For those who are appropriate candidates, recommended dosing was 15 mg or less per day in divided doses, with total daily dose increases not to exceed 5–10 mg per week. Immediate formulations of opioids are also recommended if pain is not adequately controlled with methadone. These guidelines also recommended caution in patients with sleep disorder, screening for potential OSA, and assessing patients for risk of developing prolonged QT and monitoring with ECG as appropriate. ⁷

The federal government has focused its efforts on prescriber training, screening patients for opioid use disorder, and connecting such patients with treatment for this condition. The CDC released extensive guidelines earlier this year with regard to prescribing opioids. Some of their key recommendations are summarized below:

Nonpharmacologic/nonopioid treatments are preferred for chronic pain; if opioids are indicated, discussion of realistic goals for improvement of pain/function should be discussed prior to initiating opioid therapy.

For patients who suffer from opioid dependence, the U.S. Department Health and Human Services Substance Abuse and Mental Health Services Administration previously released clinical guidelines for the use of opioid partial agonists buprenorphine and buprenorphine/naloxone in the treatment of opioid addiction. In short, their partial agonist properties allow for less withdrawal discomfort, lower abuse potential, a ceiling effect at higher doses, and overall greater safety in overdose compared with opioid full agonists. There are few contraindications to treatment with buprenorphine, but those of significance include comorbid dependence on high doses of benzodiazepines or other CNS depressants (including alcohol), significant untreated psychiatric comorbidity, and multiple previous treatments for drug abuse with frequent relapses. ⁸

As physicians and prescribers, we must remain mindful of the challenges inherent to controlled substance prescribing. In this article, we have offered a summary of recommendations on safe practices that will be on help in interactions with our patients to provide the best and safest care to our vulnerable patient population.

So how did we take care of Mr. A and his mental health and medical comorbidities? First, we checked the CURES report to monitor his ongoing opiate seeking behaviors. California’s PDMP provides information on controlled substances prescribed to a patient within the past 12 months. This information includes the quantity and types of controlled substances a patient has been prescribed and the providers who prescribed these substances, so one may easily contact said providers to better coordinate care and detect doctor shopping practices. However, in California, the administration of potent opiates to patients in emergency rooms (ERs) may not be picked up by CURES. Since our patient mostly used the ERs for high potency opiate infusions, the CURES report only showed that he was not getting opiates from non-Veterans Affairs (VA) providers. We worked with the urology team to provide minimal doses of standing narcotics during the time of crisis, with limit setting and eventual discontinuation of the medication in a controlled manner. We screened for concomitant use of benzodiazepines. Mr. A was started on the SNRI milnacipran to a dose of 50 mg PO BID for mood and pain modulation components. He was given only a 7-day supply of medications with limited refills. Over the many months of care at the VA, the patient was offered a wide array of psycho-social interventions in the outpatient clinics, including peer support, day treatment program, outpatient substance abuse treatment, and suicide prevention. It is important to recruit the many psychosocial resources in the care of such patients, though Mr. A demonstrated poor follow-up with these services. Furthermore, the patient was deemed not to be a candidate for buprenorphine due to his unrestrained opiate seeking behaviors in the local ERs (as well as intermittent opiate prescriptions by his urologist for exacerbations of his renal calculi). All these measures were explained to Mr. A and carefully documented in the record. For many reasons, patient safety and health at the forefront, and for safe prescribing measures, physicians need to be mindful of the changing climate with respect to opiates.