Earlier this year, at the prompting of Governor Christie, New Jersey’s Attorney General Chris Porrino invoked his emergency powers to impose limitations on opioid prescribing, a measure aimed at reducing the risk of opioid addiction and restricting the number of pills available for diversion. The “Emergency Rule” mandates include: (i) initial opioid prescriptions for acute pain must be limited to 5 days; (ii) prescribers must query the Prescription Monitoring Program (PMP); and (iii) prescribers must conduct a consultation with the patient, either in person, by telephone or other means of direct communication, before issuing a subsequent prescription. Although the Rule provides an exception for prescriptions to patients who are: currently in active treatment for cancer, receiving hospice care from a licensed hospice or palliative care provider, or are residents of a long term care facility, and further excepts any medications that are being prescribed for use in the treatment of substance abuse or opioid dependence, prescribers must still be mindful of the potential for harm in those situations, including the risk of misuse of a patient’s extra pills (i.e., the possibility of a minor accessing an adult family member’s prescription). Therefore, even in those exceptional situations, patients must be treated judiciously and prescriptions should only be written for the minimum amount of medication necessary for the intended purpose.
There has been a recent surge in public awareness regarding the potential for opioids to be abused. In March, the Centers for Disease Control and Prevention (CDC) published a report that suggested an association between early opioid prescribing patterns and the likelihood of long-term use. The report suggested that the authorization of a second opioid prescription doubles the risk for opioid use one year later. For providers, there is additional cause for concern: a growing consensus that irresponsible prescribing is, at least in part, to blame. New Jersey’s Emergency Rule represents a shift toward increasing prescriber accountability and potentially, liability for negligent prescribing. Thirty-one New Jersey doctors were recently investigated and sanctioned for their opioid prescribing practices. The new legislation and increased enforcement activity should place prescribers on high alert for not only the safety of their patients, but also the protection of their own professional license.
Another important topic is the dispensing and use of naloxone hydrochloride (Narcan®), a potentially life-saving antidote to the life-threatening respiratory depression caused by an opioid overdose. The CDC Guidelines for Prescribing Opioids suggest that prescribers offer naloxone for patients who present with a high risk of overdose (i.e., history of substance abuse and/or overdose, concurrent benzodiazepine use, etc.). Notably, even the most diligent prescribers make that risk determination with limited information: patient feedback (which may be unreliable), information contained in the Prescription Monitoring Program database (which should help to identify a patient’s previous or concurrent opioid and benzodiazepine prescriptions, but does not account for pills obtained through alternate channels) and urine drug screens (which may be helpful, but are also susceptible to lab error and depend upon the clearance rate of the various drugs). These tools, along with a provider’s own clinical judgment, should help to identify patients at high risk for overdose, but given the possibility that some at-risk patients will not be identified through these mechanisms, we recommend that providers discuss the availability of naloxone with every patient for whom opioids are prescribed. In some instances, providers will take the additional step of issuing an individual prescription for naloxone.
New Jersey’s Overdose Prevention Act provides (among other things) an additional safeguard by permitting pharmacies with standing orders to dispense naloxone to any person at risk for opioid overdose or any person who may be in a position to help someone who is at risk for opioid overdose. This does not supplant a provider’s obligation to the patient, but because providers and pharmacists see patients in different settings, they each have the opportunity to make observations the other may not. For example, a physician may: (i) assess the patient and consider non-opioid therapies; (ii) order a urine drug screen; (iii) query the PMP database; (iv) determine that opioids are appropriate and discuss the benefits, side effects and risks with the patient; (v) warn the patient of the perils of opioid addiction and discuss the availability of naloxone in the event of an overdose; and (vi) responsibly issue initial and subsequent prescriptions in accordance with the applicable regulations; in this case, where the physician has arguably fulfilled his legal and ethical obligations to the patient, it may be that the pharmacist is the one who observes peculiar behavior (such as slurred speech, constricted pupils, sweating, etc.) or perhaps, observes a minor child to be in the care and company of the patient. These “red flags” should trigger a reasonable pharmacist to decline to fill the opioid prescription, contact the prescriber and in some instances, dispense naloxone pursuant to an individual prescription or standing order.
Historically, a physician’s role as the “learned intermediary” apportioned the duty to warn chiefly to physicians; however, in response to the opioid epidemic, pharmacists are being asked to also be on alert for individuals at high-risk of overdose. As this is relatively novel territory for most providers and pharmacists, there is some confusion surrounding the question of who is responsible for introducing a conversation about (and in some cases, a prescription for) naloxone. We counsel both our provider and pharmacy clients to include a discussion of naloxone as part of every patient’s education/disclosure process. Patients identified as high-risk should have access to naloxone, and the requisite education component (whether by the prescriber, the dispensing pharmacist or both) should include a responsible family member or friend of the patient, as the patient would not likely be able to effectively self-administer naloxone in the event of an overdose.
An Opioid Compliance Plan is an important tool for implementing best prescribing practices and avoiding violations of the applicable regulations. For more information about developing an Opioid Compliance Plan, please contact Frier Levitt.
