June 30, 2016
The United States saw over 14,000 people die from opioid overdose in 2014. In an effort to stop this epidemic, numerous federal and state agencies have published guidelines on the proper administration of opioids. Additionally, most states have amended their regulations to allow for the distribution of naloxone kits, which can reverse the effects of opioids in an overdose situation.
With the increased emphasis on opioid prescribing issues and the legal use of naloxone, healthcare providers should consider some of the best practices related to prescribing opioids, and the rules concerning prescribing naloxone.
Prescribing Opioids in a Physician’s Office
The Center for Disease Control (CDC) published new guidelines for prescribing opioids on March 18, 2016. While these are just guidelines and not actual regulations, they are a good indication of what the federal government will expect of healthcare providers’ policies concerning opioids. The CDC advocates for nonpharmacological therapy and non-opioid pharmacologic therapy when possible and advises that clinicians should only consider opioid therapy if the benefits for both pain and function are anticipated to outweigh risks to the patient.
One consistent requirement throughout nearly every set of clinical guideline related to opioid prescriptions, including those from the CDC, is the completion of a thorough evaluation of the patient prior to prescribing opioids. During this assessment, the physician should ensure that non-opioid therapies have been tried and should also evaluate the risk of harm or misuse. When assessing a patient’s risk of harm from opioid therapy, a physician should take into account: personal or family history of substance use disorder; anxiety or depression; social and vocational assessments; possible pregnancy; age; chronic obstructive pulmonary disease; and renal or hepatic insufficiency.
The physician should also assess baseline pain and function. Assessment of the patient’s pain typically would include the nature and intensity of the pain; past and current treatments for the pain; any underlying or co-occurring disorders and conditions; and the effect of the pain on the patient’s physical and psychological functions. These evaluations will allow the physician and patient to set realistic goals for opioid therapy.
If it is certain that opioid therapy is the best course of action, clinicians should set criteria for stopping or continuing opioid use. Clinicians should then continue to evaluate the benefits and harms of continued therapy at least every 3 months. Concurrently prescribing narcotics and benzodiazepines is discouraged. Use of random urine drug screens to detect possible drug interaction and to confirm compliance is also recommended.
States have also enacted legislation aimed at addressing opioid therapy. In Virginia, for example, if prescribing for longer than 14 days, physicians will be required to check the Prescription Monitoring Program (PMP) according to recently passed regulations that go into effect on July 1, 2016.1 Prescription monitoring programs exist in a number of states and are intended to prevent dangerous drug interactions when a physician is unaware that a patient has already been prescribed medication from another physician. It is always suggested that before prescribing opioids, any state PMP or similar program should be checked to ensure patients have not been prescribed additional medication from other physicians. “The standard of care increasingly requires prescribers to consult PMPs in multiple states,” says Jerry Canaan. “It is probably the best tool for monitoring patients across state lines and justifying prescription decisions.”
There are several other tools for physicians to use when prescribing opioids. These include opioid agreements, pill counts and screening questionnaires to monitor chronic pain patients on opioid therapy.
Prescribing Opioids in the Emergency Department
Many of the same common sense procedures that are utilized in a physician’s office should be used in a hospital emergency department (ED). However, because of the short term nature of emergency visits and ability of patients to “pill shop,” there are unique issues that arise for physicians in the ED setting.
Several state medical associations have developed guidelines advocating for increased management of opioids in EDs. These guidelines propose that physicians should:
- Send patient pain agreements to local EDs and work together to include a plan for pain treatment;
- Refrain from prescribing long-acting or controlled-release opioids (such as oxycontin, fentanyl patches, and methadone);
- Prescribe opioids for the shortest duration appropriate;
- Consult the state PMP before prescribing;
- Take pictures of patients who do no present a government issued photo ID; and
- Provide each patient leaving the ED with a limited prescription for opioids with detailed information about the addictive nature of those medications.
“The ED setting is a very common locale for ‘opioid seeking patients,’” says Mary Malone. “So, coordination between EDs is essential in preventing patients from receiving multiple medications or an unwarranted amount of opioids.” By following these procedures, EDs can reduce the risk of opioid addiction and overdose. EDs may wish to create policies and procedures for opioid prescribing and addressing drug seeking behavior. But, Mary Malone cautions that such policies “must always be drafted with Emergency Medical and Labor Treatment Act laws in mind since a patient complaint of pain may be considered and “emergency medical condition” triggering the duty to provide screening and stabilizing treatment.”
Naloxone, commonly known by its brand name, Narcan, can be a potentially lifesaving medication for overdoses caused by opioids. Naloxone is a prescription medicine that blocks the opioid receptors in the brain and reverses an overdose. It begins working within about five minutes and takes approximately thirty minutes for the effects to wear off. Because a lack of oxygen to the brain can cause serious damage during an opioid overdose, naloxone must be administered quickly once a person shows signs of overdose. The medication can be given through intramuscular injection or through a nasal spray device. Reportedly, naloxone only affects those who are using opioids, and has little to no side effects when administered. If given to someone who is on opioids but not experiencing an overdose, naloxone can cause withdrawal which could be painful, but not life-threatening.
In 2001, New Mexico became the first state to amend its laws allowing for physicians to prescribe and dispense naloxone. Since then, nearly every state has passed legislation designed to increase access to the medication, including regulations giving prescribers immunity when issuing standing orders for naloxone and creating educational programs on overdose symptoms. For example, Virginia has established the REVIVE! Program which provides training on how to recognize and respond to an opioid overdoes with the administration of naloxone. To check your state’s current laws, see this interactive map.
Thirty-two states have passed legislation that allows for naloxone to be distributed based on a standing order. Under a standing order, a pharmacist is allowed to dispense naloxone, including any necessary supplies for administration, to anyone who meets the qualifications of that state’s laws. In most states, these qualifications are a minimal and generally only require brief education on administering naloxone. To help further establish procedures, state medical associations, hospital associations and boards of pharmacy have issued guidelines regarding standing orders. To check your own state’s laws and regulations, click here.
Generally, the guidelines establish the proper procedure and address the policies for a standing order, including: if naloxone should be administered intramuscularly or intravenously; what the naloxone kit must contain; what instructions the recipient should receive; what brands of naloxone should be used; and if training should be undertaken before being able to receive naloxone.
Changes have also been made to state laws to allow police officers and firefighters to possess and administer naloxone. Typically, states require that these first responders take an educational course on the signs of overdose before obtaining the medication. These laws will allow for first responders to administer naloxone when time is critical.
Physicians Prescribing Naloxone
The Substance Abuse and Mental Health Services Administration (SAMHSA) suggests that the ideal candidates for naloxone are patients who have completed detoxification but are experiencing increased stress or relapse risk, and patients who have been detoxified from opioids but who are being treated for a co-occurring alcohol disorder.
Further, the American Society of Addiction Medicine recommends that patients who are being treated for opioid use disorders and their family members be given prescriptions for naloxone. The thought behind this is that those who are overdosing would not be able to administer naloxone, so physicians should be able to issue a prescription to family members or close friends who may be present during an overdose. The American Academy of Addiction Psychiatry echoes this sentiment proposing that naloxone be prescribed to individuals at high risk of witnessing or experiencing an opioid over dose. Importantly, this should only be done in states that allow for “third party prescribing.”
To promote the use of naloxone, most states have a statutory provision that provides immunity from simple negligence to individuals who prescribe, dispense or administer naloxone or other opioid antagonist.2
This issue has now attracted the attention of the Federal government as the White House is pressing for more funding to fight opioid addiction. There are currently several bills in front of Congress, aimed at addressing and preventing opioid abuse, which we will continue to closely monitor.
In the meantime, providers should review their state laws and Center for Disease Control’s guidelines regarding opioid prescribing. Physicians should be aware of the dangers of overprescribing opioids and the availability of naloxone for patients who may be at a high risk of overdosing. Hospitals should consider the development of policies concerning opioids, and educate hospital staff on the signs of opioid addiction, and uses of naloxone.
1. Several other bills were passed affecting the Virginia PMP which can be viewed here.
2. For an example of this In Virginia, see Va. Code § 8.01-225.
The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel, Johnson & Nagle, PC, is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel, Johnson & Nagle, PC be liable for any direct, indirect, or consequential damages resulting from the use of this material.