Urgent message: Urgent care physicians may be well positioned to play a role in stemming the national epidemic of opioid dependence, providing much needed care for patients and adding a new facet to their own clinical practice.
By Paolo T. Coppola, MD, FACEP and Matthew I. Salzberg
The DSM-IV-TR defines dependence as “a cluster of cognitive, behavioral, and physiologic symptoms that indicate a person has impaired control of psychoactive substance use and continues use of the substance despite adverse consequences.”
Physiologic or physical dependence refers to tolerance and withdrawal symptoms when the drug is withdrawn or reduced.
In 2003, the National Survey on Drug Use and Health estimated there were more than 1.5 million people in the U.S. dependent on or abusing prescription painkillers or heroin. However, a 2004 estimate from the Physicians’ Research Network puts the heroin-dependent population alone at 1 million, so it is likely that the true number of Americans dependent on all opioids is much higher.
(It should be noted that in this article we will view the terms dependence and addiction as interchangeable.)
Until Congress enacted the Drug Addiction Treatment Act of 2000 (DATA 2000), also known as the “buprenorphine bill,” the only approved treatment for opioid dependence was methadone. Although methadone has a 40-year history of being a successful treatment for opioid dependence, several factors make it a less-than-ideal option:
– There is a chronic shortage of treatment capacity and of facilities permitted to dispense methadone; concerns about diversion and serious toxic effects when ingested by non-tolerant individuals justify such strict regulation.
– Many patients are hesitant to seek treatment at a methadone clinic because of the perceived stigma of attending such programs.
– The need for daily attendance at the clinic may inhibit patients from seeking help if the clinic is far from their home or workplace.
DATA 2000, however, permits office-based prescribing of Schedule III, IV, or V narcotic opioid medications by specifically certified physicians for the treatment of opioid addiction/dependence. Consequently, an individual dependent on opioids can now present for treatment at any certified physician’s office.
Currently, the only two medications approved for the treatment of opioid addiction are buprenorphine HCl sublingual tablets (Subutex, Reckitt Benckiser Healthcare) and buprenorphine HCl plus naloxone HCl dihydrate sublingual tablets (Suboxone, Reckitt Benckiser Healthcare).
A previous article (Acute Pain Management in Urgent Care Medicine, JUCM, March 2007) discussed the appropriate use of pain medication in an urgent care setting, while another (Rx Drug Abuse and the Drug-seeking Patient, JUCM, May 2008) focused specifically on identifying and managing patients seeking illicit prescriptions. This article will provide information on how to become certified in the use of buprenorphine – naloxone, how the medication works, how to identify candidates for buprenorphine – naloxone, and how to integrate it into your urgent care practice.
Certification to Prescribe Buprenorphine – naloxone
To become certified to prescribe buprenorphine – naloxone for office-based treatment of opioid dependence (i.e., to receive a DATA 2000 waiver), physicians must prove that they are qualified to treat opioid-dependent patients; further, they must notify the Substance Abuse and Mental Health Services Administration (SAMSHA) of their intent to treat these patients with buprenorphine – naloxone.
According to DATA 2000, licensed physicians – MDs or DOs – are considered qualified to prescribe buprenorphine – naloxone if they meet at least one of the criteria detailed in Table 1.
Table 1. DATA 2000 Qualifications for Prescribing
In addition, physicians must satisfy both of the
Information about buprenorphine – naloxone training courses (including dates, locations, and online registration) is available at DocOptIn.com. In addition, all of the above, including certification qualifications and training criteria, is described in more detail in the full text of DATA 2000 (available at www.buprenorphine.samhsa.gov/data.html).
Once the qualification is established, the physician must submit Waiver Notification Form SMA – 167 (available at www.buprenorphine.samhsa.gov) and apply for a second DEA number, which will have an X in the preface. This second DEA number is to be used when prescribing buprenorphine – naloxone; your regular DEA number will still be used for all other prescriptions.
Resources for Information
Phone: (401) 524-3076
American Osteopathic Academy of Addiction
Phone: (800) 621-1773
American Psychiatric Association (APA)
Phone: (703) 907-7300
E-mail: [email protected]
American Society of Addiction Medicine (ASAM)
Phone: (301) 656-3920
E-mail: [email protected]
Pharmacology of Buprenorphine – naloxone
Buprenorphine – naloxone tablets are a combination of buprenorphine and naloxone in a ratio of 4:1. They come in either 2 mg (2 mg buprenorphine/0.5 mg naloxone) or 8 mg (8 mg buprenorphine/2 mg naloxone) tablets. Buprenorphine – naloxone is administered sublingually.
Buprenorphine is not absorbed in the gastrointestinal tract, so if the pill or fragments are swallowed it will have a decreased effect or no effect.
Naloxone is bioavailable if injected, but poorly absorbed sublingually. It is added to the buprenorphine to prevent it from it being crushed and injected intravenously, as doing so will precipitate severe withdrawal.
Buprenorphine is a partial agonist at the mu opioid receptors and an antagonist at the kappa receptors in the brain. Most of the effects of opioids are mediated via the mu receptors. Buprenorphine binds to these mu receptors with a higher affinity than other opioids, resulting in blocking other narcotics’ effects if a patient is taking buprenorphine – naloxone. It also has been shown to reduce cravings and prevent withdrawal symptoms.
Because of its high affinity at the mu receptor, buprenorphine can antagonize the effects of a previously administered opioid agonist and induce an opioid withdrawal syndrome referred to as precipitated withdrawal. Therefore, a patient who is actively taking narcotics must abstain from opiates until moderate withdrawal symptoms are present before taking buprenorphine – naloxone.
Patients in Withdrawal
Patients who are in moderate withdrawal may be started on buprenorphine – naloxone in the physician’s office. The Induction phase lasts between three and 10 days and entails daily visits until the proper dose for the patient has been determined.
For the first several days of treatment, you will see your patients daily and use the Clinical Opioid Withdrawal Scale, or COWS, to determine the appropriate dose for your patient. This process is covered extensively in the training program required to become certified to administer buprenorphine – naloxone.
Following Induction is the Maintenance phase, which can last from months to years.
The decision to discontinue buprenorphine – naloxone treatment after a period of maintenance should be made as part of a comprehensive treatment plan. No controlled trials have been undertaken to determine the best protocol for dose taper at the end of the maintenance phase. Gradual dose taper appears to be associated with the best outcomes when attempting to wean patients off of buprenorphine – naloxone.
Identifying Potential Patients
Once you are certified, you may be listed as a buprenorphine – naloxone-credentialed physician on the www.samhsa.gov and/or www.suboxone.com websites. Potential patients who desire treatment will often find you through this mechanism. Word-of-mouth from your existing buprenorphine – naloxone patients will also serve as a pipeline to your practice.
Not all patients who need treatment will present as such, however. It is not unusual for opiate-dependent patients to present to your practice with a chief complaint of chronic pain syndromes such as low back pain, “fibromyalgia,” etc. Often, they will bring in old x-rays or MRIs to prove their need for narcotics. They may also present you with empty prescription bottles from another clinician – though, often, not one in your geographic area. The story is almost always the same: “My pain doctor or PMD is out of town,” or, “I’m from out of town and need a refill.”
It should be noted that educating your staff to be observant of patient behavior during the registration phase of a visit can pay dividends when evaluating a patient seeking medication for complaints of pain; reports that a patient exhibited no signs of being in pain or was observed moving freely by your staff should not be ignored.
It should also be emphasized that the use and prescribing of narcotic pain medication does have a legitimate role in the urgent care setting. Examples include managing renal colic, acute fractures, and the like. In these cases, however, one to two days of opioid medication should suffice.
Another subgroup we encounter is elderly patients who are given multiple prescriptions by different physicians and have become iatrogenically addicted without realizing what is really wrong with them. Often, a family member is aware of the problem but hasn’t known what to do. Your intervention in this scenario is often welcomed.
Approaching the Patient
Once you have identified a patient who could, potentially, benefit from buprenorphine – naloxone treatment, it is crucial to introduce them to this option properly. First and foremost, you must not be judgmental. These patients are suffering from a disease and should be treated accordingly.
At first, patients are unlikely to be receptive to the suggestion that they have an addiction/dependency problem; many will leave upset. However, by raising the issue you may plant a seed; if you can also give them a patient handout to read after they leave, then you have done your job. In our experience, these patients do occasionally return, albeit sometimes months later, for treatment.
Starting a Patient on Buprenorphine – naloxone
Before we start a patient on buprenorphine – naloxone, we follow the same procedures you will learn when you take your training course – plus some of our own, gained through experience. These include, but are not limited to:
– Having a signed and witnessed “Doctor/Patient” contract (an example of which is available in the online version of this article at www.jucm.com) so there are no ambiguities as to what you expect of the patient or what the patient can expect of you. It should be noted that these are not patients who are initially easy to treat, and this “contract” will serve you well.
– Having a patient’s spouse or parent involved from the beginning is a major key to success. Many buprenorphine – naloxone prescribers simply start patients by giving them a script and having them follow up in a month. Giving an addicted patient a script and counting on them to follow your instructions is a fool’s mission, in our experience. Having a non-addicted person involved from the beginning is a key element to a successful outcome. We insist on this in our program, with the key factor being that they, not the patient, control the medication and actively dispense it daily, increasing the likelihood that the patient actually takes it as prescribed.
– During the Induction phase, we use the Clinical Opioid Withdrawal Scale (COWS) to assess the patient’s level of withdrawal and the effect of the medication. This form is available at www.naabt.org/documents/COWS_induction_flow_sheet.pdf.
– Random, witnessed urine drug screens during their course of treatment are an essential component of our program. Don’t be lulled into believing all is well. It is also important to do a drug screen the first day of treatment, as you may discover that the patient is abusing other drugs, as well; this will need to be addressed concurrently.
– Patients have the best chance of succeeding with treatment if they are in a concurrent counseling program, whether that be Alcoholics Anonymous, Narcotics Anonymous, group programs, or with a private therapist. They did not become addicted in the absence of other psychological problems; those problems need to be addressed at this time. Be sure to get reports from the other support professionals so you will have a team approach and work together in caring for your patient.
Integrating Opioid-dependent Patients into Your Urgent Care Center
Once you have identified, evaluated, and started an opioid-dependent patient on buprenorphine – naloxone, he or she should be treated no differently than your other patients. The only exception to this is that they will return on a monthly basis for evaluation, dosage adjustment, and be called in for random drug tests.
We have taken the approach that patients pay for their visits at the time they are seen, even if they have insurance that we accept. We then submit a claim for them; if we get reimbursed for ICDM 304.0 (the ICDM-9 classification for Dependence), we credit their account or issue a refund. We follow this procedure for all patients, even if they have a carrier that has paid in the past, as each policy has different exclusions.
There are only two additional legal issues specific to treating patients for opioid dependence, compared with treating any other patient:
1. As discussed, you must be certified by SAMSHA and have received your new DEA certificate with the “X” prefix before you begin prescribing buprenorphine.
2. You must have a secure narcotics cabinet to store the medication that you will keep on hand in order to start patients (i.e., prior to them having their prescriptions filled elsewhere). You will also be required to keep a log with the required documentation when administering a narcotic medication in your center.
Members of your staff may have personal, ethical issues with treating “drug addicts” or feel that you are simply replacing one addiction with another. These concerns need to be addressed in a professional and educational manner so they understand the program and buy into its importance to both your practice and to the patients being treated.
While it’s true that buprenorphine is a narcotic, it should be explained that this is a prescription medication prescribed to treat a specific medical condition, and that treatment is being administered by a physician in a tightly controlled and medically accepted manner. Make clear that all patients are to be treated equally, without regard to the nature of their care.
Being on the front lines, you can really have a positive impact on this nationwide epidemic. Doing so, however, will require proper training and credentials, educating your staff as well as your patients, and using a team approach to treat these patients, much as you would any other serious medical condition.