Responsible Use of Opioids in Chronic Pain
By Paul Lynch, MD, Tory McJunkin, MD, Jack Anderson, MD, & Edward Swing, PhD
Dear Arizona Pain Specialists,
My partner and I recently started an interventional pain practice. We both feel that opioids have a role in the treatment of chronic pain, but we wonder if the prescriptions for opioids that we write for patients, some for high doses, are really being taken as prescribed. We have found ourselves prescribing doses of opioids for some patients that have escalated to levels that make us uncomfortable. How can we improve opioid compliance and minimize risk both to the patients and to us, the practitioners?
Dear Pill Paranoia,
These concerns are common to pain practices across the country. Though opioids can be beneficial in the treatment of pain in certain patients, the frequent news reports of prescription drug addiction and overdose fatalities have placed opioids and their potential for abuse and overdose in the national spotlight. The practitioners at Arizona Pain Specialists (APS) feel the data does not support the use of high dose opioids, but will use low to moderate dose opioids for certain patients. After researching the medical literature, national recommendations and Drug Enforcement Agency (DEA) guidelines, we created a 12-Step Compliance Checklist to use when prescribing opioids (http://boostmedical.com/services/compliance/opioid-compliance).
Boost Medical 12-Step Compliance Checklist for Long-Term Opioid Therapy
1) Assessment of pain (0-10 scale)
2) Clear documentation of rationale for opioid use (e.g. lumbar radiculitis)
3) Clear documentation of beneficial clinical response to opioid use
4) Established goals of opioid treatment and review of goals periodically
5) Current and updated medication list
6) Documentation of substance abuse/social history
7) Physical examination of painful area
8) Documentation of risks and benefits
9) Appropriate referral for additional evaluation and treatment
10) Updated state pharmacy board review (if available)
11) Current and consistent urine drug screen (UDS)
12) Patient has signed an Opioid Agreement within the last six (6) months
Opioid Related Deaths
In their Morbidity and Mortality Weekly Report, the Center for Disease Control and Prevention (CDC) reported that the number of drug overdoses in the United States had tripled from 1991 to 2007 and that prescription drugs accounted for much of that increase. In 2008 alone, there were 14,800 deaths in the United States involving opioids.1 The mortality rate of those taking opioids is strongly related to the dose taken. Gomes et al. found that those taking high doses of opioids (200-400 mg of morphine equivalent per day) had an opioid-related mortality rate nearly five times greater than those taking moderate doses (up to 200 mg of morphine equivalent per day).2
Are opioids appropriate?
In order to justify the risks involved with taking opioids, one of the goals of our opioid compliance checklist is to determine whether patients meet the criteria for the medications. The 0-10 pain scale is to determine if the patient has moderate to severe pain. If not, other non-opioid medications would be more appropriate. Upon examination of a new patient, unless the patient has severe pain, we initially try conservative therapy and non-narcotic medication, before prescribing opioids.
The diagnosis for which the opioids are prescribed should be clearly documented. Documentation should also include a complete physical examination with a detailed targeted physical examination of the area involved. If the diagnosis is in question, additional diagnostic exams including imaging may help guide your decision. In general, we feel that the doses of opioids should be proportionate to the severity of the disease. For example, an individual with multiple failed back surgeries in the past would necessitate higher opioid doses than a 22-year-old with no known pathology, a near normal MRI and no prior opioid use.
The risks and benefits of opioids should be clearly explained to the patients so they can make an informed decision. In some cases, after learning about the unwanted side effects, including the risk of death and addiction, the patient will decide to pursue other medications or modalities to treat their pain.
Determining the patient’s goals of opioid treatment is a very important element of the APS compliance checklist. Patient goals often focus on their ability to function, such as walking through the supermarket or hiking their favorite trail. This helps to monitor the effectiveness of the opioids once they are prescribed. We find that some patients expect to be completely pain free with the use of opioids. However, the available evidence indicates a more realistic expectation is a 30% mean reduction in pain intensity over time.3 With the potential benefit set at a 30% reduction and not complete resolution, some patients may opt for other options given the relatively high risk of the drugs.
Upper Dosing Limit
If you are in a group with multiple physicians and mid-level providers, it is important to discuss and formulate an overarching philosophy in regard to opioids. For instance, at APS, we aim to reduce each patient’s opioid doses as much as possible with the goal of discontinuation, if possible. Also, we strive to write for low to moderate doses of opioids with 150 mg/day of morphine equivalent as an upper limit. Having the same philosophy with clear limits helps to keep the patient’s care on the same track, even when the patient sees different providers within the same group.
Another goal of the compliance checklist is to identify those with abuse potential. A history of drug or alcohol abuse in the past, a history of psychiatric illness (prior suicide attempt, major depression, schizophrenia, borderline personality disorder, bipolar disorder, etc.), and prior release from other pain clinics for noncompliance should always make you think twice before starting or continuing opioid medications.
It is important to monitor each patient’s compliance once opioids are initiated and this should be done across the board, regardless of the patient’s age or how ‘nice’ or ‘professional’ the patient seems. Physicians are notoriously inaccurate when attempting to guess who is abusing drugs. Also, if you treat all of your patients the same, no one will feel singled out or profiled. At APS, we monitor those receiving opioid prescriptions with monthly pharmacy board reviews and regular UDS.
In 2011, the White House’s Office of National Drug Control Policy released the report Epidemic: Responding to America’s Prescription Drug Abuse Crisis which specifically emphasized the use of prescription drug monitoring programs to assist in patient care, evaluate interventions, and investigating drug diversion and insurance fraud.4 As of October 16, 2011, 37 states, including Arizona, had operational prescription drug monitoring programs. In Arizona, we can obtain data including the name of the narcotic, date prescribed, date filled, prescriber’s name, quantity dispensed and dispensing pharmacy. At APS, the updated pharmacy board data is reviewed at each opioid refill appointment, typically monthly. If the patient is filling narcotic prescriptions written by providers outside of APS, they are in breach of their pain contract. According to the CDC, patients prescribed high daily doses of opioids and seeking care from multiple doctors are at high risk for overdose themselves and are likely providing the drugs to others who are using them without prescriptions.5 Paulozzi et al. found that the risk of unintentional prescription drug overdose increases with even two prescriptions, providers or pharmacies within 6 months. The strongest predictor of overdose was the number of pharmacies that a patient uses.6
At APS, we also perform regular UDS exams to check for inconsistencies, such as unexpected positive results, suggesting that the patients are taking medications that are not prescribed by you and unexpected negative tests, suggesting the patients are not taking their medications at all. The physician should also be alert to possible adulteration of the urine sample. If collected within 4 minutes of testing, the temperature of the sample should be between 90° and 100° F, the pH should be between 4.5 and 8 and the creatinine greater than or equal to 20 mg/dl.
A common question is what to do when a patient requests an early medication refill or has inconsistencies on their pharmacy board review or UDS. While some advocate a strict three strikes philosophy, we at APS evaluate each case individually. Whichever consequences you choose to apply for noncompliance should be explained to the patient on initiation of the opioid.
Opioid Compliance Program Results
After implementation of the Boost Medical 12-step Opioid Compliance Program at APS, we performed a random chart review of 93 new patients, comparing their opioid doses at their initial consultation to their opioid doses at a follow up appointment 3-9 months after their initial visit. We found that, by using the Boost 12-step Opioid Compliance Program and aggressively weaning down from high dose opioids, the patients’ average daily dose of opioids were reduced by 34% (from 73.8 to 48.7 morphine equivalents per day). A paired samples t-test demonstrated that this reduction was statistically significant, t(92)=4.15, p<.0001. Additionally, 17.2% of the patients were completely taken off of opioid medications.
Opioids are an integral part of an interventional pain practice but come with substantial potential risk to the patient and you, the practitioner. To assess for appropriateness of use and noncompliant behavior, we at APS have implemented the Boost Medical 12-Step Compliance Checklist for Long-Term Opioid Therapy. Utilizing a compliance program and setting boundaries within your practice, such as upper limits of opioid dosing, will help you to feel comfortable when using opioids to treat your patients.
Dr. Lynch and Dr. McJunkin own and operate Arizona Pain Specialists, a comprehensive pain
management practice that provides minimally invasive, clinically proven treatments, with three locations
in the greater Phoenix area. Dr. Lynch and Dr. McJunkin also provide consulting services to other pain
doctors around the country through their partner company, Boost Medical. For more information, visit
ArizonaPain.com and BoostMedical.com.
- Centers for Disease Control and Prevention. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm. Accessed April 23, 2012.
- Gomes T, Juurlink DN, Dhalla IA, Mailis-Gagnon A, Paterson JM, Mamdani M. Trends in opioid use and dosing in the socioeconomically disadvantaged. Open Med. 2011;5(1):E13-E22.
- Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112(3):372-380.
- The White House. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan_0.pdf. Accessed June 22, 2012.
- Centers for Disease Control and Prevention. CDC Grand Rounds: Prescription Drug Overdoses – a U.S. Epidemic. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm?s_cid=mm6101a3_w. Accessed April 23, 2012.
- Paulozzi L, Kilbourne E, Shah N, Nolte K, Desai H, Landen M Harvey W, Loring L. A History of Being Prescribed Controlled Substances and Risk of Drug Overdose Death. Pain Medicine. 2012;13:87-95.