By: Tamara Yunusova
On Wednesday, July 25th a petition signed by the reform group Physicians for Responsible Opioid Prescribing (PROP) called on the FDA to implement opioid label changes that would restrict Chronic Non-Cancer (CNCP) opioid treatment for patients with severe pain only. It wasn’t too long before another petition signed by PROP’s adversary, PROMPT, (Professionals for Rational Opioid Monitoring & PharmacoTherapeutics) made its way that would initiate the great opioid debate. This would have been an ordinary debate concerning another policy readjustment request, except that it raised some of the ultimate questions of healthcare, namely: In the face of high overdosage and addiction rates, how can chronic non-cancer pain be treated safely and effectively?
With zealous efforts designed to restrict opioids to severe pain patients only, the 37 physicians, public health workers, psychiatrists and other specialists part of PROP sought to address one of the growing problems of the decade: substantial overdose death rates and rising addiction to opioids. More so, PROP proposed a maximum of 90 days of no more than 100 mg of morphine daily for patients with severe chronic noncancer pain.2 The petition stated, “Unfortunately, many clinicians are under the false impression that chronic opioid therapy is an evidence-based treatment for chronic non-cancer pain and that dose-related toxicities can be avoided by slow upward titration. These misperceptions lead to overprescribing and high dose prescribing.”
Indeed, pain is cast as a public health problem and though this may appear to be an overstatement at first glance, there is good reason to view it as such. The issue of pain is beset with misconceptions about pain, limited access to physicians who are knowledgeable about acute and chronic pain, and insufficient research. Decisions about selecting the optimal treatment for patients are not solely based on health outcomes, but they are influenced by other factors such as insurance coverage along with local/state regulations.3 Often, treatments are chosen based upon the insurance coverage’s preference rather than methods of treatment that may benefit the patient more.3 Despite the major U.S. expenditures (estimated to be $560 to $635 billion annually according to a recent report from the IOM)3, the painstaking efforts taken to cover pain treatments are not reflected by the health outcomes; the treatment itself does not ensure complete alleviation of pain.
According to Andrew Kolodny, MD, the president of PROP, the increases in overprescribing were prompted by effective marketing giving the notion that physicians were underutilizing opioids. In response, physicians began to prescribe opoids extensively, leading to unnecessary use. Far more surprising than the cause was the aftermath. Physicians made a major omission; they neglected to consider issues such as patient addiction or question the safety of the drugs prior to prescribing.2
The issues of opioid effectiveness and safety are the forefront of the PROP platform. “We think it’s now time for the FDA to communicate clearly to the medical community that long-term use of opioids for chronic non-cancer pain has not proven safe and effective” stated Dr. Kolodny. According to a large study conducted in Denmark [Pain 2006; 125:172-179], people who are on opioids for long-term for chronic pain were doing very poorly compared to those who were treated with nonopioid analgesics2. In addition, the results of similar studies replicated in the United States have cast doubt upon the effectiveness of opioids and suggest that by overprescribing opioids, pain is being undertreated.
Despite the support this measure has garnered, the opioid restriction strategy has received a scathing attack in the face of its critics who view the strategy as anything other than a tenable solution. “If the current call for more information leads our colleagues to deprive our patients of much needed relief, we will have done even a greater travesty,” contend Edward et al in their letter to the editor of the Journal of Pain. The letter was written in response to an article published in the September issue of the journal entitled “Is Lack of Evidence the Problem?” in which the author of the article, Ballantyne, attributes over prescription to regulatory failure and pharmaceutical marketing efforts. In their letter to the editor, Edwards et al argue that Ballantyne’s standpoint is short-sighted in its portrayal of the issue solely within the bounds of the pharmaceutical marketing failing to consider factors such as increases in the aging population, the changing expectations of patients, and regulatory pressures to improve pain management. Also, in commenting about opioid over prescription, the letter addressed opioid safety and effectiveness, a PROP standpoint. While the PROP contends that limited knowledge exists about opioid effectiveness and safety, no mention is made about the significant toxities of analgesic alternatives (NSAIDS). Such limitations of knowledge pose a great barrier for physicians who need substantial knowledge about opioids and alternative analgesics in order to formulate informed decisions. In this light, the PROP’s efforts to restrict opioid therapy to severe CNCP patients are misdirected. The increase in over prescription of opioids may be no more than a red flag for the need of comparative effective research.
Jeffrey Fundin, Pharm D, FCCP, a diplomate of the American Academy of Pain Management and chairman of PROMPT states that limiting dosages to 100mg morphine per day fails to account for the variability in conversion calculations that exist among different opioid products. According to a study of accepted conversion charts, variations in calculations spanned from -50% to +245% 2.As far as the safety of opioids is concerned, Fundin notes that the adverse effects targeted by the PROP (ie: bleeding disorders and kidney dysfunction) are mainly linked to non-steriodal anti-flammatory drugs rather than to opioids. Most opioid deaths result from incorrect medication use, mainly the abuse of multiple drugs or taking opioids in accompaniment with sedative medications or alcohol. These deaths could be prevented and are unlikely in patients if they take their medication correctly and are treated by physicians who are aware of the risks. Embedded in the great opioid debate are a range of strategies that can be used to address the problem. In a recent report by the Centers of Disease Control and Prevention, the report stated that the largest contributor to opioid deaths was methodone, with a death-rate of 33% (see figure). 2Fundin believes that regulations should make education necessary for all prescribers. This will promote greater knowledge of risk stratification and train physicians to interpret urine drug screening and serum anaylsis. In addition, to encouraging clinician education, the IOM Committee places particular emphasis to patient education in order to them to play an active role in managing their pain.
Whether a label change for long-term use is an overarching measure or the first step in addressing the problem, the opoid debate fine tunes the problem of pain encouraging us to question whether CNCP is adequately and safely treated. By taking into consideration the long-term effects and placing more efforts toward physician and patient education, healthcare professionals can make a difference.
- Boyer, E. W. (2012). Management of opioid analgesic overdose. New England Journal of Medicine, 367: 146-155
- Buckley B.(2012, November). The great opioid debate: PROP, PROMPT square off. Pharmacy Practice News, 39(11).
- Clark, N. M.& Pizzo, P. A. (2012). Alleviating suffering 101- pain relief in the united states. New England Journal of Medicine, 366: 197-199.
- Edwards R, Jamison, R. & Ross, E.(2011). The opioid debate-missing the point. Journal of Pain, 12(4),508. PubMed PMID: 21315661.