I was recommended an excellent interview and wanted to share a link and some discussion. The interview and its points are a much needed highlight of the negative effects that new pain management restrictions and guidelines have had on chronic pain patients, and I highly recommend it as a worthwhile perspective for any listener.
Interview Link: NPR-Here and Now: Where Chronic Pain Patients Fit Into The Opioid Crisis
Note: for resources included in this discussion/review, please see the list at the bottom. Critique, comments, and response are (as always) welcome.
The use of opioids in pain management is under attack, as governing bodies in the US desperately seek to reduce misuse of pain prescriptions and prescription drug overdoses. The CDC, DEA, and FDA have been working towards increasingly restrictive opioid guidelines in recent years, aiming to reduce the number of prescriptions written. As these governing bodies seek to reduce the significant epidemic of prescription pain overdoses and deaths, numbers continue to escalate and chronic pain patients are suffering expansive negative changes in their health care.
How do guidelines affect the broad world of medicine? Insurers, pharmacies, clinics, doctors, healthcare providers, etc., operate in a social-legal environment where the needs of a patient are balanced against laws and guidelines for practice. This continuum exists for practical and beneficial cause--without general guidelines of practice, a patient could not trust their doctors to consistently abide by safe and commonly accepted health practices. Medicine is constantly evolving and changing, relying on expansive empirical, peer-reviewed, and clinically tested treatments; healthcare providers strive to maintain up-to-date care and accreditation by acting within these advocated practices, and we as patients can trust in consistent safe care.
Guidelines for treatments vary according to (1) the practice of providers and (2) diagnoses of patients. Complications arise when different classes of patients are identified as same/similar and regulated the same. For an obvious (and unrealistic) example, consider if pregnant and nonpregnant women were regarded the same by regulation boards. Doctors would be expected to treat pregnant women as not pregnant, even when considering teratogen associated prescriptions, or they will be faced with discrimination fines/review boards. As a result, the rate of birth defects skyrocket as unsuspecting patients use treatments they would otherwise avoid. Or, if the opposite were true, with women treated as pregnant regardless of reproductive status, critical medical treatments with zero contradictions could be withheld without cause. Hormones, antidepressants, pain relievers, mood stabilizers, anti-inflammatories, and many more medications would be unavailable to women on the basis of assigned pregnancy capacity. Neither outcome would be desirable. Thankfully, current guidelines generally recognize such obvious discrepancies; unfortunately, serious consequences arise when they do not. And it seems patients in pain seem to be veering into their own impractical groupings.
Prescription drug overdose is the driving force in regulation changes seen in recent years. The epidemic is not to be trivialized--according to the National Institute of Drug abuse, total deaths due to prescription drug overdose increased 2.8-fold between 2001 and 2014. In response to the overdose, epidemic, the FDA and CDC has sought to increase restrictions on prescription guidelines of opioid pain medications. But despite increasingly restrictive guidelines, deaths continue to increase--and chronic pain patients say they are feeling the burden of the changes.
While number of deaths is deservedly a focus of the regulatory response, it seems to be the only focus, and guidelines fail to distinguish circumstances leading to overdose. In fact, they often seem to glance over cause, in favor of simply reducing access. Recognition of specifics for overdose death may seem sterile or harsh, but regulations for any product/action must consider differences leading to misuse/abuse in order to be successful in application and reducing negative outcomes.
For a well known example, age is a factor in the availability of vehicle licensure. In the USA, you must be at least 16 years old to apply for one. You must past inspection regardless, but certain ages are restricted from even trying to apply. A car can be equally deadly in the hand of an licensed adult, but age of user has predictive value in reducing risk of misuse and negative consequences. If driving license restrictions were instead dependent marital status, the value of regulation would be far lower. Sure, it would still exclude teens, reduce number of wrecks, and help prevent toddlers from driving, but it would also prevent many unmarried, productive, working adults from efficiently functioning in and contributing to society. As an intended effect, it may motivate otherwise law-abiding, unmarried citizens to drive illegally, without license, practice or knowledge, in rebellion to the restriction.
Research supports that chronic pain patients (especially ones with excessive, unmanaged pain) are at significantly higher risk for suicide. Patients are also more likely to misuse medications when their pain is not sufficiently addressed in current treatment (e.g. taking increasingly numerous pills because their prescribed dose does not make the pain bearable). Maybe restricting clinical access would reduce their use in the pain population (at least by safe and supervised means), but the outcome would likely be increased suicides by others means. Desperate users will switch to an OTC or illegal overdose risk as they struggle to manage.
Another, likely more relevant, fact that is ignored by DEA and CDC regulations, is that studies support that the majority of OxyContin addicts seeking treatment have never received a prescription (see Carise, et al.). Abuse of prescription opioids tends to happen concurrently with other illegal substance abuse, rather than within the sphere of patient treatment (Wesiner et al., 2009). This supposed link between pain patients and prescription addiction is not even under proper evaluation by relevant governing bodies. By ignoring individual sources of the problem, the value of regulation is fundamentally limited.
These governing bodies state they aim (and I believe they desire) to not negatively affect chronic pain patients, but they seem unwilling to acknowledge the consequences their guidelines carry. And problems go beyond the lack of alternative treatments (which their guidelines imply exist in abundance). The designs do not adequately distinguish between addicts and chronic pain patients or recognize differences between patients and conditions that may require opioid treatment. For example, the major distinction applied in pain treatment is cancer and non-cancer patients, (not anatomical location, duration, symptoms, etc.), and guidelines systematically group all non-cancer patients as needing less pain intervention and equal in general severity. They are far too general to be advocating such a serious restriction of treatment--people are going to be negatively affected, including those who have reliably demonstrated responsible use.
Opioids are not a panacea for pain patients. They fail to be the magic solution for intractable, incurable pain. Some conditions do respond well to alternatives. But, for many conditions, there are no existing alternatives that manage pain with even near comparable efficiency. In a meta-analysis conducted by Furlan et al. in 2006, over 41 chronic pain treatment studies were reviewed and showed that evaluated opioids significantly outperformed all studied placebos and non-opioid alternatives. Restricting availability will leave patients with less efficient pain treatment.
Lobbied guidelines and laws regarding opioid prescription cite concern for development of addiction in chronic pain patients. This is a valid and real concern, as some patients do misuse their medications or violate doctors orders. The problem is, in describing addiction risks they lack transparency of sources and do not disclose that there is currently no long-term research on the potential of long-term addiction in the chronic pain population. Many clinical studies conflict on the severity/existence of the risk for addiction in long term, and the meta-analysis mentioned previously found no reported increase. No proper research has supported their cited risks of long term use.
Every study I have read on the matter disparages the lack of adequate research in regard to the relationship between chronic pain treatment and opioid addiction. This does not mean a connection does not exist, opioid addiction is a real and serious risk to be aware of, but the extent and nature of the relationship between long term patient use and addiction is not sufficiently supported, explored, or funded. Rather than evaluate what leads to addiction in a treatment setting and how to manage the risk, regulations choose to limit availability to limit number of users, thus limiting total overdoses. Limiting prescriptions may change the number of patients filling prescriptions, but it does not change the percentage of patients or users suffering from addiction and it ignores the lack of research/interest into the causes leading to addiction. And, as evidenced by current statistics, overdoses have only increased despite increased restrictions. It's like a bandaid on a cancer patient: ignoring real intervention in favor of visible 'fixes'.
Rather than just limiting patient access, factors and risks should be the guiding principle in regulations, and regulation should aim to further identify risks for future patients. Psychological and physiological susceptibility to addiction is as significant with opioids as it is with other potentially addictive substances. For example, drinking alcohol is a common behavior in the United States, with about 87% of adults partaking, according to the National Institute of Alcohol Abuse and Alcoholism. But despite the significant addictive qualities of alcohol, less than 8% of drinkers are considered disordered/addicted in their consumption. The difference between a casual drinker and an alcoholic is not a tragic strike of chance; choices, experiences, social environments, physical traits, genetic makeup, and many more personal aspects all combine to determine an individual's susceptibility to the addictive qualities of alcohol.
Studies on chronic pain patients reveal a similar story, in that individuals vary on likelihood to abuse a substance (See Turk, Swanson, & Gatchel, 2007: Predicting opioid misuse by chronic pain patients). In fact, similar to general population (i.e., those who don't use pain killers), individuals with previous substance abuse are the greatest predictive factor for opioid abuse. Other factors, such as type of condition or length of treatment, are not recognized as valid or reliable predictors for whether someone will abuse their prescriptions. Regulations should focus on identifying and enforcing applicable differences between patients which responsible use and those that abuse their prescriptions. Lowering numbers available serves to disproportionately cripple patients that have demonstrated no problem behaviors and depend on such medications for daily living function. Education, awareness, study of risks, and restrictions based in real life application are used for recreational drugs such as alcohol--medical treatments for life altering conditions should be approached with at least the same level respect and practicality.
This is getting incredibly long, so I will try to summarize my view as this:
Guidelines and regulations have restricted opioid prescribing for over a decade, but delinquent/unconcerned practitioners and addicts continue to increase distribution and access to powerful and addictive narcotics. Response does not utilize or consider investigating patient qualities leading to abuse and overdose. Restrictions have not stopped the escalation of behaviors that lead to increased deaths and tragic loss. Failure of restrictions does not support an increase of further restrictions. It calls for a serious reassessment in approach and a more involved response to the problem. And it requires a more detailed investigation/application into the risks for development of harmful addictions.
These new 'guidelines' have already had real effect in the pain management community, and calling them mere suggestions ignores the legitimate concerns doctors have for maintaining accreditation. These guidelines affect treatment. My pain management clinic, which has actually expanded and is considered a well-respected multidisciplinary practice, is now required to treat all patients like addicts. Every patient is required to submit to monthly urinary analysis and all patients are required to sign an agreement to not consume any alcohol or marijuana, despite both being legal in the state. Patients that previously received prescriptions for medical marijuana were forced to switch treatments or clinics. Costs and frequency of required care increased, all in hopes of appeasing new guidelines. My pharmacy was forced to reject my regular, low-dose pain prescriptions because corporate policy had switched to adapt to the proposed CDC guidelines. My wonderful pharmacist managed to advocate a temporary extension (as she knows I adhere to a contract and communicate any/all changes to my clinic) but was unable to continue filling them. The cause of change? I am not a cancer patient.
I am a patient that works with my provider to maintain the lowest treatment possible. I don't like being on these medications, I use transdermal low-dose approaches because I dislike the side-effects of pills. My doctor actively strives to help me find and maintain the minimum pharmacological intervention required to allow me to function in day to day living. I'd rather not take any drugs, but I do because I have no other choice. Even with non-opioid treatments, my body cannot tolerate the combined pain of my disorders and nerve damage. Before proper pain management, I only wanted to die. Now I get to live.
Please, when considering the impact of these guidelines and laws, consider the impact it has on the people striving to overcome their destructive conditions with the tools available. Consider donating to research that seeks to study the connections between opioid addiction and prevention. Consider supporting investigations into alternative treatments or increasing availability of such treatments to those in need. Consider working to improve education and awareness of opioid addiction and resources to treat it. Whatever you do, please do it with thought and deliberate action, and consider the outcomes for those affected.
Resources for this post are included below, with links to relevant topics and studies where available without paywall. Proper footnote numbers/links will be added when I figure out how to HTML.
For those struggling with opioid addiction, please do not wait to get help, call 1-800-755-9603 for the nearest treatment center and/or help from trained addiction counselors. If you are considering suicide or are at risk for self harm, please call the National Suicide Prevention Lifeline at 1-800-273-8255.
To read more on perspectives of chronic pain patients regarding regulations and guidelines for pain management, check out the Pain News Network and their response and survey of affected pain patients.
The CDC and FDA are underfunded governing bodies that lack a sufficient number of employees, citizen accessibility, and political support. My disappointment with their actions in this matter does not change the significance of their function or importance in disease prevention and proper drug approval processes. Increased resources and management could result is more attentive regulation.
Cheatle, M. D. (2011). Depression, chronic pain, and suicide by overdose: on the edge. Pain medicine, 12(s2), S43-S48.
Tang, N. K., & Crane, C. (2006). Suicidality in chronic pain: a review of the prevalence, risk factors and psychological links. Psychological medicine,36(05), 575-586.
Reddy, B. S. (2006). The epidemic of unrelieved chronic pain: the ethical, societal, and regulatory barriers facing opioid prescribing physicians. The Journal of legal medicine, 27(4), 427-442.
Furlan, A. D., Sandoval, J. A., Mailis-Gagnon, A., & Tunks, E. (2006). Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. Canadian Medical Association Journal, 174(11), 1589-1594.
Tang, N. K., & Crane, C. (2006). Suicidality in chronic pain: a review of the prevalence, risk factors and psychological links. Psychological medicine,36(05), 575-586.
Carise, D., Dugosh, K. L., McLellan, A. T., Camilleri, A., Woody, G. E., & Lynch, K. G. (2007). Prescription OxyContin abuse among patients entering addiction treatment. American Journal of Psychiatry.
Weisner, C. M., Campbell, C. I., Ray, G. T., Saunders, K., Merrill, J. O., Banta-Green, C., ... & Von Korff, M. (2009). Trends in prescribed opioid therapy for non-cancer pain for individuals with prior substance use disorders. Pain, 145(3), 287-293.
Dworkin, R. H., O’connor, A. B., Backonja, M., Farrar, J. T., Finnerup, N. B., Jensen, T. S., ... & Portenoy, R. K. (2007). Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain, 132(3), 237-251.
Turk, D. C., Swanson, K. S., & Gatchel, R. J. (2007). Predicting opioid misuse by chronic pain patients: a systematic review and literature synthesis. The Clinical journal of pain, 24(6), 497-508.
Michna, E., Ross, E. L., Hynes, W. L., Nedeljkovic, S. S., Soumekh, S., Janfaza, D., ... & Jamison, R. N. (2004). Predicting aberrant drug behavior in patients treated for chronic pain: importance of abuse history. Journal of pain and symptom management, 28(3), 250-258.