Saturday, September 18, 2010

Recent Data Deluge Highlights Rx-Opioid Concerns

In The NewsA flurry of survey data featured in news media during the past several months presents a bleak picture of purported problems with prescription opioids: misuse, abuse, addiction, poisonings, and deaths. Policy makers and regulators often heed such data to guide their actions, so it can be important to understand the numbers and how they may be biased or misleading.

In the news on September 16, 2010, the U.S. Substance Abuse and Mental Health Services Administration released their National Survey on Drug Use & Health, which is a major source of information on the prevalence, patterns, and consequences of substance misuse and abuse in the general U.S. civilian non-institutionalized population aged 12 and older [SAMHSA 2010]. Here are some pertinent findings:
  • The prevalence of illicit drug use in this population rose from 8% in 2008 to 8.7% in 2009. Increasing use of marijuana was the greatest contributor.

  • In 2009 it was estimated that 23.5 million Americans ≥12 years of age needed treatment for a substance abuse problem but only 11.2% (2.6 million) of them received it.

  • From 2002 to 2009 the rate of nonmedical use of pain relievers increased from 4.1% to 4.8% among persons ages 18 to 25.

  • Among persons ≥age 12 who used pain relievers (typically opioids) nonmedically, 55.3% got the drugs from a relative or friend for free, another 9.9% bought them from a relative or friend, and 5% stole them from a relative/friend. In most cases — 80% — the relative/friend had a legitimate prescription for the drug, and from a single prescriber.
Three points are worthy of mention. First, an overwhelming amount of data are collected in this survey, from which snippets can be extracted in government summaries to make selectively biased impressions. Second, survey respondents are asked to report only “nonmedical” use of drugs, defined as “use without a prescription of the individual’s own or simply for the experience or feeling the drugs caused.” This would include everything from blatant abuse for recreational purposes to simply borrowing a prescribed pain reliever for a headache from a relative, and whether it was a single, isolated event or occurred multiple times; therefore, the extent of the problems may be distorted. Third, the greatest source of pain relievers for nonmedical use appears to be the sharing of legitimate prescriptions obtained from a single prescriber.

Last June, the U.S. Centers for Disease Control and Prevention released their most current data on hospital emergency department visits involving “nonmedical use” of prescription opioid analgesics [Cai et al. 2010]. From 2004 to 2008 such incidents increased by 111% reaching roughly 306,000 annual visits. Base ingredients most frequently implicated were methadone, hydrocodone, and oxycodone. The CDC definition of nonmedical use includes “taking more than the prescribed amount, taking drugs prescribed for someone else, or substance abuse”; so, it is even more inclusive than the SAMHSA survey noted above.

A document from the CDC, published last July, noted that unintentional drug overdose deaths in the U.S. have increased more than 5-fold since 1990 and are second only to automobile accident fatalities [CDC 2010]. In 2007, overdose deaths involving opioid analgesics were nearly twice the number for cocaine and more than 5 times the number involving heroin. In 2007 there were nearly 12,000 overdose deaths from opioid analgesics; however, the circumstances surrounding those fatalities are unknown from this data and prior research suggests that most cases involve multiple drugs and/or alcohol.

According to study results published in the American Journal of Preventive Medicine last May, unintentional poisonings from prescription opioids, sedatives, and tranquilizers increased by 37% from 1999 to 2006 in the U.S., while intentional poisonings from these drugs rose by a startling 130% [Coben et al. 2010]. Hospitalizations for such poisonings increased by 65%, with the largest increase (400%) in hospitalizations associated with methadone. Intentional poisonings (eg, suicide attempts) may be a particular concern as they represent a failure of the mental healthcare system in the U.S.

Findings from a national survey released September 16, 2010 from the American Pain Foundation reveal that medical professionals are aware of potential opioid risks [APF 2010]. The survey was conduct among 500 opioid-prescribing physicians (80% primary care providers) throughout America during August 2010. Here are highlights:
  • Nearly 9 in 10 (87%) practitioners said they do consider increasing rates of opioid misuse and abuse when prescribing opioids. However, most (61%) acknowledge it is not easy to identify patients who abuse opioid analgesics.

  • Almost all (92%) speak with their patients about how to prevent opioid misuse and abuse; such as, not sharing medication (89%), the importance of locking up medications (77%), appropriate medication disposal (65%), and other factors.

  • Nearly all physicians (87%) are aware that a majority of recreational opioid abusers get these drugs from legitimate prescriptions.

  • Most physicians (56%) believe that only a relatively small number of their patients misuse or abuse prescription opioids.

  • Curiously, fewer than half (47%) of respondents agreed that patients taking opioids for pain rarely become addicted to the medications. [As much as anything, however, this may reflect current misunderstandings of addiction, which is relatively rare, versus physical dependence, which naturally occurs with long-term opioid therapy.]

  • When asked who plays the most important role in preventing opioid misuse and abuse, more than half of physicians specified themselves (54%) while about a third (36%) indicated that patients and their families must assume more responsibility.
It should be noted that this was a somewhat small sampling of opioid prescribers, and there may have been a social desirability bias in their responses. That is, knowing what they should be doing regarding opioid safety, many may have responded how they would like to practice rather than how they actually do on an everyday basis. However, another report suggests that physicians in this survey may have been overly optimistic about the lack of substance misuse among their patients.

A study recently noted in Pain Medicine News involved a large number of patients with chronic pain and 281 primary care providers participating in a clinical trial of extended-release morphine [Miller 2010]. At the beginning of the study, 52% of patients were considered at moderate risk for opioid misuse or abuse; whereas, 47% were considered low risk and only 1% were rated high risk. An unexpected number of patients tested positive for illicit substances — eg, marijuana (16%), cocaine (10%), and both ecstasy and phencyclidine (6%) — and a surprising majority of those patients were initially considered as low risk. For example, of 152 patients testing positive for cocaine, about half (52%) were rated initially by the opioid prescribers as low risk. If anything, the study demonstrated that physicians’ “clinical insight” in assessing patient risk for substance misuse or abuse is often overly optimistic and inaccurate. As Howard Heit, MD, commented in the article, “You cannot [simply] observe a patient and then predict aberrant behavior.”

FURTHER COMMENTARY: The above data are a sampling from the nearly continuous stream of statistics coming from many sources and the depiction of opioid safety in America is certainly less than favorable; albeit, such data can be massaged and manipulated in many ways [which we also have previously discussed here]. However, even though one can justifiably argue that the data may be biased by variable, overly broad, or vague definitions of misuse, nonmedical use, and abuse, there clearly appears to be a population of patients with pain and in the populace at large who are “misbehavers” when it comes to the proper and safe use of opioid analgesics.

While this population of misbehavers is by all accounts from research studies relatively small in number they place a tremendous burden on society and the healthcare system. Certainly, there is no inherent evil in opioid molecules themselves; the devil is in how opioids are misused and abused — by certain people. And, it also is important to recognize that even if opioids were removed from planet Earth entirely, there still will be many other substances of abuse to choose among and persons who are so inclined will abuse those. Therefore, focusing on opioids as substances of abuse and seeking ways to further control access to these agents deflects from their vital role in pain management and loses sight of the far greater problem in American society of substance abuse and addiction that afflicts nearly 24 million persons.

In fact, the deluge of dismal data coming from the various government agencies is quite interesting in that those same reporting organizations are charged with preventing or ameliorating the conditions that appear to be deteriorating from year to year. U.S. institutions like SAMHSA (and its various Centers), CDC, NIDA, NIAAA, and ONDCP — with their multibillion dollar budgets — are expected to not only study and report on the problems but to resolve them; so, the worsening data might be perceived as attesting to their own failures.

When it comes to opioid analgesics, data from study results demonstrate strong needs for professional and public education to encourage more appropriate opioid prescribing and more responsible use. While healthcare providers bear much of the responsibility, patients and the public at large must be educated to assume far greater responsibility for safety than they have in the past. Government agencies at federal, state, and local levels appear to have adopted finger-pointing and regulating roles, placing the burden of education on private industry and independent organizations or associations; however, we wonder if this is the way it should be.

> APF (American Pain Foundation). Physician Perspective Toward Prescription Opioid Abuse and Misuse Summary of Findings. 2010(Sep 16) [
PDF available here].
> Cai R, Crane E, Poneleit K. Emergency Department Visits Involving Nonmedical Use of Selected Prescription Drugs — United States, 2004–2008. CDC MMWR. 2010(Jun);59(23):705-709 [
PDF here].
> CDC (Centers for Disease Control and Prevention). Unintentional Drug Poisoning in the United States. 2010(Jul) [
PDF available here].
> Coben JH, Davis SM, Furbee PM, et al. Hospitalizations for Poisoning by Prescription Opioids, Sedatives, and Tranquilizers. Amer J Prev Med. 2010(May);38(5):517-524 [
abstract here].
> Miller G. Study: PCPs Often Underestimate Opioid Abuse Risk. Pain Medicine News. 2010(Sep);9:09 [
available here].
> SAMHSA (Substance Abuse and Mental Health Services Administration). (2010). Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of National Findings. 2010 (Sep 16). Office of Applied Studies, NSDUH Series H-38A, HHS Publication No. SMA 10-4586Findings, Rockville, MD. [
PDF available here].