3Qs: When painkillers kill

The U.S. Food and Drug Admin­is­tra­tion recently intro­duced a series of safety mea­sures designed to reduce the risk of extended-​​release and long-​​acting opioid med­ica­tions, the abuse of which led to nearly 16,000 deaths in 2008. Northeastern University news office asked drug policy expert Leo Beletsky, an assis­tant pro­fessor of law and health sci­ences at North­eastern Uni­ver­sity, to expound upon the threat posed by opioid anal­gesics, 22.9 mil­lion pre­scrip­tions of which were dis­pensed last year.

The number of Americans who died from extended-release and long-acting opioid overdoses nearly quadrupled between 1999 and 2008, according to figures compiled by the Centers For Disease Control and Prevention. Why has opioid abuse increased over the last decade?

Starting in the 1980s, sev­eral major studies and reports shed light on the fact that far too many Amer­i­cans suf­fered from unnec­es­sary pain. This led to a growing recog­ni­tion of inad­e­quate access to effec­tive pain med­ica­tions, espe­cially among cancer, AIDS and other seri­ously ill patients. Calls by pro­fes­sional orga­ni­za­tions, pol­i­cy­makers, patient advo­cates and others raised aware­ness about this impor­tant problem, while the phar­ma­ceu­tical industry invested heavily in for­mu­lating and mar­keting pow­erful pain med­ica­tions to help meet patient needs. Opi­oids — drugs derived from, or syn­thet­i­cally mim­ic­king the prop­er­ties of the ancient drug opium — col­lec­tively serve as the best tool avail­able to modern med­i­cine in treating pain.

Over the inter­vening years, a steep rise in the pre­scrip­tion of now ubiq­ui­tous drugs such as Oxy­Contin, fen­tanyl and Vicodin were crit­ical to reduce the number of Amer­i­cans living with pain. As they worked to expand opioid access, how­ever, man­u­fac­turers, clin­i­cians and pol­i­cy­makers failed to ade­quately rec­og­nize and mit­i­gate the risks inherent to wider avail­ability of these useful and pow­erful med­ica­tions. One major risk is that these med­ica­tions are very addic­tive to some people. The other is that they are incred­ibly effi­cient at slowing down our breathing, which in some cases can lead users to slip into a coma-​​like state and die.

The rise in fatal over­dose doc­u­mented in the CDC report clearly par­al­lels the steep increase in the number of pre­scrip­tions issued for pow­erful opioid med­ica­tions. There is a sim­ilar pat­tern reflecting the con­tem­po­ra­neous increase in pain med­ica­tion access and abuse. Yet we have to be careful not to over­sim­plify the con­clu­sions we draw from these trends.

When talking about this issue, I like to use the analogy of auto­mo­bile safety. Over the course of the 20th cen­tury, the rise in car own­er­ship led to rad­ical improve­ments in our quality of life and eco­nomic pros­perity, while making us increas­ingly depen­dent on (some would even say “addicted” to) auto­mo­biles. The number of car crash injuries and fatal­i­ties also rose sharply to become the leading cause of acci­dental death in the U.S. For a long time, this was seen simply as an unavoid­able col­lat­eral cost of the “auto­mo­bile rev­o­lu­tion.” But leg­is­la­tion, law­suits and vol­un­tary industry action have been very effec­tive in curbing these risks through a number of mech­a­nisms like speed limits, strict drunk dri­ving poli­cies, driver edu­ca­tion, seat­belts and airbags. At a time when fatal opioid over­dose is quickly over­taking car-​​related fatal­i­ties as the leading cause of death in many U.S. juris­dic­tions, coor­di­nated policy, industry and health-​​care prac­ti­tioner action is crit­ical to mit­i­gating the risks cre­ated by the wider avail­ability of crit­i­cally useful, but dan­gerous opioid drugs.

How has President Barack Obama’s 2011 Prescription Drug Abuse Prevention Plan fared in curbing the abuse of prescription drugs, the second-most abused category of drugs after marijuana?

Clear signs of the pre­scrip­tion drug “problem,” including pre­scrip­tion drug abuse and over­dose, first emerged around 2007, but it took years for many public health agen­cies to mount any kind of mean­ingful response. The fed­eral gov­ern­ment has been espe­cially slug­gish, but the president’s 2011 plan was a defin­i­tive step to rec­og­nizing these prob­lems as a national crisis. The plan’s focus areas (edu­ca­tion, mon­i­toring, med­ica­tion dis­posal and enforce­ment) closely par­allel the cock­tail of strate­gies that have long formed the pil­lars of national drug policy for decades. Cer­tainly, much of what is in this doc­u­ment makes sense and is long overdue. The plan, for example, argues that med­ical providers should be more edu­cated about sub­stance abuse prob­lems, better-​​equipped to con­duct screening and pre­pared to (and com­pen­sated for) engaging their patients on this topic.

But many of the tac­tics that are used to imple­ment these strate­gies have yet to be shown to affect drug abuse because they are not suf­fi­ciently tai­lored to accom­plish the stated goals (e.g., to reduce pre­scrip­tion drug over­dose by 15 per­cent in five years). One example for this is the emphasis on pre­scrip­tion drug mon­i­toring pro­grams, which are sys­tems (usu­ally com­puter data­bases) that allow med­ical providers to track their patients’ pre­scrip­tion and dis­pensing his­tory for cer­tain med­ica­tions. Although they are pos­sibly useful to help pre­vent “doctor shop­ping” and are cer­tainly needed to address other sys­tem­atic prob­lems such as med­ica­tion errors, these pro­grams are prob­ably not capable of making a sig­nif­i­cant dent in over­dose rates. Public health data sug­gest that only a small frac­tion of over­dose vic­tims acquired their drugs through “doctor shopping.”

It is also notable that the plan omits any dis­cus­sion of over­dose edu­ca­tion, pre­ven­tion and treat­ment. It also does not address any of the “root” con­se­quences of pre­scrip­tion drug abuse and over­dose, including poor access to—and inad­e­quate quality of—healthcare and drug treat­ment ser­vices in many com­mu­ni­ties. Given Obama’s stated interest in advancing a “public health approach” toward drug abuse, I think more work needs to be done in clar­i­fying how this new approach dif­fers from the inef­fec­tive strate­gies of the past and what inno­v­a­tive approaches are being pro­posed to address this emerging epidemic.

The Food and Drug Administration’s plan to curb opioid abuse includes developing an education program for prescribers and updating the opioid medication guide for consumers. What would be your strategy for improving the safe use of opioids while ensuring access to prescription drugs for patients in pain?

Unfor­tu­nately, there are no simple answers to addressing opioid abuse and over­dose. Strate­gies to combat these prob­lems have to take a short-​​, medium– and long-​​term view. In the realm of opioid abuse, one key short– and medium-​​term strategy would be to increase funding for sub­stance abuse screening and for short inter­ven­tions in pri­mary health­care set­tings. A longer-​​term strategy would be to improve access to and quality of drug treat­ment ser­vices, which is some­thing the present admin­is­tra­tion is working toward. We also have to acknowl­edge that a sub­stan­tial por­tion of opioid drug abuse stems from unad­dressed mental health, pain man­age­ment, and health­care access needs, as well as larger social prob­lems such as under­em­ploy­ment. Such issues require big invest­ments and broader polit­ical will that is in short supply as of late.

In the realm of over­dose, the key short-​​term strategy is increasing public aware­ness about the risk fac­tors of opioid abuse, signs and symp­toms of an over­dose, and what to do when an over­dose occurs. Symp­toms of over­dose include blue lips and nails, shallow breathing, pin­point pupils and slow or unde­tectable pulse. Unlike people who are merely nod­ding off, over­dose vic­tims do not wake up when their name is called or when shaken vigorously.

Among the medium-​​term strate­gies to address over­dose is increasing avail­ability of naloxone — an opioid inverse ago­nist drug — through phar­ma­cies and its pre­scrip­tion by health­care providers. Long-​​term strate­gies include the cre­ation and dis­tri­b­u­tion of a naloxone nasal spray or auto-​​injector device sim­ilar to an EpiPen. These kinds of user-​​friendly devices can facil­i­tate wider avail­ability and usability of naloxone (which is now only approved for intra­mus­cular injec­tion with a syringe). Ide­ally, naloxone should be avail­able in all first aid kits, and cer­tainly just as acces­sible as auto­mated external defibrillators.

Opioid pain med­ica­tions are an impor­tant med­ical tool, but they do not come without risks. Mit­i­gating these risks will take a com­bi­na­tion of policy, edu­ca­tional mea­sures, changes in our health care and sub­stance abuse treat­ment sec­tors and finan­cial invest­ments. As key stake­holders, drug com­pa­nies should play an active role in addressing the social and public health “side-​​effects” that result from wider avail­ability and pop­u­larity of their products.