By J. David Haddox, DDS, MD, Vice President, Health Policy, Purdue Pharma L.P.
The U.S. is faced with two coexisting, endemic problems: about five million people currently use pain medicines for nonmedical reasons, and about 100 million of us deal with chronic pain – with well over 10 million taking prescribed pain medicines.1,2,3 These two problems – pain and medication abuse – are intertwined and each has significant implications for the person who is abusing medicines or suffering with pain. There are pervasive ripple effects, too, that affect those who care for them, their employers, the health care system, and society in general. Both are complex, multifactorial, life-altering conditions that often require long-term management and, unfortunately, are not subject to quick remedies.
Drug Abuse and Chronic Pain Cost the US Millions Each Year
The obvious costs from drug abuse involve both the cost of treatment and money spent by the criminal justice system preventing and responding to drug crimes, prosecuting dealers, providing treatment for incarcerated abusers. Some costs of abuse, however, are hidden from the health care system. Take, for example, an insurance company paying for medicine that is abused or paying for worsening of complications in a drug-abusing diabetic who is not adhering to doctor-prescribed diet, medication therapy, and behavior-change protocols. One study estimated excess health expenditures of $15,000 – 20,000 annually for each insured person who abused drugs.4
Chronic pain also costs. Direct expenses include office visits, medications, hospitalizations, diagnostic tests, and procedures. Indirect expenditures, such as sick pay, lost productivity, and disability, are substantial drains on the economy as well. Together, they are estimated to cost the nation about $600 billion annually.2 And that is just monetary cost – not the emotional cost to those suffering from pain and their families.
These two issues intersect when the very same medicines that are prescribed for millions of people with both short-lived and ongoing pain, are sought out by the millions of people who either want to abuse them or to sell them to abusers. Abuse of any medicine is, of course, unwise and unhealthy. Abuse of opioid analgesics, alone or in combination with other drugs, legal or illegal, often leads to dramatic problems and can have fatal consequences. About 16,000 people die every year of overdoses involving prescription painkillers.5 As a pain physician, I have seen both of these problems firsthand. Before joining the pharmaceutical industry, I cared for patients with each of these conditions. Sometimes, both were present concurrently in the same patient.
Good Understanding Makes Good Policy
Despite the popular image of a drug abuser as simply seeking a state of euphoria, in the words of Nora Volkow, MD, the director of the National Institute on Drug Abuse at NIH, once addiction takes hold of a person, it “hijacks” the brain.6 And, while drug abusers may start on a pharmaceutical joy ride, it often ends up in a car wreck – injuring them physically, spiritually, and emotionally, and causing upheaval in the lives of those who care about them.
I will never forget interviewing an alcoholic I encountered as a resident. A few days after I admitted him to the hospital and his delirium tremens was stabilized, I was taking a thorough history to better understand him and his disease. I asked the obvious question: “Why do you keep drinking alcohol?” He looked me squarely in the eye, thought for a moment, took a deep breath, and said, “Doc, I used to drink to get high. Now, I drink to keep from getting low.”
The same phenomenon applies to abusers of prescription pain medicines. Initially, they seek the rush, high, buzz, or euphoria, but as that becomes less intense and less predictable – a phenomenon known as “tolerance” – they begin escalating their dose and trying different drugs, often in combination, seeking feelings similar to those early on in their abuse.7 And, if they can’t get enough drugs, they get sick –“dope sick,” they call it. The medical term is opioid abstinence or withdrawal syndrome.
As a physician, it’s been painful to witness opioid withdrawal syndrome; it must be even more terrible to experience. During withdrawal, the person has severe pain everywhere, including abdominal cramping, often accompanied by nausea, vomiting, and diarrhea. They are intensely restless and anxious. They can’t concentrate. The hair on their skin stands on end, giving them gooseflesh (the origin of the phrase “quitting cold turkey”). Their eyes water. Their noses run. They can’t sleep. Their legs and arms twitch and spasm involuntarily (“kicking the habit”). They may have a fever, sweat, or yawn uncontrollably. Nothing helps – except abusing more drugs or proper medical treatment.
The plight of a person suffering with chronic pain is qualitatively different, but no less impactful on the patient or the observer. As the U.S. population ages, increasingly more of us are dealing with some degree of ongoing aches and pains. For many, we grin and bear it, stretch or exercise if we can tolerate it, or take over-the-counter analgesics. Or, perhaps, we have the kind of pain that responds to a specific non-analgesic treatment, like biologics that designed to tamp down an overactive and misdirected immune response and thereby reduce the underlying cause of painful joints in certain types of arthritis.
But there are millions of Americans who suffer with significant pain that interferes with their lives 24 hours a day, seven days a week. As a physician, these were the people I saw and who came under my care. Their histories differed, especially in how the pain began, but when it came to its effects on their lives, their stories tended to converge. Pain – and pain avoidance – became the drivers of their lives, the determining factor in everything they did or thought about doing. Pain can be a malevolent ruler, dictating whether they can enjoy being around friends or family, whether they can go shopping or to a movie or a restaurant, whether they can even sleep. One of my patients said it best: “Pain is a thief. It stole my freedom, my health, my happiness, my relationships, my money, my future hopes and dreams, my life.”
Complex biopsychosocial problems like chronic pain and drug addiction are only amenable to solutions that, on one hand, integrate science into policy decisions and, on the other, promote sustained behavioral change.
How do we fix these problems? Certainly not with a single solution. A moment’s thought reveals the necessity of a multifaceted approach, enlisting doctors and other healthcare professionals, parents, teachers, regulators, insurers, law enforcement, families, and friends. Why? They’re deep, complex, co-occurring problems, affecting many communities in many different ways.
Educating the Professional
Let’s start with healthcare professionals, who spend years learning to practice their science and art. Chronic pain and substance use disorders are both quite prevalent, yet professional-school curricula place minimal emphasis on the diagnosis and treatment of neither.1011 Adjusting the education of healthcare professionals in training and in practice to reflect the realities of what they encounter clinically seems an obvious choice.
The ONDCP emphasizes education as one of its four policy pillars to address the abuse of prescription medicines.12 The U.S. Food and Drug Administration has determined that there are knowledge gaps among prescribers of pain medicines and have required the makers of extended-release and long-acting opioids to fund accredited providers of continuing education to teach prescribers more about the safe use of this subclass.13 The federal Substance Abuse and Mental Health Services Administration is encouraging healthcare professionals to become competent in SBIRT, or Screening (for substance use disorders), Brief Intervention, and Referral for Treatment.14 Schools for healthcare professionals, postgraduate training programs, and continuing education content must incorporate the competent assessment and management of pain and substance-use disorders into everyday practice. There are simply not enough pain specialists or addiction specialists to address the current need.
Putting Education into Practice
Educating healthcare professionals is necessary, but not sufficient, for widespread behavioral change – namely, modifying how healthcare is delivered. When a healthcare professional makes the decision to prescribe an opioid analgesic, even in the short term, for, say, trauma or surgery, they should assess the risk inherent with opioids for each individual patient, employ non-opioid and non-drug therapies as appropriate, and monitor their patient’s progress carefully.15 The longer the treatment includes an opioid, as may be the case with cancer-related pain or chronic pain from arthritis or any number of other conditions, the more important careful monitoring of that patient becomes.
One tool most prescribers now have available is a State-administered prescription drug monitoring program (PDMP). PDMPs are secure databases that can be accessed by healthcare professionals to learn what, if any, other controlled substances (such as opioids, stimulants, anxiety medicines) a patient has received, from whom, and when. These are valuable tools to spot “doctor shoppers,” some of whom sell medicines and need interdiction, some of whom are abusers and need intervention. The value of a PDMP is increased when, as I often did, a prescriber has patients from multiple states and the PDMP in their state can also provide access to information about medicines dispensed in surrounding states. The National Association of Boards of Pharmacy provides a way to link this information among participating State PDMPs. To date, 27 states are participating in the PMP InterConnect program.16
As a former prescriber of opioids and other treatments for chronic pain of all types, I know that there are some patients who derive continued benefit from opioids and there are some for whom the benefit/risk assessment is unfavorable – or becomes unfavorable over time – due to adverse effects of the opioids, ranging from constipation to hormonal effects to abuse. It takes a focused effort to assess patients with pain and plan an approach that is tailored to each person, regardless of whether the treatment plan includes an opioid or not.
Preventing Addiction at its Roots
But healthcare professionals are not the only ones who need better understanding of these problems. Drug abuse often starts early in life, with tobacco, alcohol, or marijuana frequently being the first drugs abused.17 Parents and teachers, too, need to be better educated on how to prevent the initial experimentation that paves the path to abuse and addiction, how to recognize early signs of trouble, and how to intervene in a meaningful way that will help steer an adolescent back on course instead of driving them further away.
The adolescent brain undergoes daily development. These normal changes in how our brains function continue well into our twenties. Allowing brain development to be influenced and altered by substance abuse can lead to serious, life-altering consequences. As a general principle, the longer a person delays exposure to drugs with abuse potential, the less likely they are to have a problem managing that exposure, because their brains will have developed normally, including learning how to manage daily challenges and life stresses without reliance on chemicals to cope.17
Many parents are surprised to learn that over two-thirds of respondents in an ongoing federal survey of drug abusers say they got the pain reliever they most recently abused from friends or relatives.18 There’s an important message in that statistic. We have, in our homes, a large, unaudited, widely-distributed inventory of drugs that an experimenter, abuser, addict, or dealer wants.
Throwing Away and Taking Back
Another tenet of the ONDCP policy is proper disposal.12 The FDA has a site for consumers to tell them how to dispose of different drugs properly.19 Some, such as several of the opioids, are to be flushed down the toilet when no longer needed. This is not a policy established without regard to the environment, however. The ONDCP, FDA, and other agencies made a thoughtful calculation that weighed the risks of abuse of even one dosage unit of some drugs against the risks of having them in the environment.
To reduce the unneeded supply even further, the Drug Enforcement Administration (DEA) recently promulgated a rule allowing for the return of unneeded opioids to pharmacies, law enforcement, and other “take-back” programs.20 The 9th National Prescription Drug Take-Back Day took place in November of 2014. The DEA and its local partners reported taking into custody 309 tons of unneeded prescription drugs of all types – making a total of over 2,400 tons in the four years since the program’s inception.21
The Role of the Manufacturer
Manufacturers of opioid analgesics have a unique role in reducing abuse of the drugs they make. There is currently a growing movement to formulate opioids in ways that deter one or more methods of abuse. By understanding more about how medicines are abused, they are designing innovative ways to deter or foil abuse. In 2013, the FDA issued a draft guidance to the pharmaceutical industry that laid out a proposed pathway of how to design opioids that are less desirable to abusers and how to test whether a new formulation is likely to deter some types of abuse.22 These assessments include laboratory testing to simulate common methods of abuse, such as attempts to crush a tablet to enable snorting or injecting, and clinical studies in drug abusers to determine how much they like or dislike the effects of a new drug. The draft guidance also outlines the kinds of studies the FDA expects to see once a drug with abuse-deterrent properties is approved and marketed to determine how well the abuse-deterrent properties perform in real-world use. To incentivize manufacturers, the FDA will allow label claims of expected or known abuse deterrence, based on their interpretation of the results of the totality of the pre- and post-market testing. Currently, there are nine approved opioid drug products that were specifically designed to deter one or more means of abuse. There are at least 15 more in various stages of development.
How Insurers Can Help
Public and private insurers also have a role to play. Most important is adequate reimbursement for the time and effort it takes to properly assess and manage chronic pain, and to assess and treat substance-use disorders. Many proven, non-pharmacological approaches to managing ongoing pain are no longer reimbursed.23 Substance abuse screening and treatment is not uniformly covered by health insurers. Furthermore, access to specialized care for either pain or addiction may be difficult to obtain, not only due to lack of insurance coverage, but also due to availability of programs that are right for a particular patient. Treatment of opioid addiction with FDA-approved drugs, called Medication-Assisted Treatment, is still frustrated by policy or payment barriers and isn’t even available at all in some locales.
Since ONDCP has determined that opioids with abuse-deterrent properties can be a part of solving drug abuse, health insurers need to consider looking at not only the medication costs, but also at the overall costs of substance abuse to their bottom line and to society.12
Part of America’s great promise, to me, is that at our best, we collaborate to seek solutions. That is to say: we solve problems by working together, with each of us doing what we alone are best suited to do. There is no one solution for the problems surrounding the abuse of prescription pain medicines or endemic chronic pain. All of us have unique roles to play. Working together, respectfully, intelligently, diligently, we can make a difference.
1. Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014. Table 1.18A, Past Month 2012 and 2012, Total (all ages), at http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabsPDFWHTML2013/Web/PDFW/NSDUH-DetTabsSect1peTabs11to18-2013.pdf Accessed on12/02/2014.
2. Institute of Medicine. Relieving Pain in America – a blueprint for transforming prevention and care. 2011. At http://iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research/Report-Brief.aspx Accessed on 12/02/2014.
3. IMS Institute for Health Informatics. Medicine use and shifting costs of healthcare: A review of the use of medicines in the United States in 2013. Parsippany, NJ: April 2014. At http://www.imshealth.com/portal/site/imshealth/menuitem.762a961826aad98f53c753c71ad8c22a/?vgnextoid=2684d47626745410VgnVCM10000076192ca2RCRD&vgnextfmt=default Accessed 12/02/2014.
4. White AG, Birnbaum HG, Schiller M, et al. Economic Impact of Opioid Abuse, Dependence, and Misuse. Am J Pharm Benefits 3(4):e59-e70. 2011 at: http://www.ajmc.com/articles/Economic-Impact-of-Opioid-Abuse-Dependence-and-Misuse/#sthash.KwM0d7M9.dpuf Accessed 12/02/2014.
5. Centers for Disease Control and Prevention. Vital Signs: Prescription Painkiller Overdoses. 11/2011. At http://www.cdc.gov/vitalsigns/PainkillerOverdoses/index.html Accessed on 12/02/2014.
6. Volkow, ND. The Hijacked Brain (video accompanying Understanding Addiction: Addiction and the Brain's Pleasure Pathway: Beyond Willpower). HBO. At http://www.hbo.com/addiction/understanding_addiction/12_pleasure_pathway.html Accessed 12/02/2014.
7. National Institute on Drug Abuse. Drug Facts: Understanding Drug Abuse and Addiction. November 2012 rev. See Why Do Some People Become Addicted While Others Do Not? Fourth paragraph under What Happened to Your Brain When You Take Drugs? At http://www.drugabuse.gov/publications/drugfacts/understanding-drug-abuse-addiction Accessed 12/05/2014.
8. Schweitzer A. On the Edge of the Primeval Forest. (trans. Campion CT). A & C Black, Ltd., London, 1924, p 92 At https://archive.org/stream/ontheedgeofthepr007259mbp#page/n9/mode/2up Accessed on 12/02/2014.
9. Mencken HL. The Divine Afflatus. New York Evening Mail, 11/16/1917. Reproduced in Platt S.(ed) Respectfully Quoted: a dictionary of quotations. Barnes & Noble Books, 1993, p 326 At http://books.google.com/books?id=2Tu3bScwKKAC&pg=PT351&lpg=PT351&dq=divine+afflatus+mencken&source=bl&ots=xvNVDKNY_s&sig=MNqqhBgg78YCpCwLZhY0DWCssOg&hl=en&sa=X&ei=h8-BVIiVKNejyASaj4DoBQ&ved=0CCYQ6AEwADgK#v=onepage&q=divine%20afflatus%20mencken&f=false Accessed 12/05/2014.
10. Mezei L, Murinson BB, Johns Hopkins Pain Curriculum Development Team. Pain education in North American medical schools. J Pain 12(12):1199-208. 2011. doi: 10.1016/j.jpain.2011.06.006. Epub 2011 Sep 25. At http://www.ncbi.nlm.nih.gov/pubmed/21945594 Accessed on 12/02/2014.
11. Miller NS, Sheppard LM, Colenda CC, et al. Why Physicians Are Unprepared to Treat Patients Who Have Alcohol- and Drug-related Disorders. Acad. Med. 7:410-418, 2001. At http://medical-mastermind-community.com/uploads/72-Physicians-unprepared-to-treat-addiction.pdf Accessed on 12/02/2014.
12. White House Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. 2011. At http://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf Accessed 12/02/2014.
13. Extended-Release (ER) and Long-Action (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf. Accessed 12/03/2014.
14. SAMHSA. About Screening, Brief Intervention, and Referral to Treatment (SBIRT). At http://www.samhsa.gov/sbirt/about Accessed on 12/05/2014.
15. Federation of State Medical Boards. Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain. July 2013. At http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/pain_policy_july2013.pdf Accessed 12/05/2014.
16. National Association of Boards of Pharmacy. NABP PMP InterConnect. At http://www.nabp.net/programs/pmp-interconnect/nabp-pmp-interconnect Accessed 12/05/2014.
17. National Institute on Drug Abuse. Drug Facts: Understanding Drug Abuse and Addiction. November 2012 rev. See Why Do Some People Become Addicted While Others Do Not? Section entitled “Development.” At http://www.drugabuse.gov/publications/drugfacts/understanding-drug-abuse-addiction Accessed 12/05/2014.
18. Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014.
19. How to Dispose of Unused Medicines. FDA Consumer Health Information. http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm107163.pdf. Accessed 12/03/2014
20. Disposal of Controlled Substances Final Rule. Federal Register. https://www.federalregister.gov/articles/2014/09/09/2014-20926/disposal-of-controlled-substances. Accessed 12/03/2014.
21. National Take Back Day Results Report, September 27, 2014. Drug Enforcement Administration Division Control Program. http://www.dea.gov/divisions/hq/2014/hq110514.pdf. Accessed 12/03/2014.
22. Food and Drug Administration. Draft Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. January 2013. At http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf Accessed on 12/05/2014.
23. NIH Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain-draft Report of the Panel, lines 123-125, p 7; lines 376-378, p 18, at https://prevention.nih.gov/docs/programs/p2p/ODPPainPanelStatementDraft_10-02-14.pdf Accessed 12/05/2014.