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December 31, 2016

Multi-Factorial Approach to the Opioid Epidemic: Public Health Perspective

Priscilla Bowens, Haynes and Boone, Dallas, TX

Overview of the Epidemic

After nearly two decades of misuse and abuse, drug overdoses from opioids — or “pain killers” as they are more commonly known — have become the leading cause of accidental death in the United States.1 Opioids are a group of analgesic agents that act on the central nervous system. In addition to analgesia, opioids can produce euphoria, sedation, and physical dependence. Fentanyl, oxycodone, morphine, hydrocodone, and butorphanol are well-known opioid agonists — drugs that act on opioid receptors to produce analgesic effects.

Based on the latest data, in 2014 more than 28,000 people died from opioid overdose, more than any year on record.2 There has also been a sharp increase in heroin overdose, which has tripled in the last four years, and is closely tied to the increase in prescription opioid abuse — the strongest risk factor for heroin initiation and abuse.3 Much of the blame points towards an increase in the sheer number of prescriptions being written by health professionals ever since pain management became more of a treatment priority.4 As the most recent data indicates, in 2013 providers wrote nearly a quarter of a billion prescriptions.5 But how did the nation get to this point?

In 1996, the American Pain Society declared pain to be the fifth vital sign.6 It soon became common practice for clinicians to inquire, assess, and manage self-reporting painful patients, absent clear reasons for doubt.7 Moreover, in late 2000, Congress declared the 10-year period beginning in January 2001 as the “Decade of Pain Control and Research.”8 Along with the declaration, Congress passed the Pain Relief Promotion Act of 2000, finding that “the dispensing or distribution of certain controlled substances for the purpose of relieving pain and discomfort[,] even if it increases the risk of death[,] is a legitimate medical purpose and is permissible under the Controlled Substances Act.”9 Although this view and the remaining contents of the Pain Relief Promotion Act of 2000 never made it past the Senate floor, it was evident that a national effort was underway to highlight and treat painful conditions.

Subsequently, initial reports of an increasing problem with prescription opioid abuse centered on OxyContin (oxycodone) which, when approved by the Food and Drug Administration (FDA) in 1995,10 averaged an increase in the number of prescriptions dispensed more than sevenfold, from approximately 821,000 in 1997 to approximately 6.2 million in 2002.11 To note, approximately 85 percent of the diagnoses associated with the use of OxyContin were for non-cancer pain during that time period.12 This indicates a more widespread problem, as cancer patients have traditionally been treated with long-acting and extended-release opioids.

To make matters worse, in May 2007, the makers of the drug OxyContin, Purdue Pharma, pleaded guilty to criminal charges of misbranding with the intent to defraud or mislead by making false claims to doctors about the ability of the drug to cause dependency, misuse and abuse, all of which occurred and contributed to the dramatic increase in prescription drug overdoses.13 In its plea agreement, the company and its executives agreed to pay over $600 million, a combination of criminal fines and civil claims settlements.14

Mortality rates

Prescription drug overdoses are categorized and described in the field of public health as a type of unintentional poisoning.15 Although intentional poisoning mortality rates have remained relatively stable, mortality rates due to unintentional poisoning injuries have increased a dramatic 108.5 percent in the United States.16 While mortality rates were higher in men than in women across all age groups in the United States, the increased incidence in unintentional poisoning morbidity over the past two decades was higher in women. Among age groups, an increase in mortality has been documented for those aged 15-29 years, while the highest incidence of poisoning has been in individuals aged 41-50 years, with significant increases seen among women aged 50-59 years.17 Mortality rates provide an overview of the population affected by the opioid epidemic, and in addition provide information for policy makers, physicians, and those in public health to implement prevention and treatment strategies.

There is an obvious impact on years of life lost according to these figures. Notably, there has been no shortage of highly publicized celebrity deaths ranging from Michael Jackson to Anna Nicole Smith, Heath Ledger, and most recently, Prince with all signs pointing towards poisonings from prescription drugs — most commonly opioids.18

Also, while the lowest mortality rates are for children under the age of 15, emergency department visits for medication poisonings are twice as common as poisonings from other household products and are one of the most common reasons for a visit to the emergency department in children less than four years of age.19 To go one step further, human medications involving pain medicine and anti-depressants were the most common hazardous substance linked to poisonings in household pets until last year; easily surpassing insecticides, human food, plants, and veterinary medication.20 As such, veterinarians have been swept into legislation requiring participation in prescription drug monitoring programs to decrease diversion of opioids.21

Besides illness and death, dependency on prescription opioids may develop. This addiction can easily lead to persistent substance abuse. Most individuals directly affected by this crisis have been previously healthy and have no history of substance abuse.22 Moreover, over 40 percent of the OxyContin used non-medically can be traced to individuals who obtained prescriptions themselves or who obtained them from their family or friends.23 As a result, hospitalizations have risen more than 65 percent in United States, leading to more than $26 billion in medical expenses comprising more than six percent of the economic costs of injuries.24

Multiple Levels of Causal Factors

There is a complexity of factors that influence human behavior and health. In the public health arena, the ecological framework is one of the systems used to explore how macro, social, interpersonal, and individual factors contribute to the occurrence of accidental injuries related to opioid abuse and misuse.25 The characterization of these variables allows for the identification, development, and implementation of appropriate evidence-based public health intervention strategies26 Here, political/economic, socioeconomic/structural, and individual factors are explored. These categories make up a significant portion of the “web” of risk factors that contribute to societal exposure to the detrimental effects of opioids.

Political/Economic Factors

Political/economic factors are important because current and former policies drive the manufacturing, distribution, marketing, prescribing, and usage of prescription medications that have led to the high number of poisoning injuries seen in the past decade and a half. Political factors include federal and state funding for prescription medicine drug monitoring programs (PMDPs), state-by-state requirements for participation in PMDPs, regulations and recommendations regarding prescriber and patient education, FDA regulations regarding prescription drug approval, and the specification of a certain level of involvement/accountability for pharmaceutical companies. Specifically, FDA approval of longer-acting opioids,27 poorly connected nationwide tracking systems,28 Congressional declaration of the decade of pain control and research,29 and the absence of laws requiring prescriber or patient education30 are factors that promoted the use and misuse of prescription opioids. Although inadequacies remain, recently introduced prevention methods aim to address some of these problems.

Socioeconomic/Structural Factors

Socioeconomic/structural factors include level of education, accessibility and availability of prescription pain medicine, community population size, healthcare availability, and healthcare structure. The current structural system in place has encouraged patients to quickly identify, assess, and manage pain mostly through medications and few other avenues. Pharmaceutical marketing campaigns aggressively targeting prescribers,31 encouragement from medical professionals to aggressively manage pain,32 and lack of patient education from doctors and pharmacists are specific examples that promote individual use of prescription pain medication, often leading to misuse and abuse. If the behavior of healthcare personnel and pharmaceutical companies can be changed as well as the patient culture of relying predominately on medication to manage pain, this will in essence change the organizational structure, which may reduce unneeded access to prescription pain medication.

Individual Factors

Individual factors include age/developmental stage, motivations, and perception of risk of unintentional poisoning and addiction.33 On the individual level, it is evident that patients have a view that their susceptibility to poisoning is low because the numbers speak for themselves.34 One of the reasons can be attributed to understated consequences by health professionals, which can result in no cue to action. Self-efficacy is high that these patients can manage their ability to prevent an accidental overdose or access to their medication by a family member, friend, or pet. Changing individual health behavior is an important factor because one less overdose is one less poisoning injury or death. Changing an individual’s environment — through socioeconomic/structural and political/economic factors — should, in essence, affect the larger population because information will be disseminated to many groups of people through various channels.

Prevention and Intervention

Prevention of disease on the community level and as a by-product on the individual level is a main goal of the field of public health. More specifically, prevention of disease involves a change in health behavior or promotion of a positive health behavior. Behavior plays a prominent role in the development of prevention and intervention strategies in public health. Prevention can be primary, secondary, or tertiary.35 The goal of primary prevention is to “alter risk factors prior to the onset of disease, thus preventing the disease from beginning or greatly diminishing the severity of subsequent disease.”36 The goal of secondary prevention is to reduce the impact of disease that has already occurred.37 Tertiary prevention aims to manage and reduce the impact of chronic disease. Because of the nature of the disease, primary and secondary prevention appear to be the most commonly used intervention methods aimed at reducing the opioid epidemic for individuals that have yet to be exposed to prescription opioids and for those who are addicted.

Current primary prevention methods include (1) the recent Centers for Disease Control and Prevention (CDC)-recommended prescriber guidelines emphasizing the need to “Start low. Go slow;”38 (2) state-level interventions — Prescription Drug Monitoring Programs (PDMPs) — with strong prescriber mandates;39 and (3) education through community prevention programs targeting schools, parents, and patients.40 Secondary prevention methods include (1) medication-assisted treatment (MAT) services, which combine behavioral and medication therapy;41 and (2) first responder and high-risk individual education and use of the drug naloxone to reverse opioid overdoses.42

Recently, the U.S. Department of Health and Human Services (HHS) announced $53 million in federal funding to assist states and tribal nations in addressing the opioid epidemic.43 The funding supports many of the aforementioned prevention methods and also targets surveillance, improvements in toxicology, drug screening, data collection, and reporting.44 While promising and sorely needed to address the opioid epidemic, most prevention methods are in the early stages of implementation. Therefore, it is too soon to determine their effectiveness. Aggressive implementation of methods that impact political, structural, and individual factors through knowledge gained from community assessments, surveillance, and reporting will continue to promote an evidence-based approach to tackling the opioid epidemic.


The opioid epidemic is one of the most threatening public health crises in recent decades. With a record number of deaths in 2014, the situation has only worsened. While there are many contributing factors that increase the likelihood of an individual succumbing from prescription opioid misuse and abuse, funding and strategies for prevention of overdose and treatment of addiction have also improved in recent months and years. These strategies must be implemented and outcomes closely studied to determine next steps and improve the health of a nation in search of a remedy to alleviate pain.

1 NCHS Data on Drug-Poisoning Deaths, Ctrs. for Disease Control & Prevention, (last updated Apr. 5, 2016).

2 Increases in Drug and Opioid Overdose Deaths — United States, 2000–2014 , Ctrs. for Disease Control & Prevention, (last updated Jan.. 1, 2016).

3 Id.

4 Amy S.B. Bohnert et al., Increasing Mortality Rates in the United States, 1999-2006, 125(4) Pub. Health Rep. 542, 546 (2010).

5 Prescription Opioids: The Problem, Ctrs. for Disease Control & Prevention, (last updated Mar. 16, 2016).

6 The Joint Comm’n on Accreditation of Healthcare Orgs. & The Nat’l Pharm. Council, Assessment of Pain, in Pain: Current Understanding of Assessment, Management, and Treatments 20, 21 (Dec. 2001),; see also Health Library, John Hopkins Medicine,
vital_signs_body_temperature_pulse_rate_respiration_rate_blood_pressure_85,P00866/(last visited Sept. 24, 2016) (The four main vital signs routinely monitored are (1) body temperature, (2) pulse rate, (3) respiration rate, and (4) blood pressure.)

7 Id.

8 Victims of Trafficking and Violence Protection Act of 2000, Title VI, Sec. 1603 (2000).

9 H.R. 2260, 106th Cong. (2000).

10 Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse, Food & Drug Admin., (last updated Sept. 9, 2016).

11 Food & Drug Admin., Background Package: Risk Evaluation and Mitigation Strategies (REMS) for Extended-Release and Long-Acting Opioid Analgesics 2 (2010).

12 Id.

13 USA v. Purdue Fredrick Co., WDVa, Case No. 1:07CR00029 (2007), United States v. Purdue Frederick Co., 495 F. Supp. 2d 569, 572 (W.D. Va. 2007).

14 Id; see also Barry Meier, In Guilty Plea, OxyContin Maker to Pay $600 Million, N.Y. Times, May 10, 2007,

15 According to the CDC, “a poison is any substance, including medications, that is harmful to your body if too much is eaten, inhaled, injected, or absorbed through the skin. An unintentional poisoning occurs when a person taking or giving too much of a substance did not mean to cause harm.” Poisoning, Ctrs. for Disease Control & Prevention, (last updated Nov. 24, 2015).

16 See Bohnert, supra note 4, at 542.

17 Id, at 544.

18 The listed celebrities all died before the age of 60, primarily from accidental prescription drug overdose. Prince and Heath Ledger are both believed to have obtained prescription opioids shortly before death. See Anna Nicole Smith Died of Accidental Overdose, Usa Today (Mar. 27, 2007),; The Full Story on Michael Jackson’s Tragic Death, Wash. Post (June 14, 2016),; Prince’s Death: What We Know, Don’t Know Four Months Later, Usa Today (Aug, 21, 2016),; Ledger’s Death Caused by Accidental Overdose, Cnn (Feb. 6, 2008), 19 Safe Kids Worldwide, An In-depth Look at Keeping Children Safe Around Medicine 3-4 (2013),

20 Announcing the Top Pet Toxins of 2015, Am. Soc’y for the Prevention of Cruelty to Animals (Mar. 3, 2016),

21 Veterinarian, Ark. Prescription Monitoring Program, (last visited Sept. 16, 2016).

22 Supra note 11, at 1-2.

23 Id.

24 Christopher J. Hansen et al., Analysis and Validation of Putative Substances Involved in Fatal Poisonings, 8 J. Med. Tox. 94 (2012); Jeffery H. Cobin et al., Hospitalizations for Poisoning by Prescription Opioids, Sedatives, and Tranquilizers, 38 Am. J. Prev. Med. 517 (2010).

25 Jonathan E. Fielding, Steven Teutsch & Lester Breslow, A Framework for Public Health in the United States, 32 Pub. Health Revs. 174, 176-77 (2010).

26 Id.

27 See supra note 10.

28 As of January 2015, 30 states were engaged in interstate data sharing; however, as the diagram indicates, engaged does not mean that a state PDMP is sharing with other state PDMPs. PMDP Interstate and Data Sharing Status, PMDP Training and Technical Assistance Ctr., (last updated Jan. 21, 2015).

29 See supra note 9 and accompanying text.

30 While there are new CDC-recommended prescriber guidelines, there are no federal or state mandates requiring doctors to provide opioid-specific patient education. See Guideline Information for Providers, Ctrs. for Disease Control & Prevention, (last updated Aug. 19, 2016).

31 America’s Addiction to Opioids: Heroin and Prescription Drug Abuse: Hearing Before the Senate Caucus on International Narcotics Control, 113th Cong. 3 (2014) (statement of Dr. Nora D. Volkow, Director, National Institute on Drug Abuse).

32 See supra notes 4-8 and accompanying text

33 See supra note 3 and accompanying text.

34 See supra note 3 and accompanying text.

35 What Researchers Mean by... Primary, Secondary and Tertiary Prevention, Inst. for Work & Health, (last visited Sept. 2, 2016).

36 Barbara Curbow, Professor, Univ. of Fla., Psychological, Social, and Behavioral Issues in Public Health (Oct. 6, 2010).

37 Supra note 27.

38 Supra note 31

39 “As of June 24, 2016, [Pennsylvania] dispensers are required by law to collect and submit information to the PDMP about each dispensing of a controlled substance prescription drug within 72 hours. The PDMP stores the information in a secure database and makes it available to healthcare professionals and others as authorized by law.” This requirement went into effect after the passage of the Achieving Better Care by Monitoring All Prescriptions Program Act of 2014. See Prescription Drug Monitoring Program: Questions and Answers, PA.Gov, (last accessed Oct. 1, 2016).

40 Opioid Abuse Prevention, Ohio Dep’t. of Educ. (Dec. 29, 2016, 12:59 PM),; see also Guideline Information for Patients, Ctrs. for Disease Control & Prevention, (last updated Mar. 15, 2016).

41 Medication-Assisted Treatment, Substance Abuse and Mental Health Servs. Admin., (last updated May, 23, 2016).

42 Daniel P. Wermeling, Review of Naloxone Safety for Opioid Overdose: Practical Considerations for New Technology and Expanded Public Access, 6 Therapeutic Advances in Drug Safety 20, 21 (2015); Corey S. Davis et al., Emergency Medical Services Naloxone Access: A National Systematic Legal Review, 21 Acad. Emergency Med. 1173, 1174 (2014).

43 HHS Awards $53 Million to Help Address Opioid Epidemic, Health & Human Servs., (last updated Sept. 1, 2016).

44 Id.

Priscilla Bowens

Haynes and Boone, Dallas, TX

Dr. Priscilla Bowens is a licensed veterinarian, former practitioner, food safety scientist, and public health educator, as well as a recent graduate of The University of Texas School of Law. She is an Associate in the Healthcare and Life Sciences Practice Group in the Dallas office of the international law firm Haynes and Boone, LLP (Applicant for the Texas Bar). She may be reached at [email protected].