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College on Problems of Drug Dependence taskforce on prescription opioid non-medical use and abuse: position statement

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Abstract

This position paper from the College on Problems of Drug Dependence addresses the issues related to non-medical use and abuse of prescription opioids. A central theme throughout is the need to strike a balance between risk management strategies to prevent and deter prescription opioid abuse and the need for physicians and patients to have appropriate access to opioid pharmaceuticals for the treatment of pain. The epidemiology of prescription opioid use and abuse is reviewed. Non-medical use and abuse of prescription opioids are on the rise in the United States, illicit use of several widely prescribed opioids has increased disproportionately more than licit use, and the prevalence of prescription opioid abuse appears to be similar to that of heroin and cocaine abuse. There is a paucity of abuse liability testing of prescription opioids, and methods should be developed to fill critical gaps in our knowledge in this area. The role of regulatory agencies in preventing diversion of prescription opioids and identifying potential sources of diversion are discussed. More research is needed to identify those populations most at risk for abusing prescription opioids, and then to develop appropriately targeted prevention programs. Treatment options are discussed; these depend on whether or not an abuser is in pain. Prescription opioid abuse has harmful ramifications for the legitimate and appropriate use of opioids, including stigmatization, opiophobia, and undertreatment of pain. Recommended steps to take include further epidemiological research, laboratory testing of prescription opioids to determine abuse liability, and clinical trials to determine the efficacy of different approaches to the prevention and treatment of prescription opioid abuse.

Introduction

Epidemiological data indicate that non-medical use and abuse of prescription opioids is on the rise in the United States. Prescription opioids in the US include morphine (both immediate-release and sustained release, e.g. MS-Contin®), levorphanol (Levo-Dromoran®), methadone, codeine (opioid constituent in Tylenol-3®), hydrocodone (opioid constituent in Vicodin®, Lortab®), oxycodone (opioid constituent in Percodan®, OxyContin®), propoxyphene (opioid constituent in Darvon®), fentanyl (Duragesic®, Actiq®, Oralet®), tramadol (Ultram®), and hydromorphone (Dilaudid®). The epidemiological data, along with media reports of abuse of prescription opioids such as OxyContin®, Vicodin®, and Percodan®, have received a great deal of attention, and have engendered a great deal of concern in this country.

The non-medical use and abuse of pharmaceuticals, including prescription opioids, have been longstanding concerns both domestically and internationally. Understanding the current patterns of abuse and non-medical use of prescription drugs in society is essential to devising effective policy to prevent abuse and non-medical use. For over seven decades, the College on Problems of Drug Dependence (CPDD) has served a leadership role in the field of drug abuse. Its mission is to offer a scientific basis to guide drug abuse policy and practice. In 2001, CPDD commissioned a Taskforce on Prescription Opioid Abuse to craft a position statement to address several issues surrounding the non-medical use and abuse of prescription opioids. These issues include:

  • the scope of the problem (the epidemiology of prescription opioid non-medical use and abuse);

  • abuse liability assessment;

  • regulation of these opioids and diversion prevention strategies;

  • prevention and treatment of prescription opioid abuse;

  • the effect of non-medical use or abuse of prescription opioids on the proper use of opioids;

  • suggestions for research in this area.

The purpose of this position statement, which is consistent with the mission statement of the College, is to provide scientific information on which sound drug policy can be based. We want to help policy-makers and the public to understand what is known about non-medical use and abuse of prescription opioids and what is not known, so that those responsible for national drug policy can shape their efforts according to the best available scientific data. CPDD also recognizes that regulatory input and collaboration are often critical in the process of developing drug policy decisions.

One of the key points in this position statement is the following: CPDD believes that, in formulating policy decisions about prescription opioid abuse, a careful and balanced approach is needed. We concur with the World Health Organization's policy viewpoint of ‘balance’: that the need to control and reduce abuse, diversion, and trafficking of opioid analgesics must be balanced against the need for physicians and patients to have access to licit opioids for the treatment of pain (World Health Organization [WHO], 2000). The Taskforce urges taking such a balanced approach to the problem of prescription opioid abuse so that risk management strategies developed to prevent and reduce diversion and abuse of prescription opioids do not deter physicians from prescribing high-efficacy opioids when those drugs are indicated.

Section snippets

Definition of non-medical use, abuse, and dependence

It might be useful at the outset to discuss the terms ‘non-medical use,’ ‘abuse,’ and ‘dependence’ since these terms form the crux of this position paper. ‘Non-medical use’ of a prescription drug is defined in the National Household Survey on Drug Abuse (NHSDA) as using a psychotherapeutic drug ‘even once, that was not prescribed for you, or that you took only for the experience or feeling it caused’ (SAMHSA, 2002a).

Factors that influence the abuse and regulation of a drug

The risk of medication abuse is influenced by many factors: its formulation and pharmacology, marketing to the population, and availability and distribution. Other factors are the characteristics of the potential drug abusers and their environment. Regulatory control of a drug's availability to the population is society's primary tool for mediating and influencing the link between pharmacologically determined risk of abuse and actual abuse. The extent and severity of actual abuse are the

Role of the drug enforcement administration

One mission of the DEA is to regulate pharmaceutical controlled substances and

Different approaches to prevention

One way to prevent prescription opioid abuse is to make it harder for the medications to be diverted to illicit channels (see Section 4). This method focuses on the supply side of the supply/demand equation. Another approach is to focus on reducing the demand for drugs for non-medical use, with prevention programs for those at risk of abusing the drugs. A usual component of prevention programs is education about the problem. To that end, in April of 2001, NIDA launched a comprehensive public

Circumstances of opioid abuse dictate treatment options

When discussing treatment options for prescription opioid abusers, a distinction must be made between patients in pain who are abusing opioids and people not in pain who are abusing opioids.

Factors that may impede the effective use of opioids in pain relief

The history of the impact of opioid abuse on use of opioids for analgesia dates back to the 1800s (Musto, 1997). In 1989 the then director of NIDA, Dr Charles Schuster, described the use of opioids in the treatment of cancer pain (Schuster, 1989):

  • Organizations that have as their charter to combat drug abuse ‘have been so effective in warning the medical establishment and the public in general about the inappropriate use of opiates that we have endowed these drugs with a mysterious power to

Summary

  • There are multiple indicators that non-medical use of prescription opioids are on the rise in the United States. There are also indicators that abuse and dependence of these opioids, as defined by clinical diagnostic criteria (i.e. DSM-IV), are also on the rise. Prescription opioids are abused to almost the same extent as cocaine, and perhaps heroin. Availability of opioids has increased over the last 8 years, and so too, in general, has non-medical use and abuse. Two widely-prescribed and

Conclusions

When formulating policy decisions about prescription opioid non-medical use and abuse, a careful and balanced approach is needed, so that the risk management strategies developed to prevent and reduce diversion of prescription opioids do not deter physicians from prescribing high-efficacy opioids when those drugs are indicated. An overriding concern when formulating policies about prescription opioid non-medical use and abuse should be on the patients who need these opioids for adequate pain

Recommendations

To date, the science related to the abuse of prescription opioids is limited. In order to make informed policy decisions on prescription opioid abuse, the following actions should be taken in concert with scientists, and appropriate governmental, non-governmental and industry representatives:

  • Initiate a national forum to review the existing taxonomy of terms related to the non-medical use and abuse of prescription opioids and their impact on policy.

  • Initiate a comprehensive assessment of

Acknowledgements

The preparation of the position statement was funded in part by USPHS grants R37 DA08573 (J.P. Zacny), K05 DA00050 (G.E. Bigelow), P50 DA05273 (G.E. Bigelow), and R01 DA15463 (P. Compton). The authors received no pharmaceutical funding for the preparation of this paper. Several of the authors received financial support and/or honoraria from pharmaceutical companies during the writing of this statement. Dr Bigelow served as a paid consultant to Alza Pharmaceuticals and conducted research funded

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    Background of the Position Statement: In early 2001, the abuse liability of opioid prescription drugs was receiving widespread attention in the media and before the United States Congress. Because the College on Problems of Drug Dependence (CPDD) has a rich history in the assessment of abuse liability of drugs, this issue was one that Dorothy Hatsukami, the President at that time, Warren Bickel, the Policy Officer at that time, and the rest of the Executive Committee believed could be addressed by CPDD. The intent was to inform scientists, policy makers and the public of the state of the knowledge on the scope of the problem, including the epidemiology and abuse liability of opioid prescription drugs; regulatory, prevention, and treatment issues; the adverse impact of prescription opioid abuse on legitimate use, and future directions. Following the procedures for position statements described in the CPDD bylaws, Dr Hatsukami and Dr Bickel created a taskforce in July 2001 to examine the above issues. James Zacny was selected as the chair of this taskforce. Dr Zacny then selected taskforce members who would be representatives of the scientific, regulation and medical field. The Executive Committee approved these members. The position statement was written by the taskforce and a first draft was sent to the Board of Directors (BOD) and the Executive Committee for comment in February, 2002. Based on feedback from the BOD and the Executive Committee, revisions were made by the taskforce members. The second draft was sent to the BOD and the Executive Committee in May, 2002, and further suggestions for revision were made. In September, 2002 a third draft was sent to a CPDD Fellow, Charles Gorodetzky, who is employed in the pharmaceutical industry. Based on his feedback, a fourth draft was sent to the Executive Committee on October 17, 2002 and was approved at that time.

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