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- January 13-14, 2009
CENTERS FOR DISEASE CONTROL AND PREVENTIONNational Center for Injury Prevention and Control
State Strategies for Preventing Prescription Drug Overdoses MeetingJanuary 13-14, 2009Atlanta, GeorgiaRecord of the ProceedingsTABLE OF CONTENTS Page Report of the meeting 3 Opening Session 3 Scope of the Drug Poisoning Mortality Problem 5 Summary of the Conference on Legal Strategies 7 The Role of PMP Data in prescription drug overdose Prevention 11 The Role of State Medical Examiner Data in prescription drug overdose Prevention 14 The Role of Epidemiologic Data in prescription drug overdose Prevention 17 Overview of the Patient Review and Coordination Program 21 Overview of the Fentanyl Patch Patient Safety Program 25 Overview of the Washington State Opioid Dosing Guidelines 29 Overview of Utah Clinical Guidelines on Prescribing Opioids 33 Overview of the Consistent Care Program for Frequent ED Users 36 Overview of the North Carolina Chronic Pain Initiative and Project Lazarus 39 Open Discussion 43 Closing Session 46 Attachment 1: List of Participants…………………………………………………………………….47 CENTERS FOR DISEASE CONTROL AND PREVENTION National Center for Injury Prevention and Control State Strategies for Preventing Prescription Drug Overdoses January 13-14, 2009 Atlanta, Georgia Report of the Meeting The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) convened a meeting entitled the “State Strategies for Preventing Prescription Drug Overdoses.” The proceedings were held on January 13-14, 2009 at CDC’s Chamblee Facility in Atlanta, Georgia. The list of participants is appended to the report as Attachment 1. 
Ms. Amy Harris, Associate Director for Policy at NCIPC, served as the facilitator of the meeting. She welcomed the state partners to the meeting and explained that the two overarching goals of the meeting would be to (1) identify state- and local-based approaches to address prescription drug overdoses and (2) identify linkages and opportunities for collaboration among stakeholders in this area. Ms. Harris outlined the structure of the meeting. On day 1, an overview of the scope of the problem would be presented and the role of data in identifying and preventing prescription drug overdoses would be described. On day 2, various stakeholders would present their respective efforts in addressing and reducing prescription drug overdoses. The state partners would be given ample opportunity to provide CDC with advice and recommendations on this issue. The state partners also would be asked to describe their next steps from an individual or organizational level in advancing policies and strategies to address the problem of unintentional prescription drug overdoses in local jurisdictions or nationally. Ms. Harris pointed out that CDC developed and distributed a “Partnership Matrix” as a tool to systematically capture comments and recommendations the state partners would make during the meeting on collaborative efforts in prescription drug overdose prevention among various organizations, stakeholders and sectors. The state partners were also given background materials to guide their deliberations, such as definitions of key stakeholders that would play an important role in this effort. Ms. Harris concluded her opening remarks by asking the participants to be candid and open in providing input to CDC during the meeting. She recognized the State and Territorial Injury Prevention Directors Association (STIPDA) and the Home Safety Council (HSC) for providing refreshments and other support for the meeting. Dr. Ileana Arias, Director of NCIPC, joined Ms. Harris in welcoming the participants to the meeting and providing CDC with their valuable time and expertise. She explained that NCIPC’s mission is to prevent injuries and violence, reduce their consequences, and assure all Americans live their lives to their fullest potential. To fulfill its mission in the current era of limited resources, NCIPC has been deliberate over the past three years in terms of focusing its attention on issues that would have the most significant impact on public health. NCIPC’s analysis of its programs and existing resources led to the determination that prioritizing the prevention of residential fires, child maltreatment and falls in older adults would result in the best health outcomes to the most populations. NCIPC’s rationale for prioritizing these public health issues is summarized below. Residential fires, child maltreatment and falls in older adults are associated with a high burden of morbidity and mortality in the United States. Science-based interventions that have been shown to be effective in reducing injuries in these three areas are now available for immediate implementation. Moreover, partners and stakeholders have made commitments to provide support and assistance to NCIPC in reducing injury rates associated with child maltreatment, residential fires and falls in older adults. Dr. Arias conveyed that although the prevention of residential fires, child maltreatment and falls in older adults are NCIPC’s top three priorities, unintentional poisoning has emerged as a significant threat to the health of Americans and is now the leading cause of death among persons 35-54 years of age in the United States. Because this trend was unexpected and surprising, NCIPC has no proven strategies or solutions to address this complex problem at this time. However, NCIPC is still required to provide answers at national and state levels to address this issue due to its role as the “nation’s injury center.” Dr. Arias acknowledged that an effective response to the complex and difficult problem of prescription drug overdoses would require public health, law enforcement, drug enforcement, the medical profession and other sectors to bring their expertise and resources to bear. As an initial step in this effort, NCIPC held the “Promising Legal Responses to the Epidemic of Prescription Drug Overdoses in the United States” meeting in December 2008 with various stakeholders to begin creating an overall context and identifying legal and policy interventions that could be applied to address prescription drug overdoses. The conference proceedings, presentations and papers would be distributed to NCIPC’s state partners in the near future for wider dissemination at state, local or organization levels. Dr. Arias pointed out that NCIPC is now convening this meeting on State Strategies for Preventing Prescription Drug Overdoses to obtain external advice, guidance and expertise from its state partners on appropriate actions to take at state, local and program levels. CDC has no federal mandate to tackle this issue, but the agency must bring its leadership role to bear in convening various organizations and sectors to facilitate collaborations in addressing this significant public health issue. Dr. Arias concluded her opening remarks by asking the state partners to be candid in providing input on CDC’s existing capacity and limitations, important needs in the field, and necessary actions and resources to advance the prevention of prescription drug overdoses. 
DRUG POISONING MORTALITY: SCOPE OF THE PROBLEM Dr. Margaret Warner is an Injury Epidemiologist in the Office of Analysis of CDC’s National Center for Health Statistics (NCHS). She explained that data from the NCHS National Vital Statistic System (NVSS) showed motor vehicle traffic accidents and firearms as the top two leading causes of injury deaths from 1968-2003. However, poisoning became the second leading cause of injury deaths beginning in 2004, increased by 66% from 1999-2005, and is now the leading cause of death among persons 35-54 years of age. CDC used various data sources to analyze and determine the scope of drug poisoning mortality in persons 15-64 years of age from 1999-2005, including multiple causes of death files from NVSS, death certificate data, and data collected on all resident deaths in the United States. CDC performed the multiple cause of death analysis by classifying causes of death by ICD-10 code. The “underlying cause of death” was defined as a disease or injury initiating the chain of events directly leading to death or the circumstances of an accident or violence producing a fatal injury. The “contributing cause of death” was defined as significant conditions, including specified drugs, that contributed to death. Contributing causes included drugs, medicaments and biological substances and were found to be among the leading causes in the unintentional and undetermined intent categories. For purposes of the analysis, CDC grouped “other opioids,” “methadone” and “other synthetic narcotics” as “opioid analgesics.” NVSS data that mentioned drugs by mechanism and intent showed unintentional poisoning as the leading cause of unintentional injury death among persons 35-54 years of age in 2005. NVSS data showed that “other and unspecified drugs” were the most common in poisoning deaths, but cocaine, oxycodone, hydrocodone and other opioids, and methadone were the leading causes of deaths when drugs were mentioned. Benzodiazepines also were involved in a significant number of deaths. The proportion of unintentional/undetermined poisoning deaths in the 15-64 years age group involving opioid analgesics increased from 24% in 1999 to 37% in 2005. However, the absolute numbers of opioid analgesic deaths increased 185% from 3,300 to 9,500 deaths between 1999-2005. Of all opioid analgesic deaths in the 15-64 years age group in 2005, ~32% mentioned an opioid analgesic, ~17% mentioned other unspecified drugs, ~15% mentioned either cocaine or heroin, ~16% mentioned benzodiazepines, 3% mentioned both cocaine and heroin, and 17% mentioned combinations with other drugs. Persons 35-54 years of age accounted for the highest poisoning death rates in the other opioid, methadone and other synthetic narcotics categories. From 1999-2005, age-specific poisoning death rates that mentioned opioid analgesics were higher for persons 35-44 and 45-54 years of age than for persons in younger or older age groups. The rates most rapidly rose in the youngest age group of 15-24 years and the oldest age group of 55-64 years. These rates were found to be 2 to 4.5 times higher in 2005 compared to 1999. By urbanization, the data analysis showed that poisoning death rates increased in all levels from large central metropolitan areas to rural non-metropolitan areas. However, the most rapid increases were seen in rural areas and the rates between levels of urbanicity were much more similar in 2005 compared to 1999. Poisoning death rates widely varied among states and by type of opioid analgesic. By location, the data analysis showed that 65% of poisonings occurred in the home, 25% occurred in unspecified places, and 4% occurred in trade or service areas, including hotels. Of all poisoning deaths, 50% occurred in the home, 18% occurred in outpatient settings or emergency departments (EDs), 9% occurred in inpatient settings, nursing homes or other medical settings, and 4% were dead on arrival. Overall, the data analysis showed that poisoning death rates are increasing and the majority of these deaths involved drugs. By type of drug, the most rapid increases were seen in opioid-related deaths with multiple drugs involved. By geographic location, rural areas accounted for the fastest increase in poisoning deaths overall, but variations were seen in individual areas. ***** The state partners made a number of comments and suggestions for CDC to consider in refining its data analysis of drug poisoning mortality in the United States.
PROMISING LEGAL RESPONSES TO THE EPIDEMIC OF PRESCRIPTION DRUG OVERDOSES IN THE UNITED STATES Mr. Daniel Stier is an attorney in the CDC Public Health Law Program. He noted that CDC convened a conference on December 2-3, 2008 to focus on promising legal responses to the epidemic of prescription drug overdoses in the United States. The goals and objectives of the conference were to (1) create a list of promising legal measures to prevent prescription drug overdoses that could be shared with a broader audience; (2) discuss the strengths and weaknesses of each of the promising practices identified; and (3) identify opportunities for collaboration between public health, drug control authorities and other partners with an interest in prescription drug overdose prevention. The conference participants included local, state and federal representatives, public health, Prescription Drug Monitoring Programs (PMPs) and other regulators, law enforcement and the judiciary. An overview of PMPs was presented to guide discussions on promising strategies of PMPs, operational and legal issues associated with interstate sharing of PMP data, and “doctor shopping” statutes. The participants also discussed non-PMP strategies, such as state-issued prescription forms, Maine’s Unused Drug Disposal Project, Louisiana’s Pain Management Clinic legislation, drug courts, and Washington’s prescribing guidelines and subsequent litigation. The PMP overview included a review of controlled substance schedules. Schedule I substances have no recognized use in medical treatment. Schedules II-V substances have legitimate medical uses. Schedule II substances have the highest potential for abuse, while Schedule V substances have the lowest potential. A presentation was made during the conference to describe the implementation of PMPs by states from 1940-1988. California implemented the first PMP in 1940 and utilized the triplicate prescription form to issue blank forms to practitioners to write prescriptions for what are now Schedule II drugs. Law enforcement used these data to target patients, prescribers or pharmacies that obtained, prescribed or dispensed drugs in unusual quantities and frequencies. Electronic transmission of billing data from pharmacies to insurance companies via computers was a part of routine practice by the early 1990s. Oklahoma developed and implemented the first electronic PMP. The cost-effectiveness of electronic transmission of billing data provided incentives through federal Harold Rogers grants for PMPs to convert and expand tracking of controlled substances. All 38 states that currently have PMPs electronically collect prescription data and most of these states require submission of Schedules II-IV data. All operational PMPs electronically collect the basic elements of prescriptions, such as the prescription number and date dispensed; identity of the patient, prescriber and dispenser; and type of drug and quantity dispensed. However, funding, staffing levels and stage of operational development of PMPs widely vary among states. Most notably, Harold Rogers grant awards of $350,000 per year limit the capacity of states to develop robust or comprehensive PMPs. The most significant problem with interstate PMP data sharing is that no mechanism has been developed to prevent a patient from filling a prescription in another city, neighboring state or a state across the border. A potential solution to interstate PMP data sharing is for pharmacists to sign up with other PMPs in neighboring states, but this approach has been inefficient. A better strategy is to develop a “hub and spoke” system that could facilitate efficient transmission of PMP data among states. This system would eliminate the need to develop 49 separate data exchange agreements. Although California and Nevada are currently piloting a hub-spoke agreement, only Kentucky and Ohio have committed resources to this effort to date. Legal issues associated with interstate PMP data sharing include the need to assess confidentiality and privacy laws and regulations at federal and state levels. At the federal level, the Health Insurance Portability and Accountability Act (HIPAA) privacy rule shields protected health information held by physicians, pharmacists and other covered entities. Potentially relevant exceptions or exemptions to the HIPAA privacy rule include fraud and abuse prevention, controlled substance regulation, public health activities, law enforcement, treatment purposes, and child abuse and other disclosures required by law. At the state level, PMPs typically are required to (1) designate data as confidential and exempt information from public records or open records laws; (2) delineate persons who are allowed access, identify specific circumstances for access and describe lawful purposes for using accessed data; and (3) comply with all relevant state and federal privacy and confidentiality laws. However, the hub-spoke system involves additional complexities. Some states have express authority for interstate data sharing laws. For example, the Kentucky PMP can provide data to a certified or full-time peace officer of another state. Regardless of state statutes, however, legal counsel should be consulted regarding the authority of states to share data with other states. A presentation was made during the conference on “doctor shopping” practices in which patients obtain, attempt to obtain or fail to disclose the same or similar prescriptions from multiple prescribers within an inappropriate time frame. Doctor shopping statutes state that obtaining or attempting to obtain a controlled substance by deceit or fraud is unlawful. Laws in 13 states were amended to more specifically describe and prohibit doctor shopping. Florida’s doctor shopping statute was highlighted during the conference as a model. This law states that no person may withhold from a practitioner a request made to another practitioner within the previous 30 days to receive a controlled substance or a prescription for a controlled substance of like therapeutic use. Regardless of the historical motivation for passage of doctor shopping statutes, however, consideration should be given to using these laws to identify persons in need of assessment and referral for treatment. A presentation was made during the conference on non-PMP strategies. Traditional state-issued prescription forms in multiple copies no longer exist. New York, California and Texas supplement electronically transmitted data with paper serialized prescription forms. Actions taken by these three states from 1940-2006 in advancing from triplicate prescription forms to electronic transmission of Schedule II data were described during the conference. On the one hand, advocates of paper-based systems maintain that paper trails have a significant influence in reducing the availability of prescription drugs subject to abuse. On the other hand, opponents counter that paper-based systems have a deleterious effect on patient access to needed medications. A few studies have shown reductions in prescription medication use with paper-based systems, but no published peer-reviewed papers have evaluated process measures of paper-based prescription monitoring programs. Research should be conducted in the future to evaluate the efficacy of paper-based prescription systems on medical use and access, abuse and diversion. These studies should be designed to produce clinical and economic outcomes to fully evaluate the impact of paper-based prescription systems on patients, drug abuse and diversion. A presentation was made during the conference on the Maine Unused Drug Disposal Project. Maine developed this program because unused medications are a source of diversion to drug abusers. Based on conservative estimates, 4.3 million pounds of unused drugs are wasted annually and present an environmental issue as well. U.S. Drug Enforcement Agency (DEA) regulations prohibit non-registrant transfers. Moreover, pharmacy-based systems are not feasible for unused drug disposal. However, Maine obtained Senate sponsorship and endorsement from a variety of interested groups to pass legislation authorizing the “Maine Mailback Program.” The Maine program was funded with state dollars and a grant by the U.S. Environmental Protection Agency. Operational elements of the program include prepaid mailers that are available at pharmacies; the ability to directly mail unused drugs to the Maine DEA; waivers granted by the U.S. Postal Service; codes to track the movement of mailers among the pharmacy, user and Maine DEA; and appropriate destruction of medications by the Maine DEA. The Maine program was piloted at 11 sites in four counties and found an envelope containing >$7,000 worth of oxycodone. Of all participants in the pilot project, the average age was 70 years, 15% had no knowledge of the types of drugs they submitted, 83% were motivated by environmental protection, and only 8% were motivated by patient safety. However, the Maine pilot project did not sufficiently determine the adequacy of data. Moreover, comparable data have not been collected from other states to date to verify the findings of the Maine pilot project. Overall, Maine recognized the need to leverage additional resources and involve state offices to assure compliance with the Mailback Program. Legislation was passed in July 2005 for licensure of pain management clinics in Louisiana that are owned and operated by physicians. The law was passed due to the large sale of prescription drugs along the Louisiana-Texas border and the high rate of prescription drug overdose deaths each year in both states. Coroners have estimated that the legislation could contribute to a 50% reduction in prescription drug overdose deaths in Calcasieu Parish, Louisiana in 2008 compared to previous years. Violation of the statute carries a penalty of up to five years imprisonment and a fine of not more than $50,000. Texas also plans to pass pain management clinic legislation due to the efforts of its Cross-Border Task Force. Prescription drug overdose deaths increased in Jefferson County, Texas from 5 in 2005 to 55 in 2006. A presentation was made during the conference on drug courts. Judicially-supervised dockets attempt to strike a balance between the need to protect community safety and improve public health as well as the need to provide treatment and hold persons accountable for their individual actions. This approach is an alternative to the traditional “revolving door” of the correctional system. Miami created the first drug court in 1989, but 2,200 courts are now operating in all states and territories. These drug courts serve 120,000 non-violent adults and juveniles each year. A 2005 Government Accountability Office study and subsequent research showed that drug courts were effective in reducing crimes, led to a cost-benefit ratio of $3.36 saved to every $1 spent, and resulted in annual cost-savings of $26,000 based on $10,000 to treat a drug court patient versus $36,000 to house an inmate. During the conference, a judge reported extremely positive prescription drug abuser results in the Eastern Kentucky Drug Court. A presentation was made during the conference on a class action lawsuit that was filed in federal court challenging prescribing guidelines published by the State of Washington. The case is in the early procedural stage of development and involves numerous counts that allege conspiracy, conflicts of federal labeling laws and other illegal acts. The Washington class action lawsuit emphasizes the need to evaluate legal authorities regarding prescription drug abuse at the outset of the process, develop an interagency plan and consult with external stakeholders. In response to the class action lawsuit, the Washington State Department of Health recently formed the Prescription Opiate Morbidity and Mortality Prevention Workgroup. ***** The state partners made two key suggestions for CDC to consider in identifying additional promising legal responses to the epidemic of prescription drug overdoses in the United States. First, the “doctor shopping” definition should be revised to clarify the number of visits that would fall in this category. Second, CDC should link its activities to ongoing efforts to develop a cost recovery model of the hub-spoke system to facilitate efficient transmission of PMP data among states. This model will serve as a resource for states to identify potential operational and other costs associated with modifying existing data systems to exchange information through the hub. Although the hub-spoke system will be based on a low fixed fee, variable costs will be incorporated based on usage of the system. Rough estimates have shown that the fixed fee would be ~$20,000 per year if all states participate in the hub-spoke system. 
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