Centers for disease control and prevention


COMMUNITY: NORTH CAROLINA’S SuPRE DRUG PROGRAM IN WILKES COUNTY – THE CHRONIC PAIN INITIATIVE AND PROJECT LAZARUS



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COMMUNITY: NORTH CAROLINA’S SuPRE DRUG PROGRAM IN WILKES COUNTY – THE CHRONIC PAIN INITIATIVE AND PROJECT LAZARUS

Ms. Catherine Sanford is an Injury Epidemiology Consultant for the state of North Carolina. She gave a community perspective on state strategies for preventing prescription drug overdoses by describing the five necessary components of a Surveillance, Prevention, Rescue and Evaluation (SuPRE) Program.
Component 1 of a SuPRE Program is solid knowledge of the community and the establishment of coalitions to develop strong community drug overdose programs. In terms of community knowledge, Wilkes County, North Carolina has a population of 68,000 persons; a median income of $34,258; a poverty rate of >12%; layoffs by major employers; minimal heroin abuse; incidence of >600/100,000 drug-related ED visits at the regional hospital; and a drug overdose mortality rate of >36/100,000 for cocaine, methadone and other prescription controlled substances.
In terms of coalitions, community partners in Wilkes County represent substance abuse, health care, public health, law enforcement, faith-based organizations, domestic violence, child abuse, schools, parents and teens, and nonprofit organizations. Community knowledge and the formation of coalitions also should include estimates of the cost of prevention and rescue efforts as well as the cost of not conducting these activities.
The three-dimensional Haddon matrix can be used to strengthen community knowledge. The matrix analyzes 12 different factors to implement intervention strategies, provides criteria to inform decision-making, and serves as a tool to prevent drug-related adverse events in outpatient and other settings. After a pilot study is conducted with positive outcomes and the community accepts the concept of the project, funding and politics become local.
Component 2 of a SuPRE Program is surveillance of mortality, ED and PMP data. Wilkes County uses a number of resources to track accidental drug-related issues, such as death certificates, ME investigations, the state Poison Control Center, ED visits, and the North Carolina PMP. Unintentional drug-related deaths from 2003-2007 have increased in both North Carolina at the state level and Wilkes County at the local level.
Methadone, oxycodone, cocaine and fentanyl accounted for the majority of unintentional poisoning deaths in Wilkes County in 2007, but Xanax, alcohol and tramadol were contributing factors as well. The average age of these decedents was 40 years. PMP data showed that most residents in Wilkes County never fill >2 prescriptions in a single month, but some residents have >5 prescriptions for a controlled substance. The most rural areas of the state accounted for the highest mortality rates per 100,000 population and the highest prescription rates per 10,000 population.
Component 3 of a SuPRE Program is prevention. The Northwest Community Care Network (NCCN) covers six rural North Carolina counties and is one of 15 Medicaid regulatory authorities in the state. NCCN developed the Chronic Pain Initiative (CPI) to educate physicians on pain management; distribute a pain management toolkit; modify ED opioid use; provide case management of ED and Medicaid patients; use the Controlled Substances Reporting System; decrease the cost of medical care; and pilot a study of Project Lazarus in Wilkes County. CPI programs apply to physicians who treat Medicaid patients in the six-county area.
NCCN devotes a considerable amount of resources and conducts a significant number of activities to support the following goals of the CPI: physician education, a CPI best practice toolkit, guidance to EDs, case management, a pharmacy home, mental health, the North Carolina PMP, efforts to decrease the cost of treating Medicaid patients, and piloting of Project Lazarus.
Two major focus areas of the CPI are summarized as follows. Mandatory data reporting to the North Carolina PMP became effective in July 2007. The secure web-based database is password protected, provides online access to patient prescription profiles, and maintains data on ~1 million prescriptions per month. Education is provided to physicians and office staff on access and utilization of the PMP. However, physicians have raised serious concerns regarding the current lag time of 2-4 weeks between reporting and making PMP data available.
Project Lazarus was designed to provide opioid antagonist naloxone as rescue medication for potentially fatal respiratory depression from opioid overdose to pain patients and all other Wilkes County residents who are at risk. Persons with substance use disorders are also targeted for inclusion in the program through ED and substance use treatment services. Recruitment and enrollment into Project Lazarus will be made simultaneously to de-stigmatize interventions.
The three key goals of Project Lazarus are to (1) reduce deaths and ED visits related to drug overdoses and substance abuse; (2) initiate education by distributing naloxone kits and routinely co-prescribing naloxone with high-dose opioid prescriptions to high-risk patients; and (3) demonstrate broad applicability of co-prescriptions of naloxone to high-risk patients in the remainder of North Carolina and the country.
NCCN plans to pilot Project Lazarus and its five components: education, informed consent, intake form, naloxone kit and rescue. A DVD and toolkit insert were developed to provide education to patients and peers on Project Lazarus. These materials focus on patient responsibilities in pain management; instructions on recognizing signs and symptoms of opioid overdose, performing rescue breathing and administering naloxone; the importance of calling 911; and options for substance abuse treatment.
Project Lazarus was the first naloxone program in the South that was introduced into primary and general medical practice as a patient safety issue, focused on prescription opioids, included pain patients, utilized a community-based approach, and approved by a state medical board.
Component 4 of a SuPRE Program is rescue. A study on treatment provided prior to death from unintentional drug overdoses in North Carolina from 1997-2001 showed that 59% of the deaths occurred before emergency medical services or law enforcement arrived at the scene. The study emphasized the need for revised concepts because prevention is not always effective. The study also demonstrated the efficacy of naloxone in patient safety in addition to post-exposure treatment or harm reduction.
An evaluation of naloxone use among intravenous drug users (IDUs) showed no overall increase in drug use or frequency of use, no unexpected major medical side effects, and a possible increase in the desire of IDUs to seek drug treatment. The evaluation also showed that naloxone provided an excellent opportunity to identify appropriate use scenarios.
Component 5 of a SuPRE Program is an evaluation of outcome and process measures. The outcome evaluation of Project Lazarus will include a quasi-experimental design to analyze hospital ED visit trends, mortality trends, prescribed controlled substance trends, and drugs and circumstances from ME reports. The process evaluation of Project Lazarus will include patient experience and provider opinion surveys, pilot testing of the educational DVD, and monitoring of unintended consequences.
Overall, the five necessary components of community knowledge and coalitions, surveillance, prevention, rescue and evaluation should all be closely linked in designing a SuPRE community drug overdose program.

*****


The state partners made a number of comments and suggestions to strengthen linkages and collaboration with the community, NGOs and other stakeholders in developing prescription drug overdose prevention strategies.


  • The collaboration between the National Safety Council (NSC) and employer groups to distribute information and deliver educational messages to unique audiences should be reviewed as a model of providing prescription drug overdose prevention education to patients and the general public.

  • Safety messages should be a key component of the prescription drug overdose prevention initiative. NSC’s focus groups have shown that a focus on safety is effective in reducing stigma of persons who abuse drugs.

  • NGOs should segment the content of prescription drug overdose prevention messages and communication methods to deliver these messages based on the specific audience. For example, information on proper storage and security of medications should be targeted to seniors, particularly those who care for their grandchildren. Seniors who live alone should be educated on the danger of discussing controlled substances that are in their possession because common knowledge of this information could increase the risk for home invasions to steal prescription drugs. Messages to parents should provide guidance on prescription drug overdose prevention in both their children and their children’s friends.

  • NGOs should develop and deliver action-oriented messages, such as the need for persons to inventory their medicine cabinets and properly dispose of old prescriptions. The Northern New England Poison Center is currently piloting messages on medication safety and also has developed a take-home list of safe disposal recommendations for the public.

  • Professional organizations within medical, pharmacy, public health and hospital provider networks should be engaged to focus on advocacy for prescription drug overdose prevention.

  • Community coalitions should be formed to develop strategies to reduce or prevent fatal and non-fatal opiate overdoses in communities. The Massachusetts Department of Health is currently allocating funds from a federal grant for local community coalitions to undertake this effort.

  • NGOs should inform the public about state policies or laws for safe disposal of controlled substances. For example, New Hampshire has designated 24-hour drop-off locations for outdated prescription medications. Community coalitions and law enforcement in Maine partnered to provide police officers with authority to collect controlled substances from homes and deliver the drugs to pharmacies.

  • Parent and survivor groups of family members who died from or currently abuse controlled substances should be engaged as strong advocates for the prescription drug overdose prevention initiative.

  • Collaborations should be established with retailers of controlled substances due to the strong interest of this group in prescription drug overdose prevention. For example, drug retailers in Utah routinely distribute UDH’s “Use Only as Directed” campaign materials.

  • Collaborations should be formed with hospices due to their important role in meeting the needs of family members of patients who abuse controlled substances, such as applying rigorous protocols for disposing of drugs after a patient has died. Hospices also can serve as strong community advocates for changes in patient safety policies, such as prescribing controlled substances to high-risk substance abusers.




Ms. Amy Harris moderated an open discussion for the state partners to identify and describe the potential roles and activities of other stakeholders in the prescription drug overdose prevention initiative. Suggestions and comments by the state partners on this issue are outlined below.
Role of Poison Control Centers (PCCs):

  • PCCs generate timely and detailed data and can serve as a rich data source for the prescription drug overdose prevention initiative. Moreover, PCC data are useful for surveillance purposes, provide information on drug contamination, and can serve as an early warning system of new drugs circulating through individual communities or new techniques persons use to abuse existing drugs. PCC data also can be used for evaluation purposes to assess decreases in drug diversion in communities that have “take-back” drug programs.

  • Previous efforts of PCCs at the state level should be reviewed to clearly define their role in the prescription drug overdose prevention initiative. For example, the PCC and Injury Prevention Program in North Carolina collaborated in using the Health Alert Network to notify all physicians in the state about clenbuterol-contaminated heroin cases and describe strategies to identify and treat these patients. The Maryland PCC has a HRSA grant to conduct telephone assessments to detect substance abuse and provide abusers with appropriate treatment options. Some state PCCs collect medication verification data that serve as a better source for trend analyses than actual substance abuse exposures. The Pennsylvania PCC identified a geographic cluster with a greater increase in medication verifications and shared these data with law enforcement. Efforts by the Pennsylvania PCC led to the identification of a pharmacist who was illegally selling controlled substances.

  • The prescription drug overdose prevention initiative should be designed to coordinate educational outreach activities conducted by PCCs at the state level.

  • PCCs launched and targeted extremely effective campaigns throughout the country on safe storage and security of controlled substance to prevent unintentional poisoning deaths or overdoses among children. PCCs should be encouraged to replicate and target similar safety campaigns to seniors for the prescription drug overdose prevention initiative.

  • PCC resources should be gathered to inform the broader prescription drug overdose prevention initiative. For example, educators have compiled a list of activities PCCs are conducting related to prescription pain pills in preparation for “Poison Prevention Week.” The Poison Workgroup is currently creating a clearinghouse that will maintain surveillance data on poisonings and information on similar programs and activities. PCC data on severe exposures or deaths in children <6 years of age from prescription narcotic painkillers or unintentional methadone overdoses can be used to convey more powerful and compelling prescription drug overdose prevention messages than deaths among adult substance abusers or recreational drug users.


Role of Law Enforcement

  • Washington State should be reviewed as a model in forming and deploying drug task forces directly to communities to conduct substance abuse prevention activities.

  • Attorney General offices nationwide should be engaged as a law enforcement partner in the prescription drug overdose prevention initiative.


Role of Insurers

  • The Utah Labor Commission has been heavily involved in the prescription drug abuse epidemic at the state level. Injured workers in Utah who are on prescription medications, but have no improvement in pain or function and do not return to work for lengthy periods of time are a significant cost to state Medicaid and Medicare agencies.


Role of Other Stakeholders and Activities

  • The National Association of State Mental Health Program Directors and other groups in the mental health community.

  • Prescription drug overdose education by pharmacies. SAMHSA recently piloted a project in which medication safety information was distributed to 6,000 pharmacies nationwide to determine the impact of pharmacies on educating patients. SAMHSA is currently evaluating the pilot.

  • Prescription drug overdose education by patients. Patients could play a significant role in informing the development of prescription drug overdose prevention materials and outreach activities that will be effective to high-risk patients. “Recovering” patients also could be extremely useful in conveying their personal experiences and perspectives to patients who are currently undergoing substance abuse treatment.

  • Prescription drug overdose education by teens. School-based drug and alcohol education programs primarily focus their messages and other materials on illicit drugs, but prescription medications are a significant issue among teens as well.

  • Administration of prescription drug overdose surveys in rehabilitation centers.

  • Dissemination of prescription drug overdose information by faith-based organizations to raise public awareness of the problem.

  • Use of the HRSA-funded National Center for Child Death Review as a potential model to solve problems with prescription drug overdose deaths and plan future prevention strategies.

  • An initial focus of the prescription drug overdose prevention initiative on adolescent drug abuse because prescription drugs are the new “gateway” drug and now account for more drug abuse than marijuana in this age group.

  • Collection of data from the National Survey on Drug Use and Health.

  • Revision of the current process to collect prescription drug overdose death data to record more meaningful and relevant drug information on death certificates.

Role of CDC

  • Convene other federal agencies to identify research priorities, better define the magnitude and scope of the prescription drug overdose problem, and answer basic research questions, such as the efficacy of using opiates for pain treatment.

  • Augment the CDC-funded National Violent Death Reporting System by including data on unintentional or accidental prescription drug overdose deaths.

  • Develop and distribute a minimum data set with ~12 questions to facilitate the exchange and comparison of prescription drug overdose data across states and promote prescription drug overdose prevention at the state level. Extract data from ME investigations to support this effort.

  • Develop a “National Prescription Drug Overdose Prevention Research Agenda.”

  • Develop national guidelines with the following topics as a starting point: treatment of chronic pain in EDs, strong endorsement of PMPs, and prescription drug addiction.

  • Encourage and produce surveillance of prescription drug overdoses at federal and state levels to enhance knowledge of prescription drugs that are currently being used and identify populations with the highest incidence and prevalence of prescription drug overdose deaths. Partner with DOJ to increase the number of PMPs nationwide and share prescription drug overdose data in a continuous, consistent and common format across programs.

  • Create a web site or “one-stop-shop” for programs to post prescription drug overdose prevention activities, education materials, promising or best practices, effective interventions, media campaigns and other initiatives. Include contact information for the programs.

  • Promote plausible or promising practices in prescription drug overdose prevention, but conduct a rigorous evaluation at national, state and community levels first to validate and determine the effectiveness of these activities.

  • Educate and inform federal partners, funding entities and policymakers about the critical need to allocate more resources to establish new and strengthen existing PMPs at the state level.

  • Partner with the Joint Commission to develop and deliver more complete messages on treating pain without enabling addiction among patients.

  • Use the February 2009 STIPDA meeting as a forum to continue discussions on prescription drug overdose prevention and gather more information on this issue from state representatives.

  • Convene a meeting with medical associations to continue the dialogue on the prescription drug overdose prevention initiative.

  • Inform the transition team of the new Administration about the important role of PMPs in improving the medical infrastructure through medical informatics and electronic medical records.

  • Serve as the national hub-and-spoke system for state PMPs.

  • Offer solid guidance and strongly urge states to use core injury program funding to address prescription drug overdose prevention in the future.

  • Offer CME credits for physicians and other prescribers who complete prescription drug overdose prevention training initiatives.

  • Partner with DEA to develop national standards or guidelines for proper medication disposal.

  • Partner with the full spectrum of the education community to develop chronic pain treatment guidelines and standardized training for medical, nursing and pharmacy school students.

  • Develop a toolkit or talking points for providers to more easily discuss prescription drug abuse and misuse with patients.

Ms. Harris led the state partners in a review of the broad list of activities that were proposed to identify the most important areas CDC should invest resources at this time to make the most significant and rapid impact in prescription drug overdose prevention. The top six priorities the state partners identified for CDC to focus on at this time to advance the prescription drug overdose prevention initiative are outlined below. (Note: the numbered priority list reflects the order in which the state partners made suggestions and does not indicate ranking by order of importance.)




  1. Leverage resources with CSTE, STIPDA and other existing partners to conduct surveillance of prescription drug overdoses.

  2. Collaborate with the Poison Workgroup to compile materials for the new prescription drug overdose prevention “one-stop-shop” web site.

  3. Convene a wide and diverse group of stakeholders in the prescription drug overdose prevention initiative, including federal and state partners, insurers, PCCs, the medical community and NGOs.

  4. Sponsor research and rigorously evaluate promising or best practices and effective interventions in prescription drug overdose prevention. Leverage funding from the National Institutes of Health and other federal partners to support this research effort. Use the research and evaluation data to develop evidence-based prescription drug overdose prevention guidelines and strategies.

  5. Provide training to prescribers on prescription drug overdose prevention.

  6. Make a strong cost-effectiveness case for the prescription drug overdose prevention initiative and balance this argument against the societal cost of taking no actions to prevent prescription drug overdose morbidity and mortality. Compile and disseminate cost-effectiveness data from this research to assist state and local entities in leveraging resources.




Dr. Grant Baldwin, Director of the NCIPC Division of Unintentional Injury Prevention, thanked the CDC staff for planning, arranging and making logistical arrangements for this important meeting. Dr. Leonard Paulozzi, the CDC Medical Officer, led the state partners in applauding the keynote speakers for making outstanding and informative presentations.
Ms. Harris thanked the participants for providing CDC with candid dialogue and innovative strategies over the course of the meeting to advance the prescription drug overdose prevention initiative. She confirmed that CDC would regularly communicate with the state partners to provide updates on next steps and other new developments in the prescription drug overdose prevention initiative.

ATTACHMENT 1
List of Participants


Pam Archer, M.P.H.

Injury Prevention Service

Oklahoma State Department of Health

1000 Northeast 10th Street

Oklahoma City, OK 73117-1299



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