TABLE OF CONTENTS
CENTERS FOR DISEASE CONTROL AND PREVENTION
National Center for Injury Prevention and Control
[pic]
State Strategies for Preventing Prescription Drug Overdoses Meeting
January 13-14, 2009
Atlanta, Georgia
Record of the Proceedings
TABLE 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.
• CDC should be mindful that poisoning deaths in older persons are most likely underrepresented in existing data sources. For example, older adults >65 years of age are not adequately captured in NVSS, ED data, or data on substance abuse treatment admission rates by age. Prescription drug overdose deaths in this age group might be misdiagnosed and categorized as “natural causes” on death certificates. Maine and other states do not perform autopsies on persons >50 years of age if their physicians are able to confirm another cause of death.
• CDC should include alcohol in the multiple cause of death analysis along with cocaine, other opioids, methadone and benzodiazepines.
• CDC should focus on geographic clusters of opioid analgesic deaths that are occurring across the United States. Data should be analyzed by health services area because this approach would allow data on opioid analgesic deaths to be collected across states and might eliminate the problem with small data sets for deaths at the county level.
• CDC should closely collaborate with the Substance Abuse and Mental Health Services Administration (SAMHSA) in its efforts to develop prescription drug overdose prevention strategies. SAMHSA maps survey data by both state and treatment service area. SAMHSA data have shown higher rates of binge drinking and methamphetamine use in rural areas. SAMHSA data by age showed spikes in mental health and substance use issues among persons 18-24 years and prescription medication abuse among one in 10 seniors.
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.
USE OF PRESCRIPTION DRUG MONITORING PROGRAM DATA
Mr. David Hopkins is the Program Manager of the Kentucky All Schedule Prescription Electronic Reporting System (KASPER) in the Kentucky Cabinet for Health and Family Services (KCHFS). He described the rationale for Kentucky developing a controlled substance abuse program. Of all Kentuckians, 8.5% used prescription psychotherapeutic drugs for non-medical reasons in the past year; 7% used Darvon, Percodan or other prescription pain relievers for non-medical reasons in the past year; 4.6% used Valium, Xanax or other prescription tranquilizers for non-medical reasons in the past year; and 2% used prescription stimulants for non-medical reasons in the past year. Kentucky’s ranking in these four categories was either first or fourth in the nation.
KASPER is Kentucky’s PMP and tracks Schedules II-V controlled substances prescriptions that are dispensed within the state and reported by pharmacies and other dispensers. KASPER is an electronic database that can be accessed on the Internet. KASPER is a tool to help address the misuse, abuse and diversion of controlled pharmaceutical substances by providing a source of information for healthcare professionals and serving as an investigative resource for law enforcement. This problem is one of the largest threats to patient safety in the Commonwealth of Kentucky. However, KASPER was not designed to prevent persons from obtaining prescription drugs or decrease the number of doses dispensed.
KASPER was developed for $1.4 million. Drug Enforcement Branch staffing costs ~$223,000 each year, but this cost will decrease from >$1 million to ~$400,000-$500,000 after implementation of eKASPER. Annual information technology support costs ~$1 million, including hardware, software and staff development. The federal Hal Rodgers Grant provides $400,000 per year for promotion, training and data analysis of KASPER.
Schedule 1 controlled substances include heroin, cocaine, marijuana and other drugs that cannot be legally prescribed. Schedule II controlled substances are the most addictive legal drugs, have the highest potential for abuse, and include OxyContin, Percocet, Ritalin and Tylox. Schedule III controlled substances have less potential for abuse than Schedule I or II drugs and include Lortab, Vicodin and other hydrocodone combinations. Schedule IV controlled substances have less potential for abuse than Schedule II drugs and include Xanax, Valium and other benzodiazepines. Schedule V controlled substances have the least potential for abuse and include codeine-containing cough mixtures.
At this time, ~10 million controlled substance prescriptions are reported to KASPER each year. Dispensers are required to report prescription data to KASPER within eight days, but efforts are underway to enter ~80% of data into the system within one day of dispensing through RelayHealth processes. KASPER reports are only available at the request of authorized individuals and can be sent via facsimile in 2-8 hours or through the Internet in 15 seconds. KASPER reports are available 24 hours per day/7 days per week on any computer with Internet access. The KASPER web site can be accessed at chfs.kasper.
KASPER stakeholders include a variety of groups. State licensing boards investigate potentially inappropriate prescribing by licensees only. Practitioners and pharmacists review the controlled substance prescription history of current patients to determine pharmaceutical or medical treatment. Law enforcement officers review the controlled substance prescription history of individuals as part of an open bona fide drug investigation that must be certified by both an investigator and supervisor.
The state Medicaid program screens recipients for potential abuse of pharmacy benefits, determines “lock-ins,” and screens providers for adherence to prescribing guidelines for Medicaid patients only. Judges and probation or parole officers review controlled substance data to assure adherence to drug diversion or probation program guidelines.
KASPER reports show all controlled substance prescriptions an individual has had for a specified period of time as well as the practitioner who prescribed and the dispenser who dispensed the drugs. Based on 2008 data, prescribers accounted for 94.1% of KASPER users, pharmacists accounted for 3.1% of users, law enforcement accounted for 2.7% of users, and judges and other groups accounted for 0.1% of users. Of all users, 28.6% of prescribers have KASPER accounts, 21% of pharmacists have accounts, and 14.7% of law enforcement agencies have accounts.
The following KASPER data elements are available for study: the unique identifier, date of birth, gender and address of the patient; the name, quantity, strength, therapeutic category, number of supply days and date dispensed of the drug; and the name and city of both the prescriber and dispenser. The number of records maintained in KASPER increased from ~8.3 million with 2.04 prescriptions per person in 2001 to ~10.2 million records with 2.41 prescriptions per person in 2008.
In 2008, hydrocodone accounted for 43% of controlled substances prescribed in the state of Kentucky followed by alprazolam at 15% and oxycodone at 12%. The number of persons who received a controlled substance from >5 different prescribers and >5 different dispensers was 5,112 in 2007 and 2,825 in the first six months of 2008. The number of persons who received a controlled substance from >10 different prescribers and >10 different dispensers was 342 in 2007 and 200 in the first six months of 2008. The number of persons who received a controlled substance from >15 different prescribers and >15 different dispensers was 111 in 2007 and 64 in the first six months of 2008.
The Kentucky Injury Prevention and Research Center conducted a study in 2005 using 2000-2002 KASPER data to summarize demographic and geographic tends in prescriptions and the leading causes of death and hospitalization due to injuries and also to identify geographic associations between the volume of prescriptions filled and the incidence of injury.
The study showed that narcotic analgesics and benzodiazepines were the leading drugs mentioned on hospital discharges for prescription drug overdoses. The study emphasized the need to consider benzodiazepines as a high priority in terms of adverse effects on health and safety based on their role in intentional and unintentional prescription drug overdoses, motor vehicle accidents and falls in elderly persons. However, more extensive research is needed because the preliminary investigations of correlations between narcotic analgesics and benzodiazepines and injuries in Kentucky were largely inconclusive.
KASPER legislation requires KCHFS to develop trend reporting criteria and publish a quarterly trend report. KCHFS developed criteria to meet this statute in collaboration with licensure boards and a law enforcement focus group. KCHFS utilized geographic information system (GIS) software to obtain a graphical representation of the data. Maps were created to illustrate usage of all controlled substances, hydrocodone, Xanax, methadone and oxycodone in 2005-2007 based on three-digit zip code areas in Kentucky.
Overall, the challenges to KASPER include state statutes and regulations that restrict allowable access to data for research purposes; decreased staffing due to limited availability of technical and epidemiology support resources and lack of funding; de-identified data sets based on HIPAA regulations; and minimal capacity to determine health and public safety actions based on data.
*****
The state partners made a number of comments and suggestions to strengthen the role of PMP data in prescription drug overdose prevention.
• CDC should consider KASPER as a model in collecting prescription drug overdose data. KASPER breaks down prescription drug misuse, abuse and diversion in separate age groups of 65-74 years, 75-84 years, and >85 years instead of combining all persons >65 years of age in one category. KASPER can be used as a solid public education tool because different messages on prescription drug overdoses need to be developed for specific age groups.
• CDC should provide national leadership in encouraging physicians to report PMP data to states. Many providers believe this effort is a waste of time because PMP data systems are not in real time. Most notably, the delay between reporting and making PMP data available can be up to 30 days in some states. CDC also should develop and distribute guidelines and detailed instructions for providers to appropriately use PMP data.
• CDC should conduct a qualitative study with providers in states throughout the country who use PMP data to determine their experiences in utilizing these systems. Maine’s ongoing study of usage and non-usage of PMP data systems in all categories of licensees should be included in this effort.
THE ROLE OF STATE MEDICAL EXAMINER DATA IN THE PRESCRIPTION DRUG PROBLEM: AFFECTING POLICY
Dr. Marcella Sorg is the Director of the Rural Drug and Alcohol Research Program at the University of Maine. She explained that her role as a forensic and medical anthropologist is to serve as a producer and consumer of drug-related data. Medical examiners (MEs) who perform forensic death investigations provide a link between public health and public safety. The purpose of a death investigation is to determine the cause and manner of violent, suspicious and “unattended” deaths.
Because death investigations are under the jurisdiction of state or local rather than federal agencies, these investigations significantly vary among and within states based on coroner- versus-ME systems; local laws, cultures and practices; and funding or resource levels. With the exception of vital records, statute-based obligations for MEs to produce data often do not exist. MEs and coroners have dual roles in public health and public safety and can be housed in health departments, attorney general offices, public safety departments or independently. Over 3,000 MEs or coroner jurisdictions exist and their duties are regulated by statute, rule-making or customs.
MEs are hired or appointed, but board certification in pathology or forensic pathology and other requirements differ. Coroners are elected, primarily at the county or district level, and most are non-physicians. Resources for MEs and coroners are appropriated as public policy and paid for by tax dollars. As a result, resources are limited and variable. Funding for staff and services is needed in drug death investigations because MEs and coroners typically do not determine transportation, autopsy and toxicology needs and frequently outsource toxicology. Non-physician coroners outsource autopsies as well.
Drug death investigations and the level of training for local MEs, non-physician death investigators, coroners and police during scene investigations vary. For example, not all drug death investigations identify the individual who will obtain toxicology samples; determine whether an autopsy will be performed; focus on the potential involvement of criminals; or confirm the location of the death, such as the residence, hospital or outdoors.
Dose is a key component to forensic toxicity, but this element is usually unknown. The interpretation of toxicology results depends on persistence of the drug in the body, drug combinations and chemical detection. Forensic toxicology is 90% accurate, presumptive and typically requires screening and quantitative tests. Changes occur postmortem and with decomposition, such as the change from heroin to morphine. Although other sources are used, the peripheral blood test is best. Individual tolerances are an issue and are particularly critical for opiate or opioid deaths. Medical data should be collected from the heart, liver and lung to determine disease in these organs.
Data are extremely difficult to obtain on the source from which the decedent obtained drugs, whether the drugs were prescribed, and the form in which the drugs were ingested. Most notably, scenes are cleaned prior to the death investigation; requests for medical and prescription records consume resources; and the degree to which PMPs have access to ME records and include data from methadone clinics is unknown. The cause of death is the mechanism or medical reason an individual died and can include up to four links in a causal chain. The cause of death also might note other significant conditions that contributed to death. The cause of death can be recorded as a homicide, suicide, accident, undetermined death, or a natural death, including therapeutic drugs at therapeutic levels.
From an ME’s perspective, prescription drug deaths are complicated cases and require more time to investigate than other types of deaths. These investigations also are frustrating due to interpretive issues with toxicity from multiple drugs. Prescription drug deaths are a source of a large increase in workloads of MEs and often are not supported with additional resources in most jurisdictions. From an epidemiologist’s perspective, “poly-drugs” are difficult to specify, but efforts are underway to train epidemiologists to identify each individual drug involved in a death.
MEs and coroners are pressured to provide timely statistical data. These data affect decisions by policymakers in terms of drug treatment methods and funding, the focus and funding of law enforcement, and approaches for prescribers to prescribe drugs. MEs and coroners also are pressured to provide data that might not exist, such as the source from which the decedent obtained drugs, the presence or absence of a prescription for the drug, and the form in which the drug was ingested. Guidelines need to be developed that include toxicology screening parameters, date of decomposition, presence of co-intoxicants and other factors.
Of all states, 4 different providers, prescriptions filled by >4 different pharmacies, >10 prescriptions, prescriptions written by >4 different prescribers, receipt of similar services from >2 providers in the same day, or >10 office visits.
Additional criteria for PRC review and placement include any single occurrence within a 90-day period of: >2 ER visits; a medical history of “at risk” behavior; repeated and documented efforts to seek medically unnecessary services; counseling at least once by a healthcare provider or department about appropriate use of healthcare services; receipt of controlled substances from two different prescribers in one month; a history of duplicative, excessive or contraindicated healthcare services; or receipt of healthcare services that are not within acceptable medical practice.
For purposes of PRC review and placement, “at risk” is defined as forging or altering prescriptions, paying cash for controlled substances, using another client’s medical assistance identification card without authorization, or frequently seeking medically unnecessary services. Patients who are placed in the PRC Program are initially restricted for 24 months to certain providers, such as one primary care provider, one pharmacy, one narcotic prescriber and one hospital for non-emergency services. The system contains edits to deny claims from unassigned providers. The PRC restriction takes precedence over all edits in the pharmacy point of sale system.
DSHS data collected as of May 2008 showed that the top 10 diagnoses for the top 200 PRC clients were headaches or migraines; abdominal pain; lumbago or back pain, sprain or strain; chest pain; pain, sprain or strain in limbs; cervicalgia or neck pain, sprain or strain; dental disorder; other chronic pain; depressive disorder; and an anxiety state. The morphine equivalent dose (MED) was included in the PRC Program to determine the total quantity of a drug currently taken by patients. A scheduled-medication detailed report with the total MED per day for each patient is shared with prescribers.
DSHS expanded the PRC Program in 2005 with additional full-time staff and significant process improvement activities, including database systems and automated processes. The current PRC caseload of >3,060 cases is managed by three clinical nurse advisors, seven program managers for daily care management, and two support staff.
DSHS’s cost analysis showed that the PRC Program resulted in savings of >$43.9 million since FY’06 or >$1.5 million per month, a 33% decrease in ED visits, a 37% decrease in physician visits, and a 24% decrease in the number of prescriptions. Of 1,364 PRC clients who completed their two-year restriction in 2007-2008, 50% were released based on compliance, 28% were retained due to continued high ED use, 15% are no longer eligible for medical assistance, and 6% are currently under review.
Of 518 PRC clients who were referred for narcotic abuse in 2006, the average number of narcotics prescriptions decreased from 3.07 to 1.63; the average number of prescribers decreased from 4.8 to 2.8; the total MED decreased from 312 MED/day to 185 MED/day; and the total number of narcotic claims decreased from 2,274 to 839.
In January 2008, seven managed care plans that contract with DSHS were required to develop PRC Programs. Each plan identified restrictions for specific provider types and will restrict clients to a managed care plan for 12 months. Preliminary data showed that in the first four months, one plan with 42 patients achieved a 31% reduction in direct and indirect monthly costs and another plan with 158 patients achieved pharmacy and ED utilization savings of $47,222.
The Pacific states of Washington, Oregon, California, Hawaii and Arkansas ranked the highest in life use and non-medical use of pain relievers. Poisoning was the leading cause of unintentional injury death in Washington State in 2006. Over 90% of poisonings were due to drug overdoses. Deaths have continued to rise from 24 deaths in 1995 to 638 deaths in 2006.
Medicaid clients accounted for nearly 50% of prescription opioid deaths in Washington State. Of these clients, 60% died at home. The highest age group in prescription opioid deaths for both males and females was 40-59 years, but 15 children 15-19 years of age died as well. Lumbago, back pain, sprain or strain; pain, sprain or strain in limbs; and abdominal pain were the top three medical diagnoses in the year prior to prescription opioid deaths among Medicaid clients in Washington State.
DSHS reviewed the average MED/day per client in its analysis of prescription opioid deaths involving Medicaid clients in Washington State as well as a series of behavioral profiles. The alcohol and drug profile showed that 21% of 154 Medicaid clients had an at-risk diagnosis. Of these clients, 70% had a diagnosis of drug poisoning, 53% had an event that indicated the need for alcohol or drug treatment, 5% received a drug or alcohol assessment 12 months prior to death, and 22% received alcohol or drug treatment 12 months prior to death.
The mental health profile showed that 39% of Medicaid clients received mental health services in the 12 months prior to death. Depression was the number one mental health diagnosis among 26% of clients, while antidepressants and anticonvulsants were the top two medications used by 53% and 39% of clients, respectively. The top therapeutic classes of drugs involved in prescription opioid deaths within the Medicaid population were analgesics or narcotics, anticonvulsants, selective serotonin reuptake inhibitors, anti-anxiety drugs, muscle relaxants, gastric acid secretion reducers, non-steroidal anti-inflammatory drugs, beta-adrenergic agents, anti-psychotic or atypical drugs, and penicillin.
The children’s profile showed that each child who was placed in the PRC Program was from a dysfunctional family unit. Of these children, 93% were from a single parent household, 20% were in several different foster homes, 47% were raised by a relative other than the parent, 27% were homeless at some point in their lives, 67% had a parent or sibling with a history of mental disorder, substance abuse, domestic violence or criminal activity, 100% of children had a mental health disorder ranging from depression to high anxiety, 40% received 1-3 different mental health drugs with two children receiving significantly higher dosages than recommended, 73% had substance abuse issues with two children 11 years of age applying for assistance for substance abuse treatment, and 60% had co-occurring diagnoses.
Overall, Medicaid clients who inappropriately use healthcare services and have high ED visits and high narcotic use are the same or similar group that is dying from prescription opioids. DSHS uses the PRC Program as only one tool to focus on the health and safety of clients and decrease inappropriate use of healthcare services. DSHS recognizes that these complex issues will require more than one solution and public-private partnerships across sectors.
*****
The state partners made a number of comments and suggestions to strengthen linkages and collaboration among Medicaid, private insurers and other stakeholders in developing prescription drug overdose prevention strategies.
• Medicaid should place more emphasis on the extent to which EDs dispense samples of narcotics to patients. Hospitals typically do not maintain an inventory of samples that are distributed to patients and are not required to report sample narcotics to PMPs. Prescription drug abuse and diversion might be underreported in the Medicaid population due to sample narcotics that are dispensed to patients during high numbers of ED visits.
• Washington State should be reviewed as a model in establishing public-private partnerships across sectors to address the problem of prescription drug overdoses in the Medicaid population. Washington State convened multiple groups in this effort, including various state agencies; a group of medical directors representing the Department of Veterans Affairs, Department of Corrections, Department of Health and DSHS; the Medical Quality Assurance Commission along with dental and osteopathic medical boards; ED physicians; academic researchers; and local health directors.
• Efforts should be made to either allow social workers, nurses and other medical entities to access PMP data or utilize and take advantage of PMP data. In Kentucky, for example, state statutes did not permit social workers to access PMP data. However, the state granted an exception for KCHFS to provide social workers with PMP data that could be used to support an open investigation of a child or elderly person who was suspected of being in danger in the home due to drugs.
• Utah should be reviewed as a model in exchanging data between different state agencies. Utah is currently attempting to overcome statutory issues and obtain permission from the state Medicaid agency and health department to link Medicaid and PMP controlled substances databases. This strategy would allow Utah to collect more information on risk factors of persons who die from prescription drug overdoses.
• Strong collaborations should be formed with insurers due to their ability to identify and refer “suspected” prescriber abusers to medical and provider licensure boards or law enforcement if necessary.
• State health departments should identify Medicaid patients who died from prescription drug overdoses and then collaborate with state Medicaid agencies to link these decedents to PRC Programs in an effort to improve overall data quality.
• Washington State should be reviewed as a model in facilitating statewide data sharing among multiple agencies. The workers’ compensation and Medicaid agencies in Washington State collect death certificate data from the health department to review prescription drug overdose death patterns in their respective patient populations. The health department also reviews statewide data on prescription drug overdose deaths.
• DSHS should be reviewed as a model in performing a cost-benefit analysis to demonstrate the cost-savings and utilization outcomes of the PRC Program in Washington State. Legislative champions at the level of the state Secretary, Assistant Secretary or Executive Team should be identified to undertake this effort on a larger scale. Collaborations should be established with private insurers and other stakeholders to provide cost-savings information to high-level state legislators.
• Maine should be reviewed as a model in incorporating specific language into providers’ contracts with Medicaid and other insurers. According to contractual language, providers in Maine must access the state PMP each quarter to identify each patient with long-term opioid use. The contractual language has changed behaviors and served as an incentive for providers in Maine to utilize the state PMP.
AN EVALUATION OF THE DOD TRANSDERMAL FENTANYL PHARMACY EDIT
LTC Stacia Spridgen is the Director of the Department of Defense (DoD) Pharmacoeconomics Center. She gave an insurer perspective on state strategies for preventing prescription drug overdoses. The DoD Pharmacoeconomics Center is responsible for conducting clinical and cost-effective drug reviews and incorporating this information into the Uniformed Formulary to meet the needs of military beneficiaries.
The Uniformed Formulary provides free points of pharmacy services within DoD for all services, including military treatment pharmacies, ~54,000 network pharmacies and the TRICARE mail order pharmacy. The Patient Outcomes Research Team is closing the gap on formulary decisions by conducting patient outcomes research to better assess DoD’s formulary decisions and improve the impact on beneficiaries.
Of DoD’s current TRICARE population of 9.3 million beneficiaries, ~8 million used pharmacy benefits at one or more POSs. Of 9.3 million eligible TRICARE beneficiaries, retirees and family members 65 years of age account for 20.1%, and active duty personnel and their family members account for 18.3%. TRICARE beneficiaries cover the full spectrum of age groups from neonates to the geriatric population. TRICARE purchase care POSs include specialty and primary care provided by retail pharmacy networks, the mail order pharmacy and other civilian network providers. TRICARE direct care POSs include specialty and primary care provided by military treatment facilities (MTFs).
DoD developed the Fentanyl Patch Patient Safety Program due to severe reactions and fatalities caused by fentanyl transdermal patches nationwide. In June 2005, the manufacturer issued a “Dear Healthcare Professional” letter to outline the indications and safe use of fentanyl patches, reiterate their use for persistent/moderate pain to severe/chronic pain, and require patients to be opioid-tolerant prior to use.
In July 2005, the Food and Drug Administration (FDA) issued a public health advisory warning to emphasize safety issues. The Institute for Safe Medication Practices and DoD also issued safety alerts in 2005. After MTFs reported three deaths from inappropriate use of fentanyl patches in July 2006, the manufacturer and DoD issued a second alert to describe potential dangers to patients if patches were exposed to external heat sources. DoD reviewed 48 medication errors by MTFs related to patients not being opioid-tolerant prior to placement on fentanyl patches or confusion about appropriate dosages.
Despite the advisory warnings and safety alerts, fentanyl patches continued to be incorrectly prescribed and used. To prevent further errors, the U.S. Air Force enacted a policy in July 2006 that limited provider prescribing of fentanyl patches to pain specialists, oncologists and other authorized prescribers. The policy also required a pharmacist drug utilization review (DUR). A recommendation on safety intervention by the DoD Pharmacy and Therapeutics Committee was formally approved in January 2007 and implemented in August 2007 in retail and mail order pharmacy POSs only.
The Fentanyl Patch Patient Safety Program focuses on opioid tolerance and uses an automated profile review (APR). The first step in the APR process is for the pharmacist to use the Pharmacy Data Transaction System (PDTS) to review the patient profile and determine whether a strong opioid was dispensed within 60 days of the patient receiving the fentanyl patch.
The pharmacist will or will not dispense the fentanyl patch depending on whether the patient profile showed receipt of a strong opioid within the last 60 days. The pharmacist can override a reject code in the system based on a review of the patient profile or discussions with the patient or physician. Patients who are not opioid-tolerant could still receive the fentanyl patch by paying cash or using health insurance other than TRICARE. Pharmacists also could dispense a pain medication other than the fentanyl patch to the patient.
The 88SR reject code is an industry standard that was developed by the National Council on Prescription Drug Programs. The DUR reject error only applies to fentanyl patch prescriptions at this time. The pharmacist receives a reject message to confirm opioid tolerance due to no documented strong opioid use in the past 60 days along with a telephone number to ask questions or discuss options with the TRICARE Pharmacy Benefits Manager. The pharmacist then makes decisions on overriding or not overriding the reject code and is required to enter interaction and outcome codes into the system.
During the evaluation of the Fentanyl Patch Patient Safety Program in August 2007, a “strong opioid” was defined as any Schedule CII drug. No future rejects were entered into the system if the CII drug was established as an open-ended prior authorization during the look-back period. The program was modified in July 2008 to address this gap. The new definition of “strong opioids” explicitly identified fentanyl, morphine, hydromorphone, methadone, oxymorphone and single-ingredient oxycodone products. The new policy also stated that patients with >60-day intervals between prescriptions would encounter another reject.
After the Fentanyl Patch Patient Safety Program was implemented and refined, DoD performed an analysis to evaluate the impact of the APR policy on fentanyl patch use among opioid-naïve patients who used retail or mail order POSs. The study was designed to answer three key questions: (1) What patients were affected? (2) What was the response? (3) Were appropriate patients targeted?
The retrospective observational cohort study was based on PDTS data from TRICARE beneficiaries with a paid claim or an 88SR reject for the fentanyl patch between August 1, 2007 and May 31, 2008. However, additional records were reviewed through June 15, 2008 for follow-up measures. The data analysis included means and standard deviations for continuous data as well as counts and percentages for categorical data.
Key findings of the study are summarized as follows. Of 26,366 patients who presented to pharmacies with fentanyl patch prescriptions, 62% encountered no problems with the APR process and 38% received 88SR reject codes. Of 10,025 patients with 88SR reject codes, 80% obtained a pharmacist override and received the fentanyl patch, while the remaining 20% did not obtain a pharmacist override and did not receive the fentanyl patch. Older adults, females and non-active duty personnel accounted for the majority of patients who received 88SR rejects.
Of 16,341 patients who did not receive 88SR rejects, 97% had been on a fentanyl patch, strong opioid or both. The number of pharmacist overrides was higher at the beginning of the study in August 2007 than at the end of the study in May 2008. The following intervention and outcome code combinations were used to override 7,982 88SR rejects: 55% of pharmacists filled the prescription as is and the remaining 45% of pharmacists consulted with physicians before overriding the reject code and dispensing the fentanyl patch.
Of 10,025 patients with 88SR rejects, 82% eventually received the fentanyl patch within seven days, 83% received the patch within 14 days, and 86% received the patch at any time through June 15, 2008. In terms of the mean time between the 88SR reject and subsequent paid claim, 90% of patients received the fentanyl patch within one day and 95% received the patch within one week. Patients with higher fentanyl patch doses of 50, 75 and 100 micrograms did not receive rejects. Older adults, females and non-active duty personnel accounted for the majority of patients who received pharmacist overrides to 88SR rejects.
Of 2,043 patients with 88SR rejects due to any opioid use who did not receive pharmacist overrides, 42% received any opioid within seven days, 45% received any opioid within 14 days, and 59% received any opioid ever. For purposes of the study, “any opioid use” was defined as tramadol and other strong and weak opioids. Of 832 patients with 88SR rejects who did not receive pharmacist overrides or opioids through June 15, 2008, 48% had no paid claims after the 88SR reject, 21% had no paid claims after the 88SR reject or in the previous year, 10% received other pain medications, and 7% had evidence of health insurance other than TRICARE in the previous year.
The study showed that MTFs performed better than retail or mail order pharmacies in assuring appropriate usage of fentanyl patches. This finding was due to the fact that the military has more control and authority over MTFs than retail or mail order pharmacies. By branch of service, Army MTFs performed better than Navy and Air Force MTFs in detecting prior opioid use among patients within the last 60 days prior to the first fentanyl patch prescription during the study period.
Overall, ~38% of patients who were prescribed fentanyl patches during the study period were flagged as potentially opioid-naïve. The Fentanyl Patch Patient Safety Program provided an additional warning to pharmacies for patients who appeared to have a higher risk of adverse drug events. Patients affected by the program had lower initial fentanyl patch doses compared to those not affected due to prior opioid exposure. Overrides that occurred appeared to be promptly managed by pharmacies.
Despite the efforts of the Fentanyl Patch Patient Safety Program, retail network pharmacies appeared to have a higher rate of inappropriate fentanyl patch use among seemingly opioid-naïve patients compared to MTFs. Program modifications that were implemented in July 2008 resulted in a number of changes.
Prior authorizations would remain on patient profiles, but these changes would only apply to new fentanyl patch patients. If strong opioids were detected in the look-back period, a short-term prior authorization would be established within seven days to allow prescriptions to be filled. However, future rejects could occur in the system. DoD anticipates an increase in the number of 88SR rejects due to its more conservative definition of “prior strong opioid use.”
The APR policy reduced the use of fentanyl patches among seemingly opioid-naïve patients. Novel application of the APR policy provided additional data to pharmacists during prospective DURs. However, more research is needed to analyze the association between the APR policy and the risk of respiratory depression within the military healthcare system; prevent adverse events related to fentanyl patches; and educate prescribers and pharmacists on the need to more closely examine TRICARE beneficiaries who present with fentanyl patch prescriptions.
*****
The state partners made additional comments and suggestions to strengthen linkages and collaboration among Medicaid, private insurers and other stakeholders in developing prescription drug overdose prevention strategies.
• Insurers and other stakeholders should perform economic analyses to measure the actual cost of prescription drug overdose deaths in their respective patient populations. This information could be a powerful tool for policymakers to change policies and leverage funding for PMPs at the state level.
• Resources other than collaborations should be compiled and widely distributed to support the prescription drug overdose prevention initiative. For example, Washington State recently presented its opioid dosing guidelines to the Transitional Warrior Program to assist the military in addressing the same problems with chronic pain and opioid use in a different population. This strategy would help to broadly publicize technical assistance, specialty knowledge and subject matter expertise that are currently available in the field of prescription drug overdose prevention.
• Medicaid and private insurers should be extensively engaged in the prescription drug overdose prevention initiative to determine their roles in providing direct financial support to PMPs and other state efforts.
WASHINGTON STATE OPIOID DOSING GUIDELINES
Dr. Gary Franklin is a Research Professor at the University of Washington School of Public Health and a Medical Director for the Washington State Department of Labor and Industries. He gave a provider perspective on state strategies for preventing prescription drug overdoses. Most state regulations on opioid use for chronic and non-cancer pain were revised in the late 1990s from “prohibition of use” to “use without dosing guidance.” The policy change most likely was due to low-grade studies that supported the rarity of “true addiction,” strong advocacy for treatment, and “disciplinary fatigue” because physicians previously were not allowed to use any opioids for chronic pain.
The 1986 Portenoy and Foley retrospective case series on chronic non-cancer pain was the sentinel study that led to the change in opioid use policy. Of 38 patients in the study, 19 were treated for at least four years and 24 had acceptable pain relief. However, only four patients in the study received >40 mg MED/day. Moreover, the study did not document any gains in social function or employment. The study concluded that opioid maintenance therapy could be a safe, salutary and more humane alternative. No clear evidence has been generated to date to document the benefits of long-term opioid use for chronic non-cancer pain.
The 2000 Workers’ Compensation Guidelines emphasized the need to focus on the following principles for prescribing oral opioids: a single prescribing physician and pharmacy, the lowest possible dose, appearance of misuse of medications, emphasis on return-to-work, tracking of pain and function with a 1-10 scale and measure of functional status, and no concomitant use of benzodiazepines or sedative-hypnotics. An opioid treatment agreement signed by both the patient and physician and written permission for the provider to conduct random urine drug screening were included in the 2000 guidelines.
The U.S. DEA summarized national medical examiner reports on oxycodone-related deaths from 2000-2001 to publish the earliest study on prescription opioid-related deaths. Of 464 definite or probable deaths identified in the study, nearly all of the patients received more than one opioid, a short- or long-acting opioid, or an antidepressant. The study is still available on the DEA web site.
A 2005 published study on opioid dosing trends and mortality in Washington State workers’ compensation programs from 1996-2002 documented 32 definite or probable deaths and a dramatic growth in dosing for the most potent opioids. The 2005 Washington State study demonstrated the possibility of quickly reversing the severe trend of opioid morbidity and mortality by changing provider behavior related to dosing levels.
More recent workers’ compensation data in Washington State showed an increase in definite or probable opioid-related deaths from 32 deaths in 1996-2002 to >100 deaths in 2004-2006. These data also showed a dramatic shift of >50% from the use of Schedule III to Schedule II opioids; a tremendous increase in average daily doses from ~80 milligrams/day to 140 milligrams/day; and a significant increase in definite and possible prescription opiate deaths. In addition to morbidity, hospital discharge data in Washington State also showed a dramatic increase in severe mortality due to hospitalized overdose cases. Washington State is in the upper tier of states in terms of unintentional poisoning deaths.
A 2007 published study highlighted the most frequent suspect drugs in deaths and serious non-fatal outcomes that were reported to the FDA from 1998-2005. Opioid analgesic drug classes were in the top six of the 15 most frequent suspect drugs in deaths and serious non-fatal outcomes. The causes of death most likely were due to dramatically increasing average daily doses that were not proven to be associated with improved outcomes and most likely were related to increased tolerance. Tolerance for euphoric effects likely precedes tolerance for respiratory depression.
Research is now being conducted to determine a relationship between dose and morbidity or mortality effects. A 2007 published study focused on central sleep apnea and ataxic breathing related to chronic opioid use. The retrospective cohort study included 60 patients on chronic opioids and showed a 92% prevalence of ataxic or irregular breathing during non-rapid eye movement sleep at 200 mg MED. A new study with 9,000 enrollees on opioids for at least three months in a large prepaid health plan documented a dramatic 24-fold increase in risk for combined morbidity and mortality at 100 mg/day MED and a two-fold increase at 20 mg/day. This study illustrates the uncertainty in determining a safe dose for taking opioids long-term for chronic non-cancer pain.
CDC’s position is that the extent to which increases in opioid-related deaths have been due to specific prescribing practices, improper usage of medications by patients, diversions of drugs from patients to other persons, or other means has been difficult to determine. In May 2007, a pharmaceutical company submitted an opinion in response to Washington State’s dosing guidelines. The opinion stated that accidental deaths involving opioid analgesics were more often due to abuse or misuse of opioids rather than therapeutic use of opioids for chronic pain.
In May 2007, The New York Times published an admission of guilt of deceit in marketing from a narcotic maker that pleaded guilty to criminal charges and agreed to pay $600 million in fines to states. A 2007 published study concluded that the evidence supporting long-term analgesic efficacy is weak overall. The study further concluded that the putative mechanisms for failed opioid analgesia might be related to rampant tolerance or opioid-induced hyperalgesia. The study also questioned the premise that tolerance could always be overcome by dose escalation.
A large epidemiological study was conducted in Denmark with thousands of opioid and non-opioid patients and found that the quality of life was better in non-opioid patients with chronic pain than patients who were taking opioids long-term. Another problem with opioid usage is that a clear case definition has not been developed to date to distinguish between the true incidence of “addiction” versus “craving.”
In an effort to address opioid-related morbidity and mortality, 15 clinical pain specialists in the Washington State Agency Medical Directors Group (AMDG) developed the Opioid Dosing Guideline in 2006 as an educational pilot with 120 mg serving as the “yellow-flag” dose. Formal evaluation is underway to assess providers’ experiences with the guideline. The expert advisory clinical group will be reconvened to review the evaluation outcomes and plan next steps in refining the guideline. In February 2009, data from the guideline will be disseminated to all 12,000 prescribing physicians in Washington State.
Part I of the opioid dosing guideline focuses on new patients who have not experienced clear improvement in pain and function at 120 mg MED. The guideline recommends maintenance at the same dose, a decrease in the dose, or a one-time pain management consultation with a certified pain specialist, neurologist or psychiatrist. This strategy will help to prevent the development of a new cohort of patients with opioid addictions or problems.
Part II of the opioid dosing guideline is targeted to patients who are already on very high doses >120 mg MED. Techniques are offered to physicians to effectively reduce doses in a fairly short period of time of 3-6 weeks. The guideline also includes a web-based opioid dosing calculator that provides an appropriate MED in real time and two hours of free online CMEs. The state of Utah and the American Pain Society also developed opioid guidelines, but these two sets of recommendations do not offer specific dosing advice on opioids. At this time, the Washington State guidelines are the only set of recommendations that attempts to reduce or prevent high opioid doses in new patients.
In addition to the lack of guidance on opioid dosing, efforts must be made to solve the significant problem of access to pain specialists. In Washington State, only 13 certified pain specialists agreed to serve as “resource consultants” for the AMDG web site and no pain specialists in Spokane were willing to see patients with chronic pain who were on opioid doses of 120 mg/ day. In an effort to resolve the access problem, advanced training should be offered for primary care physicians to become qualified to mentor other providers.
CDC testified before Congress in March 2008 on proposed prevention measures and made the following recommendations: take advantage of out-of-state PMPs, modify patient behavior with insurance mechanisms, screen for drug misuse in EDs, provide practice guidelines for primary care, and make painkillers tamper-resistant.
Overall, dramatically increasing opioid doses and deaths occurred rather quickly after the law changed. Guidelines with “best practices” were developed quite some time ago, but have had minimal effect. A focus on opioid dosing is the most likely method to prevent high doses related to severe morbidity and mortality.
More emphasis should be placed on severe long-term effects of opioids beyond morbidity and mortality from overdoses. Most notably, Washington State published a prospective cohort study on early opioid use and disability among 1,843 workers with acute low back injury in 2008. The study showed that workers who received at least two opioid prescriptions in the first six weeks post-injury were twice as likely to be on disability one year later even after adjusting for pain, function and injury severity.
*****
The state partners made a number of comments and suggestions to strengthen linkages and collaboration among physicians, nurses, other prescribing and non-prescribing providers, and professional associations of providers in developing prescription drug overdose prevention strategies.
• Collaborations should be formed with schools of medicine to provide more coursework on the provision of pain management. The medical community has expressed concerns about the lack of training on pain management provided during medical school.
• Partnerships should be developed with professional organizations throughout the country to assist in providing practicing physicians with continuing medical education on pain management and patient medication safety. Groups that should be involved with creating prescriber education guidelines, offering incentives, and establishing standards or requirements for pain management training include state medical societies, state boards of medicine and pharmacy, state licensing boards, school health nurses, the American Medical Association and the Joint Commission. CDC or DEA should be asked to provide national leadership in this area. At the state level, individual physicians or states could write letters to professional organizations to request assistance in this effort.
• Psychologists and psychiatrists should be included in provider education and training activities. These providers should be trained in determining whether their patients have pain and conducting behavioral techniques if opioid abuse is occurring.
• Prescription drug overdose prevention resources should be offered to states free of charge, such as a national model, access to training, dosing guidelines, and other practical tools that could be integrated into existing daily practice.
• Cost-effective technologies should be implemented to provide training to providers. Innovative tools also should be provided to physicians to increase the efficiency of their practices. For example, Washington State is currently conducting beta tests on using tele-medicine to link pain specialists to rural primary physicians. Washington State sponsors a number of webinars for physicians to engage in computerized consultations. Washington State also has created a computerized program to automatically calculate MEDs of all controlled substances for physicians to rapidly use this information.
• Previous efforts by workgroups should be reviewed as guideline development models to avoid duplicating efforts. For example, workgroups formed by the Health Resources and Services Administration (HRSA), CSTE, STIPDA and other national organizations should be coordinated to pool existing resources and identify more cost-effective strategies in developing guidelines, providing training, and compiling and disseminating promising or best practices, models and other prescription drug overdose prevention tools.
• SAMHSA’s web-based portal should be reviewed as a model in providing a centralized location for persons to access information on prescription drug overdoses. SAMHSA is partnering with other federal agencies to create a Center of Excellence to compile data, conduct studies and disseminate information to stakeholders.
• CDC’s antibiotic resistance activities should serve as model of providing education to the public.
• Patient safety education activities should be designed to engage patients as true partners in the healing and treatment of prescription drug overdoses. Uniform provider-patient partnership models should be developed in this effort to ensure that education is provided and information is disseminated in a consistent manner across the country.
UTAH CLINICAL GUIDELINES ON PRESCRIBING OPIOIDS
Ms. Erin Johnson is a Pain Management Program Manager in the Utah Department of Health (UDH). She gave a provider perspective on state strategies for preventing prescription drug overdoses. Utah ranks as the second highest state in the country for persons >24 years of age who use pain relievers for non-medical purposes. Non-illicit drug overdose deaths increased from 32 in 1991 to 317 in 2007 and are now the number one cause of injury death in Utah. The state also has seen a dramatic increase in the number of methadone-related deaths from 2000 to 2004.
UDH developed Clinical Guidelines on Prescribing Opioids due to a legislative mandate. The guidelines were designed to provide advice to primary care and specialty physicians in Utah on prescribing opioids for both acute and chronic pain. The purposes of the guidelines are to provide recommendations that balance the benefits and risks of opioid use to individuals and society and disseminate useful tools to practitioners.
UDH initiated the guideline development process in June 2007 by establishing a steering committee to determine key questions, the scope of the guidelines, and inclusion criteria for the evidence review process. The literature review covered 40 existing guidelines on pain, chronic pain, opioids, pain management and related topics. Inclusion criteria for the evaluation were studies published after 1999 that provided disclosure of funding. The studies were scored on an evidence-based versus consensus-based process.
Of the 40 sets of guidelines evaluated, four received scores 2 were immediately eliminated and discussions were held to include, modify or eliminate the remaining tools. The selected tools included sample contracts, treatment plans, drug screens, screening tools to determine good candidates for opioids or identify persons at potential risk for opioid abuse, a directory of available resources in Utah, and a take-home monitor for patients to track improvement in pain and function.
The recommendations on opioid treatment for acute and chronic pain provide guidance to clinicians in the following areas:
• Appropriate and inappropriate use and prescription of opioid medications, including patient education on proper disposal of medications and information to patients on various risks and benefits.
• Comprehensive evaluation of the use of opioids.
• Adequate therapeutic trials and other alternatives to opioid treatment.
• Opioid screening prior to initiation of treatment to detect potential risks for abuse or addiction.
• Development of a treatment plan with measurable goals.
• Provision of information to patients via a written and signed treatment contract and plan.
• Initiation of a treatment trial with specific goals for long-term opioid use.
• Regular face-to-face visits with patients to evaluate progress against treatment goals and monitor the patient.
• Circumstances requiring clinical consultation, including patients with complex pain conditions, serious co-morbidities, or a history of current drug addiction or abuse.
• Appropriate prescription of methadone.
During the 45-day open comment period, UDH received >100 comments. Comments from the general public primarily focused on the requirement to present to a specialist, “government intrusion” of undergoing drug testing, and the need for public protection due to the ability of opioids to cause addiction and destroy lives. The technical and clinical comments primarily focused on the pros and cons of upper opioid doses, the complexity of drug testing, potential risks for liability to physicians, and the sleep study recommendation.
UDH will publicize and disseminate the guidelines over the next month through a number of venues, such as online and print formats, physician education presentations, and e-mail messages to physicians, hospitals, the Utah Medical Association and other groups.
In addition to developing the Clinical Guidelines on Prescribing Opioids, Utah also has taken other actions to prevent prescription drug overdoses. State legislation was passed in 2007 that authorized UDH to conduct research on the causes, risk factors and solutions to prescription drug overdoses and also to educate healthcare providers, patients, insurers and the general public. UDH conducts these activities in collaboration with its Steering Committee, Advisory Committee and workgroups that focus on specific issues, such as patient and community education; policy, insurance and incentives; and data, research and evaluation.
UDH obtains input and endorsement from diverse groups throughout Utah that represent state government, professional societies, and private and non-profit organizations. UDH provides education to physicians through small group training sessions, large group presentations and mailings. The physician education and training activities offer up to 20 CMEs.
UDH launched a media campaign in January 2008 to provide education to patients and the general public on prescription drug overdoses. The campaign was publicized through a public opinion survey, “Prescription Awareness Week,” key messages, community and press events, and television and radio broadcasts. Collateral materials for the media campaign include the “Use Only as Directed” logo, a web site, color poster, bookmarks in English and Spanish, double-sided cards, print advertisements, media kit, window clings, quick screen display and banner. The collateral materials have been tailored to meet the needs of a variety of audiences throughout Utah.
Ms. Johnson informed the state partners that other states and organizations are free to use and adapt UDH’s media campaign materials and templates to meet local needs. She concluded her overview by presenting the television and radio advertisements of the media campaign. She noted that the web site of UDH’s media campaign is .
*****
The state partners made a number of comments and suggestions to strengthen linkages and collaboration with providers in developing prescription drug overdose prevention strategies.
• Innovative strategies should be developed to overcome resource limitations or other barriers to evaluating prescription drug overdose prevention initiatives. Schools of public health, master’s or Ph.D. candidates, CDC-funded Injury Prevention Research Centers, Health Promotion and Disease Prevention agencies, and research organizations across the country might serve as creative approaches to supplementing or augmenting existing evaluation resources. Most notably, the collection and wide dissemination of strong evaluation data from UDH’s impressive and multi-factorial “Use Only As Directed” media campaign and tools for the Clinical Guidelines on Prescribing Opioids will be important in informing other states about effective and ineffective prescription drug overdose prevention activities.
• State epidemiologists should be engaged in the prescription drug overdose prevention initiative due to their strong credibility with physicians in states. Collaborations should be formed with CSTE, STIPDA and school health nurses to support this effort.
• Communication campaigns to providers, patients and the general public should be included in the broader prescription drug overdose prevention initiative.
• Local endorsement should be obtained from stakeholders to assure implementation and success of prescription drug overdose prevention activities at the local level.
• The possibility should be explored of leveraging funds from pharmaceutical companies to support and promote prescription drug overdose prevention messages and other efforts.
• National pharmacy organizations and other groups that advocate for safe medication practices should be engaged in the prescription drug overdose prevention initiative, such as the Institute for Safe Medication Practices, American Pharmacists Association and American Society of Health-System Pharmacists.
THE CONSISTENT CARE PROGRAM
Dr. Darin Neven is the Medical Director of the Providence Sacred Heart Medical Center (PSHMC). He gave a hospital perspective on state strategies for preventing prescription drug overdoses. The CCP was developed to reduce inappropriate ED visits and controlled substance prescriptions and administration in EDs. The CCP targets patients who over-utilize EDs. The goals of the CCP are achieved by coordination of care with primary care physicians and individualized Emergency Department Guidelines that are accessible to all emergency physicians throughout the city.
The CCP is guided by a number of core principles. Actions are always taken in the best interest of the patient. Enabling of non-therapeutic behavior is prevented. Care is coordinated, but the primary care provider maintains control. Prescription overmedication or abuse is prevented. Patients are empowered to treat themselves. A collaborative information technology system was established for the four hospitals in Spokane, Washington to use the same hospital data system.
The CCP was designed to address the problem of frequent ED use. Patients frequently use multiple EDs for pain medication, have concurrent mental health problems, report chronic pain, and are Medicaid or Medicare beneficiaries. Frequent ED users typically have a primary care physician and a preferred hospital, but are generally not forthcoming regarding their medical history or previous testing. PSHMC’s pilot study showed that 90% of 48 patients had a government payer.
The steps involved in the CCP process include selection of a frequent ED user by the clinician; identification of the patient via a 24-hour referral line; research on the patient’s medical history; review of the information for appropriateness; telephone consultation between the Program Coordinator and primary care physician; presentation of recommendations by the clinician to an ED Care Guidelines Committee; and development of individualized Emergency Department Care Guidelines to prevent enabling of non-therapeutic behavior when the patient revisits the ED. The committee members include a chaplain, psychiatric and ED nurses, pharmacist, ED physicians and medical director.
The patient is notified about the CCP via a mailed letter, the guidelines are entered into the shared hospital information system, and the data are distributed throughout the state of Washington. Efforts are underway to create and launch the Emergency Department Information Exchange. The web-based system will have the ability to add new hospitals, better manage complex cases, monitor patients who are not in EDs, and track progress of the CCP.
The following process is implemented when CCP patients visit the ED. The patient’s ED chart is flagged for the physician during hospital registration. The patient is triaged as usual, but the physician will not prescribe controlled substances for pain patients based on a review of the ED care guidelines. The ED physician performs a medical screening examination and the case manager speaks to the patient prior to discharge to emphasize the message of consistent care and determine the rationale for frequent ED visits.
The CCP is designed to seize teachable moments by automatically notifying the ED case manager and medical director via a recorded telephone message and text message. Automatic notification to the primary care physician, insurance company and ED via e-mail message and facsimile is planned in the future.
PSHMC piloted the CCP from October-December 2006 and enrolled 40 patients who had an average of 50 visits over a 12-month period. The maximum number of ED visits made by an individual patient was 123 and the minimum number was 14. The 40 pilot patients collectively made a total of 2,037 ED visits in the 12 months prior to enrollment. The 2,037 ED visits made in the 12 months prior to enrollment were reduced to 1,022 ED visits in the 12 months after enrollment. ED visits also decreased in all four of the Spokane hospitals. A positive impact was seen in individual changes in ED visits one year after enrollment among the majority of patients. In terms of cost-savings, the pilot showed a 33% reduction in Medicaid expenditures for ED claims or savings of $2,379 in Medicaid ED expenditures per patient. Medicaid ED payments per patient decreased from $7,228 in the 12 months prior to enrollment to $4,848 in the 12 months after enrollment. Similar savings were observed for total Medicaid expenditures.
Several solutions have been identified to overcome potential barriers to implementation of the CCP. HIPAA issues do not apply because the CCP falls under the treatment category. Consent forms should be used when needed. Emergency Medical Treatment and Active Labor Act issues do not apply if medical screening examinations for CCP patients do not differ from those for non-CCP patients. Hospital triage policies should be followed.
Physician liability concerns are addressed by providing sufficient medical information to aid in decision-making and assuring follow-up by listing primary care physicians. Physicians are paid based on responses to patient satisfaction surveys, but efforts are made not to administer these surveys to frequent ED visitors. Hospitals treat complaints by frequent ED users differently than complaints by non-CCP patients to ensure physicians are not unfairly penalized. Challenges related to information technology can be met by using an external application service provider with expertise in this area.
A number of guiding principles have resulted in the success of the CCP. An ED physician should lead the project, but strong support and approval should be obtained from the top level of the institution. Savings from inappropriate ED usage to hospitals, government payers and uninsured payers should be emphasized. The overarching goal of the CCP to provide care that is in the patient’s best interest and has the approval of the primary care physician should be emphasized. Overall, electronic medical records alone are not the solution to frequent ED users because a community-wide approach is needed. The CCP can lead to significant savings to hospitals and payers. The most frequent ED users are Medicare or Medicaid beneficiaries.
*****
The state partners made a number of comments and suggestions to strengthen linkages and collaboration with hospitals in developing prescription drug overdose prevention strategies.
• Existing federal and state models should be reviewed that promulgate brief interventions and referrals to treatment in EDs. At the federal level, SAMHSA funds the Screening, Brief Intervention, Referral and Treatment Program to provide substance abuse screening in general medical and community settings, including community health centers, school-based health clinics, student assistance programs, occupational health clinics, hospitals and EDs. SAMHSA recently obtained approval for billing codes of the program. At the state level, the Massachusetts Department of Health allocated funding for hospitals across the state to collaboratively implement the Emergency Department Screening and Brief Intervention Program and hire health promotion advocates. Similar to SAMHSA, Massachusetts is advancing toward developing billing codes for screening of brief interventions and discontinuing state funding of this initiative. Massachusetts also is interested in piloting the inclusion of its naloxone distribution project into EDs to provide naloxone to opiate overdose patients before these high-risk persons are discharged from EDs.
• Communications related to chronic pain treatment should be enhanced among EDs at the state level. Hospitals in Washington State have already initiated this effort by developing guidelines for treating chronic pain in EDs.
• Grand rounds and other forums should be utilized to provide education to ED physicians.
• Benzodiazepines should be explicitly mentioned in pain guidelines because ED physicians typically dispense these drugs with low-dose opiates or in lieu of opiates.
• A pilot study should be conducted to explore the possibility of linking electronic medical records and developing a standardized set of minimum data elements to facilitate interoperability of hospital data systems. The National Information Exchange Model should be reviewed in this effort because the tool is serving as the foundation for data exchange of PMP data across states or into a centralized hub.
• Efforts should be made to ensure that the hospital community is extensively involved in the healthcare reform agenda of the new Administration in terms of electronic medical records.
• Regulatory- and policy-based solutions or legislation should be created to eliminate political, bureaucratic and legal issues associated with sharing medical data.
• States with PMPs should be encouraged to generate reports by hospital ED to identify specific institutions that are prescribing prescription drugs and determine variations among hospital EDs in terms of drug types and doses. These reports could help to identify occurrences of “hospital ED shopping.” Patient visits could be used as the denominator to generate hospital-specific reports with PMP, Medicaid and private insurer data.
• A feedback mechanism should be created to rapidly provide physicians with real-time information on prescription drug overdose deaths in communities. Maine should be reviewed as a model in this effort due to its development of Overdose Prevention Groups that provide physicians with information on specific drugs involved in prescription drug overdoses deaths in the community.
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 ................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related searches
- table of common cardiac medications
- mbti table of personality types
- time table of examination 2019
- complete table of values calculator
- table of values equation calculator
- table of values generator
- graph table of values calculator
- linear equation table of values
- table of standard scores and percentiles
- table of derivatives pdf
- table of integrals exponential functions
- table of exponential integrals