Centers for disease control and prevention
USE OF PRESCRIPTION DRUG MONITORING PROGRAM DATA
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- THE ROLE OF STATE MEDICAL EXAMINER DATA IN THE PRESCRIPTION DRUG PROBLEM: AFFECTING POLICY Dr. Marcella Sorg
- THE ROLE OF SUBSTANCE USE EPIDEMIOLOGY, NEW MEXICO DEPARTMENT OF HEALTH Ms. Nina Shaw
- Patient Review and Coordination Program For Medical Assistance Clients Who Need Assistance In Appropriate Use of Services Ms. Phyllis Coolen
- AN EVALUATION OF THE DOD TRANSDERMAL FENTANYL PHARMACY EDIT LTC Stacia Spridgen
- WASHINGTON STATE OPIOID DOSING GUIDELINES Dr. Gary Franklin
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 www.chfs.ky.gov/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.
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, <50% have drug death data. These data are not comparable among states and might not focus on the problem of prescription drug deaths. Moreover, ME data generally are not proactively disseminated to other groups. In one state model, Maine created its Chief Medical Examiner System in 1968, but the workforce only includes two staff for the entire state population of 1.3 million persons. In overdose deaths in Maine, the ME typically does not visit the scene, performs autopsies on ~78% of decedents, and conducts a full toxicology screen and histology if indicated. The goals of an autopsy in an overdose death are to determine or rule out natural disease or trauma that might have caused the death and collect samples for toxicology and histology. Data collected from the Maine Office of the Chief Medical Examiner (OCME) showed that prescription drugs accounted for the majority of drug deaths and have increased the complexity of cases. OCME data also documented a 429% increase in drug deaths from 1997-2006. Opiate addiction, treatment episodes and demand for methadone treatment increased in Maine in 2001. To address this problem, the Maine Office of Substance Abuse formed a task force and OCME leveraged funding to conduct a study on drug-related deaths from 1997-2002. The study showed that prescription drugs accounted for 92% of drug deaths in Maine. The study and a subsequent press conference in 2002 led to a number of changes in the state. The occurrence of “take-home” methadone was reduced and OxyContin was removed from the preferred Medicaid drug list. The Maine PMP was developed and implemented in 2004. Department of Justice (DOJ) grants were awarded in 2003-2007 to continue monitoring of drug death data. Federal dollars were allocated to form the Maine Community Epidemiology Surveillance Network. A statewide prevention grant was awarded for county groups to collect county-specific data. Workshops were convened and policy briefings were held to educate legislators in Maine about the problem of drug deaths from prescription drugs. The Maine Medical Association included drug death data in training sessions throughout the state to educate providers on appropriately writing opiate prescriptions. Maine acknowledges a number of problems in using ME data to affect policy. The exclusion of methadone clinic data from the Maine PMP is a significant issue. Data from these clinics are a critical need and should be required under the concept of a “medical prescription home” because methadone accounts for ~33% of drug deaths in the state. Providers have limited knowledge on utilizing drug death data to respond to prescription drug diversion and misuse in their patient populations. The need for the state Medicaid agency to use PMP data has not yet been determined. Federal feedback loops are needed to resolve variations and discrepancies in data. Overall, the fiscal impact of drug deaths on ME/coroner systems is significant. Funding for processing and disseminating drug death data is frequently from federal sources and sporadic. Because methadone is a significant part of the drug death problem, more attention should be given to coordinating data from methadone clinics, Medicaid databases and PMPs. State-specific systems should be developed to identify solutions. Access to PMP data should be provided to MEs and coroners. Maine will change its laws over the next two years to support this effort. Requests for duplicative surveillance data should be avoided; unfunded mandates should not be created; and epidemiologists should take caution in comparing raw data across variable ME/coroner jurisdictions. ***** The state partners made a number of comments and suggestions to strengthen the role of ME/ coroner data in prescription drug overdose prevention.
THE ROLE OF SUBSTANCE USE EPIDEMIOLOGY, NEW MEXICO DEPARTMENT OF HEALTH Ms. Nina Shaw is a Substance Abuse Epidemiologist in the New Mexico Department of Health (NMDH). She explained that the NMDH Substance Abuse Epidemiology Section was formed in 1991 with three staff initially to evaluate substance abuse treatment. NMDH received three Center for Substance Abuse Treatment State Needs Assessment Program grants from 1993-2005 with funding of $200,000-$300,000 per year for nine years. This funding allowed NMDH to increase its workforce to five staff. State alcohol excise tax dollars for DWI programs supported screening and tracking of DWI offenders in 1997. Lack of funding in 2000 led to a decrease in staff, but CDC has allocated funding since 2002 to support an alcohol epidemiologist position. The NMDH Injury and Behavioral Epidemiology Bureau conducts surveillance of substance use, fatal and non-fatal injuries, and a wide variety of other health conditions and related behaviors in the state population. The Survey, Injury Prevention, and Substance Abuse Sections conduct these activities within the Bureau. The Substance Abuse Epidemiology Section describes and monitors the burden of substance use and mental health conditions in the state and provides policy recommendations as appropriate. Other activities within the Section include surveillance, analysis and dissemination of data on substance use behaviors, mental health conditions, overdose deaths and other drug- and alcohol-related mortality; special studies; and prevention activities, policy development, advocacy and epidemiology consultation. The Section includes four epidemiologists and one fellow to conduct these activities. Surveillance, data analysis and dissemination activities are designed to develop, analyze and interpret data related to substance use and mental health; respond to data requests; create indicators for the Information Based Indicator System; assess the usefulness of data sets and collection processes; link data sources to produce analysis-ready data sets; and collaborate with stakeholders, strategic workgroups and entities at state, federal and community levels. Prevention activities, advocacy, policy development and epidemiology consultation support the State Prevention Framework State Incentive Grant; assist in evaluation of prevention and intervention initiatives; evaluate NMDH performance measures; conduct legislative bill analyses related to substance use and mental health; and support the Interagency Behavioral Health Collaborative and associated workgroups and task forces. NMDH’s three-year pilot project, special studies and manuscripts have focused on overdose surveillance in two hospital EDs; the prevalence of alcohol dependence among excessive drinkers; types of alcoholic beverages consumed by high school aged youth; New Mexico-specific alcohol attributable fractions; and depression among adults. NMDH used ME data to analyze drug overdose deaths in the context of methadone, prescription drug death trends, changes in drug combinations causing death over time, urbanization levels, different trends between U.S.-Mexico border and non-border counties, and PMP linkages. NMDH uses its Strategic Prevention Framework State Incentive Grant to assist the Office of Substance Abuse Prevention; provide consultation and technical assistance to all sub-grantees; participate on the State Epidemiology Workgroup; and generate the state epidemiology profile for use by evaluators, sub-grantees and other stakeholders. NMDH’s Behavioral Health Services Division provides estimates and demographic data to meet substance abuse treatment needs for the state and planning regions; delivers assignments for the SAMHSA Substance Abuse, Prevention and Treatment Block Grant; and provides technical assistance and epidemiologic consultation for the examination of estimates of treatment needs by other drug use indicators, data quality improvement, data collection processes and the State Methadone Authority. NMDH is planning a future activity to provide estimates to meet mental health treatment needs for the state and regions. NMDH assists local DWI programs to develop and evaluate data from local grant programs; develop and implement a quality control process; provide professional evaluation guidance; generate an annual recidivism report; and provide links to administrative databases. NMDH collaborates its activities with a number of partners at local, state and federal levels. NMDH’s substance use epidemiologic data have played an important role in informing policy in New Mexico. The 1997 Harm Reduction Act established the state-funded Harm Reduction Program to facilitate syringe exchange. Legislation was passed in 2001 to expand naloxone availability to all heroin users, family members and friends. Drug overdose was added to the list of administrative codes as a notifiable and reportable condition in 2003. The Alcohol Advertising and Youth Task Force was established in 2007. During the 2009 legislative session, discussions will be held on the development of a Medication Assisted Treatment Task Force to increase the accessibility and availability of medication-assisted treatment to underserved populations; creation of the Drug Policy Task Force to examine current drug policies in New Mexico; treatment rather than incarceration for non-violent drug offenders; and a local option tax on alcohol that could be used for prevention efforts. The 911 Good Samaritan Law was passed in 2007 in New Mexico to provide limited immunity from drug possession charges when a drug-related overdose victim or witness to an overdose seeks medical assistance. The law helps to eliminate the fear of calling 911 for help during an overdose and protects witnesses from any potential police involvement or reprimand due to drug possession at the scene of an overdose. However, the law does not protect persons from prosecution for other offenses and outstanding warrants and also does not interfere with law enforcement protocols to secure the scene of an overdose. NMDH utilizes a variety of drug indicator surveillance data sources, including the Office of the Medical Investigator, vital records, law enforcement, PMP, HIV and Hepatitis Epidemiology Program, Harm Reduction Program, treatment episode data set, hospitalization inpatient discharge data, Youth Risk and Resiliency Survey, and the National Survey of Drug Use and Health. In the future, NMDH plans to use data from emergency medical services, poison control centers, Medicaid, drug courts, and CDC’s Behavioral Risk Factor Surveillance System. NMDH has used these sources to collect data on drug-induced death rates in New Mexico and the United States from 1990-2006; unintentional opioid poisoning death rates by schedule in New Mexico from 1990-2007; unintentional prescription drug death rates by demographics in New Mexico non-border and border counties from 2003-2007; hospital discharges by primary drug-related diagnosis in New Mexico from 2003-2007; primary substances of abuse at treatment admission in New Mexico in 2007; non-medical use of pain relievers in the past year; current drug use by students in grades 9-12 by gender in 2007 in New Mexico; and the mode of exposure among HIV/AIDS cases in New Mexico in 2008. NMDH also used data from multiple sources to publish numerous reports and manuscripts on drug abuse patterns and trends in New Mexico; DWI offender characteristics and recidivism rates; unintentional methadone-related overdose deaths in New Mexico; changing trends in drug overdose deaths; social indicators; and the New Mexico epidemiology profile. ***** The state partners made a number of comments and suggestions to strengthen the role of epidemiologic data in prescription drug overdose prevention.
Patient Review and Coordination Program For Medical Assistance Clients Who Need Assistance In Appropriate Use of Services Ms. Phyllis Coolen is a Clinical Nurse Advisor and Physical Rehabilitation Center Manager in the Washington State Department of Social and Health Services (DSHS). She gave a Medicaid perspective on state strategies for preventing prescription drug overdoses. National and statewide data indicate an increase in the number of deaths due to opiates. The use of prescription opiates also has increased in the Medicaid population because clients with minor medical diagnoses and high-risk medical conditions receive large amounts of narcotics. Moreover, the correlation between “ED cycling” and narcotics allows patients to easily obtain narcotics through the ED. These complex issues require multiple solutions and partnerships. Aged, blind or disabled Medicaid clients are frequent ED visitors, have high rates of co-occurring mental illness and alcohol or drug disorders, and receive large volumes of prescription opiates. Relatively few Medicaid clients receive drug or alcohol treatment services, but many receive mental health services. The average number of pain prescriptions is highest among Medicaid clients who most frequently visit the ED. Washington State developed the PRC Program as a health and safety program for Medicaid fee-for-service, managed care, and state-funded clients who overuse or inappropriately use medical services. The PRC Program is a federal requirement of all Medicaid programs. The objectives of the PRC Program are to decrease and control over-utilization and inappropriate use of health care; minimize medically unnecessary and addictive drug use; provide patient education and coordination of care; assist providers to manage clients with education and resource referrals; facilitate coordination of care; and reduce expenditures on unnecessary and inappropriate services. Internal and external direct referrals and monthly algorithms are the two approaches DSHS uses to identify Medicaid clients for PRC review. The majority of external referrals are from pharmacies, but referrals also can be made on the PRC web site. Algorithms are run to identify high numbers of narcotic users, prescribers for narcotics, and ED users with non-emergent diagnoses. PRC review and placement must be medically necessary. These criteria include any of the following two occurrences within a 90-day period: services from >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.
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 34.1%, 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.
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. Directory: associations associations -> Transatlantic Cooperation in the Fight against Terrorism associations -> Guidelines for zoo and aquarium veterinary medical programs associations -> Kern county bar association associations -> Kids in Parks track trail Network Expansion Project Grant Application associations -> Mpace privacy Policy associations -> Loss prevention techniques for surveyors associations -> Loraine and jim koski’S "alpventures" world war II tour after-action report associations -> Friday Jan 31 Atlantis A Download 266.48 Kb. Share with your friends:
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