Centers for disease control and prevention



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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.
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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 <8, but two additional sets were also included in the evaluation. UDH engaged three public health professionals to review the ratings for consistency. The Guidelines Recommendation Panel was formed with 12 multidisciplinary experts to provide recommendations based on six sets of evidence-based guidelines. The Implementation and Tool Panel was formed with 12 experts to review the recommendations, determine the feasibility of implementation and identify tools for inclusion in guidelines.
UDH took several activities during the recommendation development process in April-July 2008. Selected guidelines were reviewed for commonalities and an outline was developed based on recommendations that were supported by multiple guidelines. A Wiki was used to add new and edit existing recommendations online and create a draft of the guidelines. A third meeting was held to thoroughly discuss each recommendation, take a straw poll, revise the draft, and reach consensus on the final draft.
After the guidelines were finalized, UDH initiated the tools development process in July-August 2009. The 47 identified tools were reviewed and scored from 1-5 based on their usefulness. Tools with average 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 www.useonlyasdirected.org.
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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.





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