Scott & White Health Plan Provider Manual Quality Improvement (QI) Program Table of Contents Section 1: QI Program Description Section 2: Medical Records Standards Section 3: Clinical Practice Guidelines 3A: Tier 2 Clinical Practice Guidelines 3B: Tier 1 Guidelines 3C: Preventive Health Guidelines Section 4: Disease Management Programs Section 5: Accessibility Standards Scott & White Health Plan Provider Manual Section 1 QI Program Description A paper copy of the QI Program information included on this website is available upon request from the Scott & White Health Plan Quality Improvement Division. Call toll free 1-800-321-7947 ext. 3097 or 254-298-3097. SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Introduction Scott and White Health Plan is a federally qualified, not-for-profit, Mixed Model Health Plan. Its first Board meeting was on August 30, 1979 under the name of Centroplex Health Plan. With the aid of a $200,000 federal planning grant, a base staff for operations was established and marketing of the Health Plan began in March/April of 1980. The Health Plan officially began on January 1, 1982 when it signed up its first group, the Scott and White Hospital and Clinic employees. In 1984, the name was officially changed to Scott and White Health Plan (SWHP). SWHP is one component of an integrated delivery system that includes the Scott & White Memorial Hospital (SWMH), and the Scott and White Clinic (SWC). There are currently two service areas defined by the State and Federal Government for the Health Plan and the SeniorCare Plan. SWHP’s total service area encompasses all or part of 52 counties. The four major product areas and their membership are specified below: Product Commercial Group Medicare Effective Date 1-1-82 4-1-91 December 1, 2010 Membership 101,976 23,967 % of Total Members 62% 15% (excluding Part D) Self Insured Individual 2-1-97 27,497 10,689 Total 164,129 17% 6% 100% SWHP members receive the majority of their hospital services through 10 affiliated Scott and White hospitals. These services include Inpatient Acute Care, Observation, and Day Surgery services. SWHP contracts with 24 hospitals in the service area to provide the remaining hospital services. Hospital contracts stipulate participation in SWHP’s Quality Improvement (QI)/Utilization Management (UM) activities and access to medical records. SWMH, SWC and contracted providers provide routine Adult Mental Health/Substance Abuse, Child/Adolescent Mental Health/Substance Abuse and Eating Disorders services to SWHP Members. Mission Scott and White Health Plan adopted the mission statement of the Scott and White (SW) Institution, which is “To provide the most personalized, comprehensive, and highest quality health care enhanced by medical education and research.” Scope of the QI Program The scope of the QI Program is to monitor, evaluate and improve: The quality and safety of clinical care and quality of practitioners and providers The quality of service provided by the Health Plan SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 QI Program Goals - Objectives A. Improve Member Outcomes – through prevention, decision making assistance and disease guidance, and case management for members with complex health needs B. Increase Customer Satisfaction - by prompt identification and resolution of dissatisfaction with administrative or medical processes and evaluation of processes for improvement when appropriate C. Improve Medical Safety -by fostering a supportive environment that helps providers to improve the safety of their practice, conducting continuous improvement activities devoted to improving SWHP pharmacy medication safety, and providing Members with information that improves their knowledge about clinical safety in their own care. D. Organizational Effectiveness - By achieving statistically significant improvements in HEDIS measurements and meeting or exceeding national averages E. Decrease Cost – through reducing the variations in clinical care and member services F. Meet the cultural and linguistic needs of the Membership by providing translators services, translated materials, cultural diversity educational offerings and a network that has multilingual providers External Delegation Credentialing/Recredentialing: The SWHP Board delegates responsibility for practitioner credentialing and recredentialing, including primary source verification, office site visits and maintenance of files to: The credentialing office of Physicians of King's Daughters P.A. for King’s Daughters’ physicians Shannon Clinic credentialing office for all Shannon physicians SW Medical Staff Office for Scott & White practitioners The credentialing office of the Regional Healthcare Alliance for Trinity Mother Frances practitioners (SWHP may conduct peer review and retains the right to approve, suspend and terminate individual practitioners, providers and sites when given reason to do so). For all other practitioners, primary source verification and file maintenance is delegated to MedAdvantage. Disease Guidance: Disease or Condition Guidance Programs (Health Coaching) for commercial and self-funded members have been delegated to Health Dialog, Inc. SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Program Structures The following committees support the Quality Improvement Program: See Attachment A for committee reporting structure 1. SWHP Board of Directors Role: acts as the Governing Body for the SWHP and is the driving force to insure quality and safety for Plan members. Meets quarterly. Composition: OfficersAlfred B. Knight, M.D., President Andrejs Avots-Avotins, M.D., Vice President Donald R. Grobowsky, Sec./Treas. DirectorsJeffrey Michael Hunter Janann Williams L. Ann Farris, PhD Louis Casey, Jr. Gail L. Peek Gabe Sansing Keifer Marshall, Jr. Garlyn O. Shelton Phil Scanio GovernorsLuther M. Brewer, M.D. Jesse D. Ibarra, Jr., M.D. C. David Morehead, M.D. Other OfficersAllan Einboden, Chief Executive Officer Marylou Buyse, M.D., Chief Medical Officer Function: Approves the QI Program Description, Work Plan, and Annual Evaluation Delegation responsibilities include: Delegates externally, credentialing/recredentialing decisions and oversight of verification as defined on the previous page. Delegates oversight of delegated credentialing activities to the SWHP Credentials Committee Delegates the peer review function and credentialing/recredentialing final approval of practitioners and providers, as applicable, to the SWHP Credentials Committee Delegates approval of the Health Plan credentialing policies and procedures to the SWHP Credentials Committee SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 2. SWHP Board Quality Improvement Committee (QIC) Role: The QIC is a sub-committee of the SWHP Board of Directors. Meets quarterly. Composition: Marylou Buyse, MD, Chief Medical Officer, Chairperson James Rohack, MD, SWHP Medical Director for System Improvement Mike Averitt, DO, Vice President-Medical Director Alfred Knight, MD, President and CEO L. Ann Farris, Ph.D., Board Member Gail L. Peek, Board Member Gabe Sansing, Board Member Allan Einboden, SWHP Chief Executive Officer Ex-Officio: Associate Vice President, Medical Services QI Director Healthcare Improvement Director Functions: Reviews and evaluates the QI Program Description, QI Work Plans, and the Annual Evaluation Reviews select monthly QI Sub-committee reports that delineate recommendations, actions taken and improvements made Ensures that the QI Program and Work Plan are implemented effectively and result in meaningful improvements in care, safety and service Approves the development and implementation of disease guidance programs 3. Quality Improvement Sub-committee (QIS) Role: Establishes strategic direction and monitors and supports the implementation of the QI Program and Work Plan throughout SWHP. The QIS is scheduled to meet monthly and is a multi-disciplinary committee. The Chairman of QIS is also the Chairman of the Board QIC and acts as a conduit for communications/activities between the two groups. All designated physicians have sufficient authority and time to devote to QI activities. Composition: Chief Medical Officer, Chair Vice President-Medical Director is Vice-Chair Medical Director for System Improvement Medical Director for Quality, SW Healthcare 2 Primary Care Physicians, Regional Representatives Behavioral Health Practitioner Chief Operations Officer Associate Vice President, Medical Services SW Senior Vice President, Quality and Safety Vice President Medical Delivery Development Quality Improvement Director Healthcare Improvement Director SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Utilization/Case Management Director Member Representative(s) Clinical Pharmacy Services Director SW President (Ex-officio) Medical Director, SW Clinic (Ex officio) Functions: Annually develops and oversees the QI Program Description and Work Plan Annually evaluates the effectiveness of the QI Program Receives, reviews, and analyzes status reports from quality subcommittees, including aggregate trend reports of clinical, safety, and service indicators, clinical studies, and member/provider satisfaction Reviews aggregated, trended reports focusing on variances, contributing causes, and appropriateness of action plans Evaluates data for quantitative and qualitative trends and variances especially as it relates to medical safety Promotes benchmarks and/or performance goals Identifies and analyzes SWHP quality activities, directs action plan(s) for improvement and evaluates outcomes of action plan implementation Directs the prioritization of SWHP quality improvement initiatives to ensure that resources are adequate Reports to the SWHP Board QIC Reviews the UM Program Description, UM Program Evaluation, and UM Criteria, annually. Oversees adoption of clinical practice guidelines and medical record standards Recommends disease guidance programs to the Board QIC and monitors effectiveness of programs Oversees the evaluations of approved delegated QI activities Reviews minutes of Safety Committee 4. Technology Assessment Committee Role: Develops recommendations for SWHP coverage of new, emerging and/or updated therapies, which are then referred for review by the SWHP Utilization Management Committee and approval by SWHP QIS. Results are then reported to the SWHP Board of Directors. Meets monthly, as needed, but not less than annually. Composition: SWHP Medical Directors SWMH) Chief Medical Officer SWHP Medical Director for System Improvement SWHP Associate Vice President - Medical Services SWMH Chief Nursing Officer/Chief Operating Officer SWMH Chief Nursing Executive and System Director of Quality, Safety and Regulatory Serv. SWHC- Round Rock Chief Medical Office SWHC Chief Medical Officer SWHC Associate Chief Medical Officer SWHC Chairman of Department of Medicine SWHC Chairman of Department of Orthopedic Surgery SWHC Chairman of Department of Surgery SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Hillcrest Baptist Medical Center Chief Medical Officer and Executive Vice President Scott & White Healthcare (SWHC) Chief Operation Officer SWHC Vice President Revenue Cycle Operations Hospital Division SWHC Vice President, Managed Care and Decision Support SWHC Chief Financial Officer SWHC Vice President, Pharmacy Services SWHC Director of Sourcing and Contracting Functions: Reviews/analyzes the literature review provided by the clinical participants regarding the topic of review Makes recommendations regarding SWHP coverage of the therapy under review, including any prior-authorization review criteria needed by the Plan Maintains minutes as documentation of the outcome of the assessments and determinations made Publishes outcomes of reviews to Practitioner(s)/Providers and/or Members as appropriate 5. SWHP Utilization Management Committee Role: Monitors for over and under-utilization. Summary and trend data are reported to the SWHP QIS. Meets Quarterly or as needed. Composition: Utilization/Case Management Director, Chair Chief Operating Officer Chief Financial Officer 3 Vice Presidents-Medical Directors Director-Claims Management Configuration Analyst III Configuration Analyst Director-Provider Relations Associate Vice President, Medical Services Medical Claims Director Utilization Manager Pharmacy Director Pharmacy Clinical Specialist Medical Analyst Functions: Analyzes utilization reports Determine if patterns of fraudulent billing exist Identifies opportunities for controlling utilization and/or for cost-savings Reviews/approves any UM policy and procedure issues SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 6. SWHP Credentials Committee Role: Performs all credentialing functions and oversight for all credentialing activities. Meetings are held monthly. Composition: SWHP Staff Medical Director of System Improvement, Chairman Chief Medical Officer, Vice-Chair 3 Vice President- Medical Directors Associate Vice President-Medical Director Network Members OB/GYN practitioner 3 Family Practice physicians (Northside in Temple, Caldwell & Waco) Surgeon Functions: Review credentialing and re-credentialing data for all network providers and practitioners who will be rendering care to SWHP enrollees Review and approve Credentialing Policies and Procedures, including performance criteria Perform Peer Review of providers who fail to meet the performance criteria and decide on appropriate action(s) Provide oversight of all delegated credentialing programs and activities Review applicants’ credentials and approves or denies the applications Medical Director is responsible for the day-to-day handling of feedback on network providers and complaints/grievances 7. SWHP Pharmacy and Therapeutics Committee Role: Oversees pharmacy issues. Reports to the SWHP QIS. Meets monthly, except during the months of July and December. Composition includes but may not be limited to: SWHP Vice President- Medical Director, Co-Chairman Bruce Kohler, MD, Co-Chairman At least seventeen (17) Physician Representatives (including Behavioral Health) Vice President of Pharmacy Services (SWMH) Vice President of Pharmacy Services (SWHP) Director of Pharmacy (Clinical) Administrative Director, Department of Pharmacy Director of Pharmacy (Inpatient Pharmacy Services) Director, Pharmacy Retail Operations B/CS Pharmacy Store Manager Clinical Pharmacy Administration, UT Representative Internal Medicine, UT Representative Clinical Specialist Ambulatory Care, Women’s Health Clinical Specialist Pediatrics 2 Clinical Pharmacy Specialists SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Functions: To develop and approve policies and procedures relating to the selection, distribution, handling, use, and administration of drugs for the Scott & White Health Plan (SWHP) approved providers. To develop an evidence-based formulary of drugs accepted for use in the institution and provide for its constant revision. To establish programs and procedures that help ensure cost-effective drug therapy. To participate in quality-assurance activities related to the distribution, administration and the use of medications. To oversee medication-use review programs and studies and review the results of such activities. To advise the pharmacy in the implementation of effective drug distribution and control procedures. 8. Cultural Diversity Committee Role: Oversees cultural diversity activities/issues. Determines if there are significant social or ethnic disparities in membership and develops action plans to address them. Reports to the SWHP QIS. Meets at least annually. Composition includes but may not be limited to: QI Director, chairperson QI Specialist QI Coordinator Representatives from: Finance/Underwriting Customer Advocacy Manager UM Manager 4 Marketing Regional Directors Marketing Administrative Services Manager Provider Relations Director Vice President-Medical Delivery Development Functions: Reviews and analyzes race/ethnicity and preferred language data, making recommendations to the Quality Improvement Subcommittee, as needed Monitors interpreter usage and Health Plan materials available in other than English Establishes programs, policies and procedures that address cultural diversity Review regulatory regulations and accrediting standards to ensure Health Plan compliance Identifies areas where there is ethnic or racial disparity in care provided Develops action plans to address one or more areas of disparity among minority groups in the network SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 9. Safety Committee Role: Oversees safety issues and investigates them across the network. Reports to the SWHP QIS. Meets Quarterly. Composition includes but may not be limited to: Vice President-Medical Director is Chair Chief Executive Officer Chief Financial Officer Chief Operations Officer Associate Executive Director, Health Services Provider Relations Director Assistant General Counsel QI Coordinator Functions: Review all safety issues Review complaints regarding safety Look for “never events”, falls, avoidable infections, adverse events and other clinical safety issues Directs the investigation of inappropriate or adverse outcomes; reports findings to decision making bodies for action The SWHP QI Program is also supported by the following Health Plan Departments/Divisions/Individuals: 1. SWHP Administration (Chief Executive Officer/Associate Executive Director) The CEO and/or designee supports the QI Program through oversight and participation in the SWHP QIC and QIS. The allocation of resources, attendance to multiple committees that support the QI Program, and formal reports to the Board are coordinated through Administration. 2. SWHP Quality Improvement Division SWHP QI Division’s major functions include but are not limited to those on Attachment B and the following: Provide staff support for QI initiatives, as needed Develop initial drafts of program documents for review and approval by the QIS Develop a QI Program Description and work plan identifying the responsibilities of operations that support program implementation, and provide direction to the regions for QI initiatives Formulate scheduled reports for external review agencies SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 3. Designated Participating Practitioners/ Behavioral Health Care Practitioner Designated participating providers and a behavioral health care practitioner serve on the QIS, crossfunctional operational and administrative committees, and other subcommittees. They advise QIS regarding the community’s standards of care and resources available. Designated participating providers also use their medical knowledge to assist SWHP to identify high risk, problem-prone aspects of care, and to recommend clinical priorities for monitoring and evaluation. The designated behavioral health care practitioner advises the QIS on behavioral health and related continuity of care issues. Other responsibilities may include: Review, evaluate, and make recommendations for credentialing and recredentialing files Review individual medical records reflecting adverse occurrences Review proposed practice guidelines and clinical protocols Review proposed QI study designs Participate in the development of action plans to improve levels of care, safety and service 4. Credentialing Offices and Credentialing Verification Organization SWHP delegates the primary source verification and administrative file function to the SWMH Medical Staff Office, MedAdvantage, Shannon Clinic Credentialing Office, Trinity Mother Frances Hospitals & Clinics Credentialing Office and the Physicians of King's Daughters P.A Credentialing Office. SWHP Credentials Committee, Quality Improvement Division and the Provider Relations Department are responsible for working with these credentialing offices to assure that all regulatory and accrediting standards are being followed. In addition to the above activities, the SWMH Medical Staff Office, Shannon Clinic Credentialing Office, Mother Frances Hospitals & Clinics Credentialing Office and the office of Physicians of King's Daughters P.A., are responsible for compliance with the Health Plan’s policies and procedures, including gathering all applications, and providing complete data regarding findings or decisions to the SWHP Credentials Committee for their review. SWHP QI Coordinator provides a monthly list of the practitioners and providers credentialed/ recredentialed to the Credentialing Committee. 5. Customer Advocacy Dept. This department is responsible for resolving customer service inquiries received over the phone, in the front lobby, and through the web page. The Customer Service Advocates are trained to own and resolve issues. The goal of the group is to provide one-stop resolution of member, employer, and provider inquiries including benefit inquiries, ID card issues, PCP changes, claim status inquiries, member education, and other assistance as needed. 6. Provider Relations/Contracted Networks The Director of Provider Relations assists Administration in the contracting functions and updating of provider manuals. This department provides support through participation in various QI/advisory committees. They provide on-site education of Health Plan processes and regulations for providers SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 and ongoing communication to providers and practitioners through newsletters (The Inside Story) and the Health Plan website (www.swhp.org). 7. Utilization/Chronic and Complex Care Guidance (Management) Under the direction of the Chief Medical Officer, medical directors, Associate Vice President, Medical and the Director of Utilization/Case Management, the SWHP Health Services Division performs utilization and care guidance functions. Routine reports that show physician profiling with HEDIS utilization parameters are evaluated and reported to UM Committee for tracking over/under utilization and to QIS and are used for credentialing/ recredentialing purposes. Continuing Care Coordinators implement the UM policies and procedures, including the gathering of data regarding adverse occurrences, which are reviewed by Vice Presidents-Medical Directors. The Vice Presidents-Medical Directors will decide if occurrences should be referred to Credentials Committee or Safety Committee. The Care Guidance program includes complex and chronic care guidance (management). The program objectives are to improve outcomes, provide education, assist with health system navigation and negotiate benefits. For details refer to Care Guidance Program Description. 8. Administrative Subcommittee This group is a subcommittee of the Board Executive Committee and is composed of the President of the Board and SWHP CEO, Vice Presidents-Medical Directors, and operational leaders. Meetings are weekly or as needed. Functions: Serves as the primary operations committee for management discussion of cross functional issues which impact the Health Plan; establish policy, including perceived benefit shortcomings, customer service problems, access problems, member survey summaries, and logistical problems related to network arrangements Involved in the development and implementation of privacy/confidentiality policies and mechanisms to oversee their application, including levels of user access and mechanisms to limit access to personal health information (PHI) Reviews practices regarding the collection, use and disclosure of PHI 9. Risk Management Risk management is a function of the Scott & White integrated system. A SWHP Vice PresidentMedical Director participates with the SW system Risk Management Department and reviews potential risk management concerns. SWHP Continuing Care Coordinators and QI Coordinators may identify potential risk management cases through concurrent or retrospective reviews. Claims review nurses and the Utilization/Claims Management Group review claims data for potential fraud and abuse in billing practices. Any identified risk management cases are brought to the attention of the Risk Management Department, the medical directors, and/or administration. 10. Marketing The Marketing Division Account Representatives work with their employer group contacts/HR Directors to assess members’ needs and to improve services. They provide program information to SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 members and employers as requested regarding the existing and proposed member benefits, general guidelines and limitations of the contract, and rates. They help inform the membership and employers about preventive health services offered by the Plan. 11. Resources Staffing: SWHP QI division is staffed with a QI Manager, Research Scientist I, QI Coordinators, Quality Data Specialists, a Quality Analyst, a Health Risk Coordinator, and secretarial support. The Chief Medical Officer leads the division, with assistance from the QI and Healthcare Improvement Directors. Data: SWHP utilizes AMISYS software as a Claims Payment system, as well as, a membership and provider database. There is network support for the employees of the Plan, including access to the Internet. The SWHP utilizes external vendors to assist with the HEDIS reporting and the CAHPS survey. The SWHP Pharmacy system has its own network and a relationship with an external vendor that is able to provide member, physician, and drug utilization data. SW Medical Information Service assists at intervals as a benefit to the Plan through the system integration. Analytic Capabilities: SWHP QI Coordinators have access to statistical software, SPSS, and are trained in statistical principles. Many other statistical resources are within the SW system such as the Biostatistics Department. The Research Scientist uses SAS software for statistical analyses. 12. Quality Training Quality education may include formal classroom, “just in time” training and/or the Quality Improvement Internet/Intranet sites. Presentation topics are based on participants’ feedback and recommendations. Quality Improvement Process: The improvement effort follows the Continuous Improvement Cycle Identify Customer Needs/Expectations Measurement Implement Improvement Plan Do Act Check SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 QI Work Plan SWHP develops a QI Work Plan annually. The Work Plan covers the scope of the QI Program and includes: Written measurable yearly objectives for the quality and safety of clinical care and quality of service activities scheduled, including Behavioral Health improvement initiatives Yearly objectives and planned activities, time frames for achieving, and those responsible Monitoring of previously identified issues Schedule for evaluation of the QI Program Disease Guidance Programs See Attachment C Quality Improvement Annual Evaluation An annual written evaluation of the QI Program is submitted to the QIS, Board QIC and the SWHP Board of Directors and is the basis for the upcoming year’s work plan. The QI evaluation includes: Description of completed and ongoing QI activities that address quality and safety of clinical care and quality of service, including delegated functions. Trending of quality and safety measures and comparison with established thresholds Analysis of whether there has been demonstrated improvements, including barrier analysis when goals are not met. Analysis is conducted with participation of staff who have direct experience with the processes that have presented barriers to improvement. Evaluation of the overall effectiveness of the program includes progress toward influencing network-wide safe clinical practices, adequacy of resources, committee structure, practitioner participation, leadership involvement and any determination of restructure or change(s) to be made for the subsequent year, based on findings. Confidentiality Confidentiality is the responsibility of every SWHP employee. Upon being hired, every new employee is informed of our Confidentiality policies and guidelines during New Hire Orientation and the departmental orientation. The policies are also available in the Employee Handbook, Corporate Compliance Handbook, and on the Intranet. Unauthorized access, discussion, or release of patient or other confidential information may result in disciplinary action up to, and including, termination of employment. Confidentiality expectations continue after termination of employment with Scott & White Health Plan. Access to files (manual and computerized) is provided with a security clearance at the time of employment and revoked formally at the time of termination. Staff are expected to report violations or possible violations of patient confidentiality to their supervisor, Human Resources, or the Compliance Hotline (1-888-800-1096) for investigation and appropriate follow-up actions. The Plan provides a section in the member contract regarding the Plan’s commitment to confidentiality regarding accessing information and the use of that information. (See SWHP Health Care Agreements, Page 14-1, Confidentiality.) Members of the QIS demonstrate their commitment to privacy by signing a confidentiality statement. SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Approval: SWHP Board of Directors, Chair Date SWHP President and Chief Executive Officer Date QIS Chairperson Date SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Attachment A Quality Improvement Committees Reporting Structure SWHP Board of Directors Delegation (Governing Body) SWHP Board QI Committee (Oversight) Policies Only SWHP QI Subcommittee (Working) SWHP Pharmacy & Therapeutics Committee Medication Safety Council SWHP Credentials Subcommittee SWHP Complaint & Appeals Process SWHP Technology Assessment Committee SWHP UM Committee SWHP Retail Pharmacy Medication Safety Team Network Issues Committee Cultural Diversity Committee Safety Committee Reporting Reporting/Approval SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Attachment B SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 Attachment C Basic Disease guidance Scott & White Health Plan (SWHP) Basic Disease guidance programs actively intervene to help members with chronic diseases such as Asthma, Diabetes, Coronary Artery Disease, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease and Hypertension. The basic disease guidance programs include the following: Condition monitoring Patient adherence to the program’s treatment plans Consideration of other health conditions Lifestyle issues, as indicated by practice guidelines Members may be identified using one or more of the following methods: Claim or encounter data Pharmacy data, if applicable Health risk appraisal results Laboratory results, if applicable Data collected through the Utilization Management or case management process Member and practitioner referrals Eligible members are provided with information about the program that includes use of services, how members become eligible to participate and how to opt-in or opt-out. Program interventions are based on stratification and assessment. At least annually, satisfaction with the Basic Disease Guidance Programs is measured and participation rate is reported to the Quality Improvement Subcommittee. Program effectiveness is evaluated by measuring at least one area of performance for each disease guidance program Network Practitioners are provided with written information about the program including instructions of how to use disease guidance services and how the organization works with practitioner’s patients in the program. SWHP strives to integrate information for continuity of care from the following: Health Information and Nurse Advice Line Disease Guidance Program Case Management Program Utilization Management Program Wellness Program Care Disease/Condition Care Guidance Programs These programs address 65 different diseases and conditions and are available to Scott & White Health Plan commercial members. Participants are identified through medical & RX claims data, health risk assessments, physician referrals, alternate levels of care, self-referrals, diagnosis, ER SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 utilization, lab/diagnostic data and/or predictive modeling. Members are contacted by registered nurses, licensed practical nurses, dieticians, respiratory therapists, social workers, and health educators. Individualized support is given to members to help them discuss their treatment options with their physicians and/or manage their condition. Health coaches provide health care system navigation support, including how to best use the services available to them. Scott & White Health Plan Provider Manual Section 2 Medical Records Standards Policy QI 13 Attachment 1 SCOTT AND WHITE HEALTH PLAN MEDICAL RECORD REVIEW STANDARDS Initial Adoption Date: February 1995; Revision Dates: January 2001, September 2002, September 2003, March 2007; Reviewed Dates: November 2008 The Scott & White Health Plan Quality Improvement Sub-Committee has adopted the following Standards for written or electronic medical records: Medical Record Documentation 1. All services provided directly by a PCP. 2. There is evidence of all ancillary services and diagnostic tests ordered by a practitioner. 3. There are reports of all diagnostic and therapeutic services for which a member was referred by a practitioner such as: -Home Health Nursing Reports -Specialty Physician Reports -Physical Therapy Reports -Hospital Discharge Summaries -Other 4. History and physicals are included in each medical record. History includes past medical, surgical and substance abuse (tobacco, alcohol, and/ or other substances for 14 years and older). 5. Allergies and adverse reactions are included in each medical record. If the patient has no known allergies or history of adverse reactions, this is noted in the record. 6. The record contains a problem list. 7. The record includes medications. 8. There is documentation of clinical findings and evaluation for each visit. 9. Preventive services / risk screening are included in each medical record (at least immunizations). Confidentiality and Organization / Availability of Medical Record 10. The Staff receive periodic training in confidentiality of member information. 11. Records are organized and stored in a manner that allows for easy retrieval. 12. Records are stored in a secure manner that allows access by authorized personnel only. C:\Temp\GWViewer\MR RevStds 11-08.docx Scott & White Health Plan Provider Manual Section 3: Clinical Practice and Preventive Health Guidelines All Scott & White Health Plan guidelines are available at the following: 1. Internet: On‐line Provider Manual – www.swhp.org. Click on “Providers” green tab. Click on “Quality Improvement”. Click on “Clinical Guidelines”. 2. A paper copy is available upon request from the Scott & White Provider Relations Department. Call toll free 1‐800‐321‐7947 ext. 3064 or 254‐298‐3064. Scott & White Health Plan Provider Manual Section 3A: Tier 2 Clinical Practice Guidelines Tier #2: Address the management of a disease process managed by multiple organizational units or departments. OSTEOPOROSIS GUIDELINE Recommend to patient: Purpose: To recommend management of osteoporosis Patient Population: Women age 50 and over and men age 70 and over. Developed by: Veronica Piziak, MD PhD Endocrinology Endorsed by: Scott and White Health Plan Quality Improvement Subcommittee Adopted: 1998. Revised: 10/2000, 8/2002, 9/2003, 11/2007, 01/2008, 03/2008, 04/2010, 04/2012 Reviewed: 04/2012, Next Scheduled Review Date: 04/2014 Calcium 1,200mg to 1,500mg per day (may need supplement). Vitamin1 D3 800 to 1,000 IU per day (may need supplement). Encourage weight-bearing and muscle-strengthening exercises. Discontinue tobacco use, excess alcohol (if applicable). Patient has had a vertebral, hip, or fragility fracture and is not currently on prescription treatment. 2 Yes No Get baseline measurement of BMD for monitoring purposes. Yearly perform one of the following: 4 Is patient postmenopausal Screen for secondary - Fracture Risk Assessment (FRAX) or 5 - Osteoporosis Risk Assessment (ORAI) with assessment for secondary causes for osteoporosis. 8 One of the following is indicated: Yes Is patient? - Woman 65 years or older. - Man 70 or older. No - Alendronate 70mg per wk. - Risedronate 35mg wk. Assess yearly: If intolerant, consider: - Denosumab 60 mg sub q every 6 months - Ibrandronate sodium intravenous 3 mg every 3 months. 7 - Zoledronate 5 mg yearly. PTH (1-34) - Risks versus benefits acceptable to patient. - Bone protective doses Continue yearly assessments Osteoporosis Osteopenia 3 Continue yearly assessments and recommendations. Yes No Get baseline BMD measure- Normal Intolerant Yes No Screen for secondary causes. 8 Frax calculation = 20% risk of osteoporotic fracture or hip fracture risk 3%. One of the following: - Alendronate 35mg per wk - Risedronate 35mg wk One of the following: 8 - Alendronate 70mg per wk - Risedronate 35mg wk 3 If intolerant, consider : - Zoledronic acid 5 mg IV yearly . 7 - Ibrandronate sodium intravenous 3 mg every 3 - Raloxifene 60mg - Calcitonin (nasal spray or injectable). Continue present therapy. Follow-up recommendations: - Yearly assessment of patient's persistence of therapies (i.e. continued use of medications, supplements and life-style modifications). Encourage compliance. - Consider follow-up BMD in 1 to 5 years as guided by medical necessity, expected response. - If hip fracture occurs on bisphosphonates OR > 5 years use consider medication 3 change to PTH 1-34. 3 If intolerant, consider : - Zoledronic acid 5 mg IV yearly - Raloxifene 60mg per day - Ibrandronate sodium intravenous 3 mg every 3 months. 7 months . - Denosumab 60 mg sub q every 6 months, then the other three options in the box. - PTH (1-34) - Raloxifene 60mg per day - Calcitonin (nasal spray or injectable) Follow-up recommendations: - Yearly assessment of patient's persistence of therapies (i.e. continued use of medications, supplements and life-style modifications). Encourage compliance. - Consider follow-up BMD in 1 to 5 years as guided by medical necessity, expected response. - If hip fracture occurs on bisphosphonates OR > 5 years use consider medication 3 change to PTH 1-34 . 1 Vitamin D3 = cholecalciferol. 2. NCQA/HEDIS measure women 67 or older who have had a fracture (and no BMD or treatment for osteoporosis) will have BMD or prescription treatment within 6 months of fracture. 3. Consider Endocrinology consult. 4. Tool developed by World Health Organization (WHO) and recommended by the National Osteoporosis Foundation (NOF) for risk assessment. Online calculator or paper version can be found at http://www.shef.ac.uk/FRAX/. 5. The Osteoporosis Risk Assessment Instrument (ORAI) is a 3-item tool that uses age, body weight, and current use of estrogen therapy to assess individual risk. Should be combined with a review for secondary causes. This tool is suggested by U.S. Preventive Service Task Force (USPSTF) (http://www.ahrq.gov/clinic/3rduspstf/osteoporosis/osteorr.htm). 6. NOF, in agreement with USPSTF recommendations for postmenopausal women, recommends testing of all women age 65 and older and men age 70 and older. 7. IV bisphosphonates are only funded by Medicare if patient is intolerant of oral bisphosphonates. Denosumab is funded by Medicare for postmenopausal patients with osteoporosis at high risk for fracture and in males with osteopenia or osteoporosis using androgen deprivation therapy. 8. After 5 years of bisphosphonate treatment, patients should be encouraged to discuss the risks and benefits of further treatment with their personal physician. For health plan formulary questions: Phone (800) 344-2301. E-mail [email protected] Sources: National Osteoporosis Foundation, World Health Organization, U.S. Preventive Service Task Force (USPSTF), Division of Endocrinology. Scott and White Health Plan Treatment Guidelines for Hypertension Contact Person: Cheryl Laffer, M.D./Paul Godley, Pharm. D. Approved: 10/14/2003 Reviewed: 10/2005; Revised 12/2007, 11/2009, 9/2011, 5/2012 Source: National Heart, Lung and Blood Institute (Adapted from JNC VII). Developed by: Scott and White Physicians, Pharmacists, and reviewed by P & T Committee members Algorithm for the Treatment of Hypertension Classification of Blood Pressure (BP) Category Life Style Modifications Not at Goal Blood Pressure (<140/90 mmHg) (<130/80 mmHg for patients with diabetes, chronic kidney disease, CAD, high risk for CAD and stable angina; <125/80 for patients with LV sys. Dysfunction) Initial Drug Choices Without Compelling Indications With Compelling Indications Assessment for Major Cardiovascular Disease (CVD) SBP DBP mmHg** Normal < 120 mmHg** and <80 Pre-hypertension * 120-139 or 80-89 Hypertension, Stage 1 140-159 or 90-99 Hypertension, Stage 2 > 160 or > 100 *Lifestyle Modification and drug therapy **SBP = systolic blood pressure; DBP = diastolic blood pressure Suggested Therapy based on Compelling Indications Stage 1 Hypertension (SBP 140-159 or DBP 90-99 mmHg) Stage 2 Hypertension (SBP >160 or DBP > 100 mmHg) Thiazide-type diuretics for most. May consider ACEI, ARB, BB, CCB, or combination. 2 drugs required for most (Usually thiazide-type diuretics and ACEI, ARB, BB, CCB.) Drug(s) for the compelling indications (See Compelling Indications for Individual Drug Classes) Other antihypertensive drugs (diuretics, ACEI, ARB, BB, CCB) as needed. Not At Goal Blood Pressure Compelling Indication Initial Therapy Options Heart Failure THIAZ, BB (carvedilol, metoprolol succinate or bisoprolol) ACEI, ARB, ALDO-ANTAGONIST (hydralazine/ISDN for blacks) Post myocardial infarction BB, ACEI, ALDO -ANTAGONIST High CVD risk THIAZ, BB, ACEI, CCB Diabetes ACEI, ARB, THIAZ, BB,CCB Chronic kidney disease ACEI, ARB Recurrent stroke prevention THIAZ, ACEI Optimize dosages or add additional drugs until goal blood pressure is achieved. Consider consultation with hypertension specialist. JNC VII (The Seventh Report of the Joint National Committee on Prevention,Detection, Evaluation, and Treatment of High Blood Pressure) encourages providers to focus attention on those individuals with pre-hypertension blood pressure and to prevent them from progressing to hypertension. Bold=First Choice therapy unless contraindicated Hypertension Physical inactivity Obesity (body mass index> 30 kg/m2) Micro albuminuria estimated glomerular filtration rate < 60 ml/min Dyslipidemia Age (>55 for men, >65 for women) Diabetes mellitus Family history of premature CVD (men age <55, women age <65) Lifestyle Modification Recommendations Modification Recommendation Weight reduction Maintain normal body weight (body mass index 18.5-24.9 kg/m2). DASH eating plan Adopt a diet rich in fruits, vegetables, and lowfat dairy products with reduced content of saturated and total fat. 8-14 mmHg Dietary sodium reduction Reduce dietary sodium intake to < 1500 mg per day ( 1.5gsodium or 3.75gsodium chloride). 4-9 mmHg Tobacco cessation Advise tobacco user to quit, discuss cessation medications and cessation strategies unknown Aerobic physical activity Regular aerobic physical activity (e.g., brisk walking) at least 30 minutes per day, most days of the week. 4-9 mmHg Moderation of alcohol consumption Men: limit to < 2 drinks* per day. Women and lighter weight persons: limit to < 1 drink* per day. 2-4 mmHg Avg. SBP Reduction Range 5-20 mmHg/10kg * 1 drink = 1/2 oz or 15ml ethanol (e.g., 12 oz beer, 5 oz wine, 1.5 oz 80-proof whiskey). ACEI’s benazepril captopril enalapril fosinopril lisinopril ramipril1 Combination Antihypertensives $$ $$ $ $ $ $$$ Angiotensin Receptor Blockers Benicar®* $$$ Losartan $$ Diovan®*(generic release expected 3Q 2012) $$$$ Beta Blockers acebutolol (b1) atenolol (b1) betaxolol (b1) bisoprolol (b1) carvedilol (α, b1, b2) propranolol SR (b1, b2) $$$$$ $ $$$ $$ $$$ $$$$$ labetalol (α, b1, b2) metoprolol succinate (Toprol XL)(b1) metoprolol tartrate (bl) nadolol (b1, b2) $$$$ $$ pindolol (b1,b2) propranolol (b1,b2) $$$$ $ timolol (b1, b2) sotalol (b1, b2) $ $$$$ $$$ $$$$$$ Alpha or α, b1, b2 indicate beta receptor amlodipine/ benazepril atenolol/ chlorthalidone benazepril /HCTZ Benicar HCT®* bisoprolol/ HCTZ captopril/ HCTZ clonidine/ chlorthalidone nadolol/ bendroflumethiazide Diovan HCT®* enalapril/ HCTZ Exforge®* Exforge HCT®* fosinopril/ HCTZ Losartan/HCTZ $$ lisinopril/ HCTZ methyldopa/HCTZ metoprolol/ HCTZ propranolol/ HCTZ Tekturna-HCT®* Alpha Blockers doxazosin prazosin terazosin $$ $$ $$ $$$ $$$ $$$$ $$ $$ $$$$$ $$ $$$ $$$ $$ $$ $$ $$ $$ $$$ $ $ $ Hypertension in Pregnancy hydralazine $$ labetalol (alpha, b1, b2) $$$$ methyldopa $$ Other Agents Diuretics Thiazidechlorthalidone HCTZ metolazone $ $ $ $$ minoxidil Tekturna®* $$ $$$ Peripheral reserpine $ Central Indolines indapamide Clonidine transdermal system $$ Loop bumetanide furosemide torsemide Potassium-sparing amiloride spironolactone spironolactone/ HCTZ triamterene/ HCTZ $$ $$$$$ $$$$ $$ $$ $ $$ Calcium Channel Blockers Dihydropyridine amlodipine $$ $$ nifedipine XL $$$$$$ $ felodipine SR $$$ Combination amiloride/ HCTZ clonidine guanabenz guanfacine methyldopa $$$$ Non-Dihydropyridine $$ $ $ diltiazem verapamil *Available in Brand Only as of 11/2009 $=At least $10 in wholesale cost 1 In the HOPE trial, ramipril titrated to 10mg QD was shown to decrease macrovascular events in normotensive individuals. Heart Outcomes Prevention Evaluation Study Investigators. Lancet 2000; 355:253-9. (Texas Diabetes Council Hypertension Algorithm for Diabetes) $$ $$ Chronic Obstructive Pulmonary Disease (COPD) Guideline Tier 2 Guideline Purpose: To provide treatment recommendations to Primary Care Physicians and Specialists for COPD patients. Patient Population: Members aged 40 years or older, diagnosed with COPD, based on hospital and ED utilization. Intervention determined by stratification (mild, moderate, severe, very severe). Date of Adoption: November, 2009 Revision Dates: Contact Physician: Dr. Shirley Jones, Scott & White Pulmonary Medicine For diagnosis and staging, spirometry is needed. Therapy At Each Stage of COPD Stage IMild Stage IIModerate Stage IIISevere Stage IVVery Severe FEV1/FVC<70% FEV1>80% predicted FEV1/FVC<70% 50%<FEV1<80% predicted FEV1/FVC<70% 30%<FEV1<50% predicted FEV1/FVC<70% FEV1<30% predicted OR FEV1<50% predicted plus chronic respiratory failure Avoidance of risk factor(s); smoking cessation, influenza vaccination Add short-acting bronchodilator when needed Add regular treatment with one or more long-acting bronchodilators (when needed); Add rehabilitation Add inhaled glucocortico steroids if repeated exacerbations Add long-term oxygen if chronic respiratory failure; consider surgical treatments Tier 2 Guideline Management of Major Depressive Disorder, Non-Psychotic Acute Phase Date of Adoption: March, 2001 Revision Dates: 02/2003, 09/2004, 08/2006, 11/2008, 10/2010 Reviewed: 12/2012 Contact Physician: Dr. Virginia Maxanne Flores, MD; S&W Department of Psychiatry Depressed Patient Acute Phase Treatment Practitioner Contact Recommendations Three patient contacts in the 12 week period. Suicide risk? Bipolar? Psychotic or history of psychosis? History of ECT? Alcohol or Drug Dependence? Other Complicating Factors or Co-Morbid Psychiatric Issues (e.g., eating disorders, school phobia)? No Major Depression? Consider referral to Behavioral Health specialist Yes Yes 1) Due to General Medical Condition? 2) Medicationinduced? Yes (1) Treat General Medical Condition (2) Reconsider Medications No If adolescent/child, individual & family psychotherapy is required. Prior Major Depression? Patient improves? No No Monotherapy of Depression a) Prior effective agent b) SSRI c) Wellbutrin, Effexor, Remeron or Cymbalta d) Tricyclic (with pain) Yes Yes No Options: a) Psychotherapy b) Empirical Medication trial c) Monitor Good Response? (Remission within 4 to 6 weeks) Yes Enter Continuation Phase No Options 1. Refer to Psychiatry 2. Continue Monotherapy of Depression 3. Change to a different agent Good Response? (Remission within 4 to 6 weeks) No Is patient Improved? Yes Page 1 of 2 Treatment Ends No Refer to Psychiatry Yes Developed by physicians from the Departments of Psychiatry, Family Medicine, and Internal Medicine and by Health Integrated. Based on best practice recommendations of the Agency for Healthcare Research and Quality (AHRQ) and the Texas Algorithm Project. (See page 2 for Continuation and Maintenance Phases) Tier 2 Guideline Management of Major Depressive Disorder, Non-Psychotic Continuation and Maintenance Phases Date of Adoption: March, 2001 Revision Dates: 02/2003, 09/2004, 08/2006, 11/2008, 10/2010 Contact Physician: Dr. Virginia Maxanne Flores, MD; S&W Department of Psychiatry Developed by physicians from the Departments of Psychiatry, Family Medicine, and Internal Medicine and by Health Integrated. Based on best practice recommendations of the Agency for Healthcare Research and Quality (AHRQ) and the Texas Algorithm Project. Enter Continuation Phase Continuation Phase Treatment Recommendations 1. Medication duration: 6 - 9 months after completion of the acute phase of treatment . (Acute + Continuation =total of 9 to 12 months of treatment) 2. Practitioner Contacts: Evaluate at least once every 3 months during continuation treatment (preferably 1-2 months) Continued Good Response? Yes Evaluate for Maintenance Phase: (1) 3 or more episodes, or (2) 2 episodes, with -family history -recurrence in 1 year after stopping Tx -family history, Major Depressive Disorder -early onset, (before age 20) -severe, sudden, life-threatening episode within 3 years or (3) other factors judged by clinician No Are Criteria met? Yes Return to Acute Phase No For initial episodes of Depression (1) Taper and discontinue over 2-3 months (2) And then follow every 2 to 4 months for 8 months Treatment Ends Page 2 of 2 Maintenance Continue at full doses. Duration may be: a) 1 year b) 2 to 5 years c) Lifetime Scott and White Health Plan-Tier 2 Guideline Treatment Algorithm for Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents for Use in Primary Care (Without Co-morbidities) Adopted : 6/16/99 Last Revised: 9/2001, 11/2002, 11/2004, 01/2005, 01/2006, 08/2006, 12/2006, 08/2008, 08/2010, 08/2012 Population: Patients 18 yr. or younger Contact Physician: John Q. Thompson, Jr., DO Table 3 Me dication methylphenidate IR (Ritalin®, Methylin®) dextroamphetamine(Dexed rine®, DextroStat®) dexmethylphenidate (Focalin®) methylphenidate SR (Ritalin-SR®) methylphenidate ER (Meta date®,ER, Methylin® ER ) methylphenidate ER (Meta date® CD) methylphenidate LA (Ritalin® LA) a mphetamine-dextroamphetamine (Add erall® ) dextroamphetamine spansule (Dexedrine® Spa nsu le®) methylphenidate ER (Con ce rta®) a mphetamine-dextroamphetamine XR (Adderall XR®) a tomoxetine (Strattera®) dexmethylphenidate XR (Fo calin ® XR) methylphenidate transderma l patch-extended rele ase (Daytrana™ Transderma l Patch) Should wear 9 hours with effects lasting for 3-4 hours a fte r re moval of pa tch. lis dexa mfetamine dimesylate (Vyvanse™) * LEGEND MAS-Mixed Amphetamine Salts DEX-Dextroamphetamine NICHQ-National Initiative for Children’s Healthcare Quality For mular y Effect D uration in Hours Yes Yes No Yes No 3-6 1-6 6 8 8 Yes Yes Yes Yes 8 1 0-12 4-6 6-8 Yes Yes 12 12 Yes No Yes 24 8-12 9 Yes 12 Table 4 Alternative Non-Stimulant Medica tions (to be conside red after failure of s tages 1-3) buproprion (We llbutrin®) gua nfacine (Tenex®) - short-acting gua nfacine (Intuniv®) - long-acting c lonidine (Catapres®) Exc ept for guanfacine (Intuniv ®) - long-acting, these are not FDA indicated for the treatment o f ADHD; but Child & Adolesce nt Psychiatry may consider th ese four a lternatives if the p atient needs combination therapy or a longer duration of action, has adverse events from stimulan ts or has co-morbid conditions which require them. These medications are generally u sed more often by Child and Adolesce nt Psychiatrists or Developmen tal Be havior Ped iatricians. Source: American Academy of Child and Adolescent Psychiatry (AACAP, 2006), The Texas Children’s Medication Algorithm Project, and the American Academy of Pediatrics (AAP, 2001). Developed by: Physicians from the Departments of Psychiatry & Pediatrics, Health Integrated; and the clinical Pharm D Staff. Reviewed and Approved by: Members of the Quality Improvement Sub-committee. ** HEDIS® is a registered trademark of the National Committee for Quality Assurance (NCQA). L:\QI\NCQA\Clinical Guidelines\Current Tier 2 INTER dept\ADHD\Current stuff\ADHD for Approval Aug 2012.docx Asthma Guidelines Developed by: SWHP Asthma Intervention Team Contact Person: Felix R. Shardonofsky, M.D. Source: NHBLI Practical Guide for the Diagnosis & Management of Asthma Adopted: SWHP Quality Improvement Committee 11/12/2002: Revision/Approval: Quality Improvement Subcommittee 10/04, 10/06, 9/12/2008, 8/10, 10/12 STEPWISE APPROACH FOR MANAGING ASTHMA IN CHILDREN 0 –4 YEARS OF AGE Persistent Asthma: Daily Medication Intermittent Asthma Consult with asthma specialist if step 3 care or higher is required. Consider consultation at step 2. Step 6 Step 5 Preferred: Preferred: Step 4 Preferred: Step 3 Step 2 Step 1 Preferred: SABA PRN Preferred: Low-dose ICS Preferred: Medium-dose ICS Medium-dose ICS + either LABA or Montelukast High-dose ICS + either LABA or Montelukast High-dose ICS + either LABA or Montelukast Oral systemic corticosteroids Alternative: Montelukast Step up if needed (first, check adherence, inhaler technique, and environmental control) Assess control Step down if possible (and asthma is well controlled at least 3 months) Patient Education and Environmental Control at Each Step Quick-Relief Medication for All Patients SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms. With viral respiratory infection: SABA q 4–6 hours up to 24 hours (longer with physician consult). Consider short course of oral systemic corticosteroids if exacerbation is severe or patient has history of previous severe exacerbations. Caution: Frequent use of SABA may indicate the need to step up treatment. See text for recommendations on initiating daily long-term-control therapy. Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. ICS, inhaled corticosteroid, LABA, inhaled long-acting beta2-agonist; SABA, inhaled short-acting beta2-agonist Notes: The stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs. If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. If clear benefit is not observed within 4–6 weeks and patient/family medication technique and adherence are satisfactory, consider adjusting therapy or alternative diagnosis. Studies on children 0–4 years of age are limited. Step 2 preferred therapy is based on Evidence A. All other recommendations are based on expert opinion and extrapolation from studies in older children. 1 STEPWISE APPROACH FOR MANAGING ASTHMA IN CHILDREN 5-11 YEARS OF AGE Persistent Asthma: Daily Medication Intermittent Asthma Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Step 6 Step 3 Step 1 Preferred: SABA PRN Step 2 Preferred: Lowdose ICS Alternative: LTRA or Theophylline Preferred: EITHER: Low-dose ICS + e i the r LABA , LTRA, or Theophylline or Medium-dose ICS Step 4 Preferred: Medium dose ICS + LABA Alternative: Medium-dose ICS + either LTRA or Theophylline Preferred: Step 5 Preferred: High- High-dose ICS + LABA + oral dose ICS + LABA systemic corticosteroid Alternative: Alternative: High-dose ICS + High-dose ICS + either LTRA or either LTRA or Theophylline Theophylline + o ra l sys te m i c corticosteroid Step up if needed (first, check adherence, inhaler technique, environmental control, and comorbid conditions) Assess control Each step: Patient education, environmental control, and management of comorbidities. Steps 2−4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma (see notes). Quick-Relief Medication for All Patients: SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20 –minute intervals as needed. Short cause of oral systemic corticosteroids may be needed. Caution: Increasing use of SABA or use >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment. Step down if possible (and asthma is well controlled at least 3 months) Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. ICS, inhaled corticosteroid; LABA, inhaled long-acting beta2-agonist, LTRA, l eukotriene receptor antagonist; SABA, inhaled short-acting beta2-agonist Notes: The stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs. If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. Theophylline is a less desirable alternative due to the need to monitor serum concentration levels. Step 1 and step 2 medications are based on Evidence A. Step 3 ICS + adjunctive therapy and ICS are based on Evidence B for efficacy of each treatment and extrapolation from comparator trials in older children and adults— comparator trials are not available for this age group; steps 4–6 are based on expert opinion and extrapolation from studies in older children and adults. Immunotherapy for steps 2–4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults. Clinicians who administer immunotherapy should be prepared and equipped to identify and treat anaphylaxis that may occur. 2 USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS IN CHILDREN* Dosage Medication Form Inhaled (ICS) Corticosteroids Systemic Corticosteroids Methylprednisolone 2, 4, 8, 16, 32 mg tablets Prednisolone Prednisone 5 mg tablets, 5 mg/5 cc, 15 mg/5 cc 1, 2.5, 5, 1 0, 20, 50 mg tablets; 5 mg/cc 5 mg/5 cc 0-4 years 0.25–2 mg/kg daily in single dose in a.m. or qod as needed for control Short-course “burst”: 1–2 mg/kg/day, maximum 60 mg/day for 3– 10 days 5-11 years 0.25–2 mg/kg daily in single dose in a.m. or qod as needed for control Short-course “burst”: 1–2 mg/kg/day, maximum 60 mg/day for 3– 10 days Long-Acting Beta2-Agonists (LABAs) Salmeterol Formoterol DPI 50 mcg/ blister DPI 12 mcg/ single-use capsule Long-Acting Beta2-Agonists (LABAs) Safety and efficacy not established in children <4 years Safety and efficacy not established in children <5 years Comments 1 blister q 12 hours (Applies to all three corticosteroids) • For long-term treatment of severe persistent asthma, administer single dose in a.m. either daily or on alternate days (alternate-day therapy may produce less adrenal suppression). • Short courses or “bursts” are effective for establishing control when initiating therapy or during a period of gradual deterioration. • There is no evidence that tapering the dose following improvement in symptom control and pulmonary function prevents relapse. Patients receiving the lower dose (1 mg/kg/day) experience fewer behavioral side effects (Kayani and Shannon 2002), and it appears to be equally efficacious (Rachelefsky 2003). For patients unable to tolerate the liquid preparations, dexamethasone syrup at 0.4 mg/kg/day may be an alternative. Studies are limited, however, and the longer duration of activity increases the risk of adrenal suppression (Hendeles 2003) • Should not be used for symptom relief or exacerbations. Use only with ICSs. Should not be used alone –use in combination with an asthma controller medication. Decreased duration of protection against EIB may occur with regular use. • Most children <4 years of age cannot provide sufficient inspiratory flow for adequate lung delivery. Do not blow into inhaler after dose is activated. Most children <4 years of age cannot provide sufficient inspiratory flow for adequate lung delivery. • Each capsule is for single use only; additional doses should not be administered for at least 12 hours. Capsules should not be taken orally. • Should not be used for symptom relief or exacerbations. Use only with ICSs. *Dosages are provided for those products that have been approved by the U.S. Food and Drug Administration or have sufficient clinical trial safety and efficacy data in the appropriate age ranges to support their use. 3 USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS IN CHILDREN* (CONTINUED) Medication Dosage Form Combined Medication Fluticasone/ Salmeterol DPI 100 mcg/ 50 mcg 0–4 years Safety and efficacy not established in children <4 years 5–11 years Comments 1 inhalation bid • • • There have been no clinical trials in children <4 years of age. Most children <4 years of age cannot provide sufficient inspiratory flow for adequate lung delivery. Do not blow into inhaler after dose is activated. There have been no clinical trials in children <4 years of age. Currently approved for use in youths ≥12. Dose for children 5–12 years of age based on clinical trials using DPI with slightly different delivery characteristics (Pohunek et al. 2006; Tal et al. 2002; Zimmerman et al. 2004). Montelukast exhibits a flat dose- • • Budesonide/ Formoterol HFA MDI 80 mcg/4.5 mcg Safety and efficacy not established 2 puffs bid Leukotriene Receptor Antagonists (LTRAs) Montelukast 4 mg or 5 mg chewable tablet 4 mg granule packets Zafirlukast 10 mg tablet 4 mg qhs 5 mg qhs • (1–5 years of age) (6–14 years of age) • Safety and 10 mg bid • efficacy not established (7–11 years of age) • response curve. No more efficacious than placebo in infants 6–24 months (van Adelsberg et al. 2005). For zafirlukast, administration with meals decreases bioavailability; take at least 1 hour before or 2 hours after meals. Monitor for signs and symptoms of hepatic dysfunction. Methylxanthines Theophylline Liquids, sustained-release Starting dose 10 mg/kg/day; Starting dose 10 mg/kg/day; tablets, and capsules usual maximum: usual maximum: 16 mg/kg/day <1 year of age: 0.2 (age in weeks) + 5 = mg/kg/day ≥1 year of age: 16 mg/kg/day • Adjust dosage to achieve serum concentration of 5–15 mcg/mL at steady-state (at least 48 hours on same dosage). • Due to wide interpatient variability in theophylline metabolic clearance, routine serum theophylline level monitoring is essential. See next page for factors that can affect theophylline levels. Key: DPI, dry powder inhaler; EIB, exercise-induced bronchospasm; HFA, hydrofluoroaklane (inhaler propellant): MDI, metered dose inhaler 4 USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS IN CHILDREN* (CONTINUED) Factors Affecting Serum Theophylline Concentrations Decreases Theophylline Factor Concentrations Food Diet ↓ or delays absorption of some sustained-release theophylline (SRT) products ↑ metabolism (high protein) † Increases Theophylline Concentrations Recommended Action ↑ rate of absorption (fatty foods) ↓metabolism (high carbohydrate) ↓ metabolism Systemic, febrile viral illness (e.g., influenza) ↑ metabolism Hypoxia, cor pulmonale, and decompensated congestive heart failure, cirrhosis Age metabolism (1–9 years) Phenobarbital, phenytoin, carbamazepine ↑metabolism ↓ metabolism (<6 months, elderly) Cimetidine ↓metabolism Macrolides: erythromycin, clarithromycin, troleandomycin ↓metabolism Quinolones: ciprofloxacin, enoxacin, perfloxacin ↓metabolism Rifampin ↑metabolism ↓metabolism Ticlopidine Smoking † This list is not all inclusive. 5 ↑metabolism Select theophylline preparation that is not affected by food. Inform patients that major changes in diet are not recommended while taking theophylline. Decrease theophylline dose acco rdi ng t o se rum concentration. Decrease dose by 50 percent if serum concentration measurement is not available. Decrease dose according to serum concentration. Adjust dose according to serum concentration. Increase dose according to serum concentration. Use alternative H2 blocker (e.g., famotidine or ranitidine). Use alternative macrolide antibiotic, azithromycin, or alternative antibiotic or adjust theophylline dose. Use alternative antibiotic or adjust theophylline dose. Circumvent with ofloxacin if quinolone therapy is required. Increase dose according to serum concentration. Decrease dose according to serum concentration. Advise patient to stop smoking; increase dose according to serum concentration. USUAL DOSAGES FOR QUICK-RELIEF MEDICATIONS IN CHILDREN* Medication Dosage Form 0–4 Years 5–11 Years Comments Inhaled Short-Acting Beta2-Agonists MDI Albuterol HFA Levalbuterol HFA Pirbuterol CFC Autohaler 90 mcg/puff, 200 puffs/canister 45 mcg/puff, 200 puffs/canister 200 mcg/puff, 400 puffs/canister 2 puffs every 4–6 hours as needed Safety and efficacy not established in children <4 years Safety and efficacy not established 2 puffs every 4–6 hours as needed 2 puffs every 4–6 hours as needed Safety and efficacy not established An increasing use or lack of expected effect indicates diminished control of asthma. Not recommended for long-term daily treatment. Regular use exceeding 2 days/week for symptom control (not prevention of EIB) indicates the need for additional long-term control therapy. May double usual dose for mild exacerbations. Should prime the inhaler by releasing 4 actuations prior to use. Periodically clean HFA actuator, as drug may plug orifice. Children <4 years may not generate sufficient inspiratory flow to activate an auto-inhaler. Nonselective agents (i.e., epinephrine, isoproterenol, metaproterenol) are not recommended due to their potential for excessive cardiac stimulation, especially in high doses. Nebulizer solution Albuterol 0.63 mg/3 mL 1.25 mg/3 mL 2.5 mg/3 mL 0.63–2.5 mg in 3 cc of saline q 4–6 hours, as needed 1.25–5 mg in 3 cc of saline q 4–8 hours, as needed 0.31–1.25 mg in 3 cc q 4–6 hours, as needed 0.31–0.63 mg, q 8 hours, as needed 5 mg/mL (0.5%) Levalbuterol (R-albuterol) 0.31 mg/3 mL 0.63 mg/3 mL 1.25 mg/0.5 mL 1.25 mg/3 mL May mix with cromolyn solution, budesonide inhalant suspension, or ipratropium solution for nebulization. May double dose for severe exacerbations. Does not have FDA-approved labeling for children <6 years of age. The product is a sterile-filled preservative-free unit dose vial. Compatible with budesonide inhalant suspension. 6 USUAL DOSAGES FOR QUICK-RELIEF MEDICATIONS IN CHILDREN* (CONTINUED) Medication Dosage Form 0–4 Years Comments 5–11 Years Anticholinergics Ipratropium HFA MDI 17 mcg/puff, 200 puffs/ canister Safety and efficacy not established Safety and efficacy not established • Nebulizer solution 0.25 mg/mL (0.025%) • Safety and efficacy not established Safety and efficacy not established Systemic Corticosteroids Methylprednisolone Prednisolone Prednisone 2, 4, 6, 8, 16,32mg tablets Evidence is lacking for anticholinergics producing added benefit to beta2-agonists in long-term control asthma therapy. See “Management of Acute Asthma” for dosing in ED. Applies to the first three corticosteroids Short course “burst”: 1–2 mg/kg/day, maximum 60 mg/day, for 3–10 days Short course “burst”: 1-2 mg/kg/day, maximum 60 mg/day, for 3–10 days • • 5 mg tablets, 5 mg/5 cc, 15 mg/5 cc Short courses or “bursts” are effective for establishing control when initiating therapy or during a period of gradual deterioration. The burst should be continued until patient achieves 80% PEF personal best or symptoms resolve. This usually requires 3–10 days but may require longer. There is no evidence that tapering the dose following improvement prevents relapse. 1, 2.5, 5, 10, 20, 50 mg tablets; 5 mg/cc, 5 mg/5 cc Repository injection (Methylprednisolone acetate) 40 mg/mL 80 mg/mL 7.5 mg/kg IM once 240 mg IM once • May be used in place of a short burst of oral steroids in patients who are vomiting or if adherence is a problem. Key: CFC, chlorofluorocarbon; ED, emergency department; EIB, exercise-induced bronchospasm; HFA, hydrofluoroalkane; IM, intramuscular; MDI, metered-dose inhaler; PEF, peak expiratory flow *Dosages are provided for those products that have been approved by the U.S. Food and Drug Administration or have sufficient clinical trial safety and efficacy data in the appropriate age ranges to support their use. 7 STEPWISE APPROACH FOR MANAGING ASTHMA IN YOUTHS >12 YEARS OF AGE AND ADULTS Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Intermittent Asthma Step 6 Step 5 Step 4 Step 3 Step 2 Preferred: Low- Step 1 Preferred: SABA PRN dose ICS Alternative: LTRA or Theophylline Preferred: Low-dose ICS + LABA OR Medium-dose ICS Alternative: Low-dose ICS + either LTRA, Theophylline, or Zileuton Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS + either LTRA, Preferred: High- dose ICS + LABA AND Consider Om aliz um ab for patients who have allergies Preferred: High-dose ICS + LABA + oral corticosteroid AND Consider Omalizumab for patients who have allergies Theophylline, or Zileuton Each step: Patient education, environmental control, and management of comorbidities. Steps 2−4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma (see notes). Quick-Relief Medication for All Patients: Step up if needed (first, check adherence, environmental control, and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral systemic corticosteroids may be needed. Use of SABA >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment. Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. EIB, exercise-induced bronchospasm; ICS, inhaled corticosteroid; LABA, long-acting inhaled beta2- agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta2-agonist Notes: The stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs. If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. Zileuton is a less desirable alternative due to limited studies as adjunctive therapy and the need to monitor liver function. Theophylline requires monitoring of serum concentration levels. In step 6, before oral systemic corticosteroids are introduced, a trial of high-dose ICS + LABA + either LTRA, theophylline, or zileuton may be considered, although this approach has not been studied in clinical trials. Step 1, 2, and 3 preferred therapies are based on Evidence A; step 3 alternative therapy is based on Evidence A for LTRA, Evidence B for theophylline, and Evidence D for zileuton. Step 4 preferred therapy is based on Evidence B, and alternative therapy is based on Evidence B for LTRA and theophylline and Evidence D for zileuton. Step 5 preferred therapy is based on Evidence B. Step 6 preferred therapy is based on (EPR⎯2 1997) and Evidence B for omalizumab. Immunotherapy for steps 2–4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults. Clinicians who administer immunotherapy or omalizumab should be prepared and equipped to identify and treat anaphylaxis that may occur. 8 USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS FOR YOUTHS ≥12 YEARS OF AGE AND ADULTS Medication Dosage Form Adult Dose Comments Inhaled Corticosteroids (ICS) (See figure 4–8b, “Estimated Comparative Daily Dosages for Inhaled Corticosteroids.”) Systemic Corticosteroids Methylprednisolone 2, 4, 8, 16, 32 mg tablets Prednisolone 5 mg tablets, 5 mg/5 cc, 15 mg/5 cc Prednisone 1, 2.5, 5, 10, 20, 50 mg Tablets; tablets; 5 mg/cc, (Applies to all three corticosteroids) There is no evidence that tapering the dose following improvement in symptom control and pulmonary function prevents relapse. • Inhaled Long-Acting Beta2-Agonists (LABA) Salmeterol Formoterol DPI 50 mcg/ blister DPI 12 mcg/ single-use capsule For long-term treatment of severe persistent asthma, administer single dose in a.m. either daily or on alternate days (alternate-day therapy may produce less adrenal suppression). Short courses or “bursts” are effective for establishing control when initiating therapy or during a period of gradual deterioration. 7.5–60 mg daily in a single dose in a.m. or qod as needed for control Short-course “burst”: to achieve control, 40–60 mg per day as single or 2 divided doses for 3– 10 days 1 blister q 12 hours • 1 capsule q 12 hours • 1 inhalation bid; dose depends on severity of asthma • Should not be used for symptom relief or exacerbations. Use with ICS. *Should not be used alone-use in Combination with an asthma controller medication. Decreased duration of protection against EIB may occur with regular use. Each capsule is for single use only; additional doses should not be administered for at least 12 hours. Capsules should be used only with TM the Aerolizor inhaler and should not be taken orally. Combined Medication Fluticasone/Salmeterol Budesonide/ Formoterol 9 DPI 100 mcg/50 mcg, 250 mcg/50 mcg, or 500 mcg/50 mcg HFA 45 mcg/21 mcg 115 mcg/21 mcg 230 mcg/21 mcg HFA MDI 80 mcg/4.5 mcg 160mcg/4.5 mcg 100/50 DPI or 45/21 HFA for patient not controlled on low- to medium-dose ICS 250/50 DPI or 115/21 HFA for patients not controlled on medium- to high-dose ICS 2 inhalations bid; dose depends on severity of asthma • 80/4.5 for patients who have asthma not controlled on low- to mediumdose ICS 160/4.5 for patients who have asthma not controlled on medium- to highdose ICS USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS FOR YOUTHS ≥12 YEARS OF AGE AND ADULTS (CONTINUED) Leukotriene Modifiers Leukotriene Receptor Antagonists Montelukast 4 mg or 5 mg chewable tablet 10 mg tablet Zafirlukast 10 or 20 mg tablet 5-Lipoxygenase Inhibitor Zileuton 600 mg tablet Zileuton CR 600 mg tablet 10 mg qhs • 40 mg daily (20 mg tablet bid) • 2,400 mg daily (give tablets qid) 2,400 mg daily (give tablets bid) • Starting dose 10 mg/ kg/day up to 300 mg maximum; usual maximum 800 mg/day • • • Montelukast exhibits a flat doseresponse curve. Doses >10 mg will not produce a greater response in adults. For zafirlukast, administration with meals decreases bioavailability; take at least 1 hour before or 2 hours after meals. Monitor for signs and symptoms of hepatic dysfunction. For zileuton, monitor hepatic enzymes (ALT). CR tablets given within one hour after morning and evening meals. Methylxanthines Theophylline Liquids, sustainedrelease tablets, and capsules Adjust dosage to achieve serum concentration of 5–15 mcg/mL at steady-state (at least 48 hours on same dosage). Due to wide interpatient variability in theophylline metabolic clearance, routine serum theophylline level monitoring is important. See next page for factors that can affect theophylline levels. Immunomodulators Omalizumab Subcutaneous injection, 150 mg/1 .2 mL following reconstitution with 1 .4 mL sterile water for injection 150–375 mg SC q • Do not administer more than 150 mg 2–4 weeks, depending per injection site. on body weight and • Monitor for anaphylaxis for 2 hours pretreatment serum following at least the first 3 IgE level injections. Anaphylaxis has been reported for up to one year after initiation of therapy Key: DPI, dry powder inhaler; EIB, exercise-induced bronchospasm; HFA, hydrofluoroalkane; IgE, immunoglobulin E; MDI, metered-dose inhaler; SABA, short-acting beta2-agonist 10 USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS FOR YOUTHS ≥12 YEARS OF AGE AND ADULTS (CONTINUED) Factors Affecting Serum Theophylline Concentrations* Factor Food ↓ some sustained-release Decreases Theophylline Concentrations Increases Theophylline Concentrations or delays absorption of rate of absorption (fatty foods) Recommended Action Select theophylline preparation that is not affected by food. theophylline (SRT) products ↑ metabolism (high protein) Diet ↓ metabolism Systemic, febrile viral illness (e.g., influenza) Hypoxia, cor pulmonale, and decompensated congestive heart failure, cirrhosis ↓ metabolism ↑ metabolism (1–9 years) Age Phenobarbital, phenytoin, carbamazepine ↓ metabolism (high carbohydrate) ↑ metabolism ↓ metabolism (<6 months, elderly) Inform patients that major changes in diet are not recommended while taking theophylline. Decrease theophylline dose according to serum concentration. Decrease dose by 50 percent if serum concentration measurement is not available. Decrease dose according to serum concentration. Adjust dose according to serum concentration. Increase dose according to serum concentration. Cimetidine ↓ metabolism Use alternative H 2 blocker (e.g., famotidine or ranitidine). Macrolides: erythromycin, clarithromycin, troleandomycin ↓ metabolism Use alternative macrolide antibiotic, azithromycin, or alternative antibiotic or adjust theophylline dose. Quinolones: ciprofloxacin, enoxacin, perfloxacin Rifampin ↓ metabolism ↑ metabolism Smoking ↑ metabolism *This list is not all inclusive. 11 Increase dose according to serum concentration. ↓ metabolism Ticlopidine Use alternative antibiotic or adjust theophylline dose. Circumvent with ofloxacin if quinolone therapy is required. Decrease dose according to serum concentration. Advise patient to stop smoking; increase dose according to serum concentration. USUAL DOSAGES FOR QUICK-RELIEF MEDICATIONS FOR YOUTH S ≥ 1 2 YEARS O F AGE AND ADULTS Medication Dosage Form Adult Dose Comments Inhaled Short-Acting Beta2-Agonists (SABA) Applies to all three SABAs MDI Albuterol HFA 90 mcg/puff, 200 puffs/canister Pirbuterol CFC Autohaler Levalbuterol HFA 200 mcg/puff, 400 puffs/canister 45 mcg/puff, 200 puffs/canister 2 puffs every 4-6 hours as needed Not recommended for long-term daily treatment. Regular use exceeding 2 days/week for symptom control (not prevention of EIB) indicates the need to step up therapy. Differences in potency exist, but all products are essentially comparable on a per puff basis. May double usual dose for mild exacerbations. Should prime the inhaler by releasing 4 actuations prior to use. Periodically clean HFA activator, as drug may block/plug orifice. Nonselective agents (i.e., epinephrine, isoproterenol, metaproterenol) are not recommended due to their potential for excessive cardiac stimulation, especially in high doses. Nebulizer solution Albuterol Levalbuterol (R-albuterol) 12 0.63 mg/3 mL 1.25 mg/3 mL 2.5 mg/3 mL 5 mg/mL (0.5%) 0.31 mg/3 mL 0.63 mg/3 mL 1.25 mg/0.5 mL 1.25 mg/3 mL 1.25-5 mg in 3 cc of saline q 4-8 hours as needed May mix with budesonide inhalant suspension, cromolyn or ipratropium nebulizer solustions. May double dose for severe exacerbations. 0.63 mg – 1.25 mg q 8 hours as needed Compatible with budesodine inhalant suspension. The product is a sterilefilled, preservative-free, unit dose vial. USUAL DOSAGES FOR QUICK-RELIEF MEDICATIONS FOR YOUTHS ≥ 1 2 YEARS O F AGE AND ADULTS ( Continued) Medication Dosage Form Adult Dose Comments Anticholinergics MDI Ipratropium HFA 17 mcg/puff, 200 puffs/canister 2-3 puffs q 6 hours Evidence is lacking for anticholinergics producing added benefit to beta2agonists in long-term control asthma therapy. Nebulizer solution Ipratropium with albuterol 0.25 mg/mL (0.025%) MDI 0.25 mg q 6 hours 18 mcg/puff of ipratropium bromide and 90 mcg/puff of albuterol 200 puffs/canister Nebulizer solution 2-3 puffs q 6 hours 0.5 mg/3 mL ipratropium bromide and 2.5 mg/3 mL albuterol 3 mL q 4-6 hours Systemic Corticosteroids Contains EDTA to prevent discoloration of the solution. This additive does not induce bronchospasm. Applies to the first three corticosteroids Methylprednisolone 2, 4, 8 16, 32 mg tablets Prednisolone 5 mg tablets, 5 mg/5 cc, 15 mg/5cc Prednisone 1, 2.5, 5, 10, 20, 50 mg tablets; 5 mg/cc, 5 mg/5cc Short course “burst”: 40-60 mg/day as single or 2 divided doses for 3-10 days. Short course or “bursts” are effective for establishing control when initiating therapy or during a period of gradual deterioration. The burst should be continued until symptoms resolve and the PEF is at least 80 percent of personal best. This usually requires 3-10 days but may require longer. There is no evidence that tapering the dose following improvement prevents relapse. Repository injection (Methylprednisolone acetate) 20mg/mL 40 mg/mL 80 mg/mL 240 mg IM once May be used in place of a short burse of oral steroids in patients who are vomiting or if adherence is a problem. Key: CFC, chlorofluorocarbon; EIB, Exercise-induced bronchospasm; HFA, hydrofluoroalkane; IM, intramuscular; MDI, metered-dose inhaler: PEF, peak expiratory flow. 13 MANAGEMENT OF ASTHMA EXACERBATIONS: HOME TREATMENT Assess Severity Patients at high risk for a fatal attack (see figure 5–2a) require immediate medical attention after initial treatment. Symptoms and signs suggestive of a more serious exacerbation such as marked breathlessness, inability to speak more than short phrases, use of accessory muscles, or drowsiness (see figure 5–3) should result in initial treatment while immediately consulting with a clinician. Less severe signs and symptoms can be treated initially with assessment of response to therapy and further steps as listed below. If available, measure PEF—values of 50–79% predicted or personal best indicate the need for quick-relief mediation. Depending on the response to treatment, contact with a clinician may also be indicated. Values below 50% indicate the need for immediate medical care. Initial Treatment Inhaled SABA: up to two treatments 20 minutes apart of 2–6 puffs by metered-dose inhaler (MDI) or nebulizer treatments. Note: Medication delivery is highly variable. Children and individuals who have exacerbations of lesser severity may need fewer puffs than suggested above. Good Response Incomplete Response Poor Response No wheezing or dyspnea (assess tachypnea in young children). PEF ≥80% predicted or personal best. Contact clinician for Follow-up instructions and further management. May continue inhaled SABA every 3–4 hours for 24– 48 hours. Persistent wheezing and dyspnea (tachypnea). PEF 50–79% predicted or personal best. Marked wheezing and dyspnea. PEF <50% predicted or personal best. Consider short course of oral systemic corticosteroids. Add oral systemic corticosteroid. Continue inhaled SABA. Contact clinician urgently (this day) for further instruction. Key: ED, emergency department; MDI, metered-dose inhaler; PEF, peak expiratory flow; SABA, short-acting beta2-agonist (quick-relief inhaler) 14 dd oral systemic corticosteroid. Repeat inhaled SABA immediately. If distress is severe and nonresponsive to initial treatment: —Call your doctor AND — PROCEED TO ED; — Consider calling 9–1–1 (ambulance transport). To ED. Comprehensive Risk Reduction for Patients with Atherosclerotic Cardiovascular Disease (Tier #2 Guideline) Purpose: To delineate periodic examination requirements for adults with Atherosclerotic Cardiovascular Disease Patient Population: Patients who have had a ST Elevation Myocardial Infarction, Coronary Artery Bypass Graft, or Percutaneous Transluminal Coronary Angioplasty Developed by: Eugene Terry, M.D., Team Chair1 and SWHP Secondary Prevention of Coronary Artery Disease Team2 Clinical Resource: The American College of Cardiology and the American Heart Association (ACC/AHA) Practice Guidelines update December 2007. Adopted: SWHP Quality Improvement Committee 7/21/99 Revised: February 2008, March 2012 Reviewed: February, 2010 INTERVENTIONS Smoking Goal: Complete cessation. Blood Pressure Control Goal: B/P < than 140/90 (< than 140/90 for diabetes or chronic kidney disease. Lipid Management Goal: LDL-C substantially < 100 mg/dl. If triglycerides are >/= 200 mg/dl the nonHDL should be < 130 mg/dl. Diabetes Management Goal: HbA1c less than 8%. ASSESSMENT PERIOD RECOMMENDATIONS/GOALS Initial screening after diagnosis and at each visit if a smoker. Document counseling in patient’s medical record. Initial screening after discharge or diagnosis. Increased frequency of reassessment indicated until blood pressure within goals. Adopt a stepwise strategy aimed at smoking cessation - use the 5 A’s: Ask, Advise, Assess, Assist, and Arrange. Assess fasting lipid profile within 24 hours of hospitalization. Re-assess in 4 to 6 months if initial profile is not within therapeutic range. Re-assess yearly thereafter. Initiate lipid lowering medication before discharge to reach LDL-C < 100 mg/dl (further reduction to < 70 mg/dl is reasonable). If already on therapy intensify LDLlowering drug therapy (may require combination therapy). Reduce intake of: saturated fats to < 7% of total calories. Trans-fatty acids and cholesterol to < 200 mg/day. Add plant stanol/sterols (2 g per day) and/or viscous fiber (> 10 g per day). If triglycerides >/= to 150 mg/dl or HDL-C < 40 mg/dl, weight management, physical activity and smoking cessation should be emphasized. If triglycerides are 200 to 499 mg/dl, †† the non-HDL-C target should be < 130 mg/dl (< 100 mg/dl is reasonable). If triglycerides are >/= to 500 mg/dl ††§§ therapeutic options indicated and useful to prevent pancreatitis are fibrate‡‡ or niacin** before LDL-lowering therapy. Treat LDL-C to goal after triglyceride-lowering therapy. Achieving non-HDL-C should be < 130 mg/dl is recommended. Initiate lifestyle and pharmacotherapy to achieve near-normal HbA1c. Begin vigorous modification of risk factors. Niacin** (after LDL-C lowering therapy) can be helpful. Fibrate‡‡ therapy (after LDL-C lowering therapy) can be helpful. Initial screening after discharge or diagnosis and as needed until goal meet. Re-assess twice per year thereafter. Add blood pressure medication – initially beta blocker and/or ACE inhibitor. Add other drugs such as thiazides to achieve goal blood pressure. Follow-up, referral to special programs, or pharmacotherapy (including nicotine replacement) is useful. Initiate or maintain life-style modifications: - Weight control - Increased activity - Alcohol moderation - Sodium reduction Coordinate diabetic care with endocrinologist as indicated. Physical Activity Initial screening after diagnosis and at least annual thereafter. All patients - encourage 30 to 60 minutes of moderate intensity aerobic activity – preferably all days of the week. All patients – recommended that risk be assessed with physical activity history and/or exercise test to guide prescription. Advising medically supervised programs (cardiac rehabilitation) for high-risk patients is recommended. Encourage resistance training 2 days a week... Goal: 30 minutes, 7 days per week (minimum 5 days per week) Weight Management Assess BMI and/or waist circumference on each visit. Consistently encourage weight maintenance/ reduction. Initial goal as reduction by approximately 10% from baseline. Initiate lifestyle changes and consider treatment strategies for metabolic syndrome as indicated. Goal: BMI 18.5 to 24.9 kg/m2. Waist circumference – Men less than 40 inches (102 cm) women less than 35 inches (89 cm). Depression Influenza Vaccination Initial screening after discharge or diagnosis. Yearly reassessment. Initial screening after discharge or diagnosis for immunization history. Yearly reassessment. Screen patients for depression and refer/treat when indicated. Patients with cardiovascular disease should have an annual influenza vaccination. Antiplatelet Agents: Aspirin All post-PCI STEMI stented patients without aspirin resistance, allergy, or increased risk of bleeding – aspirin 162 mg to 325 mg daily for: - 1 month after BMS implantation. - 3 months after sirolimus-eluting stent implantation. - 6 months after paclitaxel-eluting stent implantation. Continue long-term aspirin use indefinitely at dose of 75 to 162 mg/daily. Patients with risk of bleeding – a lower dose of 75 to 162 mg/daily is reasonable after stent implantation. Antiplatelet Agents: Clopidogrel All Post-PCI patients receiving DES - Clopidogrel 75 mg daily for at least 12 months if not high risk for bleeding. All Post-PCI patients receiving BMS – Clopidogrel for minimum of 1 month and ideally up to 12 months – unless at increased risk of bleeding – then should be given for minimum of 2 weeks. All STEMI patients – not undergoing stenting (medical therapy alone or PTCA without stenting) – treatment with clopidogrel should continue for at least 14 days. Long-term maintenance therapy (e.g. 1 year) with clopidogrel – 75 mg/daily orally – is reasonable for STEMI patients regardless of whether they undergo reperfusion with fibrinolytic therapy or do not receive reperfusion therapy. Antiplatelet Agents: Warfarin Initial screening after discharge or diagnosis if not initiated at discharge. Re-assess INR, with frequency as indicated by levels. Manage warfarin to an INR equal to 2.0 to 3.0 for paroxysmal or chronic atrial fibrillation or flutter is recommended, and in post-MI patients when clinically indicated (e.g. atrial fibrillation, left ventricular thrombus). Use of warfarin in conjunction with aspirin and/or clopidogrel is associated with increased risk of bleeding and should be monitored closely. In patients requiring warfarin, clopidogrel, and aspirin therapy, an INR of 2.0 to 2.5 is recommended with low dose aspirin (75 mg to 81 mg) and a 75 mg dose of clopidogrel. ACE Inhibitors Unless contraindicated should be initiated inpatient. If not, assess for contraindications and initiate with first office visit post diagnosis. Initiate and continue indefinitely in all patients recovering from STEMI with LVEF less than or equal to 40% and for those with hypertension, diabetes, or chronic kidney disease, unless contraindicated. Initiate and continue indefinitely in patients recovering from STEMI who are not lower risk (lower risk defined as those with normal LVEF in whom cardiovascular risk factors are well controlled and revascularization has been performed), unless contraindicated. For lower risk patients recovering from STEMI (i.e. those with normal LVEF in whom cardiovascular risk factors are well controlled and revascularization has been performed) use of ACE inhibitors is reasonable. Angiotensin Receptor Blockers Assess intolerance to ACE inhibitors. Aldosterone Blockade Beta Blockers Use of angiotensin receptor blockers is recommended in patients who are intolerant of ACE inhibitors and have HF or have had an MI with LVEF less than or equal to 40%. It is beneficial to use angiotensin receptor blocker therapy in other patients who are ACE-inhibitor intolerant and have hypertension. Consider use in combination with ACE inhibitors in systolic dysfunction HF may be reasonable. Use of aldosterone blockade in post-MI patients without significant renal dysfunction¥ or hyperkalemia¶¶ is recommended in patients who are already receiving therapeutic doses of an ACE inhibitor and beta blocker, have an LVEF of less than or equal to 40% and have either diabetes or HF. Unless contraindicated should be initiated inpatient. It is beneficial to start and continue beta-blocker therapy indefinitely in all patients who have had MI, acute coronary syndrome or LV dysfunction with or without HF symptoms, unless contraindicated. ** Dietary supplement niacin must not be used as a substitute for prescription niacin. †† The use of resin is relatively contraindicated when triglycerides are greater than 200 mg per dL. ‡‡ The combination of high-dose statin plus fibrate can increase risk for severe myopathy. Statin doses should be kept relatively low with this combination. §§ Patients with very high triglycerides should not consume alcohol. The use of bile acid sequestrant is relatively contraindicated when triglycerides are greater than 200 mg per dL. ¥ Creatinine should be less than 2.5 mg per dL in men and less than 2.0 mg per dL in women. ¶¶ Potassium should be less than 5.0 mEq/L. ACE indicates angiotensin-converting enzyme; BMI, body mass index; CHF, congestive heart failure; HDL-C, high-density lipoprotein cholesterol; HF, heart failure; INR, international normalized ratio; LDL-C, low-density lipoprotein cholesterol; LOE, level of evidence; LVEF, left ventricular ejection fraction; MI, myocardial infarction; PCI, percutaneous coronary intervention; and STEMI, ST-elevation myocardial infarction. 1 E. Eugene Terry, M.D. ; Chief, Section of Intensive Care Cardiology ; Director of GME; Professor of Internal Medicine and Surgery Texas A&M Health Science Center College of Medicine; Board Certification American Board of Internal Medicine: Cardiology, Critical Care. 2 SWHP Secondary Prevention of Coronary Artery Disease Team: Edwin E. Terry, M.D. – Cardiologist – Team Chair; J a n e G a m m o n , M.D. – Internal Medicine; John Manning, M.D. – Family Practice; Paul Godley, Pharm.D. – Pharmacy; Mary Jo doVale, R.N., - Cardiac Rehabilitation Nurse; Sandra Rutherford, HEDIS ® Manager - HEDIS®; Linda Gomez, R.N. –SWHP QI Coordinator - Team Facilitator Tier 2 Guideline Microhematuria Without Evidence of Primary Renal Disease In Adults (Confirmed by Microscopic Analysis) Date of Adoption: September 14, 2010 Revision Dates: Contact Physician: Dr. Erin Bird, MD; S&W Department of Urology Internal Medicine/Family Medicine: Microscopic Evaluation of urine to confirm presence of RBC’s Exclude benign causes Signs or symptoms of infection, (e.g. dyspsuria, frequency, flank/CVA pain, leukocyte esterase, nitrites, white blood cells, bacteria)? Yes No Treat infection; confirm resolution of microscopic hematuria with follow-up urinalysis six weeks after completion of therapy. Findings in support of primary renal disease/glomerular cause (e.g. proteinuria, elevated creatine level, red cell casts, dysmophic RBC’s)? Elevated creatinine Yes No Refer to urology based on results of imaging/cytology Or Refer to nephrology subspecialist OR Evaluate for primary renal disease Treat PCP may elect to coordinate upper tract imaging (US C.T.) cytology Or Refer to urology Prepare patient for partial/ complete eval Complete Evaluation (Upper Tract Imaging Cytology Cystoscopy) Urology Consultation Negative Positive Treat Urinalysis, Blood Pressure and Cytology at 6, 12, 24 and 36 months Negative 3 Years Persistent hematuria, hypertension, and/or proteinuria Gross hematuria, abnormal cytology, persistent irritative voiding symptoms No further urologic monitoring needed Evaluate for primary Renal Disease Repeat complete evaluation Source: American Urological Association (AUA) Page 1 of 1 Diabetes Annual Assessment Purpose: To delineate yearly examination requirements for adults with diabetes. Patient Population: Patients, age 18 to 75, with diabetes. Developed by: SWHP Diabetes Team 12/18/97 Contact Person: Veronica Piziak, M.D. Adopted: 1/21/98 Date of Last Reviews: April 2004, April 2006, April 2008, and April 2010 Next Review Date: April 2014 Approved by SWHP Quality Improvement Sub-Committee: April 13, 2010, April 10, 2012 TIME FRAME FOR REQUIRED TESTS Examination Initial Visit Twice per Year Yearly 1. Eye Exam (By Optometrist or Ophthalmologist) X X 2. Hemoglobin A1c – goal <8.0% without hypoglycemia X 3. Urine Microalbumin (Therapy with ACE-I or ARB indicated if elevated) X X 4. Foot Exam (Check for sensation, reflexes, pulses, lesions, and calluses twice a year with a monofilament test at least once a year) X X 5. Lipid Panel goal–Total Cholesterol <200 mg/dL,Triglyceride <150 mg/dL, (HDL men >40 mg/dL women >50 mg/dL), and LDL <100 mg/dL ; < 70 if known vascular disease (Statin therapy should be considered in patients over age 40. X X 6. Diabetes Education- (Nutritional therapy, self monitoring blood glucose, self management skills, lifestyle changes and reducing risks and complications.) X (after initial diabetes education – refresh when recommended by primary care physician) 7. Blood Pressure (Systolic < 140) (Diastolic < 90) ACE-I or ARB recommended as first line therapy for Hypertension control (See also Scott & White Treatment Guidelines for Hypertension) X Record BP in medical record twice a year and if BP > 140/90 more frequent monitoring recommended 8. Tobacco Cessation (Educate patient on health risks associated with tobacco use, advise tobacco user to quit, discuss cessation medications and cessation strategies.) X X 9. Weight Control X X 10. Exercise X X 11. Depression Screening (include screening for history of depression and screening for symptoms of depression) X X (more frequent screening if clinically indicated) Sources: American Diabetes Association Guideline and National Quality Forum (NQF) endorsed standards submitted by the National Committee for Quality Assurance (NCQA) Page 1 of 1 content\Provider Manual\13 QI Prog\Diabetes Annual Assessment-Approved by QIS 4-10-12.docx (sjr) H:\Web page X SCOTT AND WHITE HEALTH PLAN CLINICAL PRACTICE GUIDELINES FOR DIABETES SWHP has adopted the 2011 Clinical Practice Recommendations of the National Quality Forum (NQF) endorsed Diabetes Standards submitted by the National Committee for Quality Assurance (NCQA) located at the following internet website link: http://www.qualityforum.org/Measures_List.aspx#k=Diabetes&e=1&st=&sd=549%7C798&s=&p=1 SWHP Guideline Approval Body: SWHP Quality Improvement Subcommittee Date of Adoption: December 7, 2011 Review Dates: April 2012, April 2014 Physician Sponsor: Veronica K. Piziak, M.D., Ph.D. Scott &White Healthcare Professor of Medicine and Endocrinology, Texas A&M Health Science Center College of Medicine Board Certification by the American Board of Internal Medicine in Endocrinology and Metabolism Paper Copy: A paper copy of this Guideline is available upon request by contacting the SWHP Quality Improvement Division. Call toll free 1‐800‐321‐7947 ext. 3516. L/QI/NCQA/Clinical Guidelines/Current Tier 2 INTER dept/Diabetes SCOTT AND WHITE HEALTH PLAN CLINICAL PRACTICE GUIDELINE FOR THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE Scott and White Health Plan (SWHP) has adopted the “Treatment of Osteoarthritis of the Knee (NonArthoplasty)” dated December 6,2008 of the American Academy of Orthopaedic Surgeons, as a clinical practice guideline for SWHP’s providers1. The guideline is located at the following internet website: http://www.aaos.org/research/guidelines/OAKguideline.pdf Additional Resources for Care: SWHP VitalCare Shared Decision-Making Program2: http://www.swhp.org/sites/default/files/SharedDecisioinMakingRef_FAX.pdf SWHP Formulary: http://www.swhp.org/homepage/providers/pharmacy Notes: 1. Specific recommendations for care should be discussed with your patient. All medications noted in this guideline may not be in the SWHP Formulary; however, since SWHP has an Open Formulary, non-Formulary medications are available with authorization at the nonFormulary copayment. 2. SWHP’s Shared Decision-Making program offers preference-sensitive condition support. Preference-sensitive condition support extends to conditions for which either science supports multiple acceptable treatment options, or there is inadequate scientific information about the treatment choices. Our Health Coaches can help your patient make an informed decision about the treatment he or she would like to receive. Decision support for preference-sensitive conditions addresses a wide range of topics, including osteoarthritis. SWHP Guideline Approval Body: SWHP Quality Improvement Subcommittee Date of Adoption: March 8, 2011 Review Dates: N/A Physician Sponsor: Mike Averitt, D.O. Paper Copy: If you have difficulty downloading information or would like a paper copy, please contact SWHP Provider Relations Department toll-free at 800-321-7947 ext. 3064 or direct at 254-298-3064. Scott & White Health Plan Provider Manual Section 3B: Tier 1 Clinical Practice Guidelines Tier #1: Address the expected practice or management of a specific condition or disease process within an organizational unit, i.e. division or department; may be distributed outside the respective organizational unit. Scott and White Health Plan Clinical Practice Guideline (Tier 1) for Use by Mental Health Specialists in Pharmacologic Management of Major Depression (Non-Psychotic, Non-Bipolar) Approved: December 1999 Revised: 2/2003; 2/2007 Reviewed: 2/2005; 2/2009,12/2010, 12/2012 Source: Texas Medication Algorithm Project Physician Contact: Dr. Virginia Maxanne Flores, M.D. Reviewed in 2010 by: Department of Psychiatry, Scott & White Clinics Major Depression Monotherapy (1) Previous effective drug (2) SSRI* or (3) Bup*, Vlf*, Mirtazapine, Duloxetine Stage 1 Good Response? Yes Continuation Phase (see page 2) No Stage 2 Revised * LEGEND: Bup – Bupropion or Bupropion SR ECT – Electroconvulsive therapy MAOI – Monoamine Oxidase Inhibitor. SSRI – Selective Seratonin Reuptake Inhibitors TCA – Tricyclic antidepressant Vlf – Venlafaxine or Venlafaxine XR Stage 3 Revised (1) Alternate Monotherapy (SSRI*, Bup*, Vlf*, TCA*, MAOI*, Mirtazapine, Duloxetine) or (2) Augmentation (Lithium, Thyroid, Buspirone, stimulant) or (3) Combination (TCA*+SSRI*) Good Response? Yes Continuation Phase (see page 2) No (1) Alternate Monotherapy or (2) Augmentation or (3) Combination (TCA* + SSRI*) Good Response? Yes Continuation Phase (see page 2) Yes Continuation Phase (see page 2) No Stage 4 ECT* Good Response? No Reassess: Stage 5 (1) Augmentation (Olanzapine, Lamotrigine) or (2) Combination (SSRI* + Bup*, TCA* + MAOI*) or Return to Stages 3 or 4 Maintenance Phase (see page 2) Page 1 Scott and White Health Plan Clinical Practice Guideline (Tier 1) for Use by Mental Health Specialists in Pharmacologic Management of Major Depression (Non-Psychotic, Non-Bipolar) Continuation and Maintenance Phases Approved: December 1999 Revised: 2/2003; 2/2007 Reviewed: 2/2005; 2/2009, 12/2010 Source: Texas Medication Algorithm Project Physician Contact: Dr. Virginia Maxanne Flores, M.D. Reviewed in 2010 by: Department of Psychiatry, Scott & White Clinics Acute Phase Treatment Symptom Remission? Yes Enter Continuation Phase 6 to 9 months No Evaluate for Maintenance Phase: (1) 3 or more episodes, or (2) 2 episodes, with: -family history, Bipolar Disorder -recurrence in 1 year after stopping Tx. -family history, Major Depressive Disorder -early onset (before age 20) -severe, sudden, life-threatening in 3 years Return to Acute Treatment Algorithm No Begin Maintenance? Yes (1) Taper and discontinue over 2 to 3 months and (2) Follow every 2 to 4 months for 8 months Continue at full dose (1 year to lifetime) Page 2 Scott and White Health Plan Clinical Practice Guideline for Mental Health Specialists (Tier 1) STRATEGIES FOR ALCOHOL WITHDRAWAL MANAGEMENT Adopted: 12/1998 Reviewed: 2/2003; 2/2005; 9/2009 Revised: 2/2007; 7/2011; 8/2011* Physician Contact: Virginia Maxanne Flores, MD Reviewed in 2011 by: Department of Psychiatry, Scott & White Clinics A. Thiamine 100 mg I.M. x 1, then 100 mg p.o. daily x 5 days B. Folate 1 mg p.o. daily C. Multivitamin 1 p.o. daily D. Nurse monitors and documents Abstinence Symptom Evaluation (ASE’s) q 4 hours. E. Magnesium Sulfate 1 gram q 8 hours I.M. x 2, as indicated During 1st 24 hours of monitoring ASE scores, is ASE score ≥ 10, or does ASE score increase by 3 points between assessments? Patient enters inpatient treatment facility for alcohol withdrawal. No +/- Acamprosate +/- Naltrexone +/- Antabuse Yes Is there significant hepatic impairment? Encourage patient to call MH provider for outpatient referral if patient changes mind Yes 72 hours (Fixed Schedule) No Refer to Outpatient Care Yes Will treatment duration be 24 or 72 hours? 24 hours (FrontLoading Schedule) Diazepam 20 mg p.o. q 2 hours until ASE’s < 10 or there is resolution of symtoms. On average three doses are required. Diagnosis of alcohol dependence? 72 hours (Fixed Schedule) Yes Diazepam 10 mg p.o. q 6 hours x 4 doses, then Diazepam 5 mg q 6 hours x 8 doses, Diazepam 10 mg p.o. q hour prn ASE ≥ 10 Lorazepam 2 mg p.o. q 6 hours x 4 doses, then Lorazepam 1 mg p.o. q 6 hours x 8 doses, Lorazepam 1 mg p.o. q hour prn ASE ≥ 10 Detox complete? Explain dangers (delirium, seizures, etc.) of not completing detox, including being released from facility against medical advice. Consider possibility of switching eligible patients to Front-Loading Schedule. Release from facility against medical advice if patient continues to refuse detox. No Patient agrees to Outpatient Care? Initiate treatment within 14 days of diagnosis. Other Diagnosis TX initiation complete? No Yes Yes No No +/- Naltrexone +/- Antabuse +/- Acamprosate Engage patient in treatment with a minimum of 2 follow-up services within 30 days of the initial treatment. Encourage patient to initiate treatment. * Effective August 2011 the Guideline, “Strategies for Alcohol Withdrawal Management with Front-Loading Schedule” was merged into this Guideline. Developed by the Physicians and Staff of the Department of Psychiatry, Scott & White Clinics Scott & White Health Plan Provider Manual Section 3C Preventive Health Guidelines Figure 1. Recommended immunization schedule for persons aged 0 through 18 years – 2013. (FOR THOSE WHO FALL BEHIND OR START LATE, SEE THE CATCH-UP SCHEDULE [FIGURE 2]). These recommendations must be read with the footnotes that follow. For those who fall behind or start late, provide catch-up vaccination at the earliest opportunity as indicated by the green bars in Figure 1. To determine minimum intervals between doses, see the catch-up schedule (Figure 2). School entry and adolescent vaccine age groups are in bold. Vaccines Birth Hepatitis B1 (HepB) 1st dose Rotavirus2 (RV) RV-1 (2-dose series); RV-5 (3-dose series) Diphtheria, tetanus, & acellular pertussis3 (DTaP: <7 yrs) Tetanus, diphtheria, & acellular pertussis4 (Tdap: >7 yrs) 1 mo 2 mos 4 mos 6 mos 9 mos 12 mos 15 mos 18 mos 19–23mos 2-3 yrs 4-6 yrs 7-10 yrs 11-12 yrs 13–15 yrs 16–18 yrs 3rd dose 2nd dose See 1st dose 2nd dose footnote 2 1st dose 2nd dose Haemophilus influenzae type b5 (Hib) 1st dose See 2nd dose footnote 5 6a,c (PCV13) 1st dose 2nd dose 1st dose 2nd dose 3rd dose 4th dose 5th dose (Tdap) Pneumococcal conjugate 3rd or 4th dose, see footnote 5 3rd dose 4th dose Pneumococcal polysaccharide6b,c (PPSV23) Inactivated Poliovirus7 (IPV) (<18years) Influenza8 (IIV; LAIV) 2 doses for some : see footnote 8 3rd dose 4th dose Annual vaccination (IIV only) Measles, mumps, rubella9 (MMR) 10 Varicella (VAR) Hepatitis A11 (HepA) Annual vaccination (IIV or LAIV) 1st dose 2nd dose 1st dose 2nd dose 2 dose series, see footnote 11 Human papillomavirus12 (HPV2: females only; HPV4: males and females) Meningococcal13 (Hib-MenCY > 6 weeks; MCV4-D>9 mos; MCV4-CRM > 2 yrs.) (3-dose series) 1st dose see footnote 13 booster Not routinely Range of recommended ages during recommended which catch-up is encouraged and for certain high-risk groups This schedule includes recommendations in effect as of January 1, 2013. Any dose not administered at the recommended age should be administered at a subsequent visit, when indicated and feasible. The use of a combination vaccine generally is preferred over separate injections of its equivalent component vaccines. Vaccination providers should consult the relevant Advisory Committee on Immunization Practices (ACIP) statement for detailed recommendations, available online at http://www.cdc.gov/vaccines/pubs/acip-list.htm. Clinically significant adverse events that follow vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS) online (http://www.vaers.hhs.gov) or by telephone (800-822-7967).Suspected cases of vaccine-preventable diseases should be reported to the state or local health department. Additional information, including precautions and contraindications for vaccination, is available from CDC online (http://www.cdc.gov/vaccines) or by telephone (800-CDC-INFO [800-232-4636]). Range of recommended ages for all children Range of recommended ages for catch-up immunization Range of recommended ages for certain high-risk groups This schedule is approved by the Advisory Committee on Immunization Practices (http://www.cdc.gov/vaccines/acip/index.html), the American Academy of Pediatrics (http://www.aap.org), the American Academy of Family Physicians (http://www.aafp.org), and the American College of Obstetricians and Gynecologists (http://www.acog.org). NOTE: The above recommendations must be read along with the footnotes of this schedule. FIGURE 2. Catch-up immunization schedule for persons aged 4 months through 18 years who start late or who are more than 1 month behind —United States, 2013 The figure below provides catch-up schedules and minimum intervals between doses for children whose vaccinations have been delayed. A vaccine series does not need to be restarted, regardless of the time that has elapsed between doses. Use the section appropriate for the child’s age. Always use this table in conjunction with Figure 1 and the footnotes that follow. Persons aged 4 months through 6 years Minimum Interval Between Doses Vaccine Minimum Age for Dose 1 Dose 1 to dose 2 Dose 2 to dose 3 Hepatitis B1 Birth 4 weeks 8 weeks and at least 16 weeks after first dose; minimum age for the final dose is 24 weeks Rotavirus2 6 weeks 4 weeks 4 weeks2 Diphtheria, tetanus, pertussis3 6 weeks 4 weeks Haemophilus influenzae type b5 6 weeks 4 weeks if first dose administered at younger than age 12 months 8 weeks (as final dose) if first dose administered at age 12–14 months No further doses needed if first dose administered at age 15 months or older Pneumococcal6 6 weeks 4 weeks if first dose administered at younger than age 12 months 8 weeks (as final dose for healthy children) if first dose administered at age 12 months or older or current age 24 through 59 months No further doses needed for healthy children if first dose administered at age 24 months or older 4 weeks if current age is younger than 12 months 8 weeks (as final dose for healthy children) if current age is 12 months or older No further doses needed for healthy children if previous dose administered at age 24 months or older 8 weeks (as final dose) This dose only necessary for children aged 12 through 59 months who received 3 doses before age 12 months or for children at high risk who received 3 doses at any age Inactivated poliovirus7 6 weeks 4 weeks 4 weeks 6 months7 minimum age 4 years for final dose see footnote 13 see footnote 13 Meningococcal13 6 weeks 8 weeks13 Measles, mumps, rubella9 12 months 4 weeks Varicella10 12 months 3 months Hepatitis A11 12 months 6 months Tetanus, diphtheria; tetanus, diphtheria, pertussis4 7 years4 4 weeks Human papillomavirus12 9 years Dose 3 to dose 4 Dose 4 to dose 5 4 weeks 6 months 6 months3 4 weeks5 if current age is younger than 12 months 8 weeks (as final dose)5 if current age is 12 months or older and first dose administered at younger than age 12 months and second dose administered at younger than 15 months No further doses needed if previous dose administered at age 15 months or older 8 weeks (as final dose) This dose only necessary for children aged 12 through 59 months who received 3 doses before age 12 months Persons aged 7 through 18 years 4 weeks if first dose administered at younger than age 12 months 6 months if first dose administered at 12 months or older 6 months if first dose administered at younger than age 12 months Routine dosing intervals are recommended12 Hepatitis A11 12 months Hepatitis B1 Birth 4 weeks 8 weeks (and at least 16 weeks after first dose) Inactivated poliovirus7 6 weeks 4 weeks 4 weeks7 Meningococcal13 6 weeks 8 weeks13 6 months Measles, mumps, rubella9 12 months 4 weeks Varicella10 12 months 3 months if person is younger than age 13 years 4 weeks if person is aged 13 years or older NOTE: The above recommendations must be read along with the footnotes of this schedule. 6 months7 Footnotes — Recommended immunization schedule for persons aged 0 through 18 years—United States, 2013 For further guidance on the use of the vaccines mentioned below, see: http://www.cdc.gov/vaccines/pubs/acip-list.htm. 1. Hepatitis B (HepB) vaccine. (Minimum age: birth) Routine vaccination: At birth • Administer monovalent HepB vaccine to all newborns before hospital discharge. • For infants born to hepatitis B surface antigen (HBsAg)–positive mothers, administer HepB vaccine and 0.5 mL of hepatitis B immune globulin (HBIG) within 12 hours of birth. These infants should be tested for HBsAg and antibody to HBsAg (anti-HBs) 1 to 2 months after completion of the HepB series, at age 9 through 18 months (preferably at the next well-child visit). • If mother’s HBsAg status is unknown, within 12 hours of birth administer HepB vaccine to all infants regardless of birth weight. For infants weighing <2,000 grams, administer HBIG in addition to HepB within 12 hours of birth. Determine mother’s HBsAg status as soon as possible and, if she is HBsAg-positive, also administer HBIG for infants weighing ≥2,000 grams (no later than age 1 week). Doses following the birth dose • The second dose should be administered at age 1 or 2 months. Monovalent HepB vaccine should be used for doses administered before age 6 weeks. • Infants who did not receive a birth dose should receive 3 doses of a HepB-containing vaccine on a schedule of 0, 1 to 2 months, and 6 months starting as soon as feasible. See Figure 2. • The minimum interval between dose 1 and dose 2 is 4 weeks and between dose 2 and 3 is 8 weeks. The final (third or fourth) dose in the HepB vaccine series should be administered no earlier than age 24 weeks, and at least 16 weeks after the first dose. • Administration of a total of 4 doses of HepB vaccine is recommended when a combination vaccine containing HepB is administered after the birth dose. Catch-up vaccination: • Unvaccinated persons should complete a 3-dose series. • A 2-dose series (doses separated by at least 4 months) of adult formulation Recombivax HB is licensed for use in children aged 11 through 15 years. • For other catch-up issues, see Figure 2. 2. Rotavirus (RV) vaccines. (Minimum age: 6 weeks for both RV-1 [Rotarix] and RV-5 [RotaTeq]). Routine vaccination: • Administer a series of RV vaccine to all infants as follows: 1. If RV-1 is used, administer a 2-dose series at 2 and 4 months of age. 2. If RV-5 is used, administer a 3-dose series at ages 2, 4, and 6 months. 3. If any dose in series was RV-5 or vaccine product is unknown for any dose in the series, a total of 3 doses of RV vaccine should be administered. Catch-up vaccination: • The maximum age for the first dose in the series is 14 weeks, 6 days. • Vaccination should not be initiated for infants aged 15 weeks 0 days or older. • The maximum age for the final dose in the series is 8 months, 0 days. • If RV-1(Rotarix) is administered for the first and second doses, a third dose is not indicated. • For other catch-up issues, see Figure 2. 3. Diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. (Minimum age: 6 weeks) Routine vaccination: • Administer a 5-dose series of DTaP vaccine at ages 2, 4, 6, 15–18 months, and 4 through 6 years. The fourth dose may be administered as early as age 12 months, provided at least 6 months have elapsed since the third dose. Catch-up vaccination: • The fifth (booster) dose of DTaP vaccine is not necessary if the fourth dose was administered at age 4 years or older. • For other catch-up issues, see Figure 2. 4. Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine. (Minimum age: 10 years for Boostrix, 11 years for Adacel). Routine vaccination: • Administer 1 dose of Tdap vaccine to all adolescents aged 11 through 12 years. • Tdap can be administered regardless of the interval since the last tetanus and diphtheria toxoid-containing vaccine. • Administer one dose of Tdap vaccine to pregnant adolescents during each pregnancy (preferred during 27 through 36 weeks gestation) regardless of number of years from prior Td or Tdap vaccination. Catch-up vaccination: • Persons aged 7 through 10 years who are not fully immunized with the childhood DTaP vaccine series, should receive Tdap vaccine as the first dose in the catch-up series; if additional doses are needed, use Td vaccine. For these children, an adolescent Tdap vaccine should not be given. • Persons aged 11 through 18 years who have not received Tdap vaccine should receive a dose followed by tetanus and diphtheria toxoids (Td) booster doses every 10 years thereafter. 5. 6a. 6b. 6c. • An inadvertent dose of DTaP vaccine administered to children aged 7 through 10 years can count as part of the catch-up series. This dose can count as the adolescent Tdap dose, or the child can later receive a Tdap booster dose at age 11–12 years. • For other catch-up issues, see Figure 2. Haemophilus influenzae type b (Hib) conjugate vaccine. (Minimum age: 6 weeks) Routine vaccination: • Administer a Hib vaccine primary series and a booster dose to all infants. The primary series doses should be administered at 2, 4, and 6 months of age; however, if PRP-OMP (PedvaxHib or Comvax) is administered at 2 and 4 months of age, a dose at age 6 months is not indicated. One booster dose should be administered at age 12 through15 months. • Hiberix (PRP-T) should only be used for the booster (final) dose in children aged 12 months through 4 years, who have received at least 1 dose of Hib. Catch-up vaccination: • If dose 1 was administered at ages 12-14 months, administer booster (as final dose) at least 8 weeks after dose 1. • If the first 2 doses were PRP-OMP (PedvaxHIB or Comvax), and were administered at age 11 months or younger, the third (and final) dose should be administered at age 12 through 15 months and at least 8 weeks after the second dose. • If the first dose was administered at age 7 through 11 months, administer the second dose at least 4 weeks later and a final dose at age 12 through 15 months, regardless of Hib vaccine (PRP-T or PRP-OMP) used for first dose. • For unvaccinated children aged 15 months or older, administer only 1 dose. • For other catch-up issues, see Figure 2. Vaccination of persons with high-risk conditions: • Hib vaccine is not routinely recommended for patients older than 5 years of age. However one dose of Hib vaccine should be administered to unvaccinated or partially vaccinated persons aged 5 years or older who have leukemia, malignant neoplasms, anatomic or functional asplenia (including sickle cell disease), human immunodeficiency virus (HIV) infection, or other immunocompromising conditions. Pneumococcal conjugate vaccine (PCV). (Minimum age: 6 weeks) Routine vaccination: • Administer a series of PCV13 vaccine at ages 2, 4, 6 months with a booster at age 12 through 15 months. • For children aged 14 through 59 months who have received an age-appropriate series of 7-valent PCV (PCV7), administer a single supplemental dose of 13-valent PCV (PCV13). Catch-up vaccination: • Administer 1 dose of PCV13 to all healthy children aged 24 through 59 months who are not completely vaccinated for their age. • For other catch-up issues, see Figure 2. Vaccination of persons with high-risk conditions: • For children aged 24 through 71 months with certain underlying medical conditions (see footnote 6c), administer 1 dose of PCV13 if 3 doses of PCV were received previously, or administer 2 doses of PCV13 at least 8 weeks apart if fewer than 3 doses of PCV were received previously. • A single dose of PCV13 may be administered to previously unvaccinated children aged 6 through 18 years who have anatomic or functional asplenia (including sickle cell disease), HIV infection or an immunocompromising condition, cochlear implant or cerebrospinal fluid leak. See MMWR 2010;59 (No. RR-11), available at http://www.cdc.gov/mmwr/pdf/rr/rr5911.pdf. • Administer PPSV23 at least 8 weeks after the last dose of PCV to children aged 2 years or older with certain underlying medical conditions (see footnotes 6b and 6c). Pneumococcal polysaccharide vaccine (PPSV23). (Minimum age: 2 years) Vaccination of persons with high-risk conditions: • Administer PPSV23 at least 8 weeks after the last dose of PCV to children aged 2 years or older with certain underlying medical conditions (see footnote 6c). A single revaccination with PPSV should be administered after 5 years to children with anatomic or functional asplenia (including sickle cell disease) or an immunocompromising condition. Medical conditions for which PPSV23 is indicated in children aged 2 years and older and for which use of PCV13 is indicated in children aged 24 through 71 months: • Immunocompetent children with chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure); chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy), diabetes mellitus; cerebrospinal fluid leaks; or cochlear implant. 7. 8. 9. 10. 11. • Children with anatomic or functional asplenia (including sickle cell disease and other hemoglobinopathies, congenital or acquired asplenia, or splenic dysfunction); • Children with immunocompromising conditions: HIV infection, chronic renal failure and nephrotic syndrome, diseases associated with treatment with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas and Hodgkin disease; or solid organ transplantation, congenital immunodeficiency. Inactivated poliovirus vaccine (IPV). (Minimum age: 6 weeks) Routine vaccination: • Administer a series of IPV at ages 2, 4, 6–18 months, with a booster at age 4–6 years. The final dose in the series should be administered on or after the fourth birthday and at least 6 months after the previous dose. Catch-up vaccination: • In the first 6 months of life, minimum age and minimum intervals are only recommended if the person is at risk for imminent exposure to circulating poliovirus (i.e., travel to a polio-endemic region or during an outbreak). • If 4 or more doses are administered before age 4 years, an additional dose should be administered at age 4 through 6 years. • A fourth dose is not necessary if the third dose was administered at age 4 years or older and at least 6 months after the previous dose. • If both OPV and IPV were administered as part of a series, a total of 4 doses should be administered, regardless of the child’s current age. • IPV is not routinely recommended for U.S. residents aged 18 years or older. • For other catch-up issues, see Figure 2. Influenza vaccines. (Minimum age: 6 months for inactivated influenza vaccine [IIV]; 2 years for live, attenuated influenza vaccine [LAIV]) Routine vaccination: • Administer influenza vaccine annually to all children beginning at age 6 months. For most healthy, nonpregnant persons aged 2 through 49 years, either LAIV or IIV may be used. However, LAIV should NOT be administered to some persons, including 1) those with asthma, 2) children 2 through 4 years who had wheezing in the past 12 months, or 3) those who have any other underlying medical conditions that predispose them to influenza complications. For all other contraindications to use of LAIV see MMWR 2010; 59 (No. RR-8), available at http://www.cdc.gov/mmwr/pdf/rr/rr5908.pdf. • Administer 1 dose to persons aged 9 years and older. For children aged 6 months through 8 years: • For the 2012–13 season, administer 2 doses (separated by at least 4 weeks) to children who are receiving influenza vaccine for the first time. For additional guidance, follow dosing guidelines in the 2012 ACIP influenza vaccine recommendations, MMWR 2012; 61: 613–618, available at http://www.cdc.gov/mmwr/pdf/wk/mm6132.pdf. • For the 2013–14 season, follow dosing guidelines in the 2013 ACIP influenza vaccine recommendations. Measles, mumps, and rubella (MMR) vaccine. (Minimum age: 12 months for routine vaccination) Routine vaccination: • Administer the first dose of MMR vaccine at age 12 through 15 months, and the second dose at age 4 through 6 years. The second dose may be administered before age 4 years, provided at least 4 weeks have elapsed since the first dose. • Administer 1 dose of MMR vaccine to infants aged 6 through 11 months before departure from the United States for international travel. These children should be revaccinated with 2 doses of MMR vaccine, the first at age 12 through 15 months (12 months if the child remains in an area where disease risk is high), and the second dose at least 4 weeks later. • Administer 2 doses of MMR vaccine to children aged 12 months and older, before departure from the United States for international travel. The first dose should be administered on or after age 12 months and the second dose at least 4 weeks later. Catch-up vaccination: • Ensure that all school-aged children and adolescents have had 2 doses of MMR vaccine; the minimum interval between the 2 doses is 4 weeks. Varicella (VAR) vaccine. (Minimum age: 12 months) Routine vaccination: • Administer the first dose of VAR vaccine at age 12 through 15 months, and the second dose at age 4 through 6 years. The second dose may be administered before age 4 years, provided at least 3 months have elapsed since the first dose. If the second dose was administered at least 4 weeks after the first dose, it can be accepted as valid. Catch-up vaccination: • Ensure that all persons aged 7 through 18 years without evidence of immunity (see MMWR 2007;56 [No. RR-4], available at http://www. cdc.gov/mmwr/pdf/rr/rr5604.pdf) have 2 doses of varicella vaccine. For children aged 7 through 12 years the recommended minimum interval between doses is 3 months (if the second dose was administered at least 4 weeks after the first dose, it can be accepted as valid); for persons aged 13 years and older, the minimum interval between doses is 4 weeks. Hepatitis A vaccine (HepA). (Minimum age: 12 months) Routine vaccination: • Initiate the 2-dose HepA vaccine series for children aged 12 through 23 months; separate the 2 doses by 6 to 18 months. • Children who have received 1 dose of HepA vaccine before age 24 months, should receive a second dose 6 to 18 months after the first dose. • For any person aged 2 years and older who has not already received the HepA vaccine series, 2 doses of HepA vaccine separated by 6 to 18 months may be administered if immunity against hepatitis A virus infection is desired. Catch-up vaccination: • The minimum interval between the two doses is 6 months. Special populations: • Administer 2 doses of Hep A vaccine at least 6 months apart to previously unvaccinated persons who live in areas where vaccination programs target older children, or who are at increased risk for infection. 12. Human papillomavirus (HPV) vaccines. (HPV4 [Gardasil] and HPV2 [Cervarix]). (Minimum age: 9 years) Routine vaccination: • Administer a 3-dose series of HPV vaccine on a schedule of 0, 1-2, and 6 months to all adolescents aged 11-12 years. Either HPV4 or HPV2 may be used for females, and only HPV4 may be used for males. • The vaccine series can be started beginning at age 9 years. • Administer the second dose 1 to 2 months after the first dose and the third dose 6 months after the first dose (at least 24 weeks after the first dose). Catch-up vaccination: • Administer the vaccine series to females (either HPV2 or HPV4) and males (HPV4) at age 13 through 18 years if not previously vaccinated. • Use recommended routine dosing intervals (see above) for vaccine series catch-up. 13. Meningococcal conjugate vaccines (MCV). (Minimum age: 6 weeks for Hib-MenCY, 9 months for Menactra [MCV4-D], 2 years for Menveo [MCV4-CRM]). Routine vaccination: • Administer MCV4 vaccine at age 11–12 years, with a booster dose at age 16 years. • Adolescents aged 11 through 18 years with human immunodeficiency virus (HIV) infection should receive a 2-dose primary series of MCV4, with at least 8 weeks between doses. See MMWR 2011; 60:1018–1019 available at: http://www.cdc.gov/mmwr/pdf/wk/mm6030.pdf. • For children aged ths through years high-risk conditions,seebelow. Catch-up vaccination: • Administer MCV4 vaccine at age 13 through 18 years if not previously vaccinated. • If the first dose is administered at age 13 through 15 years, a booster dose should be administered at age 16 through 18 years with a minimum interval of at least 8 weeks between doses. • If the first dose is administered at age 16 years or older, a booster dose is not needed. • For other catch-up issues, see Figure 2. Vaccination of persons with high-risk conditions: • For children younger than 19 months of age with anatomic or functional asplenia (including sickle cell disease), administer an infant series of Hib-MenCY at 2, 4, 6, and 12-15 months. • For children aged 2 through 18 months with persistent complement component deficiency, administer either an infant series of Hib-MenCY at 2, 4, 6, and 12 through 15 months or a 2-dose primary series of MCV4-D starting at 9 months, with at least 8 weeks between doses. For children aged 19 through 23 months with persistent complement component deficiency who have not received a complete series of Hib-MenCY or MCV4-D, administer 2 primary doses of MCV4-D at least 8 weeks apart. • For children aged 24 months and older with persistent complement component deficiency or anatomic or functional asplenia (including sickle cell disease), who have not received a complete series of Hib-MenCY or MCV4-D, administer 2 primary doses of either MCV4-D or MCV4-CRM. If MCV4-D (Menactra) is administered to a child with asplenia (including sickle cell disease), do not administer MCV4-D until 2 years of age and at least 4 weeks after the completion of all PCV13 doses. See MMWR 2011;60:1391–2, available at http://www. cdc.gov/mmwr/pdf/wk/mm6040.pdf. • For children aged 9 months and older who are residents of or travelers to countries in the African meningitis belt or to the Hajj, administer an age appropriate formulation and series of MCV4 for protection against serogroups A and W-135. Prior receipt of Hib-MenCY is not sufficient for children traveling to the meningitis belt or the Hajj. See MMWR 2011;60:1391–2, available at http://www.cdc.gov/mmwr/ pdf/wk/mm6040.pdf. • For children who are present during outbreaks caused by a vaccine serogroup, administer or complete an age and formulation-appropriate series of Hib-MenCY or MCV4. • For booster doses among persons with high-risk conditions refer to http://www.cdc.gov/vaccines/pubs/acip-list.htm#mening. Additional information • For contraindications and precautions to use of a vaccine and for additional information regarding that vaccine, vaccination providers should consult the relevant ACIP statement available online at http://www.cdc.gov/vaccines/pubs/acip-list.htm. • For the purposes of calculating intervals between doses, 4 weeks = 28 days. Intervals of 4 months or greater are determined by calendar months. • Information on travel vaccine requirements and recommendations is available at http://wwwnc.cdc.gov/travel/page/vaccinations.htm. • For vaccination of persons with primary and secondary immunodeficiencies, see Table 13, “Vaccination of persons with primary and secondary immunodeficiencies,”in General Recommendations on Immunization (ACIP), available at http://www.cdc.gov/mmwr/preview/ mmwrhtml/rr6002a1.htm; and American Academy of Pediatrics. Passive immunization. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS eds. Red book: 2012 report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics. Post Natal Depression (PND) Prevention Program Guideline Adopted: Feb. 2005 Revised: Feb. 2007 Reviewed: June 2011 Physician Contact: Dr. Virginia Maxanne Flores, M.D. During the postpartum period, between 30 and 85% of women will experience symptoms of depression. These are usually limited to the “baby blues” and can be treated with education and reassurance. However, 13 to 18% of women will develop major depression. These women require specific treatment for depression. I. Screening A. Recommend that all women be routinely assessed during the antenatal period for a history of depression or other mental health history. B. Patients should be screened for the symptoms of depression in the postnatal period as a part of a screening program for PND. II. Management A. PND should be managed in the same way as depression at any other time, but with additional considerations regarding the use of antidepressants when breast-feeding and in pregnancy. (See Scott & White Health Plan (SWHP) Tier 2 Clinical Practice Guideline “Pharmacological Management of Major Depressive Disorder, Non-Psychotic.”) B. Psychosocial interventions should be considered when deciding on treatment options for a mother diagnosed as suffering from PND. Note: Patients with bipolar or psychotic symptoms should be referred to Psychiatry. Also suicidal patients should be evaluated for admission, as well as patients who express fears of hurting their baby. III. Prescribing A. Establish a clear indication for drug treatment. B. Use treatments in the lowest effective dose. C. Drugs with a better evidence base (generally more established drugs) are preferable. D. Assess the benefit/risk ratio of the illness and treatment for both mother and baby/fetus, including consideration of: 2X increased risk of congenital heart defects with paroxetine 30% risk of neonatal abstinence syndrome after Selective Serotonin Reuptake Inhibitors (SSRI) exposure in late pregnancy 6X increased risk to neonate of persistent pulmonary hypertension with SSRI exposure after 20 weeks E. The risks of stopping tricyclic or SSRI antidepressant medication should be carefully assessed in relation to the mother’s mental state and previous history. There is no indication to stop tricyclic or SSRI antidepressant medication (EXCEPT PAROXETINE) as a matter of routine in early pregnancy. F. There is no clinical indication for women treated with TCA’s, paroxetine, sertraline, or fluoxetine to stop breast feeding, provided the infant is healthy and its progress monitored. Other modern antidepressants are probably also safe during lactation. Antidepressant Drug information: Rating for use in Adverse effects on breast-fed infants Medication Dosage range (mg per day)+ pregnancy * (NA=Information not available) Selective Serotonin reuptake inhibitors (SSRI) fluoxetine (Prozac) C Gastrointestinal effects, irritability, insomnia 20-40 paroxetine (Paxil) D NA 20 to 50 sertraline (Zoloft) C None 50-200 citalopram (Celexa) C Somnolence, decreased feeding, weight loss 20 to 60 escitalopram (Lexapro) C NA 10 to 20 Tricyclics (tertiary) amitryptyline (Elavil) C None 75 to 300 imipramine (Tofranil) D None 75 to 300 Tricyclics (secondary) desipramine (Norpramin) C None 75 to 300 nortriptyline (Pamelor) D None 25-150 protriptyline (Vivactil) C NA 15-60 Miscellaneous Bupropion (Wellbutrin) C None 200-450 mirtazapine (Remeron) C NA 15 to 45 trazodone (Desyrel) C NA 150 to 600 venlafaxine (Effexor XR) C NA 75 to 225 Duloxetine (Cymbalta) C NA 40-60 *--U.S. Food and Drug Administration drug rating for use of drugs in pregnancy: A=No risk in controlled human studies B=no evidence of risk to fetus; C=risk to fetus cannot be ruled out; D=evidence of risk to human fetus; + Adult daily dosages are adapted from AHCPR and women may need lower daily dosages. Guideline based on Recommendations of the Royal College of Physicians, Scotland; US Preventive Health Task Force; and other expert recommendations from the American Academy of Family Physicians. Scott and White Physicians from Dept. of Psychiatry, OB-GYN, and Family Medicine participated in the development and review of this guideline. 2007 reviewed by OB-GYN and Family Medicine physicians of the Scott and White Health Plan Prenatal Team. 2009 reviewed by OB-GYN and Family Medicine physicians of the SWHP Prenatal Team, as well as Dept. of Psychiatry, Scott & White Clinics and Health Integrated, Inc. OB-GYN Postpartum Dictation Reminder Demographics: Name; Date of Birth; MRN Name of Primary Care Physician: Chief Complaint: Allergies: Subjective or History of Presenting Illness: Age: Sex of child Race: Gestational age Gestational information Baby weight Type of Delivery Apgars Date of Delivery Breast feeding Labor and delivery information Sexual activity Vaginal Tears Bowels, Blood loss, bleeding, Bladder Periods Antepartum Patient concerns complications Evaluation of Mood: symptoms of depression. Eating, sleeping, crying, coping, suicidal ideation, feelings of wanting to harm baby etc. Medications-(including contraceptives) Past Medical History Family Medical History Objective: Vital Signs: BP, Pulse, Height, Weight General: mental status, orientation, distress Physical: Head, Neck Cervix Cardiovascular Pap Smear,(spatula, Lungs cytobrush,) Breasts Bimanual: Uterus Abdomen evaluation Pelvic: External genitalia, BUS, Rectovaginal: Vagina lesions, Discharge, Procedure(s): Muscular Support, Assessment Plan Courtesy Copy Postpartum Visit note to primary care physicians that have no access to the electronic record. Scott & White Health Plan Prenatal / Perinatal Guidelines for Normal Pregnancy Tier 2 Guideline Purpose: To recommend prenatal / perinatal management of uncomplicated pregnancy Patient Population: Uncomplicated Pregnancy patients Originally Developed / Endorsed by: SWMH Obstetrics Quality Assurance Committee Adopted: Dec. 16, 1998 Contact Physician: Dr. Mark Beaird Revised Dates: Feb. 1999; March 1999; Dec. 2000; Feb. 2001; April 2003; Feb. 2005; Feb. 2007; Feb. 2009; Dec. 2011 Date to be reviewed: December 2013 Frequency of visits and care rendered should be determined by a woman’s individual needs and risk factors. SERVICES Obstetrical Evaluations FIRST TRIMESTER (WEEKS 0 to 13) An initial evaluation should be performed prior to 13 weeks including: - Comprehensive health history, including previous history of depression and/or postpartum depression* - Family & Social history - Pregnancy history - Genetics screening and counseling about testing options, including information about optional aneuploidy, cystic fibrosis, and hemoglobinopathy screening - Physical exam, including height, weight, & blood pressure - Psychosocial screening - Tobacco cessation mgmt plan if indicated SECOND TRIMESTER (WEEKS 14 to 28) -Between 16 to 19 weeks: Ultrasonography (if clinically indicated) -Between 15 to 18 weeks: maternal serum screening should be discussed. THIRD TRIMESTER (WEEKS 29 to 42) POSTPARTUM (3 to 8 WEEKS AFTER DELIVERY) At 35-37 weeks gestational age: vaginal culture for Group B streptococcus and HIV test. -Between 24 to 28 weeks: glucose tolerance screening (unless no risk factors), and hematocrit. -At 28 weeks: If patient is Rh negative and unsensitized, and Rh of baby’s father is positive or unknown, repeat antibody testing and administer Rhogam. Testing urine at 28 weeks or as needed. -Labwork to be obtained and reviewed by early second trimester: urine culture, hemogram, platelets (optional), blood type & Rh, antibody screen, hepatitis B surface antigen, rubella titer, syphilis screening, cervical cytology, hemoglobinopathy screening (if indicated), gonorrhea & chlamydia screening (unless considered extremely low risk), and HIV testing (offered with counseling & explanation of possible consequences and benefits) -Multiparous patients do not require repeat rubella titer if previously documented as immune, or repeat blood type & Rh. Routine Office Visits Patient Education Information Presented Regarding: Every 4 to 6 weeks: Blood pressure, weight, screen for significant edema, fundal height, documentation of fetal heart activity (after approximately 10 weeks), and urine dipstick for albumin and glucose. Every 2 to 4 weeks until 36 weeks gestation, then weekly until delivery: -Blood pressure, weight, screen for significant edema, fundal height, documentation of fetal heart activity and fetal presentation, urine dipstick for albumin and glucose Follow-up on or between 21 and 56 days after delivery: -Nutrition, exercise, sexual activity, work activity -Tobacco, alcohol, and drug restriction -Postpartum Depression -Breast feeding -Onset of labor, rupture of membranes, abnormal bleeding -Fetal activity -Review Family Planning -Preparation for childbirth (Refer to classes) -Vaginal Birth After Cesarean (if indicated by patient’s history) -Breast feeding versus bottle-feeding -Family Planning *See also the Post Natal Depression Prevention Program Guideline Resources: Schedule is based on recommendations from: American College of Obstetricians and Gynecologists (ACOG) -Evaluation of weight, blood pressure, breasts, abdomen and a pelvic exam. -Screening for postpartum depression.* -Nutrition and exercise anticipatory guidance Colorectal Cancer Screening Tier 2 Guideline Purpose: To delineate screening for colorectal cancer. Patient Population: 1. Low Risk – Age < 50 or > 80 and no risk factors, non-operative candidate, or life expectancy < 3 years. 2. Average Risk – Age 50 to 80 with no risk factors. 3. High Risk - First degree relative < 70 with colon cancer, first degree relative < 60 with polyps, two first degree relatives with polyps and/or colon cancer, familial multiple cancer syndrome, or longstanding inflammatory bowel disease. Developed by: Physicians representative of the S&W Departments of Family Medicine, Internal Medicine and Surgery. Source: American Cancer Society, American College of Gastroenterology (ACG); American Gastroenterological Association (AGA) and the American Society of Gastrointestinal Endoscopy (ASGE). Contact Person: Dr Andrejs Avots-Avotins (Department of Medicine, Division of Gastroenterology). SWHP Quality Improvement Committee Approved: June 1999. Date of Last Review: June 2004, August 2004, August 2006, August 2008, August 2010, and August 2012 Scheduled Review Date: August 2014 INITIATION OF SCREENING AND SUBSEQUENT SURVEILLANCE EXAMS IN PATIENTS WITH INCREASED RISK First degree relative with polyps < age 60 or colon cancer < age 70 Colonoscopy at age 50 or 10 years younger than the youngest affected family member, whichever is earlier. Colonoscopy to be performed at 5 year intervals. Hereditary Non-Polyposis Colorectal Cancer Syndrome - HNPCC Colonoscopy beginning at age 25 or 5 years younger than the age at diagnosis of the youngest affected relative, whichever is earlier. Colonoscopy to be performed every 2 years and then annually after age 40. Genetic testing available. Familial Adenomatous Polyposis - FAP Annual sigmoidoscopy beginning at age 10-12 years with colectomy when polyps identified. After age 40 sigmoidoscopy every 3-5 yrs if polyps have not been identified. Genetic testing available. Pancolonic inflammatory bowel disease Surveillance begins after 10 years of disease duration with colonoscopy every 2 years with systematic biopsies to detect dysplasia. Left sided or segmental colitis Surveillance begins after 15 years of disease duration with colonoscopy every 2 years with systematic biopsies to detect dysplasia. Page 1 of 2 Colorectal Cancer Screening NO SCREENING • Age < 50 & no risk factors • Age > 80 • Non-operative candidate • Life expectancy < 3yrs NOTE Patients with fe def anemia or patients with NON-anal outlet bleeding should be referred for GI consultation AVERAGE RISK • Age >50 & no risk factors Colonoscopy q 10 yr or Flex Sig and BE q 5 yr or **FOBT q 1 yr + Flex Sig q 5 yr or Flex Sig q 5 yr or **FOBT q 1 yr (**Fecal Occult Blood Test (FOBT) 3 card specimen) Significant Findings: Polyp > 0.5cm or ANY + FOBT HIGH RISK • degree relative < 70 with colon cancer • 1st Degree Relative < 60 with polyps • Two 1st degree relatives with polyps and/or colon cancer • Familial multiple cancer syndrome • Longstanding inflammatory bowel disease 1st Complete Colon Exam Colonoscopy beginning at age 50 or 10 yr younger than the youngest affected family member OR FOR Longstanding inflammatory bowel disease--Colonoscopy beginning 10 yr after disease onset Colorectal Cancer Surveillance LOW RISK • Single <0.5 cm polyp • Hx of polyp(s) with 3 negative colonoscopies over a 10 year period NO Screening for 5 yr then AVERAGE RISK colon cancer screening INCREASED RISK • High risk family history of colon cancer or polyps with previously negative colonoscopy > 4 years ago • Multiple polyps (3 or more regardless of size) •Polyp > 1cm • CA in situ or low risk Duke’s A cancer in pedunculated polyp • Hx of colon cancer (assuming negative colonoscopy within 12 mo of cancer resection) COLONOSCOPY warranted: Interval from last colonoscopy should be determined by endoscopist Page 2 of 2 CLINICAL PRACTICE GUIDELINES FOR COLORECTAL CANCER SCREENING Scott and White Health Plan (SWHP) has adopted American Cancer Society Guidelines for the Early Detection of Cancer located at the following internet website link: http://www.cancer.org/docroot/PED/content/PED_2_3X_ACS_Cancer_Detection_Guidelines_36.asp and American Society for Gastrointestinal Endoscopy (ASGE) guideline: colorectal cancer screening and surveillance, Gastrointestinal Endoscopy Volume 63, No. 4 ; 2006 located at the following internet website link: http://www.asge.org/WorkArea/showcontent.aspx?id=3334 and American College of Gastroenterology Guidelines for Colorectal Cancer Screening 2008 located at the following internet website link: http://www.acg.gi.org/physicians/pdfs/CCSJournalPublicationFebruary2009.pdf SWHP Guideline Approval Body: SWHP Quality Improvement Subcommittee Date of Adoption: August 10, 2010 Physician Sponsor: Dr. Andrejs Avots-Avotins, M.D., Scott & White Healthcare Department of Medicine, Division of Gastroenterology. Board Certification American Board of Internal Medicine, (ABIM) and Gastroenterology, (ABIM) Scott & White Health Plan Provider Manual Section 4 Disease Management Programs Disease Management Programs The following are Disease Management Programs offered at no charge by the Scott & White Health Plan to all Health Plan members. Asthma: The Scott & White Health Plan (SWHP) has begun an Asthma initiative as part of its chronic disease management program. A Multi-disciplinary team consisting of physicians, administrative staff, nurses, and medical information systems personnel was assembled to monitor and enhance the program. The objectives are to improve coordination of care for asthma patients and enhance quality of life by encouraging and empowering members with asthma to participate in managing their own health through provision of pertinent information, tools, training and care management support. It was determined that an opportunity existed to decrease emergency room utilization, clinic/hospital utilization, and drug utilization (with a byproduct being decreased cost of care) while improving the quality of life for SWHP asthmatic members and increasing physician satisfaction in the system's monitoring and treatment process. Secondary Preventative Coronary Artery Disease: Scott & White Health Plan found that chest pain and unstable angina rank as the #1 and #4 inpatient diagnoses in the over 65 age group, ischemic heart disease ranks #5 in the outpatient diagnoses, and chest pain ranks #1 in emergency room diagnoses (more than doubled in 2000 over 1999). The SWHP Secondary Prevention of Cardiovascular Disease Team addresses these high volume diagnoses. Two Months After Event: 1. Letter mailed to all members who have had a cardiac event with recommendations for "heart healthy living". 2. These members can return a postage paid postcard to receive additional educational material. 3. The primary care physician (PCP) is mailed a list of their SWHP members who have had a cardiac event to facilitate timely follow-up. 4. The comprehensive list of SWHP members who have had an event is e-mailed to those administrative staff who are able to facilitate a follow-up appointment and lab work. Four Months After Event: 1. Primary Care Physicians are mailed a reminder memorandum for all SWHP members on their panel who have not had a cholesterol level taken by four months after cardiac event. 2. A letter is mailed to the member suggesting they contact their PCP for follow-up and possible lab work Yearly And As needed: 1. The Coronary Artery Disease Team meets yearly after the guideline has been measured by chart review. Based on results of the measures, the Secondary Prevention of Coronary Artery Disease Team may choose to focus on a different aspect of the guideline, initiating new program features, as the team deems necessary. 2. As new scientific evidence indicates a need for change, the guideline is reviewed and revised to serve as a reference for all S&W and contracted network physicians. Diabetes and Congestive Heart Failure: Four clinics are staffed with two Chronic Disease Management (CDM) Nurses who work with Scott and White Health Plan adult members with the diagnosis of Diabetes or Congestive Heart Failure (CHF). A multi-disciplinary team, chaired by a Family Medicine physician, reviews team activities and reports. An Endocrinologist chairs a team that meets every six months to review the clinical data and recommend interventions including an annual mail out of educational materials to members with Diabetes. CDM Nurses provided a list of members admitted as an inpatient or treated in the emergency room with the diagnosis of CHF submitted on the claim form as one of the top 3 diagnoses. Analysis of program performance data is presented to the team. Updated brochure used to provide information to health care practitioners about the program. CHF Algorithm created and approved by the CDM Team. New members eligible for the program are identified quarterly using claims data. For more information regarding these Disease Management Programs call Quality Improvement at 254-298-3097 or toll free at1-800-321-7947, extension 3097. Scott & White Health Plan Provider Manual Section 5: Accessibility Standards POLICY / PROCEDURE Standards for Timely Primary Care Access TOPIC: Accessibility of Services CATEGORY: Quality Improvement Policy Number: QI 5.A Original Effective Date: October 1996 (100.2) Review w/o revision dates: 10/96; 12/99; 4/03, 2/06; 2/08; 9/10 Revision Dates: 12/96; 2/97; 9/00 Scope: Cross Reference: Health Plan NCQA QI 5A, TDI (28 TAC §11.1606), CMS (42 CFR §417.106) Originated by: Quality Improvement Approved by: (QIS Chairman) I. POLICY: SWHP has established the following standards for timely accessibility of primary care, emergency care, and after-hours care services. A. Level of Care Standard 1. Timeliness of Preventive Primary Care appointments Examples: non-symptomatic office visits including well/preventive care appointments. (Examples: annual physicals, pediatric/adult immunization, and annual GYN exams). . 2. Timeliness of Routine Primary Care appointments. Primary care for non-urgent symptomatic conditions. (Examples: colds, rashes, headache, joint/muscle pain.) 3. Timeliness of Urgent Primary Care appointments. (Examples: high fever, persistent diarrhea and vomiting.) 30 working days 5 working days 24 hours 4. Timeliness of Emergency Care. Same day 5. Access to After-Hours Care 24 hour phone available Answering machine/service advising members of afterhour options for care present in all PCP offices. B. SWHP measures compliance with above standards by collecting and analyzing the data, identifying opportunities for improvement, implementing interventions, and measuring the effect of the interventions. This information is reported at least yearly to the Quality Improvement Subcommittee. Page 1 of 1 POLICY / PROCEDURE Standards for Timely Behavioral Health Policy Number: QI 5.3 Original Effective Date: 04/00/02 Review w/o revision dates: 4/03, 2/06, 2/08, 12/10 Revision Dates: 9/03 Scope: Cross Reference: Scott & White Health Plan NCQA Standard QI5, TDI (28 TAC §1607), CMS (42 CFR §417.106) Originated by: QI Division Access and Behavioral Health Telephone Access TOPIC: Accessibility of Services Approved by: (QIS Chairman) CATEGORY: Quality Improvement I. POLICY: A. SWHP has established the following standards for timely accessibility of behavioral and mental healthcare services: Routine office visit appointments 10 working days Urgent care 24 hours‡ Non‐life‐threatening emergency care 6 hours‡ Life‐threatening emergency care Immediately‡ ‡ SWHP members have direct access to Behavioral Health Practitioners by calling their office or going to the Emergency Room. B. Telephone Access: No centralized screening or triage is used. Page 1 of 1
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