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 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: x The quality and safety of clinical care and quality of practitioners and providers x 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: x The credentialing office of Physicians of King's Daughters P.A. for King’s Daughters’ physicians x Shannon Clinic credentialing office for all Shannon physicians x SW Medical Staff Office for Scott & White practitioners x 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: x Approves the QI Program Description, Work Plan, and Annual Evaluation Delegation responsibilities include: x Delegates externally, credentialing/recredentialing decisions and oversight of verification as defined on the previous page. x Delegates oversight of delegated credentialing activities to the SWHP Credentials Committee x Delegates the peer review function and credentialing/recredentialing final approval of practitioners and providers, as applicable, to the SWHP Credentials Committee x 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: x Reviews and evaluates the QI Program Description, QI Work Plans, and the Annual Evaluation x Reviews select monthly QI Sub-committee reports that delineate recommendations, actions taken and improvements made x Ensures that the QI Program and Work Plan are implemented effectively and result in meaningful improvements in care, safety and service x 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: x Annually develops and oversees the QI Program Description and Work Plan x Annually evaluates the effectiveness of the QI Program x 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 x Reviews aggregated, trended reports focusing on variances, contributing causes, and appropriateness of action plans x Evaluates data for quantitative and qualitative trends and variances especially as it relates to medical safety x Promotes benchmarks and/or performance goals x Identifies and analyzes SWHP quality activities, directs action plan(s) for improvement and evaluates outcomes of action plan implementation x Directs the prioritization of SWHP quality improvement initiatives to ensure that resources are adequate x Reports to the SWHP Board QIC x Reviews the UM Program Description, UM Program Evaluation, and UM Criteria, annually. x Oversees adoption of clinical practice guidelines and medical record standards x Recommends disease guidance programs to the Board QIC and monitors effectiveness of programs x Oversees the evaluations of approved delegated QI activities x 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: x x x x SWHP Medical Directors SWMH) Chief Medical Officer SWHP Medical Director for System Improvement SWHP Associate Vice President - Medical Services x SWMH Chief Nursing Officer/Chief Operating Officer x SWMH Chief Nursing Executive and System Director of Quality, Safety and Regulatory Serv. x x x x SWHC- Round Rock Chief Medical Office SWHC Chief Medical Officer SWHC Associate Chief Medical Officer SWHC Chairman of Department of Medicine x SWHC Chairman of Department of Orthopedic Surgery x SWHC Chairman of Department of Surgery SCOTT AND WHITE HEALTH PLAN QUALITY IMPROVEMENT PROGRAM DESCRIPTION 2011 x Hillcrest Baptist Medical Center Chief Medical Officer and Executive Vice President x Scott & White Healthcare (SWHC) Chief Operation Officer x SWHC Vice President Revenue Cycle Operations Hospital Division x SWHC Vice President, Managed Care and Decision Support x SWHC Chief Financial Officer x SWHC Vice President, Pharmacy Services x SWHC Director of Sourcing and Contracting Functions: x Reviews/analyzes the literature review provided by the clinical participants regarding the topic of review x Makes recommendations regarding SWHP coverage of the therapy under review, including any prior-authorization review criteria needed by the Plan x Maintains minutes as documentation of the outcome of the assessments and determinations made x 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: x Analyzes utilization reports x Determine if patterns of fraudulent billing exist x Identifies opportunities for controlling utilization and/or for cost-savings x 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: x Review credentialing and re-credentialing data for all network providers and practitioners who will be rendering care to SWHP enrollees x Review and approve Credentialing Policies and Procedures, including performance criteria x Perform Peer Review of providers who fail to meet the performance criteria and decide on appropriate action(s) x Provide oversight of all delegated credentialing programs and activities x Review applicants’ credentials and approves or denies the applications x 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: x 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. x To develop an evidence-based formulary of drugs accepted for use in the institution and provide for its constant revision. x To establish programs and procedures that help ensure cost-effective drug therapy. x To participate in quality-assurance activities related to the distribution, administration and the use of medications. x To oversee medication-use review programs and studies and review the results of such activities. x 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: x Reviews and analyzes race/ethnicity and preferred language data, making recommendations to the Quality Improvement Subcommittee, as needed x Monitors interpreter usage and Health Plan materials available in other than English x Establishes programs, policies and procedures that address cultural diversity x Review regulatory regulations and accrediting standards to ensure Health Plan compliance x Identifies areas where there is ethnic or racial disparity in care provided x 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: x Review all safety issues x Review complaints regarding safety x Look for “never events”, falls, avoidable infections, adverse events and other clinical safety issues x 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: x Provide staff support for QI initiatives, as needed x Develop initial drafts of program documents for review and approval by the QIS x 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 x 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: x Review, evaluate, and make recommendations for credentialing and recredentialing files x Review individual medical records reflecting adverse occurrences x Review proposed practice guidelines and clinical protocols x Review proposed QI study designs x 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: x 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 x 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) x 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: x Written measurable yearly objectives for the quality and safety of clinical care and quality of service activities scheduled, including Behavioral Health improvement initiatives x Yearly objectives and planned activities, time frames for achieving, and those responsible x Monitoring of previously identified issues x 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: x Description of completed and ongoing QI activities that address quality and safety of clinical care and quality of service, including delegated functions. x 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. x 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: x Condition monitoring x Patient adherence to the program’s treatment plans x Consideration of other health conditions x Lifestyle issues, as indicated by practice guidelines Members may be identified using one or more of the following methods: x Claim or encounter data x Pharmacy data, if applicable x Health risk appraisal results x Laboratory results, if applicable x Data collected through the Utilization Management or case management process x 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: x Health Information and Nurse Advice Line x Disease Guidance Program x Case Management Program x Utilization Management Program x 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. 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:OnlineProviderManual–www.swhp.org.Clickon“Providers”greentab. Clickon“QualityImprovement”.Clickon“ClinicalGuidelines”. . ApapercopyisavailableuponrequestfromtheScott&WhiteProviderRelations Department.Calltollfree18003217947ext.3064or2542983064. !"# $ % ' Tier #2: Address the management of a disease process managed by multiple organizational units or departments. OSTEOPOROSIS GUIDELINE 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, 04/2010, 04/2012 Reviewed: 04/2012, Reviewed 05/2014 Next Scheduled Review Date: 05/2016 Recommend to patient: Calcium 1,200mg (may need supplement.) 1 Vitamin2 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. Yes 3 No Get baseline measurement of B for monitoring purposes. Yearly perform one of the following: In post-menopausal women Fracture Risk Assessment (FRAX) 4 or 5 Osteoporosis Risk Assessment (ORAI) with assessment for secondary causes for osteoporosis. Screen for secondary causes 7 - Woman 65 years or older. - Man 70 or older. - Alendronate 70mg per wk. - Risedronate 35mg wk. No Yes If intolerant, consider: - Denosumab 60 mg sub q every 6 months - Zoledronate 5 mg yearly. 7, 8 - . Get baseline BMD measure PTH (1-34) Normal Intolerant Osteoporosis Osteopenia One of the following: Screen for secondary causes - Raloxifene 60mg - Calcitonin (nasal spray or injectable). Continue yearly assessments 9 Continue yearly assessments and recommendations Yes 6 Is patient? One of the following is indicated: No Continue present therapy. 7 Frax calculation = 20% risk of osteoporotic fracture or hip fracture risk 3%. One of the following: - Alendronate 35mg per wk - Risedronate 35mg wk If intolerant, consider 7, 8, 9 - Zoledronic acid 5 mg IV yearly - Raloxifene 60mg per day 7 -Alendronate 70mg per wk -Ibandronate 150 mg a month -Risedronate 35 mg wk If intolerant,consider - Zoledronic acid 5 mg IV yearly. 7, 8, 9 - Denosumab 60 mg sub q every 6 months, then - 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 > 3-5 years use consider medication change to PTH 1-34 or drug holiday. 7 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 change to PTH 1-34. 4, 7 1. Patients with normal renal function. 2. Vitamin D3 = cholecalciferol. 3. 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. 4.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. It 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). 5.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/ 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. After 3 years of bisphosphonate treatment, patients should be encouraged to discuss the risks and benefits of further treatment with their personal physician. 8. 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. 9. Consider Endocrinology Consult 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 Guideline for Hypertension Developed by: Scott and White Physicians Approved: 10/14/2003 Reviewed: 10/2005; Revised 12/2007, 11/2009, 9/2011, 5/2012, 5/2014 Baseline workup (ECG & Lab: BMP, Lipid Panel, UA) Assess for Major CVD risk factors- See Figure 1 Adult aged ≥18 years with hypertension Implement lifestyle interventions (Continue throughout management) See Figure 2 Set blood pressure goal and initiate blood pressure loweringmedication based on age, diabetes, and chronic kidney disease (CKD) General Population - (no diabetes or CKD) Diabetes or CKD present Age <60 years Age ≥60 years All ages Diabetes present No CKD Blood pressure goal Blood pressure goal SBP<150 mm Hg SBP <140 mm Hg DBP <90 mm Hg DBP<90 mm Hg Non-black Blood pressure goal Blood pressure goal SBP <140 mm Hg SBP <140 mm Hg DBP <90 mmHg DBP <90 mm Hg Black Initiate thiazide-type diuretic or ACE1 or ARB or CCB, alone or in All ages CKD present with or without diabetes All races Initiate thiazide-type diuretic or CCB, alone or in combination Initiate ACE1 or ARB, alone or in combination with other drug class Select a drug treatment monthly and titration strategy until BP goal achieved A. B. C. D. Maximize first medication before adding second or Add second medication before reaching maximum does of first medication or Start with 2 medication classes separately or as fixed-dose combination if BP ≥160 SBP and/or ≥100 DBP Compelling indications for individual drug classes-See Figure 3 At one month; At goal blood pressure? YES NO Consider causes of Resistant Hypertension- See Figure 4 Reinforce medication and lifestyle adherence For strategies A and B, add and titrate thiazide-type diuretic or ACE1 or ARB or CCB (use medication class not previously selected and avoid combined use of ACE1 and ARB). At two months; At goal blood pressure? YES NO Consider causes of Resistant Hypertension- See Figure 4 Reinforce medication and lifestyle adherence Add additional medication class (eg, β-blocker, aldosterone antagonist, or others) and/or refer to physician with expertise in hypertension management. At three months; At goal blood pressure? YES NO Consider causes of Resistant Hypertension- See Figure 4 Check for Identifiable causes of Hypertension- See Figure 5 Reinforce medication and lifestyle adherence. Add additional medication class (eg, β-blocker, aldosterone antagonist, or others) and/or refer to physician with expertise in hypertension management. At four months; At goal blood pressure? NO Consider referral or consultation with HTN specialist YES Continue current treatment and monitoring. Follow up @ 3, 6, 12 months at providers discretion *This guideline is not meant to substitute for the provider’s clinical judgment *If BP is <140/90 orthostatic without symptoms, then no need to adjust medications downward Copyright 2013 American Medical Association. All right reserved. Figure 1 Major CVD Risk Factors Hypertension 2 Obesity (BMI ≥30 kg/m Dyslipidemia Diabetes mellitus Cigarette smoking Physical inactivity Microalbuminuria, estimated GFR 60mL/min Age (>55 for men,>65 for women) Family history of premature CVD (men age<55, women age <65) Figure 2 MODIFICATION Weight reduction DASH eating plan Dietary sodium reduction Aerobic physical activity Moderation of alcohol consumption RECOMMENDATION 2 Maintain normal body weight (BMI 18.5-24.9 kg/m ) Adopt a diet rich in fruits, vegetables, and lowfat dairy products with reduced content of saturated and total fat. Reduce dietary sodium intake to ≤100 mmol per day (2.4 g sodium or 6 g sodium chloride). Regular aerobic physical activity (e.g., brisk walking) at least 30 minutes per day, most days of the week Men: limit to ≤2 drinks* per day. Women and lighter weight persons: limit to ≤1 drink* per day. (*1 drink= ½ oz or 15 ml ethanol (e.g., 12 oz beer, 5 oz wine, 1.5 oz 80 proof whiskey). Figure 3 COMPELLING INDICATION INITIAL THERAPY OPTIONS Heart failure Post myocardial infarction High CVD risk Diabetes Chronic kidney disease Recurrent stroke prevention THIAZ, BB, ACEI, ARB, ALDO ANT BB, ACEI, ALDO ANT THIAZ, BB, ACEI, CCB THAIZ, BB, ACEI, ARB, CCB ACEI, ARB, THIAZ, ACEI Figure 4 CAUSES OF RESISTANT HYPERTENSION Improper BP measurement Excess sodium intake Inadequate diuretic therapy Medication o Inadequate doses o Drug actions and interactions (e.g., NSAIDS, illicit drugs, sympathomimetics, oral contraceptives) o OTC drugs and herbal supplements Excess alcohol intake Identifiable causes of hypertension (See Figure 5) Figure 5 Identifiable Causes of HTN Sleep Apnea Drug induced/related Chronic Kidney Disease Primary Aldosteronism Renovascular Disease Cushing’s Syndrome or Steroid Therapy Pheochromocytoma Coarctation of Aorta Thyroid/Parathyroid Disease AVG. SBP REDUCTION RANGE (Effects are dose and time dependent) 5-20 mmHg/10kg 8-14 mmHg 2-8 mmHg 4-9 mmHg 2-4 mmHg Chronic Obstructive Pulmonary Disease (COPD) Guideline Tier 2 Guideline Developed by: The Scott & White COPD CHASM Working group Contact physician: Dr. Jim Barker, MD Date of adoption: November 2009 Revision date: January 2014 SWHP COPD GUIDELINE, 2014. This is an evidence based guideline built by the CHASM COPD working group and based on multiple published guidelines. Please see references at end. COPD (Chronic Obstructive Pulmonary Disease) is, in general, a combination of Chronic Bronchitis and Pulmonary Emphysema. It may also be seen in patients with other obstructive lung diseases such as asthma, bronchiectasis, and bronchopulmonary dysplasia when those individuals have smoked. The pathogenesis is by far tobacco smoking related. The 10 to 15% of individuals with COPD (at least in the United States) who are never smokers have had second hand smoke exposure, occupational exposure, or a genetic proclivity. Patients who grew up in third world countries could also develop fixed obstructive lung disease (COPD) from inhaling burning biomass under poor ventilation. COPD is the third leading cause of death in the United States and is very expensive in loss of health care dollars. See Figure 1. Specific recommendations are the following: 1. Prevention: a. Teens and pre-teens are high risk for smoking onset if their peers or parents smoke. SWHP should partner with community agencies to actively deter onset of smoking in these high risk individuals. 2. Screening: a. Smokers or former smokers age 40 or older should be screened with a simple five question questionnaire. See Figure 2. A score of 5 or higher (out of a possible 10) should trigger a diagnostic spirometry test. b. Others should be screened if there is a high index of suspicion such as positive family history, daily productive cough two years in a row, or significant occupational exposure. c. Alpha 1 antitrypsin testing should be done on those with COPD onset at age less than 45, familial COPD, or low alpha 1 serum levels. 3. Diagnosis: a. Spirometry is the gold standard. Spirometry should be done in any individual suspected of having COPD. Spirometry can be office based or Pulmonary Function hospital laboratory based. A high quality test is present when values are reproducible on at least three attempts +/- 3%. An FEV1 less than 80% and FEV1/FVC ratio below 70% is considered abnormal and proof of disease, in appropriate settings. Post bronchodilator results are the preferred ones (according to GOLD criteria). b. Suggestive symptoms are shortness of breath with minor exertion, daily productive cough, and wheezing. However, these are non-specific. c. All patients who have a positive population health screener or who are suspected of having COPD should have spirometry. Other lung diseases or even anemia can induce shortness of breath. An accurate diagnosis is always desirable! 4. Emergency Department and Inpatient Diagnosis and Treatment: a. The recommended corticosteroid dose is 40 mg/day of oral prednisone (or equivalent intravenously) for 10 days or less. b. Frequent albuterol inhalations via MDI or nebulizer are recommended. c. Antibiotics are useful in an exacerbation especially if increased sputum and fever are present. d. Arterial Blood Gases are recommended in those patients who appear ill. (Difficulty speaking, tachypnea, altered mental status, sternocleidomastoid accessory muscle use for example.) ABGs allow stratification of severity. Consider ICU admission if respiratory acidosis is present. e. Indications for hospitalization may include: i. High risk co-morbid conditions such as pneumonia, CHF, cardiac arrhythmias. ii. Failed outpatient management. iii. Unrelieved dyspnea iv. Inability to eat or sleep due to dyspnea. v. Progressive hypoxemia or hypercarbia vi. Altered mental status vii. Inability to care for oneself at home. viii. Marked worsening from baseline f. Indications for Intensive Care Admission may include: i. Respiratory Failure requiring mechanical ventilation or continuous noninvasive ventilation ii. Presence of other end organ dysfunction: shock, renal failure, coma, myocardial infarction and so on. iii. Hemodynamic instability. iv. Inability to clear secretions v. Respiratory acidosis or impending respiratory failure g. Indications for Non-Invasive Ventilation: i. Respiratory acidosis with pH < 7.36 and PaCO2 > 45 torr. ii. Tachypnea with breath rate > 25/min iii. Intact gag reflex iv. Able to cooperate and follow commands v. Consider ICU admission if non-invasive ventilation is initially continuous. h. Consider the addition of ipratropium to albuterol if unrelieved tachypnea or dyspnea. i. Consider Pulmonary Medicine consultation if the patient fails to improve promptly. j. Consider other precipitating causes for COPD exacerbation (besides viral or bacterial bronchitis) such as: i. Congestive Heart Failure ii. Community Acquired Pneumonia iii. DVT/PE k. Oxygen therapy i. Commonly needed during exacerbations because of V/Q mismatching. ii. Prescribe to attain SaO2 at least 88% or PaO2 at least 60 mm Hg. l. Criteria for Discharge: i. Symptoms returning to baseline. Patient able to eat and sleep. ii. Hemodynamics stable. iii. Able to ambulate (presuming ambulatory pre-hospitalization) iv. Understands home medications. v. Able to go at least four hours in between albuterol usages. m. Transition of care issues: i. Consider Outpatient Pulmonary Consult if frequent admissions or exacerbations are occurring. ii. See PCP within 7 days of discharge. iii. May need short term oxygen. Re-assess after 30 days or when stable at home. 5. Outpatient maintenance therapy a. Smoking cessation. i. This is the only intervention proven to change disease trajectory and lengthen lifespan. ii. Severely addicted patients will need adjunctive therapy. 1. The absolute best results occur with group therapy, nicotine replacement, and bupropion. Bupropion may be needed for several months in some individuals. b. Frequent exacerbations: i. One hospitalization or more per year and/or two or more exacerbations of COPD/year = frequent. c. d. e. f. ii. Review for possible reasons of exacerbation: CHF, poorly controlled hypertension, bronchiectasis, continued smoking. iii. Medical therapy: 1. Inhaled corticosteroid (Advair; Symbicort; others) with a long acting Beta agonist OR 2. A PGE2 inhibitor such as theophylline or roflumilast (daliresp) OR 3. A macrolide such as azithromycin or erythromycin iv. Pulmonary Medicine consultation Corticosteroids i. Only indicated for exacerbations and should be used in doses of 40 mg prednisone or less over 7 to 10 days. Vaccinations i. Yearly influenza vaccine. ii. Pneumovac is recommended although efficacy is in question from recent studies. GOLD STAGING: i. A. Minimal symptoms, no hospitalizations in the previous year, and mild to moderate obstruction on Spirometry. ii. B. More symptoms. No recent hospitalizations. Mild to Moderate obstruction on Spirometry. Dyspnea with exercise or ADLs. iii. C. Moderate to Severe Obstruction on Spirometry. Hospitalized within last year or 2 or more exacerbations. Minimal baseline symptoms or Dyspnea. iv. D. Moderate to Severe Obstruction on Spirometry. Hospitalized within last year or 2 or more exacerbations. Quite symptomatic. Therapy by GOLD Stage: i. Prn Albuterol inhaler 2 puffs every four hours indicated for all groups. ii. Some patients will benefit from addition of Ipratropium (combivent respimat inhaler). It is unclear which patients fit this however. iii. Groups B through D benefit significantly from Pulmonary rehabilitation. 1. PFTs do not typically improve but Quality of Life scores improve, exacerbations and doctor visits decrease, and hospitalizations decrease. 2. Pulmonary Rehab programs include education including tips for self-management and graded exercise to improve flexibility and endurance. iv. Group B: 1. Long acting anticholinergic such as Tiotropium 18 mcg , 1 puff a day OR 2. Long acting beta inhaler such as Formoterol or Salmeterol. v. Group C: 1. Long acting anticholinergic such as Tiotropium 18 mcg , 1 puff a day OR 2. Combination long acting Beta Agonist/Corticosteroid agonist such as Advair 250/50 1 puff twice a day. vi. Group D: 1. Long acting anticholinergic such as Tiotropium 18 mcg , 1 puff a day AND 2. Combination long acting Beta Agonist/Corticosteroid agonist such as Advair 500/50 1 puff twice a day. g. Oxygen i. Oxygen is indicated for those patients with baseline hypoxemia (PaO2 < 55 or <60 with objective erythrocytosis or right heart failure). ii. Some patients may need oxygen with exercise or sleep. Specific testing in those situations is needed to determine need. h. Surgical approaches: i. Lung Volume reduction surgery can be considered in those patients with unrelenting symptoms, apical bullous disease, and normal diffusing capacities. ii. Lung transplant can be considered for those individuals with 1. Age < 65 2. GOLD D stage and an elevated BODE score. 3. No active tobacco or substance abuse 4. No significant other co-morbidities or recent malignancies. The COPD CHASM working group consisted of: Jim Barker, MD David Perez, RRT, MBA Richard Beckendorf, MD Emran Rouf, MD, MPH David Bonnet, MD Sunita Varghees MD, PHD Monica L Brown, BS, MPH student Thu Vo, DO Elizabeth Fomby, MD Pam York, RRT Christopher Grant, MD References Used include: 1. Treatment of Stable Chronic Obstructive Pulmonary Disease: the GOLD Guidelines by HOBART LEE, MD; JEFFREY KIM, MD; and KARINE TAGMAZYAN, MD, Loma Linda University School of Medicine, Loma Linda, California, Am Fam Physician. 2013 Nov 15;88(10):655-663. 2. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, GOLD Executive Summary Jørgen Vestbo1,2, et al. Am J Respir Crit Care Med Vol 187, Iss. 4, pp. 347–365, Feb 15, 2013 3. Global Initiative for Chronic Obstructive Lung Disease, Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, Feb 1, 2013. RR Roison and J Vestbo, for the GOLD Committee. GOLD website. 4. NICE Guideline, 2013 update, National Clinical Guideline Centre, United Kingdom. Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care, http://guidance.nice.org.uk/CG101/Guidance/pdf/English 5. Anderson B, Conner K, Dunn C, Kerestes G, Lim K, Myers C, Olson J, Raikar S, Schultz H, Setterlund L. Institute for Clinical Systems Improvement. Diagnosis and Management of Chronic Obstructive Pulmonary Disease (COPD). Updated March 2013. 6. Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline from the American College of Physicians Amir Qaseem, MD, PhD, MHA; Vincenza Snow, MD; Paul Shekelle, MD, PhD; Katherine Sherif, MD; Timothy J. Wilt, MD, MPH; Steven Weinberger, MD; and Douglas K. Owens, MD, MS, for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians* Ann Intern Med. 2007;147:633-638. 7. Diagnosis and Management of Chronic Obstructive Pulmonary Disease: The Swiss Guidelines Official Guidelines of the Swiss Respiratory Society E.W. Russi a W. Karrer d M. Brutsche e et al. Respiration 2013;85:160–174. 8. Primary Care–Relevant Interventions for Tobacco Use Prevention and Cessation in Children and Adolescents: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Carrie D. Patnode, PhD, MPH; Elizabeth O’Connor, PhD; Evelyn P. Whitlock, MD, MPH; Leslie A. Perdue, MPH; Clara Soh, MPA; and Jack Hollis, PhD Ann Intern Med. 2013;158:253-260. www.annals.org 9. Management of Acute Exacerbations of COPD* A Summary and Appraisal of Published Evidence Douglas C. McCrory, MD, MHSc; Cynthia Brown, MD; Sarah E. Gelfand, BA; and Peter B. Bach, MD CHEST 2001; 119:1190–1209 10. COPD updates: What’s new in pathophysiology and management? Carlos Noujeim and Pierre Bou-Khalil (Lebanon). Expert Rev. Respir. Med. 7(4), 429–437 (2013). 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)? Consider referral to Behavioral Health specialist Yes No Major Depression? 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 67(3:,6($3352$&+)250$1$*,1*$67+0$,1&+,/'5(1 ±<($562)$*( 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 $OSKDEHWLFDORUGHULVXVHGZKHQPRUHWKDQRQHWUHDWPHQWRSWLRQLVOLVWHGZLWKLQHLWKHUSUHIHUUHGRUDOWHUQDWLYH WKHUDS\ 1RWHV ! " "#$%"&% ' (&"% $%%% ("( % ' ((&!)*+!# ,(""$%(-% &' %.*)("' ( /&'"" 0 0 ("%' 1 67(3:,6($3352$&+)250$1$*,1*$67+0$,1&+,/'5(1<($562)$*( 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-doseICS 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). Step down if possible Quick-Relief Medication for All Patients: (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 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. $OSKDEHWLFDORUGHULVXVHGZKHQPRUHWKDQRQHWUHDWPHQWRSWLRQLVOLVWHGZLWKLQHLWKHUSUHIHUUHGRU DOWHUQDWLYHWKHUDS\ 1%# 1RWHV ! " "#$%"&% ' (&"% $%%% ("( % ' &%"%"&' 2 "/&' 3 4-%& /&(((( "0 ("" %5" &( % )*+0 0 ("%%' ""% ( *)/&(%%"" &!# #("#'/&(""% !'( "%'!"""% % $% ( 0"%' 2 USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS IN CHILDREN* 'RVDJH )RUP 0HGLFDWLRQ ,QKDOHG ,&6 &RUWLFRVWHURLGV Systemic Corticosteroids Methylprednisolone 2, 4, 8, 16, 32 mg tablets 6 6 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 \HDUV 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 \HDUV &RPPHQWV 0.25–2 mg/kg daily in single dose in a.m. or qod as needed $SSOLHVWRDOOWKUHHFRUWLFRVWHURLGV • 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). 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 1 blister q 12 hours • 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). • • • 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 • Montelukast exhibits a flat dose- (1–5 years of age) (6–14 years of age) • response curve. No more efficacious than placebo in infants 6–24 months (van Adelsberg et al. 2005). Safety and 10 mg bid • For zafirlukast, administration with meals efficacy not established (7–11 years of age) • 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) Systemic, febrile viral illness (e.g., influenza) metabolism (1–9 years) Phenobarbital, phenytoin, carbamazepine ↑metabolism Cimetidine 5 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. ↓metabolism Use alternative H2 blocker (e.g., famotidine or ranitidine). ↓metabolism ↑metabolism Inform patients that major changes in diet are not recommended while taking theophylline. Adjust dose according to serum concentration. Increase dose according to serum concentration. ↑metabolism Ticlopidine Select theophylline preparation that is not affected by food. ↓ metabolism (<6 months, elderly) ↓metabolism Quinolones: ciprofloxacin, enoxacin, perfloxacin This list is not all inclusive. ↓metabolism (high carbohydrate) ↓metabolism Macrolides: erythromycin, clarithromycin, troleandomycin † ↑ rate of absorption (fatty foods) ↑ metabolism Age Smoking Increases Theophylline Concentrations Recommended Action ↓ metabolism Hypoxia, cor pulmonale, and decompensated congestive heart failure, cirrhosis Rifampin † 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 0', 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. 1HEXOL]HUVROXWLRQ 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 5–11 Years Comments Anticholinergics Ipratropium HFA 0', 17 mcg/puff, 200 puffs/ canister Safety and efficacy not established Safety and efficacy not established Safety and efficacy not established Safety and efficacy not established 1HEXOL]HU VROXWLRQ 0.25 mg/mL (0.025%) • • Systemic Corticosteroids Methylprednisolone Prednisolone Prednisone 2, 4, 6, 8, 16,32mg tablets 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 $SSOLHVWRWKHILUVWWKUHHFRUWLFRVWHURLGV 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 5HSRVLWRU\ LQMHFWLRQ (Methylprednisolone acetate) • 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. 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 67(3:,6($3352$&+)250$1$*,1*$67+0$,1<287+6!<($562)$*($1' $'8/76 Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Intermittent Asthma 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 Step 4 Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS + either LTRA, Step 6 Step 5 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: 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. 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) 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. $OSKDEHWLFDORUGHULVXVHGZKHQPRUHWKDQRQHWUHDWPHQWRSWLRQLVOLVWHGZLWKLQHLWKHUSUHIHUUHGRUDOWHUQDWLYHWKHUDS\ / 0% " 1 %# 1RWHV ! " "#$%"&% ' (&"% $%%% ("( % ' 7%&%"%-%& "&(%' $%"(%"&' +("%( 441 8%"% %' 23 ( /& 3& /&(1 /&( /&9(8%' ) ( /&& /&(1 /&9(8%' : ( /&' + ( ;/61⎯2<<=>/&("8%"' ""% ( *)/&(%%"" &!# #("#'/&(""% !'(" %'!"""% "8%"% $% ( 0"%' 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) 6HHILJXUH±E³(VWLPDWHG&RPSDUDWLYH'DLO\'RVDJHVIRU,QKDOHG &RUWLFRVWHURLGV´ 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, $SSOLHVWRDOOWKUHHFRUWLFRVWHURLGV There is no evidence that tapering the dose following improvement in symptom control and pulmonary function prevents relapse. • 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. 1 blister q 12 hours • Decreased duration of protection against EIB may occur with regular use. 1 capsule q 12 hours • 1 inhalation bid; dose depends on severity of asthma • 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 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 Decrease theophylline dose according to serum concentration. Decrease dose by 50 percent if serum concentration measurement is not available. Hypoxia, cor pulmonale, and decompensated congestive heart failure, cirrhosis ↓ metabolism Decrease dose according to serum concentration. Phenobarbital, phenytoin, carbamazepine ↑ metabolism (1–9 years) ↓ metabolism (<6 months, ld l ) ↑ metabolism 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 Smoking ↓ metabolism ↑ metabolism *This list is not all inclusive. 11 Use alternative antibiotic or adjust theophylline dose. Circumvent with ofloxacin if quinolone therapy is required. Increase dose according to serum concentration. ↑ metabolism Ticlopidine Inform patients that major changes in diet are not recommended while taking theophylline. Systemic, febrile viral illness (e.g., influenza) Age ↓ metabolism (high carbohydrate) 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) $SSOLHVWRDOOWKUHH6$%$V 0', 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. 1HEXOL]HUVROXWLRQ 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 0', 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. 1HEXOL]HUVROXWLRQ Ipratropium with albuterol 0.25 mg/mL (0.025%) 0', 0.25 mg q 6 hours 18 mcg/puff of ipratropium bromide and 90 mcg/puff of albuterol 200 puffs/canister 1HEXOL]HUVROXWLRQ 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 6\VWHPLF &RUWLFRVWHURLGV Contains EDTA to prevent discoloration of the solution. This additive does not induce bronchospasm. $SSOLHVWRWKHILUVWWKUHH FRUWLFRVWHURLGV 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. 5HSRVLWRU\LQMHFWLRQ (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: Catherine J McNeal, M.D., Eugene Terry, M.D., Michael M. Hawkins, M.D. and SWHP Secondary Prevention of Coronary Artery Disease Workgroup 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, April 2014 Reviewed: February, 2010 Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults: Synopsis of the 2013 ACC/AHA Cholesterol Guideline Neil J. Stone, MD; Jennifer G. Robinson, MD, MPH; Alice H. Lichtenstein, ScD; David C. Goff Jr., MD, PhD; Donald M. Lloyd-Jones, MD, ScM; Sidney C. Smith Jr., MD; Conrad Blum, MD; and J. Sanford Schwartz, MD, for the 2013 ACC/AHA Cholesterol Guideline Panel* Description: In November 2013, the American College of Cardiology and American Heart Association (ACC/AHA) released a clinical practice guideline on the treatment of blood cholesterol to reduce cardiovascular risk in adults. This synopsis summarizes the major recommendations. Methods: In 2008, the National Heart, Lung, and Blood Institute convened the Adult Treatment Panel IV (ATP-IV) to update the 2001 ATP-III cholesterol guidelines using a rigorous process to systematically review randomized, controlled trials (RCTs) and meta-analyses of RCTs that examined cardiovascular outcomes. The panel commissioned independent systematic evidence reviews on low-density lipoprotein cholesterol and non–high-density lipopro- A therosclerotic cardiovascular disease (ASCVD) is the leading cause of death, decreased quality of life, and medical costs in the United States. Nearly 1 in 3 Americans die of heart disease and stroke (1). Most ASCVD is preventable through a healthy lifestyle and effective treatment of cholesterol and blood pressure. The 2013 “Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults” from the American College of Cardiology and American Heart Association (ACC/AHA) provides an evidence-based approach to reducing ASCVD risk (2). GUIDELINE DEVELOPMENT PROCESS In 2008, the National Heart, Lung, and Blood Institute (NHLBI) convened the Adult Treatment Panel IV (ATP-IV) to update the 2001 ATP-III cholesterol guidelines using a rigorous systematic process to identify and review randomized, controlled trials (RCTs) with cardiovascular outcomes and meta-analyses of these RCTs. The panel comprised experts and clinicians from the fields of cardiology, epidemiology, primary care, and endocrinology tein cholesterol goals in secondary and primary prevention and the impact of lipid drugs on atherosclerotic cardiovascular disease (ASCVD) events and adverse effects. In September 2013, the panel’s draft recommendations were transitioned to the ACC/AHA. Recommendations: This synopsis summarizes key features of the guidelines in 8 areas: lifestyle, groups shown to benefit from statins, statin safety, decision making, estimation of cardiovascular disease risk, intensity of statin therapy, treatment targets, and monitoring of statin therapy. Ann Intern Med. www.annals.org For author affiliations, see end of text. (2) and received support from the Lifestyle Management and Risk Assessment Work Groups (3, 4). Systematic evidence reviews conducted according to principles recommended by the Institute of Medicine (5) were performed to answer 3 questions relevant to clinical care. Two questions focused on the evidence supporting low-density lipoprotein cholesterol (LDL-C) and non– high-density lipoprotein cholesterol (HDL-C) levels as targets of treatment. One question examined the reduction in ASCVD events and adverse effects for each cholesterollowering drug class. The panel synthesized the evidence from these 3 reviews as well as from Lifestyle Management and Risk Assessment Work Groups reviews (3, 4) that addressed 5 additional critical questions. Systematic electronic searches of relevant databases of the peer-reviewed English-language literature published from 1 January 1995 through 1 December 2009 for each critical question were conducted by an NHLBI-selected independent contractor and focused on RCTs and systematic reviews and meta-analyses of RCTs assessed as fair to good quality. In addition, RCTs with ASCVD outcomes * For a list of the members of the 2013 ACC/AHA Cholesterol Guideline Panel, see the Appendix (available at www.annals.org). This article was published online first at www.annals.org on 28 January 2014. that included coronary heart disease, stroke, and cardiovascular deaths published after that date were eligible for consideration through July 2013. Evidence tables were constructed and the strength of evidence was rated according to the NHLBI (Table 1 of the Supplement, available at www.annals.org). Recommendations were graded according to criteria from the NHLBI (Table 2 of the Supplement) and ACC/AHA (Table 3 of the Supplement). Because of the inherent differences in grading systems and the clinical questions driving the recommendations, alignment between the NHLBI and ACC/AHA formats was imperfect. A complete description of the methods used and results of the evidence review are provided in the guideline (2) and the NHLBI evidence report (www.nhlbi.nih.gov /guidelines/cholesterol/ser/index.htm). To help clinicians estimate CVD risk, the risk assessment working group developed the Pooled Cohort Equations using data from 5 NHLBI-sponsored longitudinal, population-based cohorts of African American and nonHispanic white men and women to estimate risk for a first myocardial infarction, coronary heart disease death, or fatal or nonfatal stroke on the basis of age, sex, race, smoking status, total cholesterol level, HDL-C level, systolic blood pressure, antihypertensive therapy, and diabetes (4, 6). These equations significantly advance ASCVD risk estimation by providing sex- and race-specific estimates and including stroke as an outcome. The earlier Framingham equations calculated only coronary heart disease risk for non-Hispanic whites. The draft recommendations were reviewed by 23 experts and representatives of federal agencies identified by the NHLBI. In September 2013, the recommendations developed by the panel were transitioned to the ACC/AHA and had additional review by 4 experts nominated by the ACC Foundation and the AHA. The governing bodies of the ACC and AHA approved the guideline, which also received endorsement from the American Association of Cardiovascular and Pulmonary Rehabilitation, American Pharmacists Association, American Society for Preventive Cardiology, Association of Black Cardiologists, Preventive Cardiovascular Nurses Association, and WomenHeart: The National Coalition for Women with Heart Disease. RECOMMENDATIONS The guideline focuses on treatment of blood cholesterol to reduce ASCVD risk in adults. Major recommendations are summarized here and in Table 1. The guideline report provides a complete listing of recommendations and supporting evidence behind each recommendation (2). 1. Encourage Adherence to a Healthy Lifestyle A healthy lifestyle is the foundation for cardiovascular health. The panel endorsed the 2013 ACC/AHA Lifestyle Management Guideline (3) for a diet that is low in saturated fat, trans fat and sodium; emphasizes vegetables, fruits, whole grains, low-fat dairy products, poultry, fish, legumes, nontropical vegetable oils, and nuts; and limits sweets, sugar-sweetened beverages, and red meats and engage in regular aerobic physical activity. Adults also should maintain a healthy body weight, avoid smoking, and control hypertension and diabetes when present. 2. Statin Therapy is Recommended for Adults in Groups Demonstrated to Benefit Strong RCT evidence shows that reduction in ASCVD events from statin therapy exceeds adverse events for 4 patient groups: those with clinical ASCVD (acute coronary syndromes, myocardial infarction, stable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease of atherosclerotic origin) when statins are used for secondary prevention, and those with LDL-C levels of 190 mg/dL or greater; those aged 40 to 75 years with diabetes and LDL-C levels of 70 to 189 mg/dL; and those aged 40 to 75 years without diabetes and with a 10-year ASCVD risk of 7.5% or greater when statins are used for primary prevention. Moderate evidence supports consideration of statin therapy for primary prevention in individuals with a 10year ASCVD risk of 5% to less than 7.5%. Routine initiation of statin therapy is not recommended in adults with New York Heart Association heart failure class II to IV or those receiving maintenance hemodialysis. Randomized, controlled trials in these groups showed no reduction in ASCVD. 3. Statins have an Acceptable Margin of Safety when Used in Properly Selected Individuals and Appropriately Monitored Strong RCT evidence supports safety of statins when they are used as directed in conjunction with regular follow-up assessments in properly selected patients. Adjustment of statin intensity is recommended in individuals older than 75 years with a history of statin intolerance or other characteristics (2) or those receiving drug therapy that may increase statin adverse events. Routine monitoring of hepatic aminotransferase level or creatine kinase level is not recommended unless clinically indicated by symptoms suggesting hepatotoxicity or myopathy. Given statin therapy’s potential for decreasing ASCVD events and death, it is important to confirm the relationship of muscle and other symptoms to statin treatment. Therefore, eliciting a history of muscle symptoms before statin initiation and carefully monitoring symptoms during statin discontinuation and rechallenge is recommended. Severe myopathy, rhabdomyolysis, and possibly hemorrhagic stroke are rare complications of statin therapy. Although statin therapy modestly increases the risk for type 2 diabetes, ASCVD risk reduction outweighs the excess risk for diabetes for high-intensity statins in secondary prevention or for 10-year ASCVD risk of 7.5% or greater. Similarly, ASCVD risk reduction outweighs the excess risk for diabetes for moderate-intensity statin therapy in adults with a 10-year ASCVD risk of 5% or greater. Table 1. Major Recommendations for the Treatment of Blood Cholesterol to Reduce ASCVD Risk in Adults*† Healthy lifestyle habits should be encouraged for all persons. The appropriate intensity of statin therapy should be initiated or continued: Clinical ASCVD‡ Persons aged ~75 y with no safety concerns: high-intensity statin (class I, level A) Persons aged >75 y or with safety concerns: moderate-intensity statin (class I, level A) Primary prevention: primary LDL-C level ~ 190 mg/dL Rule out secondary causes of hypercholesterolemia Persons aged ~21 y: high-intensity statin (class I, level B) Achieve ~ 50% reduction in LDL-C level (class IIa, level B) May consider LDL-C–lowering nonstatin therapy to further reduce LDL-C levels (class IIb, level C) Primary prevention: persons with diabetes aged 40–75 y with an LDL-C level of 70–189 mg/dL Moderate-intensity statin (class I, level A) Consider high-intensity statin when 10-y ASCVD risk is ~ 7.5% (class IIa, level B) Primary prevention: persons aged 40–75 y without diabetes with an LDL-C level of 70–189 mg/dL Estimate 10-y ASCVD risk (risk calculator based on Pooled Cohort Equations recommended)§ in those not receiving a statin; estimate risk every 4–6 y (class I, level B) To determine whether to initiate a statin, engage in clinician–patient discussion of potential for ASCVD risk reduction, adverse effects, drug–drug interactions, and patient preferences (class IIa, level C). Re-emphasize healthy lifestyle habits and address other risk factors. If statin therapy is chosen: Persons with ~ 7.5% 10-y ASCVD risk: moderate- or high-intensity statin (class I, level A) Persons with 5% to < 7.5% 10-y ASCVD risk: consider moderate-intensity statin (class IIa, level B) Other factors may be consideredli: LDL-C level ~ 160 mg/dL, family history of premature ASCVD, lifetime ASCVD risk, high-sensitivity C-reactive protein level of ~2.0 mg/L, coronary artery calcification score ~ 300 Agatston units, or ankle–brachial index <0.9 (class IIb, level C) Primary prevention when LDL-C level is < 190 mg/dL and person is aged < 40 y or > 75 y or has < 5% 10-y ASCVD risk Statin therapy may be considered in selected personsli (class IIb, level C) Statin initiation is not routinely recommended for persons with NYHA class II–IV heart failure or those who are receiving maintenance hemodialysis. Regularly monitor adherence to lifestyle and drug therapy with lipid and safety assessments. Nonstatin therapy can be considered in selected persons. Assess adherence, response to therapy, and adverse effects within 4–12 wk after statin initiation or change in therapy (class I, level A) Measure fasting lipid panel (class I, level A) Do not routinely monitor hepatic function with ALT levels or muscle injury with CK levels unless patient is symptomatic (class IIa, level C). Screen and treat type 2 diabetes mellitus according to current practice guidelines. Healthy lifestyle habits should be encouraged to prevent progression to diabetes (class I, level B). Anticipated therapeutic response: approximately ~ 50% reduction in LDL-C level from baseline for high-intensity statin and 30% to moderate-intensity statin (class IIa, level B) Insufficient evidence from RCTs for LDL-C or non–HDL-C treatment goals < 50% for For guidance in persons with unknown baseline LDL-C level, a level of < 100 mg/dL was observed in RCTs about high-intensity statin therapy. Less-than-anticipated therapeutic response: Reinforce improved adherence to lifestyle and drug therapy (class I, level A) Evaluate for secondary causes of hypercholesterolemia if indicated¶ (class I, level A) Increase statin intensity, or if patient is receiving maximally tolerated statin intensity, consider addition of nonstatin therapy shown in RCT to reduce ASCVD events in selected high-risk persons** (class IIb, level C) Regularly monitor adherence to lifestyle and drug therapy every 3–12 mo once statin adherence has been established. Continue to assess adherence for optimum ASCVD risk reduction and safety (class I, level A) In persons unable to tolerate the recommended intensity of statin therapy, use the maximally tolerated intensity of statin. If there are muscle or other symptoms, establish their relationship to statin therapy (class IIa, level B) Obtain a history of muscle symptoms before initiating statin therapy. If muscle or other symptoms develop during statin therapy, discontinue the statin. Once mild to moderate muscle or other symptoms resolve, rechallenge with the same dose of statin or lower; if muscle symptoms recur, discontinue statin and rechallenge with progressively lower doses of the same or a different statin. If muscle symptoms persist > 2 mo after statin discontinuation, consider other conditions that may increase the risk for muscle symptoms†† ALT = alanine aminotransferase; ASCVD = atherosclerotic cardiovascular disease; CK = creatine kinase; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; NYHA = New York Heart Association; RCT = randomized, controlled trial. * Adapted from reference 2. Reprinted with permission. † For information about class and level, please see Table 3 of the Supplement. ‡ Clinical ASCVD is defined as acute coronary syndromes or a history of myocardial infarction, stable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin. § Estimated 10-y “hard” ASCVD risk includes first occurrence of nonfatal myocardial infarction, death from coronary heart disease, and nonfatal and fatal stroke as used in the Pooled Cohort Equations on the basis of age, sex, smoking status, total cholesterol level, HDL-C level, systolic blood pressure, and the use of antihypertensive therapy. II Other factors that may influence ASCVD risk include primary LDL-C level ~160 mg/dL or other evidence of genetic hyperlipidemias; family history of premature ASCVD with onset before age 55 yin a first-degree male relative or before age 65 yin a first-degree female relative; high-sensitivity C-reactive protein level of >2 mg/L; coronary artery calcification score ~300 Agatston units or ~75th percentile for age, sex, and ethnicity (for additional information, see www.mesa-nhlbi.org/CACReference.aspx.); or ankle–brachial index <0.9 or lifetime ASCVD. ¶ Common secondary causes of hypercholesterolemia include diet (saturated or trans fats, weight gain, or anorexia), drugs (diuretics, cyclosporine, glucocorticoids, or amiodarone), diseases (biliary obstruction or nephrotic syndrome), and altered metabolism (hypothyroidism, obesity, or pregnancy). ** High-risk persons include those with clinical ASCVD; those with an untreated LDL-C level ~190 mg/dL, suggesting genetic hypercholesterolemia; or those aged 40–75 y with diabetes. †† Common causes of muscle ache, pain, or fatigue include hypothyroidism, reduced renal or hepatic function, rheumatologic disorders (especially polymyalgia rheumatica), steroid myopathy, vitamin D deficiency, or primary muscle diseases. www.annals.org Annals of Internal Medicine 4. Engage in a Clinician–Patient Discussion Before Initiating Statin Therapy, Especially for Primary Prevention in Patients with Lower ASCVD Risk Decisions to initiate statin therapy in primary prevention should be based on clinical judgment and preferences of informed patients. In adults without clinical ASCVD or diabetes whose LDL-C level is less than 190 mg/dL, calculating the estimated 10-year ASCVD risk should be the start of the clinician–patient discussion and should not automatically lead to statin initiation. As the absolute risk for ASCVD events decreases, so does the net benefit of the intervention. Therefore, discussion of the potential for ASCVD event reduction, adverse effects, drug–drug interactions, and patient preferences is especially important for lower-risk primary prevention. The discussion provides the opportunity to encourage healthy lifestyle habits and control other risk factors. Additional factors may be considered when a riskbased decision is uncertain, including LDL-C levels of 160 mg/dL or greater, family history of premature ASCVD, elevated lifetime ASCVD risk, high-sensitivity C-reactive protein level of 2.0 mg/L or greater, coronary artery calcification score greater than 300 Agatston units, and ankle– brachial index less than 0.9. After age 75 years, comorbid conditions, anticipated longevity, safety considerations, and patient preferences should play a large role in decision making. 5. Use the Newly Developed Pooled Cohort Equations for Estimating 10-Year ASCVD Risk The Pooled Cohort Equations are currently the best available method for estimating 10-year ASCVD risk to guide statin initiation (4, 6). Application of the inclusion and exclusion criteria from RCTs is cumbersome and results in under-identifying high-risk and over-identifying low-risk individuals for statin treatment. The Pooled Cohort Equations were developed using recent data from 5 NHLBI-sponsored, longitudinal, population-based cohorts of African American and white men and women (ARIC [Atherosclerotic Risk in Communities], CHS [Cardiovascular Health Study], CARDIA [Coronary Artery Risk Development in Young Adults], and the original Framingham Heart Study and its Offspring Cohorts). When the Pooled Cohort Equations were validated in 2 independent contemporary cohorts (MESA [Multi-Ethnic Study of Atherosclerosis] and REGARDS [Reasons for Geographic and Racial Differences in Stroke]), discrimination and calibration ranged from “good” to “fair.” Some overestimation of ASCVD risk was observed, primarily in higher-risk individuals, perhaps due to high rates of statin initiation after baseline examinations in these cohorts and limited duration of follow-up. Modest overestimation of ASCVD risk generally will not affect most decisions to recommend statin treatment for adults Table 2. High-, Moderate-, and Low-Intensity Statin Therapy* Statin Therapy Daily Dose High-Intensity† Moderate-Intensity‡ Atorvastatin Rosuvastatin Simvastatin Pravastatin Lovastatin Fluvastatin Fluvastatin Pitavastatin 4011–80 mg 20 (40) mg – – – – – – Low-Intensity§ 10 (20) mg – (5) 10 mg – 20–40 mg¶ 10 mg 40 (80) mg 10–20 mg 40 mg 20 mg 80 mg (Fluvastatin XL) 20–40 mg 40 mg** – 2–4 mg 1 mg FDA = U.S. Food and Drug Administration; LDL-C = low-density lipoprotein cholesterol; XL = extended-release. * Individual responses to statin therapy varied in randomized, controlled trials and vary in clinical practice. A less-than-average response may have a biologic basis. Statins and dosages in bold were reduced in major cardiovascular events in randomized, controlled trials. Statins and doses in italics were approved by the FDA but were not tested in randomized, controlled trials. † Daily dose decreases LDL-C levels by an average of ~50%. ‡ Daily dose decreases LDL-C levels by an average of 30% to <50%. § Daily dose decreases LDL-C levels by an average of <30%. II Evidence from 1 randomized, controlled trial only; down-titration if patient is unable to tolerate atorvastatin, 80 mg. ¶ Although simvastatin, 80 mg, was evaluated in randomized, controlled trials, the FDA recommends against initiation of or titration to 80 mg of simvastatin because of increased risk for myopathy and rhabdomyolysis. ** Twice daily. with a 10-year ASCVD risk of 7.5% or greater because ASCVD event reduction exceeds adverse effects in the 10year ASCVD risk range of 5% to less than 7.5%. Although over-prediction was reported by 1 group for 3 other cohorts (7), these cohorts of health professionals and women screened for a clinical trial are not representative of the U.S. population (the reason the risk assessment panel decided not to use them for derivation or validation) and probably were subject to high rates of statin use during the follow-up period (8). 6. Initiate the Appropriate Intensity of Statin Therapy The appropriate intensity of statin therapy should be used to reduce ASCVD risk and minimize adverse effects (Table 2). On the basis of strong RCT evidence, highintensity statin therapy (LDL-C level decreased by ~50%) is preferentially recommended for adults aged 75 years or younger who have clinical ASCVD and no safety concerns. Moderate-intensity statins (LDL-C level decreased by 30% to <50%) are recommended for adults aged 75 years or younger who have clinical ASCVD and safety concerns and in those older than 75 years with clinical ASCVD. High-intensity statin therapy is also recommended for individuals with LDL-C levels of 190 mg/dL or greater. In primary prevention in patients with LDL-C levels less than 190 mg/dL, moderate-intensity statin therapy is recommended, although high-intensity statin therapy also can be considered for individuals with or without diabetes who have a 10-year ASCVD risk of 7.5% or greater. When choosing the intensity of statin therapy for primary prevention, consideration may be given to a high estimated 10- year ASCVD risk, an LDL-C level of 160 to 189 mg/dL, or additional factors that may influence ASCVD risk. Lowintensity statin therapy may be used when high- or moderate-intensity statins are not tolerated. 7. Evidence is Inadequate to Support Treatment to Specific LDL-C or Non–HDL-C Goals Randomized, controlled trials of statins, nonstatin drugs, or both did not compare titration to different LDL-C goals. Thus, the panel was unable to make any evidence-based recommendations about use of treatment goals for guiding therapy. “Treating to goal” may result in treatment with less-than-optimum statin intensity or adding nonstatin therapy in the absence of RCT evidence that combination therapy improves outcomes. 8. Regularly Monitor Patients for Adherence to Lifestyle and Statin Therapy Randomized, controlled trials of statins regularly assessed adherence and safety. A fasting lipid panel is needed after initiation of or changes in statin or other drug therapy. Percentage reductions in LDL-C level should not be used as treatment goals or performance measures but should be used to assess and provide feedback to promote adherence to healthy lifestyle behaviors and statin therapy. Safety measurements should be assessed as clinically indicated. In patients with a less-than-anticipated therapeutic response or intolerance of recommended statin therapy intensity, adherence to healthy lifestyle behaviors and medications should be re-emphasized and secondary causes of hyperlipidemia excluded. A nonstatin LDL-C–lowering drug, preferably one that reduced ASCVD events in RCTs, can be considered in higher-risk adults, including those with genetic dyslipidemias, such as familial hypercholesterolemia, if the potential for additional ASCVD risk reduction outweighs the potential for adverse effects. SUMMARY Millions of U.S. adults are at increased ASCVD risk— some because they have had an ASCVD event, others because of ASCVD risk factors. Adherence to healthy lifestyle behaviors, control of blood pressure and diabetes, and avoidance of smoking is recommended for all adults. Statin therapy should be used to reduce ASCVD risk in individuals likely to have a clear net benefit (those with clinical ASCVD) or in primary prevention for adults with LDL-C levels of 190 mg/dL or greater, those aged 40 to 75 years with diabetes, and those with a 10-year ASCVD risk of 7.5% or greater without diabetes. A clinician–patient discussion that considers potential ASCVD risk reduction, adverse effects, and patient preferences is needed to decide whether to initiate statin therapy, especially in lower-risk primary prevention. Appropriate intensity of statin therapy based on ASCVD risk and potential for adverse effects is recommended rather than focusing on specific LDL-C or non– HDL-C goals. Five of 7 statins, including a high-intensity statin, are available in the United States as low-cost generics. The Pooled Risk Equations, which were developed in a geographically diverse sample of African Americans and non-Hispanic whites, identify adults at increased risk for an ASCVD event (including stroke as well as heart disease). They represent important steps forward in the ability to match intensity of preventive treatment to level of ASCVD risk. These risk equations will be reevaluated and revised as additional information becomes available, including research assessing other potentially useful markers of ASCVD risk and data required to develop equations specific to other ethnic groups. Until heart-healthy lifestyles are adopted throughout the lifespan, the need for preventive measures using evidence-based drug therapy will remain high. As with all clinical guidelines, the 2013 ACC/AHA cholesterol guidelines must be implemented in conjunction with sound clinical judgment. These evidence-based recommendations focus statin treatment on patients likely to obtain the greatest benefit, thereby reducing the ASCVD burden in adults. From Northwestern University, Chicago, Illinois; University of Iowa, Iowa City, Iowa; Tufts University, Boston, Massachusetts; University of Colorado, Aurora, Colorado; University of North Carolina, Chapel Hill, North Carolina; Columbia University Medical Center, New York, New York; and University of Pennsylvania, Philadelphia, Pennsylvania. Potential Conflicts of Interest: Disclosures can be viewed at www .acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum =M14-0126. Corresponding Author: J. Sanford Schwartz, MD, University of Penn- sylvania, Blockley 1101, 423 Guardian Drive, Philadelphia, PA 19104; e-mail, [email protected]. Current author addresses and author contributions are available at www.annals.org. References 1. 2. 3. 4. 5. 6. 7. 8. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics–2013 update: a report from the American Heart Association. Circulation. 2013;127:e6-e245. [PMID: 23239837] Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, Blum CB, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013. [PMID: 24239923] Eckel RH, Jakicic JM, Ard JD, Miller NH, Hubbard VS, Nonas CA, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013. [PMID: 24239922] Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D’Agostino RB Sr, Gibbons R, et al. 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk: A Report of the American College of Cardiology/American HeartAssociation Task Force on Practice Guidelines. Circulation. 2013. [PMID: 24222018] Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, eds; Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Pr; 2011. American Heart Association. 2013 Prevention Guidelines Tools: CV Risk Calculator. Dallas, TX: American Heart Association; 2013. Accessed at http://my.americanheart.org/professional/StatementsGuidelines/PreventionGuidelines/PreventionGuidelines_UCM_457698_SubHomePage.jsp on 10 January 2014. Ridker PM, Cook NR. Statins: new American guidelines for prevention of cardiovascular disease. Lancet. 2013;382:1762-5. [PMID: 24268611] Lloyd-Jones DM, Goff D, Stone NJ. Statins, risk assessment, and the new American prevention guidelines [Letter]. Lancet. 2013. [PMID: 24315619] Current Author Addresses: Dr. Stone: Feinberg School of Medicine, Northwestern Medical Faculty Foundation, Northwestern University, 676 North St. Clair, Suite 600 (Cardiology), Chicago, IL 60611. Dr. Robinson: Department of Epidemiology, University of Iowa, 200 Hawkins Drive, SE 226 GH, Iowa City, IA 52242 Dr. Lichtenstein: Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA 02111. Dr. Goff: Colorado School of Public Health, University of Colorado, Building 500, 3rd Floor, Suite 300, Anschutz Medical Campus, Aurora, CO 80045. Dr. Lloyd-Jones: Department of Preventive Medicine, Northwestern University, 680 North Lake Shore Drive, Suite 1400, Chicago, IL 60611. Dr. Smith: UNC Health Care System, 101 Manning Drive, Chapel Hill, NC 27514. Dr. Blum: Columbia College, P & S, 16 East 60th Street, New York, NY 10022. Dr. Schwartz: University of Pennsylvania, Blockley 1101, 423 Guardian Drive, Philadelphia, PA 19104. APPENDIX: 2013 ACC/AHA CHOLESTEROL GUIDELINE PANEL The members of the 2013 ACC/AHA Cholesterol Guideline Panel are Neil J. Stone, MD (Chair); Jennifer G. Robinson, MD, MPH (Vice-Chair); Alice H. Lichtenstein, ScD (Vice-Chair); Donald M. Lloyd-Jones, MD, ScM (CoChair, ASCVD Risk Assessment Expert Work Group); Robert H. Eckel, MD (Co-Chair, Lifestyle Management Expert Work Group); C. Noel Bairey Merz, MD; Conrad B. Bloom, MD; Anne C. Goldberg, MD; David Gordon, MD; Daniel Levy, MD; Patrick McBride, MD, MPH; Susan T. Shero, MS, RN; Karol Watson, PhD; and Peter W.F. Wilson, MD. Although he is not a member of the ACC/AHA Cholesterol Guideline Panel, David C. Goff Jr., MD, PhD, is Co-Chair of the ASCVD Risk Assessment Expert Work Group Tier 2 Guideline Microhematuria Without Evidence of Primary Renal Disease In Adults (Confirmed by Microscopic Analysis) Date of Adoption: September 14, 2010 Revision Dates: 8/2013 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. Resolved Yes No Release from Care 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: May 2016 Approved by SWHP Quality Improvement Sub-Committee: April 13, 2010, April 10, 2012, May 13, 2014 TIME FRAME FOR REQUIRED TESTS Initial Visit Examination Twice per Year Yearly 1. Eye Exam (By Optometrist or Ophthalmologist) X X 2. Hemoglobin A1c Control – 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 L:\QI\NCQA\Clinical Guidelines\Current Guidelines\Diabetes\Annual Assessment and Guideline 2014\Diabetes Annual Assessment-2014.docx 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, May 2016 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 ScottandWhiteHealthPlan(SWHP)hasadoptedthe“Treatment of Osteoarthritis of the Knee” dated May18,2013oftheAmericanAcademyofOrthopaedicSurgeons,asaclinicalpracticeguidelinefor SWHP’sproviders1.Theguidelineislocatedatthefollowinginternetwebsite: http://www.aaos.org/research/guidelines/TreatmentofOsteoarthritisoftheKneeGuideline.pdf Additional Resources for Care: x SWHP VitalCare Shared Decision-Making Program2: https://www.swhp.org/sites/default/files/SharedDecisioinMakingRef_FAX.pdf x SWHP Formulary:https://swhp.org/providers/pharmacyservices/prescriptiondruglists x Notes: 1. Specificrecommendationsforcareshouldbediscussedwithyourpatient.Allmedicationsnoted inthisguidelinemaynotbeintheSWHPFormulary;however,sinceSWHPhasanOpen Formulary,nonFormularymedicationsareavailablewithauthorizationatthenonFormulary copayment. 2. SWHP’sSharedDecisionMakingprogramofferspreferencesensitiveconditionsupport. Preferencesensitiveconditionsupportextendstoconditionsforwhicheithersciencesupports multipleacceptabletreatmentoptions,orthereisinadequatescientificinformationaboutthe treatmentchoices.OurHealthCoachescanhelpyourpatientmakeaninformeddecisionabout thetreatmentheorshewouldliketoreceive.Decisionsupportforpreferencesensitive conditionsaddressesawiderangeoftopics,includingosteoarthritis. SWHP Guideline Approval Body:SWHPQualityImprovementSubcommittee Date of Adoption: Review Dates:March8.2011 Physician Sponsor:MichaelHawkins,MD Paper Copy:Ifyouhavedifficultydownloadinginformationorwouldlikeapapercopy,pleasecontact SWHPProviderRelationsDepartmenttollfreeat8003217947ext.3064ordirectat2542983064 !*# $ % ' 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 RUGRHV$6(VFRUH 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) Diagnosis of alcohol dependence? 72 hours (Fixed Schedule) Yes Diazepam 20 mg p.o. q 2 hours until ASE’s < 10 or there is resolution of symtoms. On average three doses are required. No Patient agrees to Outpatient Care? 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 No Initiate treatment within 14 days of diagnosis. Other Diagnosis TX initiation complete? Detox complete? No Yes 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. Yes 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 !% ' 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 Pneumococcal conjugate6a,c (PCV13) 1st dose 2nd dose Pneumococcal polysaccharide6b,c (PPSV23) Inactivated Poliovirus7 (IPV) (<18years) Influenza8 (IIV; LAIV) 2 doses for some : see footnote 8 1st dose 2nd dose 3rd dose 4th dose 5th dose (Tdap) 3rd or 4th dose, see footnote 5 3rd dose 4th dose 3rd dose 4th dose Annual vaccination (IIV only) Annual vaccination (IIV or LAIV) Measles, mumps, rubella9 (MMR) 1st dose 2nd dose Varicella10 (VAR) 1st dose 2nd dose Hepatitis A11 (HepA) 2 dose series, see footnote 11 Human papillomavirus12 (HPV2: females only; HPV4: males and females) 13 Meningococcal (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 Vaccine Minimum Age for Dose 1 Minimum Interval Between Doses Dose 1 to dose 2 Dose 2 to dose 3 Dose 3 to dose 4 Dose 4 to dose 5 6 months3 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 4 weeks 6 months 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 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 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 Meningococcal13 see footnote 13 see footnote 13 Haemophilus influenzae type b5 6 weeks 8 weeks13 Measles, mumps, rubella9 12 months 4 weeks Varicella10 12 months 3 months Hepatitis A11 12 months 6 months Persons aged 7 through 18 years Tetanus, diphtheria; tetanus, diphtheria, pertussis4 7 years4 Human papillomavirus12 9 years 4 weeks 4 weeks if first dose administered at younger than age 12 months 6 months if first dose administered at 12 months or older 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 Measles, mumps, rubella9 Varicella10 6 months if first dose administered at younger than age 12 months 6 months 12 months 4 weeks 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. Hepatitis B (HepB) vaccine. (Minimum age: birth) Routine vaccination: At birth t "ENJOJTUFSNPOPWBMFOU)FQ#WBDDJOFUPBMMOFXCPSOTCFGPSFIPTQJUBMEJTDIBSHF t 'PSJOGBOUTCPSOUPIFQBUJUJT#TVSGBDFBOUJHFO)#T"H oQPTJUJWFNPUIFSTBENJOJTUFS)FQ#WBDDJOFBOEN-PGIFQBUJUJT#JNNVOF 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). t *GNPUIFST)#T"HTUBUVTJTVOLOPXOXJUIJOIPVSTPGCJSUIBENJOJTUFS)FQ#WBDDJOFUPBMMJOGBOUTSFHBSEMFTTPGCJSUIXFJHIU'PSJOGBOUT XFJHIJOHHSBNTBENJOJTUFS)#*(JOBEEJUJPOUP)FQ#XJUIJOIPVSTPGCJSUI%FUFSNJOFNPUIFST)#T"HTUBUVTBTTPPOBT 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 t 5IFTFDPOEEPTFTIPVMECFBENJOJTUFSFEBUBHFPSNPOUIT.POPWBMFOU)FQ#WBDDJOFTIPVMECFVTFEGPSEPTFTBENJOJTUFSFECFGPSF age 6 weeks. t *OGBOUTXIPEJEOPUSFDFJWFBCJSUIEPTFTIPVMESFDFJWFEPTFTPGB)FQ#DPOUBJOJOHWBDDJOFPOBTDIFEVMFPGUPNPOUITBOE NPOUITTUBSUJOHBTTPPOBTGFBTJCMF4FF'JHVSF t 5IFNJOJNVNJOUFSWBMCFUXFFOEPTFBOEEPTFJTXFFLTBOECFUXFFOEPTFBOEJTXFFLT5IFöOBMUIJSEPSGPVSUI EPTFJOUIF HepB vaccine series should be administered no earlier than age 24 weeks, and at least 16 weeks after the first dose. t "ENJOJTUSBUJPOPGBUPUBMPGEPTFTPG)FQ#WBDDJOFJTSFDPNNFOEFEXIFOBDPNCJOBUJPOWBDDJOFDPOUBJOJOH)FQ#JTBENJOJTUFSFEBGUFS the birth dose. Catch-up vaccination: t 6OWBDDJOBUFEQFSTPOTTIPVMEDPNQMFUFBEPTFTFSJFT t "EPTFTFSJFTEPTFTTFQBSBUFECZBUMFBTUNPOUIT PGBEVMUGPSNVMBUJPO3FDPNCJWBY)#JTMJDFOTFEGPSVTFJODIJMESFOBHFEUISPVHI 15 years. t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF 2. Rotavirus (RV) vaccines. (Minimum age: 6 weeks for both RV-1 [Rotarix] and RV-5 [RotaTeq]). Routine vaccination: t "ENJOJTUFSBTFSJFTPG37WBDDJOFUPBMMJOGBOUTBTGPMMPXT 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: t 5IFNBYJNVNBHFGPSUIFöSTUEPTFJOUIFTFSJFTJTXFFLTEBZT t 7BDDJOBUJPOTIPVMEOPUCFJOJUJBUFEGPSJOGBOUTBHFEXFFLTEBZTPSPMEFS t 5IFNBYJNVNBHFGPSUIFöOBMEPTFJOUIFTFSJFTJTNPOUITEBZT t *G373PUBSJY JTBENJOJTUFSFEGPSUIFöSTUBOETFDPOEEPTFTBUIJSEEPTFJTOPUJOEJDBUFE t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF 3. Diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. (Minimum age: 6 weeks) Routine vaccination: t "ENJOJTUFSBEPTFTFSJFTPG%5B1WBDDJOFBUBHFToNPOUITBOEUISPVHIZFBST5IFGPVSUIEPTFNBZCFBENJOJTUFSFE as early as age 12 months, provided at least 6 months have elapsed since the third dose. Catch-up vaccination: t 5IFöGUICPPTUFS EPTFPG%5B1WBDDJOFJTOPUOFDFTTBSZJGUIFGPVSUIEPTFXBTBENJOJTUFSFEBUBHFZFBSTPSPMEFS t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF 4. Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine. (Minimum age: 10 years for Boostrix, 11 years for Adacel). Routine vaccination: t "ENJOJTUFSEPTFPG5EBQWBDDJOFUPBMMBEPMFTDFOUTBHFEUISPVHIZFBST t 5EBQDBOCFBENJOJTUFSFESFHBSEMFTTPGUIFJOUFSWBMTJODFUIFMBTUUFUBOVTBOEEJQIUIFSJBUPYPJEDPOUBJOJOHWBDDJOF t "ENJOJTUFSPOFEPTFPG5EBQWBDDJOFUPQSFHOBOUBEPMFTDFOUTEVSJOHFBDIQSFHOBODZQSFGFSSFEEVSJOHUISPVHIXFFLTHFTUBUJPO regardless of number of years from prior Td or Tdap vaccination. Catch-up vaccination: t 1FSTPOTBHFEUISPVHIZFBSTXIPBSFOPUGVMMZJNNVOJ[FEXJUIUIFDIJMEIPPE%5B1WBDDJOFTFSJFTTIPVMESFDFJWF5EBQWBDDJOFBT UIFöSTUEPTFJOUIFDBUDIVQTFSJFTJGBEEJUJPOBMEPTFTBSFOFFEFEVTF5EWBDDJOF'PSUIFTFDIJMESFOBOBEPMFTDFOU5EBQWBDDJOFTIPVME not be given. t 1FSTPOTBHFEUISPVHIZFBSTXIPIBWFOPUSFDFJWFE5EBQWBDDJOFTIPVMESFDFJWFBEPTFGPMMPXFECZUFUBOVTBOEEJQIUIFSJBUPYPJET (Td) booster doses every 10 years thereafter. t $IJMESFOXJUIBOBUPNJDPSGVODUJPOBMBTQMFOJBJODMVEJOHTJDLMFDFMMEJTFBTFBOEPUIFSIFNPHMPCJOPQBUIJFTDPOHFOJUBMPSBDRVJSFEBTQMFOJB or splenic dysfunction); t $IJMESFOXJUIJNNVOPDPNQSPNJTJOHDPOEJUJPOT)*7JOGFDUJPODISPOJDSFOBMGBJMVSFBOEOFQISPUJDTZOESPNFEJTFBTFTBTTPDJBUFEXJUI treatment with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas and Hodgkin disease; or solid organ transplantation, congenital immunodeficiency. 7. Inactivated poliovirus vaccine (IPV). (Minimum age: 6 weeks) Routine vaccination: t "ENJOJTUFSBTFSJFTPG*17BUBHFToNPOUITXJUIBCPPTUFSBUBHFoZFBST5IFöOBMEPTFJOUIFTFSJFTTIPVMECFBENJOJTUFSFE on or after the fourth birthday and at least 6 months after the previous dose. Catch-up vaccination: t *OUIFöSTUNPOUITPGMJGFNJOJNVNBHFBOENJOJNVNJOUFSWBMTBSFPOMZSFDPNNFOEFEJGUIFQFSTPOJTBUSJTLGPSJNNJOFOUFYQPTVSF to circulating poliovirus (i.e., travel to a polio-endemic region or during an outbreak). t *GPSNPSFEPTFTBSFBENJOJTUFSFECFGPSFBHFZFBSTBOBEEJUJPOBMEPTFTIPVMECFBENJOJTUFSFEBUBHFUISPVHIZFBST t "GPVSUIEPTFJTOPUOFDFTTBSZJGUIFUIJSEEPTFXBTBENJOJTUFSFEBUBHFZFBSTPSPMEFSBOEBUMFBTUNPOUITBGUFSUIFQSFWJPVTEPTF t *GCPUI017BOE*17XFSFBENJOJTUFSFEBTQBSUPGBTFSJFTBUPUBMPGEPTFTTIPVMECFBENJOJTUFSFESFHBSEMFTTPGUIFDIJMETDVSSFOUBHF t *17JTOPUSPVUJOFMZSFDPNNFOEFEGPS64SFTJEFOUTBHFEZFBSTPSPMEFS t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF 8. Influenza vaccines. (Minimum age: 6 months for inactivated influenza vaccine [IIV]; 2 years for live, attenuated influenza vaccine [LAIV]) Routine vaccination: t "ENJOJTUFSJOøVFO[BWBDDJOFBOOVBMMZUPBMMDIJMESFOCFHJOOJOHBUBHFNPOUIT'PSNPTUIFBMUIZOPOQSFHOBOUQFSTPOTBHFEUISPVHI 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 UIBUQSFEJTQPTFUIFNUPJOøVFO[BDPNQMJDBUJPOT'PSBMMPUIFSDPOUSBJOEJDBUJPOTUPVTFPG-"*7TFF..83/P33 BWBJMBCMF at http://www.cdc.gov/mmwr/pdf/rr/rr5908.pdf. t "ENJOJTUFSEPTFUPQFSTPOTBHFEZFBSTBOEPMEFS For children aged 6 months through 8 years: t 'PSUIFoTFBTPOBENJOJTUFSEPTFTTFQBSBUFECZBUMFBTUXFFLT UPDIJMESFOXIPBSFSFDFJWJOHJOøVFO[BWBDDJOFGPSUIFöSTU UJNF'PSBEEJUJPOBMHVJEBODFGPMMPXEPTJOHHVJEFMJOFTJOUIF"$*1JOøVFO[BWBDDJOFSFDPNNFOEBUJPOT..83o available at http://www.cdc.gov/mmwr/pdf/wk/mm6132.pdf. t 'PSUIFoTFBTPOGPMMPXEPTJOHHVJEFMJOFTJOUIF"$*1JOøVFO[BWBDDJOFSFDPNNFOEBUJPOT 9. Measles, mumps, and rubella (MMR) vaccine. (Minimum age: 12 months for routine vaccination) Routine vaccination: t "ENJOJTUFSUIFöSTUEPTFPG..3WBDDJOFBUBHFUISPVHINPOUITBOEUIFTFDPOEEPTFBUBHFUISPVHIZFBST5IFTFDPOEEPTF may be administered before age 4 years, provided at least 4 weeks have elapsed since the first dose. t "ENJOJTUFSEPTFPG..3WBDDJOFUPJOGBOUTBHFEUISPVHINPOUITCFGPSFEFQBSUVSFGSPNUIF6OJUFE4UBUFTGPSJOUFSOBUJPOBMUSBWFM 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. t "ENJOJTUFSEPTFTPG..3WBDDJOFUPDIJMESFOBHFENPOUITBOEPMEFSCFGPSFEFQBSUVSFGSPNUIF6OJUFE4UBUFTGPSJOUFSOBUJPOBM 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: t &OTVSFUIBUBMMTDIPPMBHFEDIJMESFOBOEBEPMFTDFOUTIBWFIBEEPTFTPG..3WBDDJOFUIFNJOJNVNJOUFSWBMCFUXFFOUIFEPTFTJT weeks. 10. Varicella (VAR) vaccine. (Minimum age: 12 months) Routine vaccination: t "ENJOJTUFSUIFöSTUEPTFPG7"3WBDDJOFBUBHFUISPVHINPOUITBOEUIFTFDPOEEPTFBUBHFUISPVHIZFBST5IFTFDPOEEPTFNBZ 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: t &OTVSFUIBUBMMQFSTPOTBHFEUISPVHIZFBSTXJUIPVUFWJEFODFPGJNNVOJUZTFF..83</P33>BWBJMBCMFBUhttp://www. cdc.gov/mmwr/pdf/rr/rr5604.pdf IBWFEPTFTPGWBSJDFMMBWBDDJOF'PSDIJMESFOBHFEUISPVHIZFBSTUIFSFDPNNFOEFENJOJNVN 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. 11. Hepatitis A vaccine (HepA). (Minimum age: 12 months) Routine vaccination: t *OJUJBUFUIFEPTF)FQ"WBDDJOFTFSJFTGPSDIJMESFOBHFEUISPVHINPOUITTFQBSBUFUIFEPTFTCZUPNPOUIT t $IJMESFOXIPIBWFSFDFJWFEEPTFPG)FQ"WBDDJOFCFGPSFBHFNPOUITTIPVMESFDFJWFBTFDPOEEPTFUPNPOUITBGUFSUIFöSTUEPTF t "OJOBEWFSUFOUEPTFPG%5B1WBDDJOFBENJOJTUFSFEUPDIJMESFOBHFEUISPVHIZFBSTDBODPVOUBTQBSUPGUIFDBUDIVQTFSJFT5IJTEPTF can count as the adolescent Tdap dose, or the child can later receive a Tdap booster dose at age 11–12 years. t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF Haemophilus influenzae type b (Hib) conjugate vaccine. (Minimum age: 6 weeks) Routine vaccination: t "ENJOJTUFSB)JCWBDDJOFQSJNBSZTFSJFTBOEBCPPTUFSEPTFUPBMMJOGBOUT5IFQSJNBSZTFSJFTEPTFTTIPVMECFBENJOJTUFSFEBUBOE 6 months of age; however, if PRP-OMP (PedvaxHib or Comvax) is administered at 2 and 4 months of age, a dose at age 6 months is not indicated. One booster dose should be administered at age 12 through15 months. t )JCFSJY1315 TIPVMEPOMZCFVTFEGPSUIFCPPTUFSöOBM EPTFJODIJMESFOBHFENPOUITUISPVHIZFBSTXIPIBWFSFDFJWFEBUMFBTU 1 dose of Hib. Catch-up vaccination: t *GEPTFXBTBENJOJTUFSFEBUBHFTNPOUITBENJOJTUFSCPPTUFSBTöOBMEPTF BUMFBTUXFFLTBGUFSEPTF t *GUIFöSTUEPTFTXFSF1310.11FEWBY)*#PS$PNWBY BOEXFSFBENJOJTUFSFEBUBHFNPOUITPSZPVOHFSUIFUIJSEBOEöOBM dose should be administered at age 12 through 15 months and at least 8 weeks after the second dose. t *GUIFöSTUEPTFXBTBENJOJTUFSFEBUBHFUISPVHINPOUITBENJOJTUFSUIFTFDPOEEPTFBUMFBTUXFFLTMBUFSBOEBöOBMEPTFBUBHF 12 through 15 months, regardless of Hib vaccine (PRP-T or PRP-OMP) used for first dose. t 'PSVOWBDDJOBUFEDIJMESFOBHFENPOUITPSPMEFSBENJOJTUFSPOMZEPTF t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF Vaccination of persons with high-risk conditions: t )JCWBDDJOFJTOPUSPVUJOFMZSFDPNNFOEFEGPSQBUJFOUTPMEFSUIBOZFBSTPGBHF)PXFWFSPOFEPTFPG)JCWBDDJOFTIPVMECFBENJOJTUFSFE 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: t "ENJOJTUFSBTFSJFTPG1$7WBDDJOFBUBHFTNPOUITXJUIBCPPTUFSBUBHFUISPVHINPOUIT t 'PSDIJMESFOBHFEUISPVHINPOUITXIPIBWFSFDFJWFEBOBHFBQQSPQSJBUFTFSJFTPGWBMFOU1$71$7 BENJOJTUFSBTJOHMF supplemental dose of 13-valent PCV (PCV13). Catch-up vaccination: t "ENJOJTUFSEPTFPG1$7UPBMMIFBMUIZDIJMESFOBHFEUISPVHINPOUITXIPBSFOPUDPNQMFUFMZWBDDJOBUFEGPSUIFJSBHF t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF Vaccination of persons with high-risk conditions: t 'PSDIJMESFOBHFEUISPVHINPOUITXJUIDFSUBJOVOEFSMZJOHNFEJDBMDPOEJUJPOTTFFGPPUOPUFD BENJOJTUFSEPTFPG1$7JG 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. t "TJOHMFEPTFPG1$7NBZCFBENJOJTUFSFEUPQSFWJPVTMZVOWBDDJOBUFEDIJMESFOBHFEUISPVHIZFBSTXIPIBWFBOBUPNJDPSGVODUJPOBM 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. t "ENJOJTUFS1147BUMFBTUXFFLTBGUFSUIFMBTUEPTFPG1$7UPDIJMESFOBHFEZFBSTPSPMEFSXJUIDFSUBJOVOEFSMZJOHNFEJDBMDPOEJUJPOT (see footnotes 6b and 6c). Pneumococcal polysaccharide vaccine (PPSV23). (Minimum age: 2 years) Vaccination of persons with high-risk conditions: t "ENJOJTUFS1147BUMFBTUXFFLTBGUFSUIFMBTUEPTFPG1$7UPDIJMESFOBHFEZFBSTPSPMEFSXJUIDFSUBJOVOEFSMZJOHNFEJDBMDPOEJUJPOT (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: t *NNVOPDPNQFUFOUDIJMESFOXJUIDISPOJDIFBSUEJTFBTFQBSUJDVMBSMZDZBOPUJDDPOHFOJUBMIFBSUEJTFBTFBOEDBSEJBDGBJMVSF DISPOJDMVOHEJTFBTF (including asthma if treated with high-dose oral corticosteroid therapy), diabetes mellitus; cerebrospinal fluid leaks; or cochlear implant. t 'PSBOZQFSTPOBHFEZFBSTBOEPMEFSXIPIBTOPUBMSFBEZSFDFJWFEUIF)FQ"WBDDJOFTFSJFTEPTFTPG)FQ"WBDDJOFTFQBSBUFECZUP 18 months may be administered if immunity against hepatitis A virus infection is desired. Catch-up vaccination: t 5IFNJOJNVNJOUFSWBMCFUXFFOUIFUXPEPTFTJTNPOUIT Special populations: t "ENJOJTUFSEPTFTPG)FQ"WBDDJOFBUMFBTUNPOUITBQBSUUPQSFWJPVTMZVOWBDDJOBUFEQFSTPOTXIPMJWFJOBSFBTXIFSFWBDDJOBUJPO 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: t "ENJOJTUFSBEPTFTFSJFTPG)17WBDDJOFPOBTDIFEVMFPGBOENPOUITUPBMMBEPMFTDFOUTBHFEZFBST&JUIFS)17PS)17 may be used for females, and only HPV4 may be used for males. t 5IFWBDDJOFTFSJFTDBOCFTUBSUFECFHJOOJOHBUBHFZFBST t "ENJOJTUFSUIFTFDPOEEPTFUPNPOUITBGUFSUIFfirst dose and the third dose 6 months after the first dose (at least 24 weeks after the first dose). Catch-up vaccination: t "ENJOJTUFSUIFWBDDJOFTFSJFTUPGFNBMFTFJUIFS)17PS)17 BOENBMFT)17 BUBHFUISPVHIZFBSTJGOPUQSFWJPVTMZWBDDJOBUFE t 6TFSFDPNNFOEFESPVUJOFEPTJOHJOUFSWBMTTFFBCPWF GPSWBDDJOFTFSJFTDBUDIVQ 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: t "ENJOJTUFS.$7WBDDJOFBUBHFoZFBSTXJUIBCPPTUFSEPTFBUBHFZFBST t "EPMFTDFOUTBHFEUISPVHIZFBSTXJUIIVNBOJNNVOPEFöDJFODZWJSVT)*7 JOGFDUJPOTIPVMESFDFJWFBEPTFQSJNBSZTFSJFTPG.$7 with at least 8 weeks between doses. See MMWR 2011; 60:1018–1019 available at: http://www.cdc.gov/mmwr/pdf/wk/mm6030.pdf. t 'PSDIJMESFOBHFENPOUITUISPVHIZFBSTXJUIIJHISJTLDPOEJUJPOTTFFCFMPX Catch-up vaccination: t "ENJOJTUFS.$7WBDDJOFBUBHFUISPVHIZFBSTJGOPUQSFWJPVTMZWBDDJOBUFE t *GUIFöSTUEPTFJTBENJOJTUFSFEBUBHFUISPVHIZFBSTBCPPTUFSEPTFTIPVMECFBENJOJTUFSFEBUBHFUISPVHIZFBSTXJUIB minimum interval of at least 8 weeks between doses. t *GUIFöSTUEPTFJTBENJOJTUFSFEBUBHFZFBSTPSPMEFSBCPPTUFSEPTFJTOPUOFFEFE t 'PSPUIFSDBUDIVQJTTVFTTFF'JHVSF Vaccination of persons with high-risk conditions: t 'PSDIJMESFOZPVOHFSUIBONPOUITPGBHFXJUIBOBUPNJDPSGVODUJPOBMBTQMFOJBJODMVEJOHTJDLMFDFMMEJTFBTF BENJOJTUFSBOJOGBOU series of Hib-MenCY at 2, 4, 6, and 12-15 months. t 'PSDIJMESFOBHFEUISPVHINPOUITXJUIQFSTJTUFOUDPNQMFNFOUDPNQPOFOUEFöDJFODZBENJOJTUFSFJUIFSBOJOGBOUTFSJFTPG)JC.FO$: 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. 'PSDIJMESFOBHFEUISPVHINPOUITXJUIQFSTJTUFOUDPNQMFNFOUDPNQPOFOUEFöDJFODZXIPIBWFOPUSFDFJWFEBDPNQMFUFTFSJFT of Hib-MenCY or MCV4-D, administer 2 primary doses of MCV4-D at least 8 weeks apart. t 'PSDIJMESFOBHFENPOUITBOEPMEFSXJUIQFSTJTUFOUDPNQMFNFOUDPNQPOFOUEFöDJFODZPSBOBUPNJDPSGVODUJPOBMBTQMFOJBJODMVEJOH 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. t 'PSDIJMESFOBHFENPOUITBOEPMEFSXIPBSFSFTJEFOUTPGPSUSBWFMFSTUPDPVOUSJFTJOUIF"GSJDBONFOJOHJUJTCFMUPSUPUIF)BKKBENJOJTUFS 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. t 'PSDIJMESFOXIPBSFQSFTFOUEVSJOHPVUCSFBLTDBVTFECZBWBDDJOFTFSPHSPVQBENJOJTUFSPSDPNQMFUFBOBHFBOEGPSNVMBUJPOBQQSPQSJBUF series of Hib-MenCY or MCV4. t 'PSCPPTUFSEPTFTBNPOHQFSTPOTXJUIIJHISJTLDPOEJUJPOTSFGFSUPhttp://www.cdc.gov/vaccines/pubs/acip-list.htm#mening. 1. 5. 6a. 6b. 6c. Additional information t 'PSDPOUSBJOEJDBUJPOTBOEQSFDBVUJPOTUPVTFPGBWBDDJOFBOEGPSBEEJUJPOBMJOGPSNBUJPOSFHBSEJOHUIBUWBDDJOFWBDDJOBUJPOQSPWJEFST should consult the relevant ACIP statement available online at http://www.cdc.gov/vaccines/pubs/acip-list.htm. t 'PSUIFQVSQPTFTPGDBMDVMBUJOHJOUFSWBMTCFUXFFOEPTFTXFFLTEBZT*OUFSWBMTPGNPOUITPSHSFBUFSBSFEFUFSNJOFECZDBMFOEBS months. t *OGPSNBUJPOPOUSBWFMWBDDJOFSFRVJSFNFOUTBOESFDPNNFOEBUJPOTJTBWBJMBCMFBUhttp://wwwnc.cdc.gov/travel/page/vaccinations.htm. t 'PSWBDDJOBUJPOPGQFSTPOTXJUIQSJNBSZBOETFDPOEBSZJNNVOPEFöDJFODJFTTFF5BCMFi7BDDJOBUJPOPGQFSTPOTXJUIQSJNBSZBOE 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 44FET3FECPPLSFQPSUPGUIF$PNNJUUFFPO*OGFDUJPVT%JTFBTFTUIFE&ML(SPWF7JMMBHF*-"NFSJDBO"DBEFNZPG1FEJBUSJDT 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: ?"9(@1? Name of Primary Care Physician: Chief Complaint: Allergies: Subjective or History of Presenting Illness: 0( 1 A A(" ! (9& 9(9& ( &(" 0%& B ! 6 %" 6 " Evaluation of Mood: " "( '/ %(( !"' Medications-;% &> Past Medical History Family Medical History Objective: Vital Signs:66%CD General:"% Physical: C?# Cervix &% 6 "; % % %> "%E% " &% Pelvic/0E 1& B9 6%;> @%% % 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. Richard Jones Revised Dates: Feb. 1999; March 1999; Dec. 2000; Feb. 2001; April 2003; Feb. 2005; Feb. 2007; Feb. 2009; Dec. 2011; July 2013 Date to be reviewed: : Dec. : 2015 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 - Ultrasonography to confirm or establish gestational dating if indicated - Screening for gestational diabetes if patient is at high risk (and repeat late 2nd TM if negative during first TM) - advise ideal weight gain in pregnancy for patient’s BMI - 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: perform maternal serum screening for aneuploidy and/or neural tube defect if desired. -Between 24 to 28 weeks: glucose tolerance screening (unless no risk factors), and hematocrit. 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. Administer Tdap vaccine during 3rd TM (regardless of patient’s prior vaccination history). -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. -Lab work 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 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. All women who will be pregnant during the influenza season (Oct – May) should be vaccinated, regardless of trimester. 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 Follow-up on or between 21 and 56 days after delivery: -Evaluation of weight, blood pressure, breasts, abdomen and a pelvic exam. -Screening for postpartum Patient Education Information Presented Regarding: -Nutrition, exercise, sexual activity, work activity -Tobacco, alcohol, and drug restriction -Postpartum Depression -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) albumin and glucose depression.* -Breast feeding -Onset of labor, rupture of membranes, abnormal bleeding -Fetal activity -Nutrition and exercise -Review Family Planning anticipatory guidance Colorectal Cancer Screening Tier 2 Guideline Purpose: To delineate screening for colorectal cancer. Patient Population: Low Risk – Age < 50 or > 83 with no major co-morbidities, 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. 1. Developed by: Physicians representative of the S&W Departments: Gastroenterology, 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 2016 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 with moderate of severe co-morbidities or age 83-86 with no major co-morbidities •Non-operative candidate • Life expectancy < 3yrs NOTE Patients with fe def anemia or patients with NON-anal outlet bleeding 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 **FIT q 1 yr + Flex Sig q 5 yr or Flex Sig q 5 yr or **FIT q 1 yr (**Fecal Immunochemical Testing (FIT) 3 card specimen) Significant Findings: Polyp > 0.5cm or ANY + FOBT HIGH RISK st • 1 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 Complete Colon Exam Colonoscopy beginning at age 50 or 10 yr younger than the youngest affected family member OR FOR Longstanding inflammatory bowel diseaseColonoscopy beginning 10 yr after disease onset Colorectal Cancer Surveillance LOW RISK No polyps or hyperplastic rectosigmoid polyps on last surveillance colonoscopy 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) • Serrated adenoma of any site NO Screening for 5 yr then AVERAGE RISK - usually 10 year follow-up unless other risk factors present COLONOSCOPY warranted: Interval from last colonoscopybe determined by endoscopist (usually 1-5 years) References: Guidelines for Colonoscopy Surveillance After Screening and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer Gastroenterology 2012;143-844-857. And - Colorectal Cancer Screening Be Considered in Elderly Persons without Previous Screening? A Cost Effectiveness Analysis Annals Int Med 2014-160 (11): 750-759 - possibly with hyperlinks. 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) + Disease Management Programs (!9@"6"(( T DC6C6""' Asthma: TDC6; DC6>%"& ("" "'@% "( "&((%"("" ! "" "' -&" &((" $%((%" !""!" "!% &( (" ""% '!" %0 ""%8, %8%%8;! %(>!" &$%((( DC6 """ ("Z" " ' Secondary Preventative Coronary Artery Disease: TDC6(% %#[2[) & +:% "#[:% #[2"";"%...&2<<<>' DC6 6&(&%9" &%"' Two Months After Event: 2' """!&&!"" (\&\' ' ""% & %"' 3' " ;66>"( DC6""! &&("(!% ' )' " &( DC6""!&&" "&((!((!% " !#' Four Months After Event: 2' 6"6""""%"( DC6 "" !&&#(% "(&' ' """%66((!% !# Yearly And As needed: 2' 9""(% "%&!'%("% 6&(9""(%(( (%! "(%"" ' ' !(&(%&! &&(( TD!# ' Diabetes and Congestive Heart Failure:V%((!! 9@";9@>?%!!#! DC6% ""!(9&CV%;CV>' "% "V"@ &!" & '/""&0" &!""&%%"%( %"""!9'9@?% &( """ ""!( CV%""("( 3'( " (" "'E %% &(" % "'CV" & 9@"'?!""( "($%% "' V"("9@"6"]% " &":)<U3.<=(2U..32=<)=03.<=' ,# " - . 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: DC6(!("( "" (%&' ' Level of Care Standard 2' "(Preventive Primary Care " ' 3.!# /0" " "((&% !, && "' ;/0" % ,% ""%8%AY?0">' ' "(Routine Primary Care "' 6"(%" "' (/0" -,"% ') 3' "(Urgent Primary Care "' (/0" (& &"') ) )' "(Emergency Care' :' After-Hours Care :!# % " )% & !",& &""(fterhour ( 66((' ' DC6"%" !&8( %(" &"" "&"%(((&' (" ]%" &" %""' 62(2 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. SWHPhasestablishedthefollowingstandardsfortimelyaccessibilityofbehavioralandmental healthcareservices: Routineofficevisitappointments 10workingdays Urgentcare 24hours‡ Nonlifethreateningemergencycare 6hours‡ Lifethreateningemergencycare Immediately‡ ‡SWHPmembershavedirectaccesstoBehavioralHealthPractitionersbycallingtheir officeorgoingtotheEmergencyRoom. B. TelephoneAccess:Nocentralizedscreeningortriageisused. 62(2
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