Maryland Department of Health and Mental Hygiene
Lyme Disease Prevention and Control in Maryland
A Strategic Plan
Draft Plan and Notes for Subcommittee Review: January 2007
TABLE OF CONTENTS
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
History of Lyme disease in Maryland . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Vision of Maryland's Lyme Disease Program . . . . . . . . . . . . . . . . . . . . . . 3
Maryland Public Health: Strengths, Challenges, and Opportunities . . . . . . . . . . 4
Maryland Lyme Disease Subcommittee
Topic Area Group Summaries . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Response to Challenges/Problems and Recommendations
Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Ecology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Public Awareness and Provider Education . . . . . . . . . . . . . . . . . . . 8
Diagnostic Best Practice and Treatment Guidelines . . . . . . . . . . . . . . . 9
Public Policy Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
A relatively new but rapidly growing body of knowledge about Lyme disease (LD) has emerged in recent years. Human Lyme disease was first recognized in 1977 with the identification of similarities in cases of juvenile rheumatoid arthritis in Lyme, Connecticut. It was recognized that the rash resulting from an insect/arthropod bite was associated with later symptoms of other organ systems, and, in particular, with arthritis, and was experienced by people who lived where animals were more likely to be found carrying Ixodes scapularis ticks, the vector commonly associated with LD. By 1981, a scientist named William Burgdorfer along with colleagues had identified a spiral–shaped bacterium found both in the midgut of Ixodes scapularis and in skin lesions and body fluids of LD patients.
Lyme disease is responsible for significant morbidity to the population and imposes a considerable financial and social burden on society. The Immunization and Infectious Diseases section of Healthy People 2010, refers specifically to the public health issues represented by Lyme disease (LD):
The direct and indirect costs of infectious diseases are significant. ... A typical case of Lyme disease diagnosed in the early stages incurs about $174 in direct medical treatment costs. Delayed diagnosis and treatment, however, can result in complications that cost from $2,228 to $6,724 per patient in direct medical costs in the first year alone. " 1
LD is the most commonly reported tick-borne illness in Maryland and in the United States. In 2005, Maryland reported an incidence of 22.1 cases per 100,000 population compared with a nationwide incidence of 7.9 cases per 100,000 population. The disease burden of LD is clustered in the northeast and north-central regions of the US. The rise in prevalence of LD depends upon many elements, such as the ecological factors maintaining the propagation of the Ixodes vector and the increased exposure to humans. The geographic distribution of the Ixodes vector is maintained mostly by small mammal hosts: such as mice (in the early developmental stage of disease), and deer during the mature late stages of disease. The increased risk of LD to humans is linked to the rise of residential development in semi-wooded areas inhabited by increasing populations of mice and deer.
History of Lyme Disease in Maryland
The Centers for Disease Control and Prevention (CDC) initiated systematic surveillance of LD in 1982 in 11 states, and by 1988 nearly all states were reporting LD cases. During 1982-1988, the numbers of reported LD cases increased steadily as active surveillance captured a truer incidence rate.
The Maryland Department of Health and Mental Hygiene (DHMH) received the first patient report of LD in 1985. With changes to the Maryland disease reporting regulations, it became a formally reportable disease for Maryland providers in 1989. Statute changes in 1996 required laboratories to also report LD test results.
The following table shows the annual numbers of confirmed LD cases in Maryland during the last sixteen years:
The twelve hundred and thirty-five confirmed cases in 2005 represent a sizeable increase when compared to the numbers of confirmed cases documented in previous years of Maryland LD surveillance.
Vision of Maryland's Lyme Disease Program
Our ultimate goal is to develop an integrated public health program that provides Lyme disease prevention and control measures evidenced by the following:
· LD would be recognized as an ongoing health hazard to human beings that needs to be understood and prevented. However, it is recognized that the causative agent of LD and its vectors are well-established in the environment, and their total elimination is not feasible. In the absence of a vaccine, public education about tick avoidance and disease management at the early signs of LD must be emphasized. Public health, healthcare organizations, and patient support and advocacy groups would cooperate to ensure that the messages about LD reach the widest possible audience. Research into alternative control methods would be encouraged and conducted to support prevention recommendations.
· Within public health in Maryland, responsibility for LD would include not only communicable disease and veterinary public health programs, but also chronic disease mitigation programs, minority disparity elimination programs, cardio-vascular disease prevention programs, and professional licensing boards, and others, to provide an integrated, comprehensive LD program for the State.
· Health care research on LD would have advanced to the point where there is strong scientific support for regimens to manage all stages of LD, and, in particular, the stage(s) characterized by ongoing symptoms after antimicrobial treatment.
· Healthcare providers and provider associations would be aware of recent recommendations about LD clinical diagnosis, the possible role of laboratory testing, if indicated, would use appropriate antibiotics if needed, and would counsel patients about risk factor reduction and later stages or consequences of LD.
· Healthcare providers and consumers would be informed about the various approaches to management of LD treatments, and the therapeutic approach chosen for each care plan would meet the provider’s accepted standard of care as well as the patient’s need to provide informed consent.
· Healthcare providers would report all LD-like illnesses promptly to LHD communicable disease staff, and respond to requests for follow-up information from public health investigators. A Case Report Form is available online to all healthcare providers and contains links to professional-level LD information.
· Public health staff members at LHDs would investigate every case of LD received, and analyze the epidemiologic characteristics of any LD report which is not "confirmed" by the public health case definition.
· A system to provide real-time information about LD reports in Maryland would be available to the public. Using this information, a geographic information system can be used to highlight high-risk areas in the State.
· Maryland residents will use appropriate personal protection techniques to prevent tick contact, and to look for and locate ticks on the body before they become embedded. Maryland residents would know the early signs of tick-related diseases, and promptly seek healthcare attention and if needed, treatment. An interactive program geared to young children (5 - 8 years of age) and to their parents would be developed to provide key LD prevention messages.
· Harm reduction programs will be developed, based on survey research among households in high-risk areas, to educate the public and physicians about LD manifestations that may occur months to years after initial infection, and about medical evaluation techniques.
Maryland Public Health: Strengths, Challenges, and Opportunities
Maryland’s public health system currently consists of a health department structure established at both the State and local level. Each of the 24 Maryland jurisdictions (23 counties and the City of Baltimore) maintains a full service health department to focus on disease prevention and health promotion, with particular focus on the challenges to public health in that jurisdiction.
Each local health department is staffed by a local health officer and a professional staff that includes epidemiologists, sanitarians, and communicable disease professionals, who implement Maryland guidelines for disease investigation and control. These guidelines are consistent with national communicable disease authorities, such as the Centers for Disease Control and Prevention (CDC) of the United States Public Health Service, and also with Maryland law and regulations.
Current strengths of Maryland’s Lyme disease program at the State and local levels include:
Current challenges relating to Lyme disease at State and local public health agencies and related health/healthcare organizations in Maryland:
· Rising LD activity in several regions of Maryland and in other States in the Mid-Atlantic region (especially Pennsylvania, Delaware, and New Jersey).
· Staffing shortages in some local health departments that severely limit the full investigation of reports of Lyme disease.
· An increasing disparity between the number of requests for DHMH consultation and assistance with communicable disease issues and the number of staff available to handle these requests.
· A functional yet developing surveillance system for LD in Maryland.
· Lack of provider awareness about proper reporting and follow up with local public health investigators.
· Lack of patient knowledge and awareness in seeking early screening and prompt treatment for tick-borne illness.
· Difficulty in clinical recognition and laboratory assessment of LD, due to absence of typical LD clinical signs at presentation, or presentation with late LD symptoms.
· Disparate viewpoints within the medical community about appropriate treatment methods.
· Provider reluctance to care for LD patients due to concerns about licensing penalties and adverse legal actions.
· Absence of federal support for LD surveillance programs and research studies in Maryland, coupled with funding cutbacks for other communicable disease control efforts.
Current opportunities include:
Maryland Lyme Disease Subcommittee
DHMH recognized the potential benefits of enhanced collaborative efforts by multiple disciplines in Lyme disease control and appointed a Lyme Disease Subcommittee to the Maryland Vector-borne Disease Interagency Task Force in 2005. Diverse representatives from various State agencies with a professional interest in this disease, as well as from Lyme disease advocacy groups whose primary mission is to aid those persons infected with Lyme and other tick-borne infectious diseases; and medical and public health professionals in related areas were invited to participate. All were brought together to discuss and clarify the burden of such diseases in our State, and to achieve a proposed strategic plan for LD prevention and control based on consensus on current needs and appropriate intervention plans.
The Committee identified six topic areas of particular interest, and the subcommittee was divided into Topic Area Groups (TAGs) accordingly. Each topic area was reviewed, and recommendations were made for enhanced public health response to LD in Maryland. The subcommittee's topic areas included:
1. Surveillance: Monitor and investigate LD and other tick-borne communicable diseases in Maryland.
2. Ecology: Review human host behavior, the agent of Lyme disease and its direct and indirect vectors, and the environment in which they all interact. Mobilize community partnerships and actions to identify and solve health problems.
3. Public Awareness and Provider Education: Inform and educate the public and medical providers about the causes and risks of LD.
4. Diagnosis: Ensure competence of public and private health care providers and availability of laboratory testing services.
5. Treatment: Link persons seeking assistance with sources of information and personal health care services.
6. Public Policy: Develop policies and plans that support individual and community health efforts. Enforce applicable laws and regulations. Evaluate and assure quality of health care services. Support research to better understand the causes of LD and evaluate the effectiveness of proposed interventions.
Responses to Challenges/Problems Associated with Lyme disease in Maryland
Surveillance: The Subcommittee reviewed LD surveillance in Maryland.
The following major weaknesses were identified:
Several recommendations were made to enhance surveillance for tick borne diseases:
· Add "Southern tick-associated rash illness (STARI)" and "Bartonellosis" as reportable conditions or diseases. Add the term "Anaplasmosis" as a separately listed reportable disease. Change the currently reportable disease group "Ehrlichiosis" to "Human monocytic ehrlichiosis". [Affects Maryland Annotated Code 18-205; COMAR 10.06.01.03.].
· Review DHMH and LHD case investigation procedures and practices, including the Maryland LD Case Report Form.
· Assess the need to modify existing case report forms to include additional symptoms, test results, risk factors or exposure history relevant to the more common agents known to co-infect individuals with LD; and
· Identify and remove barriers to appropriate reporting and case investigation of LD and other tick-borne diseases or conditions.
Several subcommittee members recommended that better definitions of federal surveillance case criteria and diagnostic criteria should be made available to health professionals, and are included under the Public Awareness and Provider Education or Public Policy issues sections below.
Ecology: The Ecology topic area group reported that expanded research and evaluation in this topic area was needed, including vector control, deer population growth, and community development. The topic area group discussed possible use of additional educational resources, such as the Connecticut Tick Management Handbook. Several subcommittee members expressed interest in seeing ongoing discussion of the above topics as well as related topics including tick abundance and personal and professional tick management systems. The group also suggested an expansion of field surveillance efforts to quantify tick vector densities.
The central recommendation of the Ecology group:
Promote research to develop more effective environmentally-based control strategies and to promote a better understanding of environmental risk factors for LD among the public health, natural resources, and agricultural communities.
Public Awareness and Provider Education: This topic area group discussed existing efforts in Maryland to educate and inform health professionals and the public about LD.
The following needs were identified:
· Improved physician awareness about Lyme disease diagnosis and treatment options; and
· Patient awareness of Lyme disease early signs and the need for prompt evaluation, especially among minority populations or groups with limited healthcare access.
There was considerable discussion about the best strategies to use for continuing education of physicians and the expected roles and responsibilities of physicians and patients in interpreting medical information. Several members of the topic area group offered examples of educational documents regarding education and prevention issues. The group also discussed the importance of tailoring LD education information to minority populations.
Maryland state health officials provided formal information to medical providers about Lyme disease through a LD surveillance update posted on the Web site of the Medical and Chirurgical Faculty of Maryland (MedChi) in November 2005 at www.medchi.org.
DHMH also recognizes the importance of training public health students in the control of vector-borne diseases. PHASE students from the Johns Hopkins University Bloomberg School of Public Health assisted with the development of educational material to promote awareness of LD in summer recreational and camp programs.
A Lyme disease and tick ecology educational training session was presented by a DHMH/EDCP epidemiologist to camp inspectors and students. The training presentation and other resources were subsequently made available to camp inspectors. Material was uploaded to the Division of Community Services Web site, which regulates youth camps in Maryland. This Web site serves as a regular source of information and communication for camp counselors and directors.
The annual Zoonotic Disease Update conference coordinated by the EDCP, Center for Veterinary Public Health serves as another vehicle for disseminating LD information to local health departments. The June 13, 2006 conference included a presentation entitled “Lyme Disease: An Educational Initiative” by Anne Arundel County Health Department officials, and “Tick-borne Rickettsial Diseases” by a senior EDCP staff member.
Recommendations for DHMH:
§ Update the Lyme Disease page on the EDCP Web site (http://www.edcp.org/vet_med/lyme_disease.html) on statistical information, access to downloadable educational materials for health care providers and school-aged children, and additional resources.
§ Develop an educational flyer targeting school-aged children.
§ Promote provider education via information sharing on CME opportunities.
§ Continue LD educational programs for staff of local health departments to maintain their knowledge and skill levels.
Diagnostic Best Practices and Treatment Guidelines:
The topic area group discussed major areas of discordance relating to:
These two TAGs (Diagnosis and Treatment) confronted some of the most difficult aspects of LD surveillance and control: clinical and laboratory diagnosis and clinical management of the disease.
A. Diagnostic methods:
The CDC case definition of Lyme disease, which describes clinical symptoms supported by a positive laboratory test, is used for national LD surveillance. CDC recommends a two-tiered testing protocol of an enzyme-linked immunosorbent assay (ELISA) and Western blotting in the presence of a characteristic clinical picture of Lyme disease. These test results are interpreted according to criteria established by the CDC/Association of State and Territorial Public Health Laboratory Directors.
The difficulty in culturing the LD spirochete (spiral-shaped bacterium) coupled with shortcomings in laboratory testing procedures and many different manifestations of LD all often lead physicians to rely indirectly on serological (blood serum) tests to support the clinical presentation of LD. Diagnosis based on blood tests is insensitive early in the infection: it does not differentiate between new and old infections, or between persistent infection and re-infection of Lyme disease, and it is not predictive of the efficacy of antibiotic therapy during the course of treatment. Problems have also arisen concerning the standardization and reproducibility of the results obtained through such serological assays.
Recommendations for DHMH:
The subcommittee discussed several guidelines currently used by medical practitioners to determine the best treatment approach for LD. The wide variation in strategies for treatment has created controversy among physicians and among patients as well.
The spectrum of treatment approaches is anchored by two well-known guidance documents: the Infectious Diseases Society of America (IDSA) guidelines2 and the International Lyme and Associated Diseases Society (ILADS) guidelines3. These two sets of guidelines represent examples of the variety of resources and guidance that individual providers may utilize in formulating individual care plans for their patients.
Many similarities can be found between these documents and among most approaches to the prevention and early treatment of Lyme disease.
In addition to these differences in approach to use of medications for patients with ongoing manifestations of symptoms, these guidelines vary in their reliance on laboratory diagnostic tests, diagnosis and treatment of other tick-borne co-infections, and their use of complimentary or supportive therapies including diet, probiotics, vitamins and other supplements, physical therapy, joint infusions, surgery, and acupuncture.
Presentation of prolonged or recurrent infection in Lyme disease can be identical or similar to that of other multisystem disorders. The current debate within the medical community over issues concerning management of patients with recurrent, chronic or post-Lyme syndrome demonstrates that the practice of medicine is not an exact science. As illustrated by the controversy surrounding Lyme disease diagnosis and treatment, a pressing need exists for the medical community to improve its understanding of approaches to addressing the complications of Lyme disease.
General recognition was reached that considerable scientific work remains to be done in order to clarify the best approach to treatment uncertainties as well as further discussion needed on all aspects of the Lyme disease spectrum.
General recognition was also reached that providers and patients would be well-served by open discussions of options and preferred approaches before venturing into the more controversial aspects of LD care. Providers will benefit from opportunities for patients to advise them of their understanding of the disease process and their possible desire for a particular approach. Patients should be encouraged to solicit information and answers to their questions and either agree to the treatment as offered or state their interest in identifying a provider with a different approach. Although ideally the provider and patient would reach consensus of opinion on a course of treatment, it is unlikely that this will happen in each instance. Where variability in approaches exists, providers are encouraged to document in the patient record the discussion of options, the rationale for recommended therapy, and the patient’s concerns and/or agreement with the provider’s recommendations.
No consensus was reached by the subcommittee on recommending use of either of the two treatment guidelines discussed. It was determined that the role of DHMH is not to recommend a specific treatment protocol to providers, except in those cases where adequate treatment could prevent further dissemination of disease (i.e. tuberculosis). LD is not considered as such a communicable disease.
Ultimately, it was recommended that DHMH and its partner agencies enhance provider and patient education in the following areas:
Public Policy Issues:
A public policy topic area group was not assembled. However, the subcommittee members discussed related public policy issues. Concern was raised that the Maryland Board of Physicians would follow the lead of similar agencies in several other states in which legal action was initiated against providers who chose to practice according to ILADS guidelines. In its Fall 2005 Newsletter4, the Board clarified that:
This document reviews the background and historical information about Lyme disease in Maryland. A vision of a more comprehensive approach to preventing the disease is presented along with the current picture of Maryland’s public health strengths, challenges, and opportunities for combating LD. The efforts of the LD Subcommittee are presented along with specific recommendations in the topic areas of surveillance, diagnosis, treatment, ecology, public and provider education, and policy. These recommendations address: 1) enhancements to surveillance for LD and other tick-borne illnesses for a more accurate portrayal of the burden of disease in Maryland, 2) public education about tick population control and the need for additional research on the effectiveness of certain host control measures, and 3) increased information sharing for the public and providers to enhance easy access to current diagnostic and treatment information, and 4) availability of educational materials and programs for school-aged children and campers. The recommendations also support heightened awareness by providers and patients of the spectrum of treatment approaches, increased provider-patient communications, as well as prompt evaluation, early recognition and treatment of LD signs and symptoms. Greater clarification to providers is needed about the role of licensing entities (e.g. Maryland Board of Physicians) in regulating practice and licensing matters. Taken together, these recommendations form the basis for the strategic approach to be taken by DHMH, partner agencies and providers, individuals and organizations on collaboratively achieving enhanced LD prevention and control programs in Maryland.
1 Healthy People 2010; Section 14: Immunization and Infectious Diseases. http://www.healthypeople.gov/document/html/volume1/14immunization.htm .
2 Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by Infectious Disease Society of America. Clin Infect Dis. 2006 Nov 1:43(9): 1089-1134.
3 The ILADS Working Group. Evidence-based guidelines for the management of Lyme disease. Expert Rev Anti-infect Ther 2004;2:S1-S13.
4 Maryland Board of Physicians, Newsletter, Fall 2005
Link to full report PDF- http://ideha.dhmh.maryland.gov/CZVBD/pdf/Recommendations_LD_Plan07.pdf