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6 Training and Education Pharmaceutical investment in new medications, from discovery to marketing, is expensive and risky (OTA, 1993; Chapter 7), and it depends on a strong infrastructure to support a return on investment. The infrastructure for research and development of a new medication has many components: strong federal leadership and private sector commitment, federal and industry support of research, basic scientists dedicated to elucidating the mechanisms of disease, clinical investigators designing and conducting clinical research and identifying potential leads for new treatments, clinicians specifically trained in the diagnosis and treatment of the disease, health care professionals knowledgeable about recent research findings, adequate reimbursement for treatment, and an educated public that supports effective treatments. In the area of anti-addiction medications development, however, many of those components are scarce or nonexistent. This chapter explores three paths towards strengthening the clinical research and treatment components of the infrastructure for anti-addiction medications development: increasing the number of clinicians and clinical researchers in the field of addiction research and treatment; providing all physicians with training in the diagnosis and treatment of drug dependence; and expanding the capabilities and coordination of federal drug abuse research centers for all aspects of research, training, treatment, and education. Drug abuse is a major public health problem in the United States (Chapter 1~. The economic consequences of drug abuse are staggerin~the United States spends more than $66 billion annually on drug-abuse related health care costs and on the indirect costs of crime, incarceration, and drug supply control (D. Rice, University of California at San Francisco, personal communication). Yet, 134

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TRAINING AND EDUCATION 135 the federal government has not provided sustained support or innovative programs to increase the number of clinical researchers and clinicians in the field of drug addiction-a critical component of the infrastructure. There are too few clinicians trained in diagnosis and treatment, and there are limited numbers of clinical investigators interested in pursuing careers in drug addiction research. While the biomedical sciences in general are having difficulty in attracting and funding young researchers, especially clinical investigators (IOM, 1988, 1990; NRC, 1994), the numbers being attracted to the field of drug addiction research are particularly sparse. That fact has led addiction medicine to be identified as an orphan field of medicine (IOM Workshop, June 1994~. It is possible, however for the federal government to stimulate the discovery of anti-addiction medications. Historically, there have been other types of medications for which research and development were not initially embraced by the pharmaceutical companies. Comparable to the early history of acquired immune deficiency syndrome (AIDS) research and drug development, for example, the field of addiction treatment is faced with obstacles that include a stigmatized patient population, a lack of specialized clinicians and researchers, and limited scientific knowledge regarding the disease mechanism. Despite those difficulties, federal investment and support in AIDS research has led to an increase in researchers and clinicians and to the development of several medications. During the past 10 years, four medications have been developed and approved for the treatment of AIDS, as compared to three anti-addiction medications in the past 30 years. Given the enormous burden of drug abuse on society, drug abuse research and treatment deserve a similar level of attention and resources from the federal government. EXPANDING THE CORE OF RESEARCHERS AND CLINICIANS The critical need for scientists, clinical investigators, and clinicians to specialize in drug addiction research and treatment has been recognized by Congress and the executive branch (ONDCP, 1994; U.S. Congress, 1994~. However, there are numerous disincentives to entering this field, such as the perceived low prestige of the field of addiction medicine, low-paying positions, difficulties in conducting clinical research, personal health risks of working with patients who often have serious illnesses (e.g., HIV infection and tuberculosis), uncertain treatment reimbursement, a stigmatized patient population, and the involvement of many patients with crime and the criminal justice system. Although the limited availability of scientists and clinicians specializing in drug abuse research and treatment has direct consequences for the delivery of health care services and research on new treatments, it has a less obvious, but equally important, effect on pharmaceutical R&D investment. Pharmaceutical

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136 DEVELOPMENT OF MEDICATIONS companies traditionally market their products to health care professionals and promote their products through personal visits by sales representatives, through journal and mail advertising, and through support of scientific symposia and continuing medical education. Pharmaceutical companies distribute their products through hospital and community pharmacies, pharmacy chains, and distributors. To the extent that the treatment of drug dependence is often delivered outside that system by specialized clinics (e.g., narcotic treatment programs, typically with part-time physicians and limited marketing opportunities for pharmaceutical companies), and to the extent that drug abuse treatment involves many fields of medicine (e.g., family practice, internal medicine, psychiatry), pharmaceutical companies see greater difficulty in marketing anti-addiction medications than in marketing other products. Pharmaceutical firms also rely on academic clinical investigators and practicing clinicians to advise them on drug development issues such as current therapeutic trends, the role of drugs in the overall treatment strategy, unmet medical needs, indications to be evaluated, clinical trial design and appropriate therapeutic endpoints. Therefore, increasing the number of trained specialists is critical to anti-addiction medication development. Many organizations are involved in efforts to strengthen the infrastructure (Box 6. 1), and although some progress has been made, addiction medicine is still a relative unknown to many in the health professions and continues to be neglected by the pharmaceutical industry. Drug abuse treatment is intrinsically interdisciplinary and involves a variety of health care professionals, including counselors, social workers, therapists, psychologists, nurses, and physicians. The committee supports increased training opportunities for all health care profession- als involved in drug abuse treatment, but the focus here is on increasing the numbers of clinical investigators and clinicians working in drug addiction research and treatment. The following section examines current efforts to increase the numbers of physicians and scientists specializing in drug addiction research and treatment, through the National Institute on Drug Abuse (NIDA) training programs, fellowships offered by private institutions and the government, and certification programs. Training Programs The committee heard throughout its work and at its June workshop that there is a severe shortage in the number of clinical investigators in the field of addiction medicine. Physician-researchers are needed to take the lead in developing and implementing clinical research programs on new pharmacological and behavioral treatments. NIDA offers research career development awards to support mentored research by scientists and clinicians interested in pursuing

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TRAINING AND EDUCATION 137 careers as independent investigators. However, there is difficulty in attracting physicians to these programs. The Scientist Development Award for Clinicians (K20) provides drug abuse or mental health research experience for clinically trained individuals, especially physicians; the Scientist Development Award (K21) provides experience for biological or behavioral scientists (NIH, 19931. Stipends for those awards are based on institutional base salaries and range up to $75,000. NIDA funding of research career development awards has increased annually from $507,000 in fiscal year (FY) 1991 (funding five awards) to an FY 1994 estimate of $3.9 million (38 awards) (NIDA, 1994a). However, those programs are not filling the critical shortage of clinical investigators. Only two of the 18 recent applicants for K20 and K21 grants were physicians. NIDA's $7.9 million training budget for FY 1994 was 2.4 percent of its FY 1994 total extramural research funding. Since FY 1986 NIDA's training budget has averaged 2.0 percent of its extramural research funding (Table 6.1~. In contrast, other institutes of the National Institutes of Health (NIH:and the organization as a whole have larger proportional training budgets. Since FY 1986 the training budget for the National Institute of Neurological Disorders and Stroke averaged 3.1 percent of total extramural research (2.7 percent in FY 1993), the National Institute on Mental Health averaged 7.7 percent (6.4 percent in FY 1993), and NIH as a whole averaged 4.8 percent (4.3 percent in FY 1993) (NIDA, 1994a). In the FY 1994 bypass budget, NIDA requested an increase in the number of trainees to 440 fill-time positions, but only modest increases were funded. For FY 1995 NIDA has requested $17.4 million for research training, which would more than double its training budget (NIDA, 1994b). Actual funding increases are expected to be modest. Funding for the National Research Service Awards (NRSA), the majority of training funding, is appropriated by Congress to NIH as a whole. Once the final appropriation is made, NIDA competes with other NIH institutes for a share of the funds. Fellowships Another mechanism for developing expert practitioners, researchers, and teaching faculty is through postresidency fellowships, primarily sponsored by ~NRSAs fund training opportunities that include predoctoral and postdoctoral research and mentored research for career development. In 1994, NIDA awarded 68 NRSA fellowships (36 predoctoral and 32 postdoctoral) to support individuals working with experienced researchers and 245 NRSA training awards (105 predoctoral and 140 postdoctoral) to support drug abuse research training at public or nonprofit institutions (NIDA, 1994a).

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138 DEVELOPMENT OF MEDICATIONS BOX 6.1 Some Organizations Involved in Training and Education Federal Government . National Institute on Drug Abuse (NIDA) supports biomedical and behavioral research, health services research, and research training on drug abuse, including prevention end treatment. NIDA's training opportunities include individ- ual and institutional awards to train predoctoral and postdoctoral clinicians and researchers and support of the Minority Access to Research Careers (MARC) program for minority undergraduate research training. Additionally, NIDA offers mentored research career development programs for scientists and clinicians. . Substance Abuse and Mental Health Services Administration (SAMHSA) supports prevention and treatment services for mental health and addictive problems and disorders. The three major components of SAMHSA are the Center for Substance Abuse Treatment (CSAT), the Center for Substance Abuse Prevention (CSAP), and the Center for Mental Health Services (CMHS). CSAT currently funds l 1 addiction training centers that focus on increasing the number and knowledge of health professionals of all disciplines involvedinsubstanceabusetreatment. Additionally, CSATsponsorsaddiction counselor training programs and develops and disseminates the National HIV/AIDS Training Curriculum. CSAP has four components in its training system: curriculum development, community prevention training, volunteer training in prevention activities, and the Faculty Development Program, which provides part-time support for faculty in health professional schools to implement or strengthen drug abuse education at their institutions. . CMHS training programs include institutional grants to enhance clinical training of mental health professionals from many disciplines, regional grants for in-service training of practicing mental health professionals, and HIV/AIDS education programs for mental health care providers. Health Resources and Services Administration (HRSA) Bureau of Health Professions has established the Physician Consortium on Substance Abuse Education, which brings together representatives from academia, government agencies, medical professional organizations, and accrediting agencies to focus on drug abuse education for all levels of medical training. Additionally, HRSA has funded faculty development programs in this area. Department of Veterans Affairs (VA) medical centers offer chemical dependency fellowship programs.

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TRAINING AND EDUCATION Academic Institutions Individual academic medical centers vary widely in medical school and residency education on drug abuse. Fellowships in addiction medicine are offered at more than 35 institutions, primarily in departments of psychiatry. Health education schools of many disciplines also offer training. Foundations Many foundations provide support for drug abuse curriculum development and sponsor educational activities on drug abuse which have included conferences of medical educators, scholarship programs for medical student training on substance abuse, and continuing medical education programs. Associations and Professional Societies . American Academy of Psychiatrists in Alcoholism and Addiction (AAPAA) has 1,300 members who are board-certified psychiatrists or residents of psychiatry interested in furthering education, research, and treatment of addicted patients. AAPAA offers continuing education review courses and sponsors the publication of The American Journal on Addictions. . . American Society of Addiction Medicine (ASAM) has a membership of more than 3,000 physicians involved in education, treatment, research and prevention of drug abuse. This organization offers continuing education courses for practicing physicians, administers the independent (non-ABMS) certification in addiction medicine, and sponsors the Journal of Addictive Diseases. Association for Medical Education and Research in Substance Abuse (AMERSA) has a current membership of more than 400 health professional educators. It works to expand drug abuse education and to support faculty and curriculum development. AMERSA was formed in 1976 by many of those involved in the Career Teacher Program. The journal, Substance Abuse, is sponsored by AMERSA. . College on Problems of Drug Dependence (CPDD) is an interdisci- plinary research society focusing on the problems of drug dependence. Its annual scientific meeting brings together basic scientists and clinical investigators from industry, academia, and government. CPDD sponsors the journal, Drug and Alcohol Dependence, which reports scientific research. . Professional medical societies including the Society of Teachers of Family Medicine and the Society of General Internal Medicine offer continuing education courses, develop drug abuse curricula for residency training, and support faculty development efforts. 139

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140 DEVELOPMENT OF MEDICATIONS academic institutions. A 1992-1993 survey conducted by the Center for Medical Fellowships in Alcoholism and Drug Abuse reported 46 fellowship programs inthe addiction field providing 88 fellowship positions, however, only 61 ofthose positions were filled (Center for Medical Fellowships, 1993~. The total number of fellows for 1992-1993, including all training years, was 170. The fellows spent an average of one-third of their time in research, and almost half of their time in patient care. Typically, the fellowship programs are affiliated with psychiatry departments, either solely (85 percent) or jointly with other depart- ments including internal medicine and family practice; few of the programs were affiliated solely with family practice programs or departments. TABLE 6.1 NIDA Research Training Funding as a Percentage of Total Extramural Research Funding ($ millions) Research Training Individual Institutional Total No. Amount No. Amount No. Percent of Total Extramural Amount Research 1986 24 0.40 48 1.03 72 1.43 2.2 1987 36 0.67 66 1.58 102 1.25 2.0 1988 31 0.57 67 1.73 98 2.30 1.9 1989 35 0.64 52 1.73 87 2.37 1.5 1990 42 0.83 1 13 2.98 155 3.81 1.4 1991 73 1.26 217 5.55 290 6.81 2.1 1992 61 1.11 224 6.01 285 7.12 2.1 1993 65 1.26 237 6.1 1 302 7.37 2.2 1994 68 1.38 245 6.52 313 7.90 2.4 Estimate. SOURCE: NIDA, 1994a. Fellowships are also offered by NIDA's Addiction Research Center and through the Department of Veterans Affairs. Additionally, NIDA and the Food and Drug Administration (FDA) offer a joint fellowship program aimed at training physicians in drug-abuse treatment research, specifically focused on clinical trials to aid in the development of new anti-addiction medications. That

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TRAINING AND EDUCATION 141 program provides stipends for three clinicians per year to receive 3 years of training through rotations at NIDA's Medications Development Division, the FDA Center for Drug Evaluation and Research, and the NIDA Addiction Research Center. There has been, however, limited applicant response to that program (IOM Workshop, June 1994~. Certification Board certification has become a"de facto postdoctoral licensing mecha- nism" for physicians in the United States (Moore and Lang, 19819. Hospitals and managed care companies often require that physicians become board certified in their fields of specialization. In the addiction field, the push for physician certification has resulted in part from third-party insurance carriers' and regulatory agencies' attempts to ascertain the qualifications of physicians responsible for chemical dependency units (Chappel and Lewis, 19924. The American Board of Medical Specialties (ABMS), a nationally recognized organization with oversight for medical specialty board certification, includes 24 member boards that give annual examinations in core specialties (e.g., internal medicine or psychiatry). Many of these core specialty boards offer certification examinations in subspecialty areas, such as geriatric medicine or addiction psychiatry. In 1991, the American Board of Psychiatry and Neurology (ABPN), an ABMS member board, established the field of addiction psychiatry as a subspecialty. Certification for added qualifications in addiction psychiatry requires ARMS board certification in psychiatry, completion of a fellowship in addiction psychiatry (required after 1998) or extensive clinical practice time with addicted patients, and successful completion of the added qualifications examination (ABPN, 1993~. The American Society of Addiction Medicine offers independent (non- ABMS) certification in addiction medicine for physicians of all specialties. Qualifications for certification include completion of a residency training program, at least one additional year of work in the field of alcohol and drug dependency, and successful completion of the multi-disciplinary certification examination. The move toward certification is strongly supported by the committee. It increases the number of physicians with a subspecialty in addiction medicine and it increases the knowledge and skills of those physicians who choose certification in addiction medicine.

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142 DEVELOPMENT OF MEDICATIONS Conclusions and Recommendations The committee applauds current efforts aimed at increasing the number of researchers and clinicians in the field of addiction research and medicine, but it recognizes that those efforts have had only limited success. Given the paucity of trained professionals in this area, coupled with other disincentives to the pharmaceutical industry, it is clear that additional measures must be taken to overcome this obstacle. The committee recommends that the federal government increase its efforts to attract researchers and clinicians to the field of drug addiction treatment. That may be accomplished by implementing one or all of the following options: NIDA's training budget could be increased, but not at the expense of their research programs. Requests from NIDA for large increases in its training budget have not been filled in FY 1993 or FY 1994, and NIDA has received a lower percentage of training funds than several other institutes. Increasing NIDA's training budget such that it will enable NIDA to offer fellowships that are competitive with private sector salaries, and therefore, more attractive to potential candidates would "jump-start" the expansion of the field of drug addiction treatment and research; it could have nationwide impact by increasing the numbers of scientists and physicians recruited, trained, and working in the field of drug addiction. An educational loan repayment program in return for work in drug abus~related clinical research could attract young physi- cians with substantial educational debt into careers as clinical investigators. There is a precedent: the NIH Loan Repayment Program (LRP) for AIDS Research (P.L. 100~07 and P.L. 103~3) allows NIH to repay education loans for NIH scientists, physicians, and registered nurses who spend at least 80 percent of their time involved in AIDS research. Applicants for the LRP program must have qualified educational debt in excess of 20 percent of their annual NIH basic pay or stipend and must be employed under a mechanism that allows for their NIH employment to last a minimum of 2 years (Health Policy and Biomedical Research News of the Week, 1994~. To achieve greater national impact, loan repayment for work in the drug addiction field could be extended beyond NIH employees to encompass NIDA trainees and others working in the field.

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TRAINING AND EDUCATION Mid-career programs could be developed to encourage a cadre of practicing physicians and scientists to enter the field of drug addiction treatment and research. 143 Mid-career programs have been sponsored in the field of geriatric medicine with success. The Bureau of Health Professionals and the John A. Hartford Foundation have sponsored one-year training programs for physicians interested in redirecting their careers toward geriatric medicine (IOM, 1993; Robbins, 1993~. Similar programs could fill the current needs for physicians in drug addiction treatment and research, while new researchers and physicians are receiving training. In addition, short-term, mid-career training programs should be made available at NIDA's existing research centers and proposed comprehen sive drug abuse centers. INCREASING KNOWLEDGE AND SKILLS AMONG PRIMARY CARE PHYSICIANS Just as critical as infusing the addiction field with researchers and medical specialists is expanding primary care physicians' knowledge and skills in the diagnosis and treatment of drug abuse. Given the consequences of managed care, health care reform efforts, and the potential for new medications to treat drug addiction, primary care physicians must be able to diagnose drug addiction, and they must be familiar with its treatment modalities. It has been shown that physicians do not diagnose drug abuse disorders with the same accuracy as other chronic diseases (Coulehan et al., 1987; Gopalan et al., 1992~. Although they are often the first to see drug-dependent patients (Kamerow et al., 19861. Because of their minimal training in drug abuse, many physicians lack confidence in their diagnostic ability and they are ambivalent or pessimistic about the effectiveness of treatment (Chappel et al., 1977; Cotter and Callahan, 1987~. This is not surprising; the curriculum on drug abuse and its treatment varies greatly in medical schools. Over the past 20 years, drug abuse education (most often combining information about alcohol dependence and other addictions) has evolved slowly and has only recently begun to make inroads into the medical school curriculum, residency training programs, and the certification process. A concerted effort to stimulate medical school education in addiction medicine began in 1972 with the Career Teacher program sponsored by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and NIDA. Funded in 59 U.S. medical schools, the program trained faculty to develop and implement curricula. That program provided two key elements for raising awareness and expanding knowledge regarding the addiction field a dedicated faculty member serving as a role model for students and a high profile in

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144 DEVELOPMENT OF MEDICATIONS medical schools for drug abuse education. During its 10-year existence (1972-1981) the program resulted in an increase in curriculum hours, although the percentage of total time required for drug abuse education remained under 1 percent (Pokorny and Solomon, 1983~. Currently, the Center for Substance Abuse Prevention (CSAP) sponsors the Faculty Development Program, begun in 1989, which funds grants to 34 schools of medicine, nursing, social work, and psychology. Each grant provides part-time support for a program director, an evaluator, and three to five faculty fellows with the goal of developing a cadre of faculty to- provide leadership in expanding and improving clinical teaching about drug abuse (CSAP, 1994; Fleming et al., 1994a). Faculty development in drug abuse education also has interested medical professional organizations, including the Society of General Internal Medicine and the Society of Teachers of Family Medicine, which, with funding from the Health Resources and Services Administration (HRSA) have developed and implemented faculty development courses (Fleming et al., 1994a). Additional efforts have been made to define and promote education for primary care physicians. The 1985 Conference on Alcohol, Drugs, and Primary Care Physician Education produced a consensus statement identifying core skills and competencies for primary care physicians and set out educational strategies for implementation (U.S. DHHS, 1985; Lewis et al., 19871. In 1989, under the auspices of the HRSA Bureau of Health Professions, the Physician Consortium on Substance Abuse Education was formed and subsequently drafted recommen- dations for improving drug abuse education at all levels of medical education (U.S. DHHS, 19911. Work is ongoing to implement those recommendations. Through private and public funding, model undergraduate medical curricula on alcohol and drug abuse have been developed at several universities. Project ADEPT (Alcohol and Drug Education for Physician Training), a core curriculum, was developed at Brown University, and is used in more than 75 percent of U.S. medical schools (Chappel and Lewis, 1992~. Gains have been made in increasing medical school and residency education on drug abuse issues, although it is often fragmented between departments and frequently is not linked to adequate clinical training (Cotter and Callahan, 1987; Lewis et al., 1987~. Little attention is being given to cross-cultural and special-population issues in drug abuse education at all levels (U.S. DHHS, 1991). Required Education in Medical Schools A 1991-1992 survey of medical schools found that 93 percent of the 124 medical schools responding had at least one curriculum unit in drug abuse; at least two-thirds of those units were required (Fleming et al., 1994b). That was double the amount found in a similar 1986-1987 survey (Davis et al., 19881. The

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TRAINING AND EDUCATION 145 curriculum units ranged from single lectures to clinical experience. The number of departments reporting drug abuse curriculum units ranged by specialty 95 percent of psychiatry, 87 percent of family medicine, 59 percent of pediatrics, 47 percent of internal medicine, 46 percent of emergency medicine, and 45 percent of obstetrics-gynecology departments had at least one unit (Fleming et al., 1994b). The multifaceted nature of the consequences and treatment of drug abuse suggests that medical school education in this field should be cross- departmental and that the basic science and clinical aspects should be sequenced appropriately throughout medical training (Cotter and Callahan, 1987; Burger and Spickard, 19911. Only eight medical schools surveyed by the Liaison Committee on Medical Education in 1991-1992 had a separate required course on drug abuse (Fleming et al., 1994b). Far more had separate required courses in other special multidis- ciplinary topics. For example, 17 require a geriatrics course, 32 require a community health course, and 40 require a nutrition course (Fleming et al., 1994b). Few medical schools require clinical experience with drug-abuse patients, and if it is available the clinical experience is often limited to hospital inpatient settings where it is reported that the students are less likely to see the continuum of problems or the range of treatments (Kamerow et al., 1986; Lewis et al., 1987). Residency Training Residency education in addiction medicine is highly concentrated in psychiatric programs. A 1991-1992 survey of residency programs in four specialties found that 95 percent of psychiatry programs offered at least one addiction medicine curriculum unit, followed by family medicine (85 percent), pediatrics (59 percent), and internal medicine (47 percent) (Fleming et al., 1994b). Most of the required units were lectures and seminars; the electives were usually 2- to 8-week clinical rotations. Residency programs also rely on inpatient treatment settings for clinical training although most offer clinical exposure to two or more treatment settings (Davis et al., 1988~. The Josiah Macy, Jr. Foundation targeted residency education on drug abuse as the topic for its October 1994 conference. Leadership of the primary care certifying boards and of the residency review committees in internal medicine, family practice, pediatrics, and OBGYN along with business purchasers of health care, state legislative leaders, and drug abuse experts met and reached consensus on the urgency and necessity for primary care residency review committees to require drug abuse education for all residents under their supervision. Additional- ly, consensus was reached on the need for certifying boards to better reflect in their evaluation process the clinical magnitude of the drug abuse problem (D.

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146 Lewis, Brown University, personal communication). Continuing Education DEVELOPMENT OF MEDICATIONS Most currently practicing physicians had received minimal formal training if any in the diagnosis or treatment of drug abuse while they were in medical school or during their residencies. Continuing medical education (CME) can fill the gap, and several organizations, including the American Society of Addiction Medicine and the American Society for Medical Education an Research in Substance Abuse conduct workshops and conferences that prepare faculty for teaching continuing medical education courses. National professional organizations and state medical societies are also key to CME efforts. For example, the American Medical Association, the American College of Physicians, the Society of Teachers of Family Medicine, the Ambulatory Pediatric Association, and the American College of Obstetrics and Gynecology have al prepared continuing education materials, workshops, and courses in this field. The transfer of new research findings on treatment is especially critical as greater numbers of primary care physicians become involved in diagnosing and treating drug-dependent patients. Conclusions and Recommendations Increasing the depth and breadth of drug abuse education at all levels of physician training will result in heightened awareness of the physiological, psychological, and behavioral components of addiction and heightened understanding of the effectiveness of and the need for a range of treatment modalities. By understanding the spectrum and effectiveness of treatment services, physicians will be able to recommend the most appropriate and cost- effective intervention for the individual patient (Simek-Downing and Forman, 1987~. The committee recommends an increased emphasis on drug abuse education throughout medical school and primary care residency programs. To accomplish this, the following could be implemented: Drug abuse education could follow a systematic, integrated approach to coordinate the curriculum across specialty depart- ments.

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TRAINING AND EDUCATION Training institutions could develop affiliations with commu- nity-based treatment centers, where feasible, to provide student access to multiple treatment settings. The National Board of Medical Examiners2 and the primary care specialty boards of the American Board of Medical Specialties (ABMS) could pay increased attention to drug abuse issues, skills, and knowledge on their examinations for certification. Faculty development programs could receive increased federal support. CSAP's Faculty Development Program which trains medical school faculty members to serve as role models, educators, and mentors in the field of drug abuse research and treatment, is a good model. COMPREHENSIVE DRUG ABUSE CENTERS 147 The goal of a solid infrastructure needed to support anti-addiction medica- tions development and comprised of specialists and primary care physicians who are knowledgeable in the diagnosis and treatment of drug abuse, can be realized in part through the implementation of comprehensive, multidisciplinary drug abuse centers recommended by the committee (Chapter 2~. The centers of excellence would focus on all aspects of research and treatment, and they would offer the added benefit of serving as training sites for new investigators and mid- career physicians entering the field. They also would be clinical training sites for medical students and residents as they learn to diagnose and treat drug-dependent patients. A characterization of the centers, as envisioned by the committee, is provided below. Additionally, current NIDA and Substance and Mental Health Services Administration (SAMHSA) centers are briefly described and options for implementation of the centers are given. Proposed Model For optimal effectiveness the centers should have clinical research, treatment, basic research, and training components. Built around a core clinical research program with both inpatient and outpatient treatment capability, they could be funded directly using the model of the National Cancer Institute's (NCI) Comprehensive Cancer Centers (Box 6.2), as discussed in Chapter 2. 2The National Board of Medical Examiners prepares and administers to medical students a two-part examination that is accepted by individual states as part of licensing.

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148 DEVELOPMENT OF MEDICATIONS BOX 6.2 NCI Cancer Centers Program Begun in the early 1960s, NCI currently supports 55 research centers with diverse focus, structure, size, and funding. . research. Basic science cancer centers are primarily engaged in basic laboratory Clinical cancer centers focus on basic and clinical research. Comprehensive cancer centers are multidisciplinary and are designated as meeting NCI's criteria for strong basic and clinical research programs, state-of- the-art patient care, strong participation in NCI-designated high-priority clinical trials, significant prevention and control research, and community outreach activities. Consortium centers focus on cancer control and prevention research and work with state and local public health agencies. The centers are funded through a variety of sources, including the cancer center core grants (P-30 grants from NCI), which cover centralized administrative and program costs including personnel, shared resources, and services (including laboratory equipment), development, planning, and evaluation. SOURCES: IOM, 1989; NCI, 1993. The core clinical research program would not be linked to any given research project but would be available to investigators for specific projects and used as a site for training. Pilot projects could be reviewed by a local committee that would decide which proposals could make use of the core treatment unit for research. It would be expected that many of these pilot projects would result in peer-reviewed research project grant (ROT) funding. The core treatment unit of the comprehensive center would provide state-of-the-art patient care, serving as a valuable community treatment resource treatment costs could be supported in part by community or state block grant funding administered by the Center for Substance Abuse Treatment (CSAT). Strong participation in NIDA- and NIH- designated high-priority clinical trials and sponsorship of community outreach activities would be additional priorities for the centers. An equally essential component of the comprehensive center would be the conduct of preclinical research and the timely transfer of basic research findings to the clinical arena, which should result in the incorporation of pertinent information into clinical protocols to improve their viability. Collaboration between preclinical and clinical researchers is essential and at a minimum should

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TRAINING AND EDUCATION 149 involve regular interdisciplinary seminars that would be expected to lead to collaborative projects. The training component of the comprehensive centers should involve undergraduates and graduate students, to train physicians and other health care professionals including social workers, nurses, psychologists, and rehabilitation counselors. The center training programs also should include a postdoctoral training program primarily for research, but including training in treatment techniques. Training programs should include funding for faculty and administra- tive support of training. Competitive salaries for trainees are essential, given the precarious financial situations of most recent medical graduates, and a loan forgiveness program should be explored for trainees in the centers. The comprehensive centers should be encouraged to develop collaborative ties with the pharmaceutical industry. This would involve testing new medica- tions in preclinical laboratories and conducting clinical trials in the core treatment units. By supplying clinical trial site capability, the centers would provide industry with an incentive to develop anti-addiction medications. The centers would screen patients and obtain the necessary regulatory approvals- overcoming many of the hurdles cited by industry as strong disincentives. Existing Research and Training Centers To expand on its recommendation (Chapter 2), the committee explored the existing research and training centers sponsored by NIDA and SAMHSA. CSAT Centers The Center for Substance Abuse Treatment initiated its addiction training center (ATC) program in FY 1993 to link publicly funded addiction treatment and recovery programs with institutions that train health and allied health practitioners. The centers serve as training sites for students, provide continuing education to currently practicing treatment staff, and strengthen the drug abuse curriculum within the participating institutions. All ATCs are multidisciplinary and provide training opportunities for addiction counselors and other profession- als, including social workers, marriage and family therapists, psychologists, psychiatrists, and primary care physicians and nurses. ATC funds are used to develop clinical training programs, support faculty, and conduct training needs assessments. Implementation of the program began in FY 1994, and 11 centers are now funded through cooperative agreements three through state alcohol and other

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150 DEVELOPMENT OF MEDICATIONS drug addiction agencies, and eight at academic institutions (including three medical-school based-programs). NIDA Research Centers In FY 1993 NIDA funded 23 specialized research centers through the P50 Specialized Center extramural grant mechanism, at a cost of $24 million. Specialized centers are multiple-investigator, long-term programs planned around a major research objective or theme. Funded centers cover all aspects of NIDA's mission. Additionally, NIDA has finned treatment research units (TRUs), which conduct clinical studies examining multiple aspects of treatment. Initially funded as research demonstration grants, TRUs now apply competitively for new center grants as they come up for renewal. NIDA's intramural research center, the Addiction Research Center in Baltimore, Maryland, is the site for clinical and basic research on behavioral arid pharmacological treatments. The FY 1995 Department of Health and Human Services appropriations bill calls on NIDA to "support up to five multidisciplinary comprehensive substance abuse centers that will undertake research, service, arid training activities to demonstrate the effectiveness of such coordinated activities focused on women, children, alla minorities" (U.S. Congress, Senate, 19941. The committee supports the implementation of those centers and stresses the importance of a multidisci- plinary effort. Conclusions and Recommendations Upon examination of the CSAT and NIDA centers, it appears that there is ail opportunity for collaboration. Many of the individual components necessary for the centers, as recommended by the committee, are currently in place. A coordination of efforts between NIDA and SAMHSA could increase the number of facilities available to patients, increase services, enhance research opportuni- ties, and provide additional training opportunities without the need for a concomitant increase in fimding. A possible NIDA/SAMHSA collaboration effort could be the use of the ATCs as sites for treatment or prevention research. The committee envisions the comprehensive centers as maximizing effective research arid implementing innovative and effective drug abuse treatments. The committee recommends that comprehensive drug abuse centers be developed to engage in and coordinate all aspects of drug-abuse research, treatment, and education. Further, the committee recommends that NIDA and SAMHSA work together to coordinate

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TRAINING AND EDUCATION the effective and efficient use of existing centers by adding, where feasible, research, training, and/or treatment components. 151 The enormous public health and societal costs of drug abuse justify federal funding of comprehensive centers that will train physicians and scientists, provide state-of-the-art treatment, and expand basic research. The committee is aware of federal budgetary constraints and has therefore recommended a mechanism of cooperation between existing resources and capabilities, by expanding the mission and goals of existing NIDA and SAMHSA centers. SUMMARY The current involvement of the research and medical communities in research on arid treatment for drug abuse is limited. Few clinicians and clinical researchers have been interested in pursuing careers in drug abuse research and treatment, arid current efforts, through fellowships, traineeships, research development awards, and certification, have not attracted sufficient interest in the drug addiction field. This shortage of medical specialists has had a negative effect on the pharmaceutical industry. All physicians need to be educated in diagnosing and treating the chronic nature of drug abuse. Current efforts must be strengthened to increase medical school and primary care residency curricula, provide faculty development programs, and expand continuing medical education. Comprehensive drug abuse centers, as recommended by the committee, could fulfill the multiple goals of providing sites for state-of-the-art drug abuse treatment and research while serving as training facilities for generalists and specialists. As the societal costs of drug abuse increase, it is time to address the shortage of specialists and the inadequacy of drug abuse education. Those efforts will strengthen the infrastructure needed for research and treatment and will encourage pharmaceutical investment in this field. REFERENCES ABPN (American Board of Psychiatry and Neurology). 1993. Information for Applicants for Added Qualifications. Deerfield, IL:ABPN. Burger MC, Spickard WA. 1991. Integrating substance abuse education in the medical school curriculum. American Journal of the Medical Sciences 302:181-184. Center for Medical Fellowships in Alcoholism and Drug Abuse. 1993. Postgraduate Medical Fellowships in Alcoholism and Drug Abuse. New York: New York University School of Medicine, Depart lenient of Psychiatry.

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152 DEVELOPMENT OF MEDICATIONS Chappel JO, Jordan RD, Treadway BJ, Miller PR.1977. Substance abuse attitude changes in medical students. American Journal of Psychiatry 134:379-384. Chappel JN, Lewis DC. 1992. Medical education in substance abuse. In: Lowinson JH, Ruiz P. Millman RB, eds. Substance Abuse: A Comprehensive Textbook. 2nd ed. Baltimore: Williams & Wilkins. 958-969. Cotter F. Callahan C. 1987. Training primary care physicians to identify and treat substance abuse. Alcohol Health and Research World, Summer:70~73. Coulehan JL, Zettler-Segal M, Block M, McClelland M, Schulberg HC.1987. Recognition of alcoholism and substance abuse in primary care patients. Archives of Internal Medicine 147:349-352. CSAP (Center for Substance Abuse Prevention). 1994. CSAP Training System: Faculty Development Program Information Sheet. Davis AK, Cotter F. Czechowicz D. 1988. Substance abuse units taught by four specialties in medical schools and residency programs. Journal of Medical Education 63:739-746. Fleming M, Barry K, Davis A, Kahn R. Rivo M. 1994a. Faculty development in addiction medicine: Project SAEFP, a one-year follow-up study. Educational Research and Methods 26:221-225. Fleming M, Barry K, Davis A, Kropp S. Kahn R. Rivo M. 1994b. Medical education about substance abuse: changes in curriculum and faculty between 1976 and 1992. Academic Medicine 69:362-369. Gopalan R. Santora P. Stokes EJ, Moore RD, Levine DM. 1992. Evaluation of a model curriculum on substance abuse at the Johns Hopkins University School of Medicine. Academic Medicine 67:26~266. Health Policy and Biomedical Research News of the Week ("The Blue Sheet"~. 1994. NIH Loan Repayment Program for AIDS Research. 37~28~:S4. July 13, 1994. IOM (Institute of Medicine). 1988. Resources for Clinical Investigation. Washington, DC: National Academy Press. IOM (Institute of Medicine). 1989. A Stronger Cancer Centers Program. Washington, DC: National Academy Press. IOM (Institute of Medicine). 1990. Funding Health Sciences Research: A Strategy to Restore Balance. Washington, DC: National Academy Press. IOM (Institute of Medicine). 1993. Strengthening Funding in Geriatrics for Physicians. Washington, DC: National Academy Press. Kamerow DB, Pincus HA, MacDonald DI. 1986. Alcohol abuse, other drug abuse, and mental disorders in medical practice. Journal of the American Medical Association 255:205~2057. Lewis DC, Niven RG, Czechowicz D, Trumble JG. 1987. A review of medical education in alcohol and other drug abuse. Journal of the American Medical Association 257:2945-2948. Moore FD, Lang SM. 1981. Board-certified physicians in the United States. New England Journal of Medicine 304:1078-1084. NCI (National Cancer Institute). 1993. Cancer Facts: The National Cancer Institute Cancer Centers Program. July 1993. NIDA (National Institute on Drug Abuse). 1994a. Research Training Trends FY1994. Rockville, MD: NIDA Office of Science Policy, Education and Legislation.

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TRAINING AND EDUCATION 153 NIDA (National Institute on Drug Abuse). 1994b. National Institute on Drug Abuse 1995 Budget Estimate. Rockville, MD:NIDA. NIH (National Institutes of Health), Division of Research Grants. 1993. The K Awards. Bethesda, MD:NIH. NRC (National Research Council), Commission on Life Sciences. 1994. The Funding of Young Investigators in the Biological and Biomedical Sciences. Washington, DC: National Academy Press. ONDCP (Office of National Drug Control Policy). 1994. National Drug Control Strategy: Reclaiming Our Communities from Drugs and Violence. Washington, DC: Executive Office of the President, ONDCP. OTA (Office of Technology Assessment). 1993. Pharmaceutical R&D: Costs, Risks, and Rewards. Washington, DC: U.S. Government Printing Office. OTA-H-522. Pokorny AD, Solomon J. 1983. A follow-up survey of drug abuse and alcoholism teaching in medical schools. Journal of Medical Education 58:31~321. Robbins LJ. 1993. Mid-career faculty development awards in geriatrics: does retraining work? Journal of the American Geriatrics Society 41:570571. Simek-Downing L, Forman SI. 1987. The teaching of substance abuse: a national survey and a residency training curriculum. Substance Abuse 8:42-52. U.S. Congress, Senate. 1994. Departments of Labor, Health, and Human Services, and Education and Related Agencies Appropriation Bill, 1995. 103d Cong., 2d sess. S. Report 103-318. U.S. DHHS (U.S. Department of Health and Human Services). 1985. Consensus Statements from the Conference Alcohol, Drugs, and Primary Care Physician Education: Issues, Roles, Responsibilities. November 12-15, 1985. U.S. DHHS (U.S. Department of Health and Human Services). 1991. Policy Report ofthe Physician Consortium on Substance Abuse Education. Washington, DC: U.S. Government Printing Office. Publication No. HRSA-P-DM-91-3.