INTRODUCTION:Clinical Pharmacology is the consultant specialty with the goal of achieving optimal drug treatment. The specialty is based on in depth knowledge of human pharmacology and therapeutics.
GENERAL OBJECTIVES:The nature of clinical pharmacology requires that the resident must become a consultant with a broad knowledge of human pharmacology and therapeutics, usually with special expertise in a specific area of pharmacotherapy. Often this special expertise is by virtue of research conducted by the resident. The breadth of many career possibilities require the resident and supervisor to clearly identify the future career goals and setting of the resident. The appropriate training for individuals in community clinical practice, academic clinical practice, clinical research, government, administration or the pharmaceutical industry, will be quite different.
In keeping with the resident's background, it is assumed an individual will have the broad knowledge of pathophysiology in their discipline. While the acquisition of knowledge and skills in areas of greatest relevance to a future career is appropriate, a sound understanding of the principles of clinical pharmacology as they affect different age groups (pediatric and adult) and patients with different diseases is essential.
During the course of training in clinical pharmacology the resident must acquire clinical competence in the management of complex therapeutic problems together with an advanced background in basic and human pharmacology and relevant basic science (e.g. pharmacology, computer science, clinical epidemiology). Residents must learn to serve as consultants concerning clinical pharmacology and therapeutics to general internal medicine, pediatric, psychiatric or anesthesia services as well as selected specialty services (e.g. infectious disease, geriatrics, obstetrics). The resident must become capable of critically evaluating scientific publications in this field and participate in research during training.
Finally, the resident must become an effective communicator and educator. Teaching and education of students, residents, colleagues, other health personnel and the general public is a major role for the clinical pharmacologist. All residents must demonstrate the knowledge, skills and attitudes relating to age, gender, culture, and ethnicity pertinent to clinical pharmacology. Usually, these skills will be acquired in conjunction with structured clinical experience, research projects and supervised consultation related to pharmacotherapy in hospital, community, government and ambulatory care settings.
Specific
Features:
At the time of entering the program, the resident should have determined plans regarding practice, teaching and research. The program must provide opportunities for the resident to pursue intensive experience in the clinical pharmacology of the resident's primary specialty. There must also be opportunity for experience of shorter duration in clinical pharmacology in other disciplines.
By the completion of the program the resident should possess a broad knowledge of the principles of pharmacotherapy of diseases related to the primary specialty and be able to consult effectively on drug related problems.
As determined by the needs of the primary and secondary disciplines, the resident should have a complete knowledge and skills in:
1.1 selection of appropriate agents, doses, and
delivery methods
1.2 effects of drugs on the disease(s) treated, coexisting diseases, other drugs
(drug interactions)
1.3 effects of disease on the pharmacokinetics and pharmacodynamics of the
administered drugs.
1.4 the advantages and disadvantages of multiple drug therapy.
o age: as appropriate from the fetus and neonate, through puberty, to the extremes of old age
2.2
3.1 short and long term adverse effects
3.2 overdose
3.3 abuse of legal and illegal substances
3.4 poisoning (to include experience in Poison Control)
3.5 teratogenicity
3.6 adverse effects of drugs on growth and development
3.7 drug and food interactions
There must be an organized program of rotations and other educational experiences, both mandatory and elective, designed to provide each resident with the opportunity to fulfill the educational requirements and achieve competence in the specialty.
The following are the minimum educational requirements for programs in the subspecialty of clinical pharmacology. Additional experience may be required by the program director.
The equivalent of at least one year must be spent
in clinical work during which time the resident has supervised responsibility
for the care of patients and experience in the pharmacotherapy required to
manage these patients. Over the years of the program, the resident must be
provided with increasing responsibility appropriate to his/her level of
competence, in the clinical, laboratory and research aspects of the specialty.
All residency programs in clinical pharmacology must be able to provide a
complete educational program in at least one of the four specialties of clinical
pharmacology.
For those entering from internal medicine and pediatrics: three years of internal medicine or pediatrics must be completed prior to entry into the clinical pharmacology program.
For those entering from anesthesia and psychiatry: four years of anesthesia or psychiatry including a basic clinical year must be completed prior to entry into the clinical pharmacology program.
RESOURCES:
There must be sufficient resources including teaching faculty, the number and variety of patients, physical and technical resources, as well as the supporting facilities and services necessary to provide the opportunity for all residents to complete the program and achieve the educational objectives in clinical pharmacology.
In those cases where a university has sufficient resources to provide most of the training in clinical pharmacology but lacks one or more essential elements, the program may still be accredited provided that formal arrangements have been made to send residents to another accredited residency program for periods of appropriate prescribed training.
There must be a sufficient number of qualified teaching staff to supervise the residents and provide teaching in the basic and clinical sciences related to clinical pharmacology. The teaching staff should have an appropriate nucleus of full-time teachers. Multi-departmental collaboration is required. The combined clinical pharmacology staffs of the Departments of Anesthesia, Medicine, Pediatrics and Psychiatry, in conjunction with other academic and clinical services or departments, should provide the program and the program facilities.
The number and variety of patients available for teaching must be sufficient to allow residents to attain the objectives.
It is essential that there be adequate numbers of patients available for teaching, in whose management the resident actively participates to provide adequate consultation experience in the following areas: pharmacotherapy of single system and multi-system disease, acute and intensive care; drug overdose; adverse drug reactions; interpretation of therapeutic drug monitoring.
In the course of this experience it is expected residents will have experience with respect to adverse reaction monitoring and interpretation; therapeutic drug monitoring; effects of renal and hepatic failure on drug kinetics and response and the treatment of alcohol and drug dependence.
Where certain clinical conditions occur so infrequently that clinical material is not always available, the program must ensure that those conditions are covered by other educational means.
Clinical pharmacology services participating in the program must have access to an adequate number of beds and facilities organized for teaching and should actively participate in the investigation and treatment of patients with complex therapeutic problems. The clinical services or patients must be under the supervision of a qualified specialist.
There must be access to specialized ambulatory clinics (e.g. adverse drug effects clinic, drug assessment clinics, reproductive toxicology clinics, hypertension and cardiovascular risk clinics, preoperative clinics, psychopharmacology clinics, neurology clinics).
An active consultation service is essential for the resident to gain experience in providing consultations to referring physicians.
Facilities should be adequate to provide both in-patient and out-patient consultation, experience in the neonatal nursery (for pediatrics), exposure to the therapeutic drug monitoring service and to the Poison facility. In coordination with programs in psychiatry and internal medicine, experience should be gained in the management of adolescent drug abuse problems and in the identification and management of adverse reactions in children as well as adult populations.
There should be access to a laboratory in which both routine and investigational drug analyses are conducted.
It is essential that there be an association with pharmacists skilled in areas of drug information research and the preparation of pharmaceutical supplies for research studies.
The resident should have access to appropriate computer facilities with the appropriate software for data management and biostatistical analysis and teaching applications.
The hospitals and/or affiliated research institutes to which the resident is attached must have sufficient out-patient and in-patient facilities for the appropriate conduct of studies involving patients and healthy volunteers. Ideally, there should be a Clinical Research Unit in which the patient or volunteer can be studied in a comfortable, private and safe manner.
The institution must have an active Ethics Review Board to permit prompt evaluation of research protocols in which the resident is participating. The resident should be able to attend meetings of the Ethics Committee.
The academic and scholarly aspects of the program must be commensurate with the concept of a university postgraduate education. The quality of scholarship in the program will in part, be demonstrated by a spirit of enquiry during clinical discussions, rounds, and conferences. Scholarship implies an in-depth understanding of basic mechanisms of normal and abnormal states and the application of current knowledge to practice.
A coordinated educational program must be provided in clinical pharmacology. The educational program may include lectures and/or seminars, which may be interdisciplinary in nature, teaching rounds, special conferences, assignments of laboratory work, technical demonstrations and critical appraisal of the literature.
The educational program must include organized teaching in the basic sciences related to clinical pharmacology. Each program will offer a core program for all residents. The program should include lectures, seminars and individual reading in the areas of developmental pharmacology, toxicology and teratology. Both an introductory and advanced level course are required. The introductory level course should include the elements of pharmacokinetics, pharmacodynamics, clinical trial design and analysis, therapeutic drug monitoring, analytic methodology, applied statistics, drug regulation, drug utilization, education and teaching. The advanced course may be in any one of these areas in more depth or take the form of a series of selected topic or tutorial discussions. It is expected such courses will be developed in conjunction with academic pharmacologists or pharmacists. In addition, it is strongly advised that residents take courses in clinical epidemiology and/or computer science.
Residents expecting to follow an academic career should be in a position to obtain a Master's or doctorate in conjunction with their clinical pharmacology specialty training.
The program must ensure that residents gain an understanding of the basic principles and practice of biomedical ethics as it relates to clinical pharmacology.
The program must ensure that residents to learn effective communication skills for interacting with patients and their families, colleagues, co-workers from other disciplines and students. Clearly defined educational objectives for teaching these skills and mechanisms of formal assessment should be in place.
Residents must be given opportunities to develop effective skills in collaborating with all members of the patient care team.
Programs are expected to involve residents in the administrative and consultation work important in the field with, for example, Pharmacy and Therapeutics Committees, Human Experimentation (Ethics) Committees, Government Formulary Committees, liaison with the pharmaceutical companies, and participation in national and international professional societies.
Residents must be given opportunities to develop effective teaching skills by teaching junior colleagues and students, as well as through conference presentations, clinical and scientific reports, and patient education.
Residents must be given opportunities to develop skills in management as applied to clinical pharmacology such as efficient practice and records management and the ethical use of health care resources. Residents should also be prepared for their role as a health care advocate.
The program must provide residents with opportunities to gain an understanding of the principles and practice of quality assurance/improvement. Opportunities should be provided for residents to participate actively in such programs in their hospital departments.
There must be a faculty member with the responsibility to facilitate the involvement of residents in research and other scholarly work. Residents must gain adequate research experience in clinical pharmacology. All residents must demonstrate an ability to incorporate age, gender, cultural and ethnic perspectives in research methodology, data presentation and analysis. Although clinical research is stressed, advanced epidemiology and/or pharmacology may be desirable. Residents are expected to plan and complete at least one human clinical research project during their program. In addition, studies focussing on related problems in pharmacokinetics, or epidemiology are encouraged. Residents are also encouraged to undertake research at a more basic level. Because of the nature of studies in clinical pharmacology, it is often impossible for a resident to plan and complete a well-designed controlled study within 12 months. However, careful planning should permit the work to be completed in the two-year period.
The residents are expected to learn the essential methodology, e.g. experimental design, pharmacokinetics, analytical methods, statistics, etc., to be able to develop, in the near future, their own research program. The program must include a human clinical research project and an opportunity to conduct a basic science project arising from a clinical problem. The research project(s) may be carried out in collaboration with other clinical and basic departments or scientists.
Cooperation with the Department of Pharmacology or a pharmacology research program and cognate departments or disciplines at the parent institution is an essential element in developing a program. It should be possible for the resident to have access to the intellectual, teaching and technological aspects of such departments or programs. Through this interaction it should be possible for basic scientists to provide a meaningful evaluation of the pharmacological knowledge base of the resident. Possible mechanisms by which this interaction could occur include: the participation of basic science faculty in core courses designed for the residents; formal presentations by the residents at seminars within the department or programs; full participation of residents in courses offered by the department which may include seminar presentations, participation in journal clubs, research programs or thesis preparation, where appropriate.
A satisfactory level of research and scholarly activity must be maintained among the faculty identified with the program.
All programs must promote development of skills in self-assessment and self-directed life-long learning. To promote this end, the program should provide opportunities for residents to attend conferences outside their own university.
PROGRAMS (WITH TRAINING REQUIREMENTS):
Eighteen months of approved training.
Thirty six months of approved training.
Forty eight months(four years)of approved training.