Reproductive Toxicology. Vol.6, pp. 293-295, 1992 Printedin the U.S.A.All rightsreserved.
0890-6238/92 $5.00 + .00 Copyright© 1992PergamonPressLtd.
• Special Article
A QUALITY ASSURANCE PROGRAM FOR TERATOGEN INFORMATION SERVICES GIDEON KOREN, M D The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics & Research Institute, The Hospital for Sick Children, Toronto; Department of Pediatrics, Pharmacology and Pharmacy, The University of Toronto have decided to move toward identification of such requisites, similar to the way genetic counselors or poison control specialists have done. Beyond the obvious need to insure high professional standards for this newly formed field of medical knowledge, there is an urgent need to address the issue of quality of such services: there are no similar medical areas, where complicated information, which is very seldom clear-cut, "black and white," is administered over the telephone to pregnant women who are at such high levels of anxiety. Potentially this will expose the TIS to medicolegal liability. Because 1% to 3% of children will have major malformations, many callers of TIS will have malformed children after being advised over the telephone that they don't have a risk higher than the baseline of 1% to 3%. This makes the documentation of all information given to the caller most crucial. Since its inception in 1985, the Motherisk Program in Toronto has developed a quality assurance (QA) mechanism that is built into the system at various levels. We recognize that different TIS have a variety of functions; however, because Motherisk has both the telephone and clinic components, as well as routine follow-up of pregnancy outcome and research arms, we believe our QA program may be helpful to other TIS. In this paper the various functions of the Motherisk Program are described with special focus on the QA aspects of each step.
INTRODUCTION Ever since the thalidomide disaster, public awareness of the potential reproductive risks of drugs and chemicals used by the pregnant mother has steadily increased. To date, three decades later, no more than 30 xenobiotics have been proven to be teratogenic in humans, hundreds have been proven safe (1), while for many more not enough data are available to establish clear safety/risk ratios. There is evidence that maternal anxiety after drug exposure may be high and may lead women to consider terminations of otherwise wanted pregnancies (2). To address the need for authoritative information on teratogenic risk, Teratogen Information Services (TIS) have been established in many countries (3). Although these programs vary in their structure and mandate, all of them answer over the telephone inquiries about the teratogenic potential of drugs, chemicals, radiation, and infections. While some services advise only health professionals, most accept calls from the public at large. The minority of TIS conduct follow-up as part of prospective research and, similarly, only a few programs see patients to counsel them in a clinical setting. To date, no general criteria have been established to address the educational and training requirements of staff serving as TIS counselors. In 1987 the Organization of Teratology Information Services was founded, and by 1990 its executive and membership
RECRUITMENT AND TRAINING OF COUNSELORS
Dr. Koren is a Career Scientist o f Ontario Ministry o f Health. Presented at the Annual meeting o f the Organization of Teratology Information Services, Chicago, IL, February 1991. Address correspondence to Gideon Koren, MD, ABMT, FRCP(¢), Division o f Clinical Pharmacology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G IX8 Canada.
The Motherisk counselors come from several sources:
1. Individuals who trained at the pharmacology-toxicology Specialty program at the University of To293
294
Reproductive Toxicology
ronto, who took their Project course (PCL 474Y) in Motherisk. This is a whole-year, 2 days per week exposure to the counseling experience, followed by more intensive training by the Program's coordinator. It includes a formal series of lectures and mostly practical work. Prior to the Project course, these students had already had structured courses in the areas of experimental and clinical pharmacology, toxicology, and teratology. 2. Registered nurses with experience in either clinical medicine or research. Their initial training is done "on the job" and includes reading assignments, instructions, and participation in the lectures series as in 1. 3. Graduate students in pharmacology or pharmacy; their training is similar to 2. All counselors participate in the weekly Motherisk rounds (on Fridays), where cases to be seen that week, new literature, and research projects are discussed. Simlar to medical trainees and graduate students, each counselor presents in the "Journal club" part of these rounds. The counselors are sent to formal courses in the area of reproductive toxicology, such as the one organized by Dr. L. Holmes in Boston, and participate in the annual meetings of OTIS. Once yearly we conduct an in-service examination that includes case presentation. The test is taken by all counselors and physician-trainees serving in Motherisk and is delivered without previous notice during one of our routine rounds. A week later we discuss the correct answers and their basis, and the Director discusses areas of deficiencies with each counselor and medical trainee.
Volume 6, Number 4, 1992
teria) (4) the case is discussed personally with the counselor or physician who completed the form. QA OF T H E CLINIC C O N S U L T A T I O N Prior to counseling patients in clinic, all physician-trainees, who are already specialized pediatricians or specialists in internal medicine or emergency medicine are instructed by the Director about the steps and special features of this process. The forms completed during the clinic visit are reviewed by the Director when he is reviewing and signing the consultation letters. Areas of deficiency are discussed with the trainee. The consultation letter includes the statements about the various exposures the patient experienced. A new statement is constructed by the first team physician who had to address an exposure (for example, fluoxetine), and existing statements are revised whenever new information becomes available and has been discussed by the team in its weekly meetings. All statements are stored in a computer program to be used by the medical secretary typing the letters as well as by other team members. These statements are routinely the basis for the answers given by the counselors to patients and health professionals. RESEARCH While conducting follow-up of pregnancy outcome based on the patient's computerized data, we often identify items that should be corrected or improved, either in the recording of the information or in its storage. DISCUSSION
QA OF T H E C O U N S E L I N G PROCESS All inquiries are answered first by a counselor, who decides, according to known criteria, who should be referred to a clinic consultation or who should be answered through the telephone by the physician coveting the service. During the initial months of the counselors' work, both Motherisk coordinator and assistant director overhear the counseling process and routinely discuss shortcomings or items that should be changed, either in style or in content. Bimonthly, one of the clinical fellows reviews a random sample of telephone forms to assess the completeness of the recorded data, and the appropriateness of the advice given. The findings of this analysis are discussed in a special team meeting, addressing deficiencies, suggestions for new policies, changes in the forms, etc. Whenever a major deviation from Motherisk policy is found (for example, a patient was not referred to a clinic visit despite meeting the cri-
The area of reproductive toxicology is characterized by a very rapid growth in the body of knowledge, coupled with difficult methodologic issues in conducting and interpreting data on gestational exposures. This means that health professionals dealing with these issues have to be open minded, ready to continuously learn new information and adapt new concepts. Moreover, dealing with very anxious pregnant women over the telephone means that a combination of compassion and scientific rigor has to be synthesized. While it is possible that in the future a process will be created to accredit TIS counselors and maybe even programs, probably most of the burden of training and maintaining competence and quality of TIS will rest on the services themselves. ~Copies of the documents referred to in this article are available from the author.
Quality assurance for TIS • G. KOREN
REFERENCES 1. Koren G. Teratogenic drugs and chemicals in humans. In: Koren G (ed). Maternal-fetal toxicology: a clinician's guide. New York: Marcel Dekker; 1990:15-28. 2. Koren G, Bologa M, Long D, Feldman Y, Henderson K, Shear N. The perception of teratogenic risk by women exposed to drugs and chemicals during the first trimester of pregnancy. Am J Obstet Gynecol. 1989; 160:1190-4.
295
3. Vogt BL. Teratogen information programs. In: Koren G (ed). Maternal-fetal toxicology: a clinician's guide. New York: Marcel Dekker; 1990:329-44. 4. Pellegrini EM, Koren G. Motherisk; 1: A new model for counseling in reproductive toxicology. In: Koren G (ed). Maternalfetal toxicology: a clinician's guide. New York: Marcel Dekker; 1990:355-72.
0890-6238/92 $5.00 + .00 Copyright© 1992PergamonPressLtd.
• Special Article
A QUALITY ASSURANCE PROGRAM FOR TERATOGEN INFORMATION SERVICES GIDEON KOREN, M D The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics & Research Institute, The Hospital for Sick Children, Toronto; Department of Pediatrics, Pharmacology and Pharmacy, The University of Toronto have decided to move toward identification of such requisites, similar to the way genetic counselors or poison control specialists have done. Beyond the obvious need to insure high professional standards for this newly formed field of medical knowledge, there is an urgent need to address the issue of quality of such services: there are no similar medical areas, where complicated information, which is very seldom clear-cut, "black and white," is administered over the telephone to pregnant women who are at such high levels of anxiety. Potentially this will expose the TIS to medicolegal liability. Because 1% to 3% of children will have major malformations, many callers of TIS will have malformed children after being advised over the telephone that they don't have a risk higher than the baseline of 1% to 3%. This makes the documentation of all information given to the caller most crucial. Since its inception in 1985, the Motherisk Program in Toronto has developed a quality assurance (QA) mechanism that is built into the system at various levels. We recognize that different TIS have a variety of functions; however, because Motherisk has both the telephone and clinic components, as well as routine follow-up of pregnancy outcome and research arms, we believe our QA program may be helpful to other TIS. In this paper the various functions of the Motherisk Program are described with special focus on the QA aspects of each step.
INTRODUCTION Ever since the thalidomide disaster, public awareness of the potential reproductive risks of drugs and chemicals used by the pregnant mother has steadily increased. To date, three decades later, no more than 30 xenobiotics have been proven to be teratogenic in humans, hundreds have been proven safe (1), while for many more not enough data are available to establish clear safety/risk ratios. There is evidence that maternal anxiety after drug exposure may be high and may lead women to consider terminations of otherwise wanted pregnancies (2). To address the need for authoritative information on teratogenic risk, Teratogen Information Services (TIS) have been established in many countries (3). Although these programs vary in their structure and mandate, all of them answer over the telephone inquiries about the teratogenic potential of drugs, chemicals, radiation, and infections. While some services advise only health professionals, most accept calls from the public at large. The minority of TIS conduct follow-up as part of prospective research and, similarly, only a few programs see patients to counsel them in a clinical setting. To date, no general criteria have been established to address the educational and training requirements of staff serving as TIS counselors. In 1987 the Organization of Teratology Information Services was founded, and by 1990 its executive and membership
RECRUITMENT AND TRAINING OF COUNSELORS
Dr. Koren is a Career Scientist o f Ontario Ministry o f Health. Presented at the Annual meeting o f the Organization of Teratology Information Services, Chicago, IL, February 1991. Address correspondence to Gideon Koren, MD, ABMT, FRCP(¢), Division o f Clinical Pharmacology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G IX8 Canada.
The Motherisk counselors come from several sources:
1. Individuals who trained at the pharmacology-toxicology Specialty program at the University of To293
294
Reproductive Toxicology
ronto, who took their Project course (PCL 474Y) in Motherisk. This is a whole-year, 2 days per week exposure to the counseling experience, followed by more intensive training by the Program's coordinator. It includes a formal series of lectures and mostly practical work. Prior to the Project course, these students had already had structured courses in the areas of experimental and clinical pharmacology, toxicology, and teratology. 2. Registered nurses with experience in either clinical medicine or research. Their initial training is done "on the job" and includes reading assignments, instructions, and participation in the lectures series as in 1. 3. Graduate students in pharmacology or pharmacy; their training is similar to 2. All counselors participate in the weekly Motherisk rounds (on Fridays), where cases to be seen that week, new literature, and research projects are discussed. Simlar to medical trainees and graduate students, each counselor presents in the "Journal club" part of these rounds. The counselors are sent to formal courses in the area of reproductive toxicology, such as the one organized by Dr. L. Holmes in Boston, and participate in the annual meetings of OTIS. Once yearly we conduct an in-service examination that includes case presentation. The test is taken by all counselors and physician-trainees serving in Motherisk and is delivered without previous notice during one of our routine rounds. A week later we discuss the correct answers and their basis, and the Director discusses areas of deficiencies with each counselor and medical trainee.
Volume 6, Number 4, 1992
teria) (4) the case is discussed personally with the counselor or physician who completed the form. QA OF T H E CLINIC C O N S U L T A T I O N Prior to counseling patients in clinic, all physician-trainees, who are already specialized pediatricians or specialists in internal medicine or emergency medicine are instructed by the Director about the steps and special features of this process. The forms completed during the clinic visit are reviewed by the Director when he is reviewing and signing the consultation letters. Areas of deficiency are discussed with the trainee. The consultation letter includes the statements about the various exposures the patient experienced. A new statement is constructed by the first team physician who had to address an exposure (for example, fluoxetine), and existing statements are revised whenever new information becomes available and has been discussed by the team in its weekly meetings. All statements are stored in a computer program to be used by the medical secretary typing the letters as well as by other team members. These statements are routinely the basis for the answers given by the counselors to patients and health professionals. RESEARCH While conducting follow-up of pregnancy outcome based on the patient's computerized data, we often identify items that should be corrected or improved, either in the recording of the information or in its storage. DISCUSSION
QA OF T H E C O U N S E L I N G PROCESS All inquiries are answered first by a counselor, who decides, according to known criteria, who should be referred to a clinic consultation or who should be answered through the telephone by the physician coveting the service. During the initial months of the counselors' work, both Motherisk coordinator and assistant director overhear the counseling process and routinely discuss shortcomings or items that should be changed, either in style or in content. Bimonthly, one of the clinical fellows reviews a random sample of telephone forms to assess the completeness of the recorded data, and the appropriateness of the advice given. The findings of this analysis are discussed in a special team meeting, addressing deficiencies, suggestions for new policies, changes in the forms, etc. Whenever a major deviation from Motherisk policy is found (for example, a patient was not referred to a clinic visit despite meeting the cri-
The area of reproductive toxicology is characterized by a very rapid growth in the body of knowledge, coupled with difficult methodologic issues in conducting and interpreting data on gestational exposures. This means that health professionals dealing with these issues have to be open minded, ready to continuously learn new information and adapt new concepts. Moreover, dealing with very anxious pregnant women over the telephone means that a combination of compassion and scientific rigor has to be synthesized. While it is possible that in the future a process will be created to accredit TIS counselors and maybe even programs, probably most of the burden of training and maintaining competence and quality of TIS will rest on the services themselves. ~Copies of the documents referred to in this article are available from the author.
Quality assurance for TIS • G. KOREN
REFERENCES 1. Koren G. Teratogenic drugs and chemicals in humans. In: Koren G (ed). Maternal-fetal toxicology: a clinician's guide. New York: Marcel Dekker; 1990:15-28. 2. Koren G, Bologa M, Long D, Feldman Y, Henderson K, Shear N. The perception of teratogenic risk by women exposed to drugs and chemicals during the first trimester of pregnancy. Am J Obstet Gynecol. 1989; 160:1190-4.
295
3. Vogt BL. Teratogen information programs. In: Koren G (ed). Maternal-fetal toxicology: a clinician's guide. New York: Marcel Dekker; 1990:329-44. 4. Pellegrini EM, Koren G. Motherisk; 1: A new model for counseling in reproductive toxicology. In: Koren G (ed). Maternalfetal toxicology: a clinician's guide. New York: Marcel Dekker; 1990:355-72.
