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MEDWatch: A good idea
J Diab Cony
1994; 8:69
EDITORIAL
MEDWatch: A Good Idea In this issue of the Journal ofDiabetesand Ifs Compli~ tions, I have chosen to reproduce an editorial written by Dr. David A. Kessler, Commissioner of the Food and Drug Administration, that was originalIy published in the Journal of the American Medical Association in June of 1993. This editorial is entitled “Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems.” I thought it important to share this information with the readers of the Journal of Diabetes and Its Complications because diabetes has become a “device intensive” type of disease. With all the advances in diabetes care, the management of the diabetic patient has become dependent on specialized equipment as adjunct to insulin and oral agents in patients with diabetes. For example, the use of portable insulin pumps is becoming more and more wide spread, and blood glucose monitoring systems have proliferated over the past decade. There are other devices that are being used to a lesser degree and others such as implantable insulin pumps are on the horizon. Physicians have been asked to be vigilant for adverse effects of medications for a long time. Being on the watch for the adverse effects of medical devices is rather new. Thus, I thought it important to share Dr. Kessler’s ideas and the new mechanisms for the reporting of adverse events for medical devices and medications to the FDA. This new reporting system, called MEDWatch, will combine both. I was also interested in republishing this article because I have had personal experience with reporting the malfunction of a diabetes related device to the Food and Drug Administration. This occurred in the early 1980s when portable insulin pumps were first being used by patients. A patient of mine had a problem with what I thought was a malfunctioning insulin pump. I immediately contacted the FDA to report this product problem. There ensued a complete investigation. I do remember that the report processes at that time were quite cumbersome. In fact, I remember that medical devices were so new that nobody really seemed to know how to proceed. I know that the initial clinical trials of new medica0 1994 Journal of Diabetes and Its Complications
tions and of medical devices are performed carefully and, with specific search for adverse effects. If these initial clinical trials uncover a bad side effect from a new investigational drug or device, that side effect is usually quite obvious and easily identifiable. I submit to you that there are many potential serious adverse effects that can never be discovered in the initial clinical trial phase and that continued surveillance of the product, once it is on the market, needs to be done. Most clinical trials on new medications are done with a few thousand or at least a few hundred patients. Clinical trials on new medical devices are probably done on even fewer numbers of patients. When these medications or devices get into wide spread use, it is easy to understand that problems that were not identified with a few patients can become evident. Dr. Kessler has outlined exactly how to report these adverse effects using this new MEDWatch program. Now there is a single form to report adverse drug reactions and drug quality product problems as well as problems with medical devices. There is a single, seemingly simple form to fill out (page 72). In addition, he tells us what to report. Serious adverse effects such as death or life-threatening events seem obvious, but he also suggests that we should report problems even if we are not sure that the product caused the problem or even if we don’t have all the details surrounding the problem. The practice of medicine is becoming much more complicated. There are always new drugs, new devices, and new procedures to help our patients. The development of these drugs and products are always done as rapidly as possible and on usually a “limited” number of individuals. We, as health care providers, must be ever vigilant to the problems caused by medications or devices that we prescribe. I think it is helpful to have a single simple form that we can fill out and send to the FDA, who is charged with the responsibility of overseeing the medications and medical products that are used by the American public. I think we should increase our sensitivity to reporting adverse drug or product problems. In this regard, the FDA is on the ball! Philip Raskin, MD 1056-8727/94/$7.00
1994; 8:69
EDITORIAL
MEDWatch: A Good Idea In this issue of the Journal ofDiabetesand Ifs Compli~ tions, I have chosen to reproduce an editorial written by Dr. David A. Kessler, Commissioner of the Food and Drug Administration, that was originalIy published in the Journal of the American Medical Association in June of 1993. This editorial is entitled “Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems.” I thought it important to share this information with the readers of the Journal of Diabetes and Its Complications because diabetes has become a “device intensive” type of disease. With all the advances in diabetes care, the management of the diabetic patient has become dependent on specialized equipment as adjunct to insulin and oral agents in patients with diabetes. For example, the use of portable insulin pumps is becoming more and more wide spread, and blood glucose monitoring systems have proliferated over the past decade. There are other devices that are being used to a lesser degree and others such as implantable insulin pumps are on the horizon. Physicians have been asked to be vigilant for adverse effects of medications for a long time. Being on the watch for the adverse effects of medical devices is rather new. Thus, I thought it important to share Dr. Kessler’s ideas and the new mechanisms for the reporting of adverse events for medical devices and medications to the FDA. This new reporting system, called MEDWatch, will combine both. I was also interested in republishing this article because I have had personal experience with reporting the malfunction of a diabetes related device to the Food and Drug Administration. This occurred in the early 1980s when portable insulin pumps were first being used by patients. A patient of mine had a problem with what I thought was a malfunctioning insulin pump. I immediately contacted the FDA to report this product problem. There ensued a complete investigation. I do remember that the report processes at that time were quite cumbersome. In fact, I remember that medical devices were so new that nobody really seemed to know how to proceed. I know that the initial clinical trials of new medica0 1994 Journal of Diabetes and Its Complications
tions and of medical devices are performed carefully and, with specific search for adverse effects. If these initial clinical trials uncover a bad side effect from a new investigational drug or device, that side effect is usually quite obvious and easily identifiable. I submit to you that there are many potential serious adverse effects that can never be discovered in the initial clinical trial phase and that continued surveillance of the product, once it is on the market, needs to be done. Most clinical trials on new medications are done with a few thousand or at least a few hundred patients. Clinical trials on new medical devices are probably done on even fewer numbers of patients. When these medications or devices get into wide spread use, it is easy to understand that problems that were not identified with a few patients can become evident. Dr. Kessler has outlined exactly how to report these adverse effects using this new MEDWatch program. Now there is a single form to report adverse drug reactions and drug quality product problems as well as problems with medical devices. There is a single, seemingly simple form to fill out (page 72). In addition, he tells us what to report. Serious adverse effects such as death or life-threatening events seem obvious, but he also suggests that we should report problems even if we are not sure that the product caused the problem or even if we don’t have all the details surrounding the problem. The practice of medicine is becoming much more complicated. There are always new drugs, new devices, and new procedures to help our patients. The development of these drugs and products are always done as rapidly as possible and on usually a “limited” number of individuals. We, as health care providers, must be ever vigilant to the problems caused by medications or devices that we prescribe. I think it is helpful to have a single simple form that we can fill out and send to the FDA, who is charged with the responsibility of overseeing the medications and medical products that are used by the American public. I think we should increase our sensitivity to reporting adverse drug or product problems. In this regard, the FDA is on the ball! Philip Raskin, MD 1056-8727/94/$7.00