medwatch is the food and drug administration’s “safety information and adverse event reporting program.” it interacts with the fda adverse event reporting system (faers or aers). founded in 1993, this system of voluntary reporting allows such information to be shared with the medical community or the general public. medwatch also distributes information on medical recalls and other clinical safety communications via its platforms. an adverse event is any undesirable experience associated with the use of a medical product. as of the summer of 2011, the program had received more than 40,000 adverse event reports.
reporting can be conducted online, by phone, or by submitting the medwatch 3500 form by mail or fax.  the medwatch system is intended to detect safety hazard signals for medical products. important safety information is disseminated to the medical community and the general public via the medwatch web site.  raw data from the medwatch system, together with adverse drug reaction reports from manufacturers as required by regulation, are part of a public database.  the database was used by journalists to investigate fda’s drug approval practice.
the purpose of this article is to highlight and analyze possible improvements to spontaneous reporting systems, in particular, and drug safety, in general. any given medication will cause allergies in some proportion of patients, and often the allergies will not be foreseeable prior to use of the drug. overall, awareness of and attention to the increased medication risks for adolescents could be helpful in dealing with these problems.  it is clear that the implementation of a computerized system and other error prevention mechanisms should be seriously considered by health organizations.  it is estimated that in the united states in the mid-1980’s only 1% of adverse drug events were reported, with the number rising to 5.2% in 1994 following changes to the reporting system.  the reporting process has been reduced to a one-page form that is identical for each type of fda-regulated product (except vaccines which are treated separately). in 1993, the fda launched a large-scale advertising effort to inform physicians of medwatch, its procedures and the benefits of reporting. it is estimated that in the uk, which has utilized the “yellow card” system for reporting adverse drug reactions to the committee on safety of medicines since 1964, only 10-15% of severe reactions are reported. although the studies assessing the reasons for underreporting may be useful for maximizing drug reaction information, it is not clear that they accurately represent the reasons for underreporting in the united states and elsewhere. the handling costs of this much reporting would be very high and it is likely that the time saved would be marginal.  unawareness of reporting systems does not seem to be the cause of underreporting. it has been suggested that spontaneous reporting is often subject to reporting biases, and these may reflect the fact that reporting is not habitual. correspondingly, the surgical specialists in the dutch survey were much less likely to be aware of the need to report adrs. in the united states, more “advertising” is not likely to dramatically change reporting habits.  interestingly, about 20% of respondents in the italian study said that the legal requirements mandating reporting were a factor in deciding to report. only about 58% of the doctors in the italian study correctly identified that according to italian law all suspected reactions to any drug on the market should be reported.  it appears that the selectivity of reports is somewhat related to where they are submitted. comprehensiveness is less of a concern given that the details of what ought to be reported can be neatly summarized on reporting forms. however, it is clear that a new regime such as this would require a significant awareness campaign so as to avoid the situation in the united kingdom where doctors are not familiar with the symbol and its meaning. and if the doctor does have reason to believe that the event was caused by human error, it is questionable whether reporting it would be valuable to a spontaneous reporting system. depending on the complexity, it may not be too difficult for staff members to provide most, if not all, of the relevant reporting information by getting a summary from the doctor and looking through a patient’s file. if it were paid to health organizations employing doctors, it may result in a more pro-reporting environment but may have less of a direct effect on the doctors’ individual attitudes. gifts from the industry to physicians are limited to those that entail a benefit to patients and are not of substantive value. still, because of the possibility of creating exceptions to the ethical rules and kickback laws, it may be valid to question the assumption that, in sum, this would be detrimental to patients. it would be important to factor in this cost when determining the desirability of an incentive structure.
of the possible explanations for this, a few seem to be particularly likely. however, to the extent that doctors recognize the benefits of the spontaneous reporting systems, and a large number seem to, it may be very difficult for them to admit, even to themselves, that they would be willing to forego those benefits in order to avoid liability. interestingly, this suggests that it may be possible to bypass this disclosure in a malpractice case targeting the prescriber of the medicine if someone other than the prescriber files the adverse event report. the question of whether a reaction was foreseeable and how that relates to reporting is rather complicated. the inclusion of multiple adverse event reports is also not useful in proving causation because, as explained previously, a compilation of reports cannot be used to determine the frequency of reactions and should not be used for epidemiological purposes. this provision, however, may not be sufficient to prevent manufacturers from being compelled to release the reporters’ or patients’ identities pursuant to a discovery order.” it is remarkable that the fda chose not to apply the same line of reasoning in their decision not to prevent the admission of adverse drug event reports at trials.  he said that a majority of adverse reactions reported in the medical journals are not reported to the csm. in the italian study only 2.9% of the survey respondents admitted to having reported adverse drug reactions to a scientific journal. there is undoubtedly a gap between patients and physicians that further limits the reporting of adverse reactions. there is reason to believe that involving patients in reporting yields a different set of adverse event data. “the odds of an adverse reaction being reported to the doctor were increased by a factor of 2.2 for patients given a leaflet.” it is noteworthy that the study concluded that this increase was not statistically significant at the 5% level. a second concern with patient reporting is that there may be no way to prevent an individual from sending or calling in false or multiple reports so as to skew the data. product labels printed with the medwatch reporting website as well as a word encouraging patients to report problems to their physicians may be an ideal mix of information and encouragement. it may not be accurate to compare the responses to the two different kinds of questions because of a memory-triggering effect created by the multiple choice and yes/no questions. , 281 jama 1728, 1732 (1999) (“expected toxic effects from marketed drugs, even when used appropriately, is estimated to rank among the top 10 causes of death in the united states and is estimated to cost more that $30 billion annually.”). dr. siegfried’s explanation is similar to that of dr. gerald faich, the former fda director of epidemiology and biostatistics center for drugs and biologics: [o]ne or even many reports of adverse reactions often do not provide sufficient information to confirm that a drug caused the reaction. these cases are known in regulatory languages as “periodic reports” because the manufacturer is required to submit them to fda on a cyclical basis. medwatch data are not used to calculate the frequency of particular adverse events in clinical practice but rather to signal safety concerns and generate appropriate responses.”). it is very unlikely, for example, that doctors who were worried about legal liability or had feelings of guilt for having harmed a patient would have admitted this and returned the questionnaires. the black triangle symbol means that the csm is paying specific attention to the medication and wants enhanced reporting of all adrs, not just serious ones. the black triangle drugs are monitored closely for a minimum of two years and the black triangle symbol is not removed until the safety of the drug is well established.  there is one piece of data that sheds light on the extent to which liability concerns are central in physician’s thoughts.  “fda believes that if the identities of reporters or patients were made public or available to third parties, health care professionals would be much more reluctant to submit voluntary adverse event reports for fear of involving themselves and their patients in litigation.” 59 fed. it is interesting that in only one article that i read did it mention that the fda encourages anyone aware of a serious adverse reaction, including consumers , to file a medwatch report. j.
medwatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, medwatch is used for reporting an adverse event or sentinel event. founded in 1993, this system of voluntary reporting allows such information to be shared with the medwatch system collects reports of adverse events from consumers, healthcare professionals, and patients to help detect potential safety hazards., medwatch reporting requirements, medwatch reporting requirements, medwatch 3500a, form fda 3500a – mandatory reporting, fda medwatch form 3500a instructions.
the medwatch adverse event and reporting system allows anyone to report to the fda injuries and/or deaths caused by medical products. submitting a report is search fda medwatch drug and medical device adverse event data. search the fda’s adverse events reporting system (faers / aers) database for drug part i of this article will provide a background on adverse drug reactions and spontaneous reporting systems, with particular emphasis on the medwatch reporting, sample medwatch form, fda medwatch phone number, fda adverse event reporting form, fda adverse event reporting database, fda adverse event reporting requirements, medwatch login, who can report to medwatch, fda form 3500 vs 3500a, medwatch reviews, medwatch fax number.
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