Adverse event reporting - reporting morale slightly increased
The spontaneous reporting system for adverse drug reactions is of enormous importance for the early identification of new risks of medicinal products. However, its functioning depends crucially on the cooperation of all healthcare professionals.
In 2016, the total number of adverse reaction reports (initial and follow-up reports) increased by +13% (from 8,961 to 10,132), and the number of initial reports considered particularly relevant increased by + 9% (from 5,615 to 6,132)
The highest number of reports came from pharmaceutical companies, which with +8% (4,834 to 5,232) on the one hand fulfilled their legal obligation to report all adverse drug reactions, and on the other hand demonstrated a generally good reporting morale.
A particularly high increase, albeit from a low level, was observed in patient reportingwith a plus of 78% (124 to 220). The voluntary option for patients to report side effects to the authorities themselves has only existed since 2014 and is not yet generally known.
Hardly noticeable, on the other hand, was the slight increase in reports from health care professionals. With a hesitant increase of 3% in total (657 to 680), the health care professions remained the clear laggard as far as the growth rates were concerned. This seems to be an improvement, as these occupational groups still report significantly less than seven years ago, despite the current slight increase. Compared to 2009, adverse event reporting has fallen by as much as 40% overall, meaning that healthcare professionals reported nearly 350 fewer adverse events to the agency in 2016 than in 2009.
At this point, it should be recalled that according to §75g AMG as amended, all healthcare professionals are legally obliged to immediately report suspected adverse drug reactions or other relevant events to the authority (i.e. to the Federal Office for Safety in Health Care (BASG)).
While at least among pharmacists there has recently been a clearly positive trend with an increase of 90% (88 to 167 reports), a significant decline with minus 27% (= decrease from 302 to 221 reports) was regrettably noticeable among physicians in private practice.
The Federal Office for Safety in Health Care (BASG) therefore appeals to all health care professionals to increasingly comply with the legal obligation to report adverse drug reactions in the future.
Background to the facts:
Any suspicion of adverse drug reactions should be reported!
The spontaneous reporting system, the reporting of all suspected cases of adverse drug reactions by a reporting body (e.g. physician, pharmacist, etc) to a central body or authority (in Austria: Federal Office for Safety in Health Care, BASG), is of enormous importance for the early identification of new risks of approved drugs. Only the systematic recording of all unknown and also already known side effects allows a continuous analysis of the benefit-risk profile of a drug speciality. This can change over time, e.g. through the extension of the approval to new indications, routes of administration or patient groups, the transition from prescription to self-medication, or changing prescribing habits.
According to §75g of the German Medicines Act, all healthcare professionals are legally obliged to report relevant events to the Federal Office for Safety in Health Care (BASG). This includes suspected adverse drug reactions, failure to achieve the desired effect, misuse, quality defects, medication errors, and any use beyond the intended use (off-label use, occupational exposure, e.g., cytostatic administration, overdoses, etc.).
In recent years, however, the number of reports of adverse drug reactions by healthcare professionals in Austria has largely stagnated. In this context, a report to the BASG can be made quickly and unbureaucratically online (after registration) or by mail (by form with signature and stamp).
Only four pieces of information are required for a valid report: the patient, the reporter, the observed reaction and the suspect drug. (for biologics: additionally the manufacturing batch).
All reports are treated as strictly confidential by the BASG and are subject to data protection.
How to report adverse drug reactions:
Online reporting at:
https://www.basg.gv.at/marktbeobachtung/meldewesen/nebenwirkungen
Paper reporting forms to download and forward to the
Federal Office for Safety in Health Care (BASG) /
AGES Medical Market Surveillance, Traisengasse 5, 1200 Vienna
Further information:
Stats:
https://www.basg.gv.at/ueber-uns/statistiken
