Patients can inform authorities about side effects of drugs

patients to report side effects from todayOnline side effects of drugs report
On the Internet, there are several portals where patients can report adverse drug reactions. However, these websites operated commercially and usually serve only to share experiences of the patients. As of now, however, may report to the competent supervisory authorities concerned directly change and side effects of drugs. To this end, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (Pei) has called for vaccines in collaboration own portal into life.
 

As of today (Tuesday), patients may report side effects of oral drugs or vaccines. The beta for the new Internet portal was already set up according to the authorities, so that information can be collected in the future faster, easier and more effective. The Federal Institute for Drugs and Medical Devices hopes that by doing this, yet carry on unknown side effects and faster public really needed to take measures to minimize risk, such as the PEI in Langen said. "The transmission of side effects to the federal authorities may be over-www.verbraucher uaw.pei.de by the input form is activated via the link displayed. The message is forwarded to the appropriate authority for the particular drug (BfArM or PEI). "Says the PEI.Thus have the new portal for patients and consumers quick access to simplified reporting system. Entertains a patient suspects that symptoms such as headaches, nausea, dizziness or severe symptoms by taking a drug made, the suspicion without the doctor's certification to be reported. The PEI emphasized that "subject to the confidentiality of the data." In the "suspicious transaction report to the specified adverse event or in the documents sent personal data are not transferred to the central database side effect of the PEI / BfArM". However, people should "contact with potential side effects for further diagnosis and treatment immediately to the doctor," even if a message already on the form was.Often side effects, despite clinical trials unknownIs a new drug approved, the knowledge of side effects on results from clinical trials is limited, which may be carried out only with a limited number of people and a select group of people. Although large numbers of cases in clinical trials prior to approval are resulting in widespread use of new knowledge and most side effects that were previously unknown.The European Union is currently planning significant legislative changes to strengthen patients' rights. The patient reporting should be strengthened. In some countries the process of patient reporting is already running. So far, past experiences have shown that help direct reporting by patients of potential drug side effects to identify risks at an early stage. Besides remain drug companies, doctors and pharmacists required to report suspected cases of adverse drug reactions in a timely manner.Positive experience in other countriesThe experience in other countries were rather good. Studies in the UK, U.S. and Canada showed that patients described more general complaint images such as nausea, malaise, dizziness, rapid heartbeat, restlessness, or falling asleep. It differed from the pathologies that of doctors who use the system as well. The medical staff was limited more to "specific information", but gave patients a much more pathologies, as nurses or doctors.A Norwegian study also showed that 70 percent of the input side effects are not life threatening or serious were. In Denmark, the rate was, however, only 55 percent of Selbsteinträger. About 35 percent of the informed side effects in the Danish patients were those which did not previously appeared on the package insert.