At the time of market approval of a medicinal product knowledge about its safety is based on nonclinical experiments and clinical studies, carried out with calculated numbers of selected volunteers and patients. Thus, safety information of a just launched medicinal product requires further input which remains so in varying degrees even years after approval and continued administration to increasing numbers of patients. In most cases the knowledge gap concerning safety is getting smaller during the course of the application of a medicinal product due to reports from physicians, pharmacists and other health care professionals, as well as reports from patients. Of special interest are reports about adverse drug reactions that rarely occur, which occur in specific patient groups (e.g. in children, elderly, etc.) or might be related to long-term use. Moreover, it is also very important to learn more about the medicinal product’s interactions with other medications. Of special interest is also the use of medicinal products during pregnancy, as studies are only done in pregnant women if a specific pregnancy related problem is treated. Furthermore, reports of medication errors of our products are collected.

Thus, in order to get comprehensive information about the safety of a medicinal product it is obligatory for Marketing Authorization Holders to systematically collect, and update suspected adverse drug reactions, process and forward it to the local authorities.

Such information is then provided by most local authorities on their home page in local language. For those concerned it is advised to visit the respective homepage as required.
 

How can you report?

In order to report adverse drug reactions please download and fill in the form as indicated below:

In case you would prefer to report to the Competent Authority responsible for Biotest products, the German Paul-Ehrlich-Institute (PEI) – please use this Link:

http://www.pei.de/DE/arzneimittelsicherheit-vigilanz/pharmakovigilanz/meldeformulare-pharmakovigilanz/meldeformulare-pharmakovigilanz-node.html

Alternatively, you may report directly to your local authority in local language. Please check the home page of your local authority as appropriate.

If you want to report a use of a Biotest product during pregnancy, please use the following form.

For the use during pregnancy, it is important to provide information if there were any unusual observations during the pregnancy and of course the outcome of the pregnancy. To collect this information, we will contact you once more after the calculated birth date, to collect the information on the health status of mother and child.

If you wish to report medication errors of Biotest products, please use the following form.

In recent years, there have been repeated cases of medication errors of medications, so such reports are being collected to prevent this in the future.

Please fill out the respective report forms providing the most complete information. Attachment of additional documents (e.g. doctor's records, laboratory results, etc.) are highly appreciated, as they would support Biotests medical assessment. According to the obligations stated in the European General Data Protection Regulation, we keep all personal data provided strictly confidential.

To avoid misuse, we will not process anonymous reports. Persons reporting an adverse drug reaction are therefore asked to include their contact information.

Recording of adverse drug reactions and other risks of our products during their entire marketing cycle and analysis of these records might lead to further action, like change of content of the package leaflet, which will also benefit the subscriber/patient.
 

Definitions / Explanations

Adverse Drug Reaction is a response to a medicinal product which is noxious and unintended. It may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure.

Serious Adverse Drug Reaction is a reaction which results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenial anomaly/birth defect.

Pregnancy Reports are reports of the use of a medical product during pregnancy. It is important to know, that we will collect a pregnancy report as well, if no suspected drug reactions occurred. This is done to collect data on the safety and tolerability of product use during pregnancy.

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Mistakes in the prescribing, dispensing, storing, preparation and administration of a medicine are the most common preventable cause of undesired adverse events in medication practice and present a major public health burden.
 

What happens with these reports at Biotest?

All data concerning reports will be entered into the global pharmacovigilance safety database of Biotest and assessed by a medical or pharmaceutical staff member of the drug safety department.

In accordance with legal requirements, Biotest must report suspected cases of side effects that meet certain criteria to the health authorities.