Crisis Communication & Adverse Events

To protect Bayer’s reputation and comply with all health and safety regulations, you must monitor the comments on your social media channel at least once every working day. If you come across an incident or adverse events, you must pass it on immediately to your local pharmacovigilance contact. In the event of a crisis, seek help from your local communication department or contact the crisis team in Leverkusen. If you encounter other legally-sensitive issues surrounding glyphosate, neonicotinoids, dicamba, or other legacy Monsanto topics, report them immediately to global security.

 

How to Behave in Times of Crises

icon_crisis_communication Negative conversations in social media can quickly turn into a serious crisis that risks having a negative and long-term impact on Bayer’s business and reputation. If negative conversations seriously escalate and develop into a crisis, forward the conversation to the crisis team in Leverkusen (Hans-Bernd Schmitz, Christophe Kampa, Markus Brandl) and keep monitoring.

 

Reacting Promptly to Adverse Event Reports

For Bayer as a global pharmaceutical company, pharmacovigilance goes beyond mere compliance with worldwide regulations. Capturing adverse reactions to medication is of crucial importance for continued patient and drug safety.

If you encounter any adverse event reports it is important to react promptly and follow the relevant procedure. Note that such procedures apply to all Bayer social media channels. Please ensure partner agencies do the same.

icon_important Make sure your website is checked on a daily basis for product safety and quality related information. Any relevant messages must be immediately forwarded to the local pharmacovigilance contact. The global pharmacovigilance department maintains an up-to-date list of pharmacovigilance country contacts on the intranet.

 

For Bayer Pharmaceuticals and Consumer Health medicinal products for human use, adverse event messages must be passed on to the department responsible within 24 hours of receipt. Please read the Bayer policy Product Safety and Quality: Reporting Obligations of Employees (available only on the Bayer intranet), chapters 2 and 3 for further guidance. In any event contact your local pharmacovigilance department to ensure that the requirements described in the regulation are adequately covered on your channel.

 

 

How to Deal with Comments on Adverse Events

Whenever any reports of side effects appear on your page you should take the following steps in your comments section.

  1. Hide the comment which contains a Bayer product name immediately.
  2. Make a screenshot of the dialogue. 
  3. Copy and paste the text into a Word document (include the date of the post!) or an email cover letter. 
  4. Forward the information immediately to Pharmacovigilance. Add a note when sending a private message to the user would not be possible.
  5. If applicable: Send a private message to the user and explain purpose of hiding the post, request contact information for PV purposes.*
  6. Delete the post if no hiding functionality is available.

 

*Sample text for explanation:
“Dear xxx, Thank you for your post! According to our comments policy and regulations, we had to hide your post to prevent product related content on our websites. Anyhow we take your post seriously and therefore have forwarded your information to our safety department. In that context, may we have your email address to contact you in case of follow up questions to your case? By providing your e-mail address you will be granting permission to Bayer Pharmacovigilance Department to contact you for the follow-up of adverse events, product technical complaints and/or usability issues or other safety related events. Thank you very much!”

 

Depending on the platform you use, the individual steps may vary.

 

We recommend that, as long as this complies with the law in the respective country, all Bayer social media channels add the following disclaimer, translated and adjusted as necessary, to the comments policy. Please discuss any changes with your local pharmacovigilance officer.

Humans vary in their biological reactions to medicinal products. This is why not all adverse reactions (side effects) associated with the use of medicinal products can be detected during clinical development, not even by the most comprehensive clinical trials. Capturing as many of these adverse reactions, however rare they may be in absolute terms, from worldwide sources is of paramount importance for continued patient and drug safety (pharmacovigilance).

For Bayer as a global pharmaceutical company, pharmacovigilance takes center stage, beyond mere compliance with worldwide regulations. To enable Bayer to provide up-to date safety information on Bayer products, your support is pivotal, whether you are a customer, patient or healthcare professional.

If you want to report a side effect or quality complaint, please contact your healthcare professional (e.g. physician or pharmacist) or your local health authority.

Reports can also be made on our Side Effect Reporting website.

Menschen reagieren unterschiedlich auf Medikamente und deren Wirkstoffe. Deswegen können nicht alle möglichen Nebenwirkungen eines Produktes während der Entwicklung, nicht mal in den umfassendsten klinischen Studien, festgestellt werden. Für die Patienten- und Medikamentensicherheit (Pharmakovigilanz) ist es jedoch von höchster Bedeutung, Nebenwirkungen aller Art zu erfassen, unabhängig davon wie oft diese in absoluten Zahlen vorkommen können.

Für Bayer als global tätiges Pharma-Unternehmen ist die Patienten – und Medikamentensicherheit von herausragender Bedeutung und geht weit über die einfache Einhaltung weltweiter Vorgaben hinaus. Damit Bayer aktuelle Informationen über die Sicherheit seiner Produkte bereitstellen kann, ist Ihre Unterstützung unerlässlich, egal ob Sie Kunde, Patient oder im Gesundheitsbereich tätig sind.

Wenn Sie Nebenwirkungen oder Qualitätsbeanstandungen melden wollen, wenden Sie sich bitte an Ihren Arzt oder Apotheker, die örtliche Gesundheitsbehörde oder nutzen Sie unsere Website zur Meldung von Nebenwirkungen.