Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media | Pharmacovigilance Notes Unit 3

Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media | Pharmacovigilance Notes Unit 3

Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

Communication with Media:
Who are the media?
 Print -magazines, newspapers, community newspapers
 Electronic -radio, TV, internet
 Local and national levels

Some basic questions a reporter will ask you….
 WHO-is affected, responsible
 WHAT-has happened and what is being done about it
 WHERE-has it happened
 WHEN-did it happen
 WHY-did it happen
 WILL-it happen again

Communications practices to avoid
 “Spinning”! (distortion or decoration of facts for beneficial effects)
 All communications are subjective, but do not be manipulative or dishonest
 Avoid “No comment”–rather say why there’s nothing to say and what is being done
 Avoid confusing statistics
 Do not avoid taking responsibility
 Don’t attack the messenger/accuser
 Don’t deny, justify or excuse your mistakes

Pharmaceutical industry response
As a result of this increased scrutiny, the pharmaceutical industry has been taking action, demonstrating their commitment to self-regulation by developing robust
internal guidelines and processes to ensure that their interactions with HCPs are legitimate, ethical, and transparent. Compliance Departments, Compliance
Teams, and Compliance Guidelines are appearing in pharmaceutical companies across the US and Europe with increasing frequency.

The effect of these HCP compliance initiatives is also being felt by healthcare communications agencies. These agencies work in close partnership with the clinical,
medical, and/or marketing teams in the pharmaceutical industry, and interact on a daily basis with HCPs, including clinical trial investigators and those acting in
an advisory capacity to the pharmaceutical industry.

Therefore, it is in a pharmaceutical company’s best interests to ensure that their agencies do not inadvertently compromise the industry–physician relationship.
Changes that are being seen by healthcare communications agencies include the following:

Most contracts and master services agreements from their pharmaceutical company clients now include some form of wording stipulating that the agency must be compliant with all relevant laws, regulations, and guidelines. Thus, the agency has a contractual obligation to fully comprehend the various laws and guidelines and, more importantly, understand how to apply them to the services that they provide.

• Pharmaceutical company compliance departments are mitigating against any risk of contravening extending their internal compliance training to their contracted agencies.
• Some pharmaceutical companies require signatures from agency staff who have undergone training, verifying that they have understood and will adhere to their client’s policies.
• Pharmaceutical companies are more readily sharing their internal guidelines and Standard Operating Procedures with their agencies. These range from guidelines governing appropriate interaction with HCPs through to specific guidance and templates for use with HCPs when establishing advisor-contracted services and associated compensation arrangements.
• Pharmaceutical company legal departments have become more visible, often being involved in project approval processes and checking whether appropriate compliance documentation is in place.

What should agencies be doing?
Healthcare communication agencies should ensure that their own compliance processes are rigorous and that they match the requirements of the pharmaceutical industry, HCPs, and relevant regulatory bodies. Indeed, agencies with an in-depth understanding in this area can often act in an advisory capacity, providing feedback to their pharmaceutical company clients and HCPs on proposed activities and programs.

Compliance Team

  • 1.Compliance Officer & Team
  • 2.Written Policies & Procedures
  • 3.Training & Education
  • 4.Lines of Communication
  • 5.Auditing & Monitoring
  • 6.Enforcing Standards
  • 7.Response to Problems & Corrective Action

Written Policies & Procedures

The internal compliance policy for a full-service agency should include several key sections:
• Introduction, outlining the need for compliance, and how the internal program will be implemented, including internal lines of communication
• The Compliance Program – outlining the objectives of the Compliance Committee, the training process, communication channels, the auditing and monitoring
process, how the program will be enforced, and corrective action procedures
• Guidelines on interaction with HCPs, including ethical practice, relevant laws (e.g., US False Claims Act), thought leader development programs, required
documentation, and guidelines on payment for HCP services (fair market value)
• Guidelines relating to the development and use of promotional materials, including on-label versus off-label information, product claims and comparisons, company transparency
• Gifts and hospitality
• Guidelines relating to meetings, including advisory board meetings, single-sponsored meetings, satellite symposia
• Good publication practice guidelines
• Guidance on appropriate terminology
• Listing of useful information sources, links to relevant websites, etc.
• Appendices containing all related forms, templates, and sample documents

MCQ given in Lecture see above lecture

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