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Communication in Pharmacovigilance and Crisis management.pptx
Communication in pharmacovigilance Effective communication in Pharmacovigilance Communication in Drug Safety Crisis management Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media
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Communication in Pharmacovigilance and Crisis management.pptx
- 1. Communication in pharmacovigilance Dr. KoppalaR.V.S.Chaitanya M.Pharm., Ph.D. Associate Professor
- 2. Contents: Effective communicationin Pharmacovigilance Communication in Drug Safety Crisis management Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media
- 3. Definition of Crisis: •Any event that comes to public notice and threatens the health or safety of individuals or groups, or the reputation or stability of an organization. Crises usually erupt suddenly and dramatically; they require rapid and effective response and communications. • Management of a crisis requires not only resolution of the crisis event, but also very skilled management of the often intense emotions and outrage that the public may feel.
- 4. Unexpected or not? •Crises are generally regarded as sudden and unexpected, but many arise from conditions where there has been a history of neglect, carelessness or poor safety management; where warning signs and vulnerabilities have been ignored. • Many crises were long in the making and were waiting to happen; many of these could have been prevented or the damage they caused reduced through early awareness, planning and action.
- 5. Prevention of CrisisManagement • Every system and organization has actual or potential weaknesses and vulnerabilities arising from internal and external sources. • Every aspect of – Management and safety systems, – Communications, – Data collection; – Staff motivation, – Knowledge and commitment; – Quality control, – Supplier management • Needs to be examined for any potential failures, weaknesses or problems: what could possibly go wrong and how can it be anticipated and prevented?
- 6. • The secondaspect of prevention is being in a high state of alert for early, maybe weak signals of problems: – A handful of ADR reports; – A newspaper report of patient injury; – New safety concerns emerging in another country; – Unexplained failure of treatment; – Anything that could escalate over time into a major crisis.
- 7. • The thirdelement of crisis prevention is REPUTATION. • An organization that has open communications with its audiences, conscientiously explains what it is doing at all times, is known and trusted, will suffer far less in crisis than one that is regarded as remote and secretive. • A regulator that has thoroughly and openly communicated about the risks of medicines and its activities will be subject to much less criticism than one that has been defensive and distant; indeed some crises arise simply because patients, or the media, or healthcare professionals have been kept in the dark about what is going on and are angry and hostile when the facts eventually emerge.
- 8. A sudden batchof unexpected and serious ADRs • This is one of the commonest causes of crisis in pharmacovigilance for which every PV centre should plan. Identify the risk: unexpected injury to patients and public outrage – Assess the risk: probable and serious – Initiate preventive measures: a constant state of high alert and attention for any evidence or allegation, however seemingly weak, from any source, of unexpected injury or death or other problems – Establish procedures for rapid investigation, review, analysis and decision-making about problems, and for communication with all stakeholders (this may require, for example, immediate access to pre- designated technical experts to be sent out into the field) – Review and rehearse procedures prior to crisis erupting.
- 9. Steps of CrisisManagement in Drug Safety 1. Step one: • Context analysis of the project of drug safety crisis management: • It is a subsystem of the international drug monitoring program. • All processes influencing in the main process of drug safety should be reviewed. • These processes include: – Manufacturing, – Prescribing, – Order communication, – Packaging, – Labelling, – Nomenclature, – Compounding, – Dispensing, – Distribution, – Administration, – Education, – Monitoring – Use.
- 10. 2. Stakeholders analysis Table1 (see above for link of lecture) shows common stakeholders involved in drug safety crises. 3. Problem analysis Root- cause analysis should be conducted in this section, e.g., in case of mioflex, there were errors in different levels of drug handling. Problem tree can be helpful in this section. 4. Objective analysis Objectives should be discussed in different levels. – Overall objectives: e.g., Improving drug safety – Purpose: e.g., preventing adverse events induced by suspected medicine in drug safety crisis – Results: e.g., abrupt discontinuation of observed adverse event in drug safety crisis
- 11. 5. Activities Scheduling Itis recommended to prepare a list of necessary activities to manage drug safety crises. These activities can be divided to two types. The first group includes activities required for controlling of the crisis. The second group includes required activities for preventing similar crises in the future. 6. Resource scheduling It is recommended to preparing trained team for evaluating drug safety crises, predict budget recourses, issue necessary regulations and guidelines and prepare required equipment. 7. Indicators recognition Success indicators should be determined and the tools for its assessment should be predicted, e.g., in Mioflex example, immediate recall of the product from community, pharmacies and no other occurrence of the reaction can be considered as indicators which can be assessed by inspection and scanning IPC database.
- 12. 8. Risk analysis: Factorswith possibility of negative impact on the project of drug safety crisis management should be recognized and alternative strategies should be taken, e.g., in case of Counterfeit lidocaine, multiple resources for producing counterfeit product should be regarded
- 13. Communicating with Regulatory Agencies,Business Partners, Healthcare facilities & Media
- 14. REGULATORY AGENCIES • Communicatingwith regulatory agencies in pharmacovigilance is essential for ensuring the safety of pharmaceutical products and protecting public health. • Some key aspects to consider when communicating with regulatory agencies in pharmacovigilance:
- 15. 1. Adverse EventReporting:- • Promptly report adverse events (AEs) and suspected adverse reactions (ADRs) to regulatory agencies as per their reporting requirements. • Follow the standardized formats and procedures for AE reporting outlined by regulatory authorities such as the ICH guidelines. • Provide comprehensive information on the reported AEs, including patient demographics, medical history, concomitant medications, and details of the suspected drug reaction.
- 16. 2. Signal Detectionand Evaluation:- • Collaborate with regulatory agencies in signal detection and evaluation activities to identify potential safety concerns associated with pharmaceutical products. • Share data, analyses, and risk assessments with regulatory authorities to support the detection and investigation of emerging safety signals. • Participate in regulatory discussions and meetings to discuss signal findings, assess causality, and determine the need for regulatory action, such as label updates or safety advisories.
- 17. 3. Risk Managementand Pharmacovigilance Plans: • Develop and implement risk management plans (RMPs) and pharmacovigilance plans (PV plans) in collaboration with regulatory agencies to proactively monitor and mitigate product-related risks. • Communicate updates and revisions to RMPs and PV plans to regulatory authorities, ensuring compliance with regulatory requirements and expectations. • Engage in ongoing dialogue with regulatory agencies to review and refine risk minimization measures and pharmacovigilance strategies based on evolving safety data and emerging risks
- 18. 4. Regulatory Submissionsand Compliance:- • Prepare and submit pharmacovigilance-related regulatory documents, such as periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and risk management plans (RMPs), in accordance with regulatory timelines and requirements. • Address regulatory queries, requests for additional information, and inspection findings related to pharmacovigilance activities in a timely and comprehensive manner. • Demonstrate compliance with pharmacovigilance regulations, guidelines, and best practices through robust documentation, quality assurance processes, and adherence to industry standards
- 19. 5. Communication Channelsand Meetings: • Establish regular communication channels with regulatory agencies, including designated pharmacovigilance contacts or liaisons, to facilitate information exchange and collaboration. • Participate in pharmacovigilance-related meetings, workshops, and working groups organized by regulatory authorities to discuss safety- related topics, share best practices, and address regulatory challenges. • Proactively engage with regulatory agencies to address any emerging safety issues, product recalls, or post-market surveillance activities that may impact public health and regulatory compliance.
- 20. Effective communication withregulatory agencies in pharmacovigilance requires – Transparency, – Collaboration, – Commitment to patient safety. By maintaining – Open lines of communication, – Adhering to regulatory requirements, and – Proactively addressing safety concerns, – Pharmaceutical companies can contribute to the continuous monitoring and improvement of drug safety profiles and promote public confidence in the pharmaceutical industry.
- 21. • In thecommunication with regulatory agencies, the companies have to submit all the brief information about the medicinal product and their adverse events so that the regulatory agency can implement the laws or beneficial rules on new medicinal products and the investigational product. • Regulatory agencies can also help in product development by regulating the beneficial rules. • The roles of regulatory authorities are to collect and analyze care reports of ADRs to make regulatory decisions based on strengthened signals and to alert public about the risks and benefits of drugs by various methods e.g. newsletters, papers etc
- 22. BUSINESS PARTNERS • Communicatingeffectively in pharmacovigilance is essential for ensuring the safety of pharmaceutical products throughout their lifecycle. • Here are some key aspects to consider when communicating with business partners in pharmacovigilance:
- 23. 1. Establishing ClearResponsibilities and Expectations: Clearly define the roles, responsibilities, and expectations of each business partner regarding pharmacovigilance activities, including – Adverse event reporting, – Signal detection, – Risk management, and – Compliance with regulatory requirements. Ensure that all parties understand their obligations and commitments related to pharmacovigilance, including – Timelines for reporting, – Data sharing, and – Regulatory submissions.
- 24. 2. Sharing PharmacovigilanceInformation and Data: Establish mechanisms for sharing pharmacovigilance information and data with business partners, such as – Adverse event reports, – Safety updates, – Risk management plans, and – Regulatory submissions. Ensure that data exchange processes are secure, compliant with data protection regulations, and maintain the confidentiality and integrity of pharmacovigilance data.
- 25. 3. Collaborating onSafety Monitoring and Risk Management:- Collaborate with business partners on – Safety monitoring activities, – Including signal detection, – Risk assessment, and – Risk minimization strategies. Share insights, analyses, and findings related to – Product safety profiles, – Emerging safety signals, and – Risk mitigation measures to inform decision-making and product development strategies.
- 26. 4. Addressing SafetyConcerns and Compliance Issues: – Establish channels for reporting and addressing safety concerns, compliance issues, and quality-related matters related to pharmacovigilance activities. – Encourage open communication and transparency in reporting adverse events, product quality issues, and regulatory compliance challenges to facilitate timely intervention and resolution.
- 27. 5. Training andEducation:- – Provide training and education to business partners on pharmacovigilance principles, processes, and requirements to ensure a shared understanding of safety responsibilities and best practices. – Offer support and resources to help business partners implement effective pharmacovigilance systems, including training materials, guidelines, and tools for adverse event reporting and risk management.
- 28. 6. Engaging inRegular Communication and Collaboration: – Establish regular communication channels, such as meetings, teleconferences, and email updates, to facilitate ongoing collaboration and information exchange with business partners. – Encourage feedback, questions, and suggestions from business partners to improve pharmacovigilance processes, enhance safety monitoring capabilities, and address emerging challenges
- 29. Effective communication withbusiness partners in pharmacovigilance requires – Collaboration, – Transparency, and – A shared commitment to patient safety. By – Fostering strong relationships, – Sharing information, and – Working together to address safety concerns, – Pharmaceutical companies can ensure the timely detection, assessment, and management of adverse events and contribute to the continuous improvement of drug safety profiles.
- 30. HEALTHCARE FACILITIES Communication withHealthcare Facilities Communicating effectively with healthcare facilities in pharmacovigilance is essential for ensuring the timely detection, reporting, and management of adverse drug reactions (ADRs) and other safety concerns associated with pharmaceutical products.
- 31. 1. Educating HealthcareProfessionals:- – Provide educational resources, training materials, and guidelines to healthcare professionals on pharmacovigilance principles, including the importance of reporting ADRs, medication errors, and product quality issues. – Offer workshops, webinars, and continuing education programs to enhance healthcare professionals' knowledge and skills in pharmacovigilance activities, such as adverse event identification, assessment, and reporting
- 32. 2. Establishing ReportingMechanisms:- – Establish clear and accessible reporting mechanisms for healthcare facilities to report ADRs and other safety concerns associated with pharmaceutical products. – Provide guidance on how to complete and submit adverse event reports, including the required information and reporting timelines, to ensure compliance with regulatory requirements
- 33. 3. Encouraging TimelyReporting:- – Encourage healthcare facilities to report ADRs and other safety-related information promptly to facilitate timely assessment and intervention. – Emphasize the importance of early detection and reporting of potential safety signals to prevent harm to patients and inform risk management strategies.
- 34. 4. Facilitating Two-WayCommunication: – Establish channels for two-way communication between healthcare facilities and pharmacovigilance teams to facilitate dialogue, information exchange, and collaboration on safety- related matters. – Encourage healthcare professionals to provide feedback, questions, and suggestions related to pharmacovigilance processes, product safety profiles, and risk management
- 35. MEDIA Communicating effectively withthe media in pharmacovigilance is crucial for disseminating accurate information, addressing public concerns, and promoting transparency and trust in the pharmaceutical industry.
- 36. 1. Establishing MediaRelations:- – Develop and maintain relationships with journalists, media outlets, and healthcare reporters who cover topics related to pharmacovigilance and drug safety. – Provide media contacts with accurate and up-to-date information about pharmacovigilance processes, regulatory requirements, and key safety issues affecting pharmaceutical products.
- 37. 2. Responding toInquiries and Requests: – Respond promptly to media inquiries, requests for interviews, and requests for information related to pharmacovigilance activities, adverse events, and drug safety concerns – Designate a spokesperson or media liaison within the pharmacovigilance team to handle media inquiries and coordinate responses with relevant experts and stakeholders.
- 38. 3. Providing Transparentand Balanced Information: – Provide transparent and balanced information to the media regarding pharmacovigilance findings, safety assessments, and regulatory actions related to pharmaceutical products. – Avoid sensationalizing or downplaying safety concerns, and ensure that messaging is evidence based, accurate, and contextualized within the broader context of drug benefit- risk profiles.
- 39. 4. Disseminating PublicHealth Messages:- – Use media channels to disseminate public health messages, educational materials, and safety alerts related to pharmacovigilance issues, including medication errors, product recalls, and emerging safety signals. – Collaborate with media partners to raise awareness of pharmacovigilance principles, encourage reporting of adverse events, and promote patient engagement in medication safety initiatives.
- 40. 5. Addressing Misinformationand Rumours:- – Monitor media coverage and social media channels for misinformation, rumours, and inaccuracies related to pharmacovigilance and drug safety. – Proactively address misinformation and clarify misconceptions through targeted communications, fact- checking, and engagement with journalists and media influencers.