DRUG REACTION AND PHARMA ACCOUNTABILITYIn pharmaceutical marketing, some may feel detached when adverse reactions occur, assuming it’s solely a manufacturer’s concern. But patient safety is a shared responsibility. This is to emphasises the accountability of marketers and sellers in reporting, responding, and upholding ethical standards when a product causes unintended harm like allergic reactions.It needs to be understood that if a product you’re associated with causes an allergic reaction in a patient, even unintentionally, you carry ethical, professional, and in some contexts, legal responsibilities. While manufacturers bear primary liability, marketers and sellers play a critical role in ensuring safety, transparency, and regulatory compliance.Onus & Responsibilities of a Pharmaceutical Marketer/Seller in Case of an Adverse Reaction (e.g., Allergy):

• JAKSTAR PHARMA CHANDIGARH
  1. Immediate Ethical Responsibility: He needs to express concern and empathy to the affected patient or healthcare provider and not to dismiss the complaint or downplay the seriousness, even if it seems minor. Plus Promptly inform the company’s pharmacovigilance team or medical department.
  2. Report the Adverse Event:According to Schedule Y of the Drugs and Cosmetics Act (India) or global pharmacovigilance regulations, adverse drug reactions (ADRs) must be reported immediately to:
    a)The manufacturer
    b)The Drug Controller General of India (DCGI) via PvPI (Pharmacovigilance Programme of India)
    Or the local regulatory authority (e.g., CDSCO)
    In fact even as a marketer, you are a part of the pharmacovigilance chain. Non-reporting can amount to professional negligence.
  3. Documentation needed to record the details like:
    a)Patient demographics
    b)Nature of reaction (type, severity, timeline)
    c)Batch number of the product
    d)Date and method of administration
    e)Maintain documentation as part of Good Pharmacovigilance Practices (GPvP).
  4. Initiate Internal Notification: Inform your company’s quality, regulatory, and medical affairs departments as it helps in assessing if the issue is due to:
    a)Batch-specific defect
    b)Excipients or coloring agents
    c)Drug interactions or off-label use
  5. Avoid Blame-Shifting or Misrepresentation:Do not blame the patient or prescriber, especially in verbal communication and Avoid giving unverified assurances or alternate medical advice. Also Do not promise outcomes that exceed your role or authority.
  6. Cooperate with Investigation:Assist the company or regulatory bodies in root cause analysis, including providing samples, sales data, or distribution information.
  7. Review Marketing Claims:If the allergy points to a previously unknown risk, the company may revise:
    a)Product label or package insert
    b)Marketing materials (remove any “safe and well-tolerated” claims, if inappropriate)
    c) Communication to doctors
  8. Educate Sales Teams:
    a)Train team members to:
    b)Recognise early signs of ADRs
    c)Know the reporting pathway
    d)Avoid exaggerated or misleading product claims
  9. Corporate Responsibility & Patient Safety
    If allergic reactions are confirmed and recurring, the company may:
    a)Issue safety alerts
    b)Recall batches, if warranted
    c)Revise formulation or packaging
    Even though a marketer may not be legally liable in the same way as the manufacturer, you have a moral, regulatory, and l onus to Report,Respond, and Participate in corrective actions.
    This builds credibility, protects patient safety, and aligns with good pharmaceutical ethics.
    Regards,
    JAKSTAR PHARMA

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