Ensuring Accuracy of Prescribing Information in Today’s Digital Landscape

May, 2024

A recent judgement by the Prescription Medicines Code of Practice Authority (PMCPA) targeted outdated prescribing details available on Novartis UK’s website. Documents hosted for download by healthcare providers contained prescribing information that diverged from the officially approved product characteristics.

Novartis acknowledged shortcomings in keeping materials synchronized with legal drug specifics. They conceded nonadherence with principles of upholding excellence and furnishing precise prescribing facts. Human mistakes during internal processes to update data following drug approval alterations were blamed.

The panel expressed strong concern regarding potential clinical repercussions of some missing risk particulars. They ruled Novartis compromised industry integrity through jeopardizing reliance on their communications by medical professionals.

This case illuminates pharmaceutical companies’ indispensable duty to diligently oversee processes updating drug learning materials as product knowledge progresses. With broad access to health records digitally, oversight bodies will reasonably demand demonstrated care from industry.

Some question relevance of prescribing information independent from the other legal drug monographs approved by regulators like the MHRA. The requirement for prescribing information comes from legislation derived from the original Medicines Act of 1968. In today’s digital environment, merely connecting to such formal documents may better ensure clinicians obtain the most current safety and application guidance. Rather than hosting proprietary information, companies could focus communication efforts on interpreting and applying knowledge in standards of care.

This case provides a lesson that engineering human and technological systems thoughtfully, and collaborating with codes to modernize recommendations for clear and consistent patient-centered online interaction. Upholding public trust demands industries routinely better practices.

In summary, as medical facts transition hazier from print to screens, this judgement underscores industry’s accountability for rigorously surveilled information quality – fundamental to safe and effectual care. Practical remedies are necessary to placate regulator’s worries around supporting skillful decision making in dynamic digital realms.

Reference(s)

  1. CASE AUTH/3725/1/23

 

Click TAGS to see related articles :

ABPI | LIFE SCIENCE | NOVARTIS | PATIENT SAFETY | PMCPA | REGULATORY

About the Author

  • Dilruwan Herath

    Dilruwan Herath is a British infectious disease physician and pharmaceutical medical executive with over 25 years of experience. As a doctor, he specialized in infectious diseases and immunology, developing a resolute focus on public health impact. Throughout his career, Dr. Herath has held several senior medical leadership roles in large global pharmaceutical companies, leading transformative clinical changes and ensuring access to innovative medicines. Currently, he serves as an expert member for the Faculty of Pharmaceutical Medicine on it Infectious Disease Commitee and continues advising life sciences companies. When not practicing medicine, Dr. Herath enjoys painting landscapes, motorsports, computer programming, and spending time with his young family. He maintains an avid interest in science and technology. He is a founder of DarkDrug

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