Collaborating for better compliance in Pharma

Although most pharma companies strive to develop a collaborative working environment, conflicts between departments can still arise: perhaps nowhere more so than between commercial and medico-regulatory teams. With one trying to meet its deadline-driven marketing and sales challenges and the other needing to take a cautious, judicious approach to ensure compliance, friction and stress is almost inevitable.

The importance of cross-functional collaboration

Cross-functional working between pharmacovigilance (PV) and commercial is not just a ‘nice-to-have’ though: it is business-critical and a lack of collaboration exposes the company to huge compliance risk.

Taking Adverse Event Reporting (AER) as an example, PV and safety professionals are obliged to gather reports on far more than just side effects; they now look at occupational exposure to drugs, misuse, abuse, off-label use and medication errors. Closer collaboration with commercial teams would bring these real-world insights into the marketing mix and in turn, this could lead to a review of patient information, messaging and education, to name but a few.

Consider too, Summaries of Product Characteristics (SPCs), which companies are required to update as new safety data emerge. However, with pharma companies now having so much online content, older versions or copies of the SPC can easily remain hidden in remote corners of their web estate.

Misconceptions Around Prescribing Information

The problem is even greater when it comes to prescribing information (PI) online. According to PMCPA, some companies believe that there is a 3-month grace period in which to update prescribing information to reflect changes to the SPC and that presenting the updated SPC alongside promotional material with outdated prescribing information is enough to regularise the position. However, neither of these propositions is true and the general principle is that the prescribing information must be up-to-date, must comply with Clauses 12.1​ and 12.2 of the Code and must be consistent with the particulars given in the SPC.

Leveraging Technology for Compliance

But where there’s a will, there’s a way. By deploying proactive monitoring and automated scanning, a pharma company’s entire web estate can be examined on a regular basis so that out-of-date SPCs, prescribing information and other safety-critical information – or even just ‘problematic’ words within such documents – can be quickly found so that the situation is remedied as soon as possible, thereby minimising compliance risk and ensuring the safe and effective use of the product.

Get in Touch

If you’re a pharmaceutical director, manager, or part of a digital governance team, and want to know more about how our technology can help you streamline and automate compliance, please get in touch.