Whether you call it a Core Datasheet, Global Datasheet or SPC, it is vital that a company agrees on one single ‘source of truth’ for every product: an approved ‘parent’ document from which all other ‘child’ documents cascade. It is equally important that when those child documents are safety-critical (such as local prescribing information, patient support materials etc) the wording is entirely consistent with the approved parent source.
This may sound obvious but at Digital Control Room, we come across instances where local interpretation has led to mismatches with the company’s approved source of truth – and because the changes can be quite subtle or nuanced, they often won’t get noticed. However, such inconsistencies cause confusion thereby exposing the company to greater risk. Here are 3 examples:
Examples of Potential Confusion
1: Confusion by omission
The Patient Information (PI) on a product website says ‘Keep out of reach of children’ but the Datasheet for the very same product says ‘Keep out of the reach and sight of children’. Not much of a difference maybe, but the source document clearly covers a wider set of circumstances and is therefore a ‘safer’ statement to use.
2: Confusion by inconsistency
In another instance, the Datasheet says the product is not to be used under the age of 12, whereas the PI says not to be used under the age of 18. As this would still embrace the under-12 cohort, the PI is still safe (and arguably ‘safer’) but it is unnecessary and confusing as a result.
3: Confusion by juxtaposition
The PI on a product website says to keep the preparation out of the reach of children – immediately followed by advice to seek medical help if swallowed. Poor juxtaposition could easily, and wrongly, imply that one need only seek medical help if ingested by a child. On the Datasheet however, the instructions appear on separate lines making it clear and unambiguous that the accidental swallowing advice applies to all ages thereby avoiding any confusion.
Root Causes of Such Inconsistencies
Situations like these may occur from having multiple reference points rather than one single source of truth. Equally, it can be due to an unclear internal policy about the relationship between parent and child documentation; poor adherence to that policy; local/affiliate interference; or simply not updating safety messages on web content quickly/regularly enough leading to things getting out of sync.
The Role of Technology in Ensuring Consistency
Thankfully, technology now exists that can examine a pharma company’s entire web estate on a regular basis, spotting old/outdated content that does not adhere to your company’s parent documentation – your single source of truth. This way, the situation can be quickly remedied, 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.