Quality management is a hot topic in medical information. Findings from pharmacovigilance regulatory inspections and cost controls are bringing quality under the spotlight. So this session set high expectations which were met and exceeded by the three speakers.
Lillian Auberson, Global Medical Information Director, Actelion discussed the quality chain from standards to SOPs whilst Sarah Dunnett, Baxter Healthcare based her presentation upon SOPs and training. The final speaker in the session, Sabine Lischka-Wittman, Eli Lilly GmbH presented the results of a survey into physicians preferences for enquiry responses. Sarah & Sabine are covered in a separate blog posts.
Lillian’s background is in risk assessment before she moved to Medical Information so she took a risk- based emphasis towards the topic. She defined quality as matching the inherent characteristics to the requirements. Through globalisation, people, cultures and commodities spread more quickly and easily across the world. Medical Information is no different. Using technology, access to consistent information is easier and more rapid. However, our errors are also more easily exposed.
we need standards because rapid access and wide dissemination also applies to errors
Lillian described the medical information set up in Actelion. The Global Medical Information group has a central repository for global responses documents, created under a common methodology (SOPs?). They are reviewed by relevant clinical. regulatory and legal experts to create a position statement for Actelion. This proactive service is also complemented by a reactive enquiry answering service for the affiliates.
Service consumers expect global consistency and quality. For example, McDonalds produces a food facts document that details the ingredients and detailed nutritional information. With their global reach, McDonalds has to satisfy customer expectations in both the product and information available. The Big Mac is the same the world over – whether that’s good or not is another matter!
To ensure the quality of medical information, the Acetlion service is underpinned by
- global policy
- mission statement
- global handling of enquiries standards
- local enquiry handling standards
- job descriptions
Quality has been assessed by pharmacovigilance inspections and a physician review of their global response documents. Many Med Info departments have now been inspected by their local regulatory authority and are only too aware of any deficiencies in their own systems or processes.
The opportunity for a physician to review the enquiry responses highlighted some interesting points. His first observation was that Medical Information departments are highly respected by physicians.
You are a trusted source of information
Some of the comments will seem very familiar to experienced medical information folks.
- A summary of key points is a must
- Answering the question must come before the disclaimers
- Use colours to highlight key information – more later…
- Post marketing studies are of more importance to physicians
What about use of colour? To the Nintendo Generation, use of just black & white text must seem prehistoric. It’s an interesting idea that I put to several colleagues who all seemed against the idea but couldn’t quite articulate why. It seemed to make a response more promotional in appearance. A good discussion point for the LinkedIn group for Medical Information & Communications
If you’re not quite sure what LinkedIn is about, you can read my blog post on Virtual Friends or check out their website