How confident are you that your medical information (MI) service meets customer and business needs AND is compliant with regulations and codes? If you are responsible for a regional MI service, could you be doing more to help your affiliates to provide great service, stay compliant and benefit from shared best practice?
As part of the PIPA Information Impact awards, Charlotte Wormleighton, European Medical Information (EMI) Director, AstraZeneca, presented an innovative way to audit the MI service provided from 17 Western European countries for customers using a telephone-based questionnaire. Working together, Charlotte and I devised an audit process that checked out;
- enquiry services.
- copyright practices.
- data privacy procedures.
- spontaneous adverse event reporting.
Audits can be a costly business – all those travel costs let alone the time factor. Could we reduce costs whilst retaining the audit effectiveness? By eliminating the need to visit every market, savings could be made in both affiliate time and EMI travel costs. Meticulous planning meant there was minimal disruption for most of the markets. Yet the process was sufficiently robust and effective to spot potential issues. In my role as the auditor, I checked over 1000 documents; SOPS training records, example enquiries: in fact any relevant document that a medical information or medical affairs department must have available to stay compliant.
An audit is often seen as a necessary evil as preparation for a regulatory inspection. However this audit revealed many examples of best practice that could be shared in other markets (e.g. creating an ideal SOP framework as well as identifying affiliate examples of clear, comprehensive SOPs). The outcome was raised standards and better customer service, as well as inspection readiness. It also highlighted areas where affiliates needed further help or advice to implement business improvements or remain compliant. Many managers don’t like to admit they could do with a little help, even if it comes from their own organization. Equally some managers didn’t realise what a great job they were doing so it was a pleasure to feed back good news and help them to celebrate their success.
The methodology could be adapted to provide a quick comprehensive health check for any department. If you want to know more, it was presented at the DIA Clinical Forum meeting October 2009 and PIPA 2009 Conference by Charlotte Wormleighton.
It’s not published:
Wormleighton C, Leighton S. Auditing Medical Information services Across Western Europe: A Cost-Effective Approach. Drug Inf. J. 2009;43(5): 655-662