QUALITY STANDARDS FOR MEDICAL INFORMATION

Professional Information recognises that the Medical Information environment demands high quality work and service against a background of strict criteria to ensure compliance with the legislation, codes of practice and ethical beliefs of the Company. Working Practices and SOPs provide a vital framework to support compliance whilst encouraging consistency of response across the whole Medical Information Department.

AIOPI guidelines recommend a regular audit of the Medical Information service. This places an extra burden on a Department already stretched to meet deadlines, but few would argue that there is little point in providing a service if it is not meeting the needs of the customers, or indeed if it cannot be shown to be doing so.

In the increasingly business-focussed pharmaceutical industry, management also demands measurement of the quality of the services that Medical Information is providing, both internally and in response to requests from external customers.

Within the "quality" portfolio, Professional Information also includes the service it provides for the approval of Promotional Material.

Professional Information supports the following services relating to quality standards:

• SOPs and Working Practices
• Audit of Medical Information
• Customer Surveys and Metrics
• Approval of Promotional Material
• Induction programmes focussed on quality standards

Despite the clear need for robust procedures to assure quality and consistency, Medical Information has tended to lag behind some other functions within the pharmaceutical industry in developing and implementing SOPs and Working Practices to underpin their operations. Professional Information has extensive experience of working with the Medical Information Departments of a broad range of pharmaceutical companies to support their development and implementation of SOPs and Working Practices covering the full spectrum of Medical Information responsibilities.

Conducting audits places extra demands on a Medical Information Department that is often struggling against a heavy workload to achieve its service specifications. Furthermore, if the audit is not carried out in a rigorously controlled manner, results can be highly misleading resulting in a detrimental effect on the service and its providers, rather than the positive, forward-looking outcome that an audit should seek to produce. Professional Information carries out audits of the customers of Medical Information using a range of techniques including postal questionnaires, telephone interviews and face-to-face discussion groups. Audit calls into Medical Information can also be conducted to measure the level of performance against the service level that the Department is seeking to achieve.

Customer surveys enable management to step back from the action of the busy Medical Information Department in order to reassess what the customer requires and to complete a reality check that this is what the Department is delivering. Regular surveys and audits also provide the metrics data that management now demands in order to identify areas requiring attention as well as generating the facts necessary to demonstrate the good work that is being achieved by Medical Information.

Approval of Promotional Material is a key activity for the Medical Department, and Medical Information often performs a critical role within the process by checking the technical content of the material. The objective is to ensure accuracy and quality of the data, whilst freeing up the time of the Medical Adviser to focus on areas such as the reliability of the medical content. Medical Information Departments often lack the experience to provide an effective Copy Approval service as this is a skill that is learnt over time through exposure to a wide variety of promotional material. Professional Information does have an excellent working knowledge of the ABPI Code of Practice as well as extensive practical experience of Promotional Copy Approval.

Professional Information offers quality-focussed training as a stand-alone course for new entrants to Medical Information, or as part of a general induction course. The focus is on ensuring an awareness of the SOPs and Working Practices together with an understanding of why these are essential documents and what consequences can result should there be a failure of quality within the Medical Information Department. This training also reinforces the potential for Medical Information to contribute to the overall business success of the pharmaceutical company by providing a quality service that delights the customers.

For further information on quality services, please contact Professional Information.