Quality Assurance Practices for Pharmaceutical Industry-Based Drug Information Departments: A Review and Case Study
- PDF / 14,892,601 Bytes
- 11 Pages / 596.639 x 780.599 pts Page_size
- 11 Downloads / 235 Views
Stacey M. Fmg, PbarmD Senior Medical Communications Scientist
Joyce Serrana Martin, PbarmD Medical Communications Scientist Genentech, lnc., Medical Communications Department, South San Francisco, California
Key Words Quality assurance; Medical communications: Medical information: Drug information services Correspondrace Address Stacey M. Fung, PharmD, Genentech, Inc., 1 DNA Way, South San Francisco. CA 94080 (e-mail: Fung.Stacey-m @gene.com). Presented at the Drug Informution Association 14'h Annual Medical Communications Workshop, March 12,2003, San Francisco. CA.
Quality Assurance Practices for Pharmaceutical Industry-Based Drug Information Departments: A Review and Case Study
Scientific information concerning new drug therapies is increasingly becoming available. Medical communications departments in the pharmaceutical industry fulfill the roles of storing, retrieving, evaluating, and sharing this information, upon request, with external and internal customers. As the volume of data and medical information inquiries increase, the effectiveness of the entire response procedure can be stressed and the potential for errors increased. Quality assurance (QA) is a formal method that ensures that standards are established and maintained, in addition to identifying solutions if standards are not maintained. Formal QA programs are common in many areas of healthcare and the pharmaceutical industry. However, few QA programs have been reported for maintaining quality in pharmaceutical industry-based drug information departments. The literature describes a number of QA programs (referring to the provision of drug information [not product]) in hospital pharmacy departments as well as institutional and academic drug information centers). Limited information on QA programs has been reported in the literature (1-17). QA practices utilized by pharmaceutical industry-based drug information groups that have been described include: a review of responses, turnaround times, the tracking database, and having QA meetings (18).Drug information and
Quality assuranceprograms are developed to ensure the quality of products and services. Reasons for performing quality assurance and the types of quality assurance programs in industry-based drug information departments will be reviewed. Recent findings from a benchmarking survey will also be provided. Finally, the quality assurance program for the Medical CommunicationsDepartment at Genentech, lnc. will be described. Factors to consider and the lessons learned will be highlighted.
poison control centers have reported listening to calls or have prospectively asked a predetermined question to assess the competence of the staff and determine the quality of verbal responses to information requests. QA programs for drug information requests answered by the pharmacy staff in hospitals have included using audit forms and satisfaction surveys. This paper will describe the QA program for the Medical Communications Department at Genentech, Inc. The comprehensive QA program was proactively develop
Data Loading...
