Sind Anwendungsbeobachtungen ein Marketing-Tool?

Impact of physicians’ participation in non-interventional post-marketing studies on their prescription habits: A retrospective 2-armed cohort study in Germany

“…This study is the first to our knowledge to show in a quasi-experimental design that physicians participating in an NIPMS show changed prescription rates in favor of the investigated drug. Marketing indicators described in [9] and S4 Appendix. � NIPMSs fulfilling the characteristics; n = 24.…”

“…Differences in prescription volume during and after the study regarding the studied drugs as well as alternative drugs were used to assess the impact of participation in an NIPMS on prescription practices. In addition, we collected data on the following NIPMS characteristics, which could potentially be indicators of NIPMSs being conducted for marketing purposes: inappropriate remuneration, the medication having been on the market too long, low scientific quality, low formal quality, negligible effort required of physician, missing report regarding the results of the NIPMS, and presence of a secrecy clause in the contract for participating physicians (see S4 Appendix and [9] for further details). These indicators were summarized in a "marketing score" as described in our previous publication, where a higher score indicates a higher likelihood of the NIPMS having been initiated for marketing purposes (see S4 Appendix and [9]).…”

“…In addition, we collected data on the following NIPMS characteristics, which could potentially be indicators of NIPMSs being conducted for marketing purposes: inappropriate remuneration, the medication having been on the market too long, low scientific quality, low formal quality, negligible effort required of physician, missing report regarding the results of the NIPMS, and presence of a secrecy clause in the contract for participating physicians (see S4 Appendix and [9] for further details). These indicators were summarized in a "marketing score" as described in our previous publication, where a higher score indicates a higher likelihood of the NIPMS having been initiated for marketing purposes (see S4 Appendix and [9]). Associations between these characteristics and prescription volume were used to assess whether NIPMSs found to be more likely to have been initiated for marketing reasons had a higher impact on prescription practices.…”

“…In a previous study [9], we gathered data on NIPMSs at the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), of which some data were used in the current study. The local ethics committee of the Landesärztekammer Rheinland-Pfalz decided that it was not necessary to conduct an ethics review for this previous study.…”

“…A recent study of German NIPMSs by Spelsberg et al showed that they rarely serve to improve drug safety because their sample sizes are usually too small to allow for the detection of rare adverse events [8]. Other studies have also pointed in this direction by showing that NIPMSs usually lack scientific quality [4,5,9]. In addition, Spelsberg and colleagues raised the concern that strict confidentiality clauses in combination with the high remuneration for participation in NIPMSs could actually serve to discourage physicians from reporting adverse events [8].…”