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Koch, Cora; Schleeff, Jörn; Techen, Franka; Wollschläger, Daniel; Schott, Gisela; Kölbel, Ralf and Lieb, Klaus (2020): Impact of physicians' participation in non-interventional post-marketing studies on their prescription habits: A retrospective 2-armed cohort study in Germany.
In: PLOS Medicine 17(6) [PDF, 585kB]


Background: Non-interventional post-marketing studies (NIPMSs) sponsored by pharmaceutical companies are controversial because, while they are theoretically useful instruments for pharmacovigilance, some authors have hypothesized that they are merely marketing instruments used to influence physicians' prescription behavior. So far, it has not been shown, to our knowledge, whether NIPMSs actually do have an influence on prescription behavior. The objective of this study was therefore to investigate whether physicians' participation in NIPMSs initiated by pharmaceutical companies has an impact on their prescription behavior. In addition, we wanted to analyze whether specific characteristics of NIPMSs have a differing impact on prescription behavior. Methods and findings: In a retrospective 2-armed cohort study, the prescription behavior of 6,996 German physicians, of which 2,354 had participated in at least 1 of 24 NIPMSs and 4,642 were controls, was analyzed. Data were acquired between 6 October 2016 and 8 June 2018. Controls were matched by overall prescription volume and number of prescriptions of the drug studied in the NIPMS in the year prior to the NIPMS. Primary outcome was the relative rate of prescriptions of the drug studied in the NIPMS by participating physicians compared to controls during the NIPMS and the following year. Secondary outcomes were the proportion of prescriptions of the studied drug compared to alternative drugs used for the same indication, the revenue generated by these prescriptions, and the association between the marketing characteristics of the NIPMS and prescription habits. Of the 24 NIPMSs, the 2 largest drug groups studied were antineoplastic and immunomodulatory agents (7/24, 29.2%) and agents for the nervous system (4/24, 16.7%). Physicians participating in an NIPMS prescribed more of the studied drug during and in the year after the NIPMS, at a relative rate of 1.08 (95% CI 1.07-1.10;p < 0.001) and 1.07 (95% CI 1.05-1.09);p < 0.001), respectively. Participating physicians were more likely than controls to prescribe one of the studied drugs rather than alternative drugs used for the same indication (odds ratio 1.04;95% CI 1.03-1.05). None of the marketing characteristics studied were significantly associated with prescription practices. The main limitation was the difficulty in controlling for confounders due to privacy laws, with a resulting lack of information regarding the included physicians, which was mainly addressed by the matching process. Conclusions: Physicians participating in NIPMSs prescribe more of the investigated drug than matching controls. This result calls the alleged non-interventional character of NIPMSs into question and should lead to stricter regulation of NIPMSs. Author summary: Why was this study done? After drugs are authorized, non-interventional post-marketing studies (NIPMSs) are initiated to study rare side effects or other aspects of the drug that may have been missed during the authorization trials. Previous studies have shown that NIPMSs, while conducted regularly, often lack scientific rigor, rarely lead to relevant results, and are rarely published. Some authors have therefore hypothesized that NIPMSs primarily serve marketing purposes for pharmaceutical manufacturers by familiarizing physicians with new drugs. So far, it is unclear whether NIPMSs actually do have an impact on physicians' prescribing behavior. What did the researchers do and find? We conducted a study in Germany comparing the prescription behavior of 2,354 physicians who had participated in at least 1 of 24 NIPMSs and 4,642 comparable physicians who had not participated in such studies. We found that physicians participating in an NIPMS prescribed 6%-8% more of the drug studied in the NIPMS than comparable physicians during the NIPMS and the year after. We also looked at certain characteristics of the NIPMSs to see whether they predicted the impact on prescription behavior, but found no characteristics that were associated with the impact. What do these findings mean? NIPMSs seem to have an impact on physicians' prescribing behavior despite their "non-interventional" nature. Up to this point, NIPMSs have been only very loosely regulated because it was assumed that they have a low potential to cause harm. However, with the possibility that physicians prescribe differently due to their participation in an NIPMS, which may or may be detrimental to patients, only NIPMSs that are designed to collect essential data should be permitted.

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