PMID- 32589633
OWN - NLM
STAT- MEDLINE
DCOM- 20200810
LR  - 20200810
IS  - 1549-1676 (Electronic)
IS  - 1549-1277 (Print)
IS  - 1549-1277 (Linking)
VI  - 17
IP  - 6
DP  - 2020 Jun
TI  - Impact of physicians' participation in non-interventional post-marketing studies 
      on their prescription habits: A retrospective 2-armed cohort study in Germany.
PG  - e1003151
LID - 10.1371/journal.pmed.1003151 [doi]
LID - e1003151
AB  - 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.
FAU - Koch, Cora
AU  - Koch C
AUID- ORCID: 0000-0003-0827-7023
AD  - Clinic of Neurology and Neurophysiology, Medical Center-University of Freiburg, 
      Faculty of Medicine, University of Freiburg, Freiburg, Germany.
AD  - Department of Psychiatry and Psychotherapy, University Medical Center Mainz, 
      Mainz, Germany.
FAU - Schleeff, Jorn
AU  - Schleeff J
AD  - National Association of Statutory Health Insurance Funds, Berlin, Germany.
FAU - Techen, Franka
AU  - Techen F
AD  - National Association of Statutory Health Insurance Funds, Berlin, Germany.
FAU - Wollschlager, Daniel
AU  - Wollschlager D
AD  - Institute for Medical Biostatistics, Epidemiology and Informatics, Mainz, 
      Germany.
FAU - Schott, Gisela
AU  - Schott G
AD  - Drug Commission of the German Medical Association, Berlin, Germany.
FAU - Kolbel, Ralf
AU  - Kolbel R
AD  - Law Faculty, Ludwig Maximilian University of Munich, Munich, Germany.
FAU - Lieb, Klaus
AU  - Lieb K
AD  - Department of Psychiatry and Psychotherapy, University Medical Center Mainz, 
      Mainz, Germany.
LA  - eng
PT  - Journal Article
DEP - 20200626
PL  - United States
TA  - PLoS Med
JT  - PLoS medicine
JID - 101231360
SB  - IM
MH  - Germany
MH  - Humans
MH  - Physicians/psychology/*statistics & numerical data
MH  - Practice Patterns, Physicians'/*statistics & numerical data
MH  - Product Surveillance, Postmarketing/methods
MH  - Retrospective Studies
PMC - PMC7319278
COIS- I have read the journal's policy and the authors of this manuscript have the 
      following competing interests: CK and KL are members of MEZIS, the German "No 
      free lunch"-association. RK, FT, JS and GS state they have nothing to disclose. 
      DW reports grants from German Federal Ministry of Education and Research during 
      the conduct of the study.
EDAT- 2020/06/27 06:00
MHDA- 2020/08/11 06:00
PMCR- 2020/06/26
CRDT- 2020/06/27 06:00
PHST- 2019/11/24 00:00 [received]
PHST- 2020/05/27 00:00 [accepted]
PHST- 2020/06/27 06:00 [entrez]
PHST- 2020/06/27 06:00 [pubmed]
PHST- 2020/08/11 06:00 [medline]
PHST- 2020/06/26 00:00 [pmc-release]
AID - PMEDICINE-D-19-04307 [pii]
AID - 10.1371/journal.pmed.1003151 [doi]
PST - epublish
SO  - PLoS Med. 2020 Jun 26;17(6):e1003151. doi: 10.1371/journal.pmed.1003151. 
      eCollection 2020 Jun.