PMID- 29027301
OWN - NLM
STAT- MEDLINE
DCOM- 20190916
LR  - 20191210
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 27
IP  - 5
DP  - 2018 May
TI  - Challenges of post-authorization safety studies: Lessons learned and results of a 
      French study of fentanyl buccal tablet.
PG  - 457-463
LID - 10.1002/pds.4331 [doi]
AB  - PURPOSE: Recruiting and retaining participants in real-world studies that collect 
      primary data are challenging. This article illustrates these challenges using a 
      post-authorization safety study (PASS) to assess adverse events (AEs) experienced 
      with fentanyl buccal tablet (FBT) over 3 months of treatment. METHODS: This was 
      an observational, prospective, multicenter study in France conducted over 1 year. 
      The study employed primary data collection in FBT-treated patients and their 
      treating physicians via a site qualification questionnaire and patient log 
      completed by physicians and a questionnaire and pain diary completed by patients. 
      Strategies to increase participation included reminders, newsletters, frequent 
      follow-up telephone calls, and reducing the extent of data collected. RESULTS: Of 
      the 1118 physicians contacted who returned the participation form or responded to 
      a telephone call, only 128 expressed willingness to participate. Key reasons for 
      non-participation were lack of interest (69.7%) and FBT not being used in 
      practice by the contacted physician (25.1%). Overall, 224 patients were screened 
      by 31 physicians, and 97 were enrolled. Key reasons for patient non-inclusion 
      were unwillingness or inability to complete the patient AE diary or questionnaire 
      (40.9% [52/127]) and patients' decision (33.9% [43/127]). CONCLUSIONS: Despite 
      efforts to increase participation, enrollment in this study was low. Recruitment 
      and retention methods are limited in their capacity to optimally execute a 
      primary data collection in a PASS. For a PASS to provide reliable and valid 
      information on medication use, involvement from health care agencies, regulators, 
      and pharmaceutical companies is needed to establish their importance, drive study 
      participation, and reduce patient withdrawal.
CI  - Copyright (c) 2017 John Wiley & Sons, Ltd.
FAU - Gavrielov-Yusim, Natalie
AU  - Gavrielov-Yusim N
AUID- ORCID: 0000-0003-2273-231X
AD  - Teva Pharmaceutical Industries Ltd., Petach-Tikva, Israel.
FAU - Bidollari, Ilda
AU  - Bidollari I
AD  - Teva Pharmaceuticals, Toronto, Canada.
FAU - Kaplan, Sigal
AU  - Kaplan S
AD  - Teva Pharmaceutical Industries Ltd., Petach-Tikva, Israel.
FAU - Bartov, Netta
AU  - Bartov N
AD  - Teva Pharmaceutical Industries Ltd., Petach-Tikva, Israel.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20171013
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Tablets)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Buccal
MH  - Analgesics, Opioid/administration & dosage/*adverse effects
MH  - Diaries as Topic
MH  - Fentanyl/administration & dosage/*adverse effects
MH  - France
MH  - Humans
MH  - Intersectoral Collaboration
MH  - Multicenter Studies as Topic
MH  - Observational Studies as Topic
MH  - Pain/drug therapy
MH  - Patient Participation/psychology
MH  - *Patient Selection
MH  - Physicians/statistics & numerical data
MH  - *Pragmatic Clinical Trials as Topic
MH  - Surveys and Questionnaires/statistics & numerical data
MH  - Tablets
MH  - Treatment Outcome
OTO - NOTNLM
OT  - patient selection
OT  - postmarketing
OT  - product surveillance
OT  - safety
EDAT- 2017/10/14 06:00
MHDA- 2019/09/17 06:00
CRDT- 2017/10/14 06:00
PHST- 2017/04/25 00:00 [received]
PHST- 2017/09/07 00:00 [revised]
PHST- 2017/09/13 00:00 [accepted]
PHST- 2017/10/14 06:00 [pubmed]
PHST- 2019/09/17 06:00 [medline]
PHST- 2017/10/14 06:00 [entrez]
AID - 10.1002/pds.4331 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2018 May;27(5):457-463. doi: 10.1002/pds.4331. Epub 
      2017 Oct 13.