PMID- 32989664
OWN - NLM
STAT- MEDLINE
DCOM- 20220209
LR - 20220209
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Linking)
VI - 44
IP - 2
DP - 2021 Feb
TI - Patient Organizations' Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation.
PG - 181-191
LID - 10.1007/s40264-020-00999-0 [doi]
AB - INTRODUCTION: European drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities. AIM: The aim of this study was to understand patient organizations' perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV. METHODS: A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study. RESULTS: The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities. CONCLUSION: Both study phases show congruent results regarding patients' involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.
FAU - Chinchilla, Katherine
AU - Chinchilla K
AD - Centro Nacional de Información de Medicamentos, Instituto de Investigaciones Farmacéuticas, Facultad de Farmacia, Universidad de Costa Rica, San José, Costa Rica.
AD - Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
FAU - Matos, Cristiano
AU - Matos C
AUID- ORCID: 0000-0002-6279-1421
AD - Instituto Politécnico De Coimbra, ESTESC-Coimbra Health School, Farmácia, Coimbra, Portugal.
FAU - Hall, Victoria
AU - Hall V
AD - Centro Nacional de Información de Medicamentos, Instituto de Investigaciones Farmacéuticas, Facultad de Farmacia, Universidad de Costa Rica, San José, Costa Rica.
FAU - van Hunsel, Florence
AU - van Hunsel F
AD - Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl.
LA - eng
PT - Journal Article
DEP - 20200928
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - Humans
MH - *Patient Participation/methods/statistics & numerical data
MH - *Pharmacovigilance
MH - Qualitative Research
EDAT- 2020/09/30 06:00
MHDA- 2022/02/10 06:00
CRDT- 2020/09/29 05:38
PHST- 2020/09/08 00:00 [accepted]
PHST- 2020/09/30 06:00 [pubmed]
PHST- 2022/02/10 06:00 [medline]
PHST- 2020/09/29 05:38 [entrez]
AID - 10.1007/s40264-020-00999-0 [pii]
AID - 10.1007/s40264-020-00999-0 [doi]
PST - ppublish
SO - Drug Saf. 2021 Feb;44(2):181-191. doi: 10.1007/s40264-020-00999-0. Epub 2020 Sep 28.
PMID- 35294016
OWN - NLM
STAT- MEDLINE
DCOM- 20220602
LR - 20220602
IS - 2042-7174 (Electronic)
IS - 0961-7671 (Linking)
VI - 30
IP - 2
DP - 2022 May 26
TI - Pharmaceutical services in public hospitals in Mexico: a cross-sectional study.
PG - 143-152
LID - 10.1093/ijpp/riac015 [doi]
AB - OBJECTIVE: To describe the provision of pharmaceutical services within Ministry of Health hospitals in Mexico and identify the main factors that affect their implementation. METHODS: Between November 2018 and April 2019, we conducted telephone interviews with the heads of pharmacy departments of 413 state and federal Ministry of Health hospitals in Mexico. Responses were analyzed with descriptive and inferential statistics to determine the main factors influencing the implementation of pharmaceutical services within these public hospitals. KEY FINDINGS: Of the 413 hospitals, a total of 96 hospitals in 27 states reported the provision of at least one pharmaceutical service. The most frequently reported services were: patient education on the correct use of medications (23%), provision of information to other health professionals on the rational use of medications (21%), and participation in the hospital´s pharmacovigilance system (19%). The main factors associated with the implementation of HPS were the number of pharmacists (46%, n = 215, p=0.001) and the pharmaceutical- or health sciences-oriented education of the head of the pharmacy department of the hospital (46%, n = 215, P = 0.001). CONCLUSIONS: Hiring more pharmacists and ensuring the appropriate professional education of the head of the pharmacy department are key factors to expanding the implementation of pharmaceutical services in Mexico's public hospitals.
CI - © The Author(s) 2022. Published by Oxford University Press on behalf of the Royal Pharmaceutical Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
FAU - Vargas López, Laura C
AU - Vargas López LC
AUID- ORCID: 0000-0003-2366-3846
AD - Health Sciences Institute, Autonomous University of Hidalgo State, Hidalgo, Mexico.
FAU - Wirtz, Veronika J
AU - Wirtz VJ
AD - Department of Global Health, Boston University School of Public Health, Boston, MA, USA.
FAU - Reich, Michael R
AU - Reich MR
AD - Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, MA, USA.
LA - eng
GR - National Council for Science and Technology of Mexico/
PT - Journal Article
PL - England
TA - Int J Pharm Pract
JT - The International journal of pharmacy practice
JID - 9204243
SB - IM
MH - Cross-Sectional Studies
MH - Hospitals, Public
MH - Humans
MH - Mexico
MH - *Pharmaceutical Services
MH - Pharmacists
MH - *Pharmacy Service, Hospital
OTO - NOTNLM
OT - Mexico
OT - health systems research
OT - hospital pharmaceutical service
OT - pharmaceutical services
OT - pharmacy practice
EDAT- 2022/03/17 06:00
MHDA- 2022/06/03 06:00
CRDT- 2022/03/16 12:14
PHST- 2021/09/14 00:00 [received]
PHST- 2022/02/02 00:00 [accepted]
PHST- 2022/03/17 06:00 [pubmed]
PHST- 2022/06/03 06:00 [medline]
PHST- 2022/03/16 12:14 [entrez]
AID - 6549612 [pii]
AID - 10.1093/ijpp/riac015 [doi]
PST - ppublish
SO - Int J Pharm Pract. 2022 May 26;30(2):143-152. doi: 10.1093/ijpp/riac015.
PMID- 36508012
OWN - NLM
STAT- MEDLINE
DCOM- 20230130
LR - 20230202
IS - 1432-1041 (Electronic)
IS - 0031-6970 (Print)
IS - 0031-6970 (Linking)
VI - 79
IP - 2
DP - 2023 Feb
TI - Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.
PG - 229-236
LID - 10.1007/s00228-022-03422-y [doi]
AB - INTRODUCTION: Because patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012. OBJECTIVES: To describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance. METHOD: Using the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare the characteristics of adverse drug reaction (ADR) reports from patients and healthcare professionals (HCP) between 2011 and 2020. The relationship between regional patient ADR report activity and regional care provision and socio-professional characteristics was analyzed using the principal component analysis. RESULTS: A significant and higher increase in ADR reports over time from patients (r = 0.89, p < 0.001) compared to HCP (r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p < 0.001), younger age classes (p < 0.001), reporting through web portal (83% vs. 17%, p < 0.001), and less serious events (26% vs. 63%, p < 0.001). In the principal component analysis, regional patient reporting activity was related to socio-professional categories, age classes, and densities of hospital beds and physicians. CONCLUSION: Our results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.
CI - © 2022. The Author(s).
FAU - Adopo, D
AU - Adopo D
AD - Department of Pharmacology, Universite Victor Segalen, Bordeaux, France.
FAU - Daynes, P
AU - Daynes P
AD - Agence Nationale de Sécurité du Médicament, Saint-Denis, 93200, France.
FAU - Benkebil, M
AU - Benkebil M
AD - Agence Nationale de Sécurité du Médicament, Saint-Denis, 93200, France.
FAU - Debs, A
AU - Debs A
AD - Agence Nationale de Sécurité du Médicament, Saint-Denis, 93200, France.
FAU - Jonville-Berra, A P
AU - Jonville-Berra AP
AD - Pharmacology & Pharmacovigilance Department, Regional Pharmacovigilance Centre of Tours, Tours, France.
FAU - Polard, E
AU - Polard E
AD - Pharmacology & Pharmacovigilance Department, Regional Pharmacovigilance Centre of Rennes, Rennes, France.
FAU - Micallef, J
AU - Micallef J
AD - Pharmacology & Pharmacovigilance Department, Regional Pharmacovigilance Centre Marseille Provence Corse, Marseille, France.
FAU - Maison, P
AU - Maison P
AD - Agence Nationale de Sécurité du Médicament, Saint-Denis, 93200, France. patrick.maison@ansm.sante.fr.
AD - Faculté de Santé, Université Paris-Est Créteil, Créteil, EA, 7379, France. patrick.maison@ansm.sante.fr.
AD - CHI Créteil, Créteil, France. patrick.maison@ansm.sante.fr.
LA - eng
PT - Journal Article
DEP - 20221212
PL - Germany
TA - Eur J Clin Pharmacol
JT - European journal of clinical pharmacology
JID - 1256165
SB - IM
MH - Humans
MH - Female
MH - Patient Participation
MH - Pharmacovigilance
MH - Adverse Drug Reaction Reporting Systems
MH - *Physicians
MH - France
MH - *Drug-Related Side Effects and Adverse Reactions/epidemiology
PMC - PMC9744045
OTO - NOTNLM
OT - Adverse drug reaction reporting systems
OT - Drug safety
OT - Patient empowerment
OT - Pharmacoepidemiology
OT - Pharmacovigilance
OT - Social pharmacology
COIS- The authors declare no competing interests.
EDAT- 2022/12/13 06:00
MHDA- 2023/01/31 06:00
CRDT- 2022/12/12 12:00
PHST- 2022/08/05 00:00 [received]
PHST- 2022/11/07 00:00 [accepted]
PHST- 2022/12/13 06:00 [pubmed]
PHST- 2023/01/31 06:00 [medline]
PHST- 2022/12/12 12:00 [entrez]
AID - 10.1007/s00228-022-03422-y [pii]
AID - 3422 [pii]
AID - 10.1007/s00228-022-03422-y [doi]
PST - ppublish
SO - Eur J Clin Pharmacol. 2023 Feb;79(2):229-236. doi: 10.1007/s00228-022-03422-y. Epub 2022 Dec 12.
PMID- 28770283
OWN - NLM
STAT- MEDLINE
DCOM- 20180618
LR - 20181113
IS - 1432-1041 (Electronic)
IS - 0031-6970 (Linking)
VI - 73
IP - 11
DP - 2017 Nov
TI - The key role of clinical and community health nurses in pharmacovigilance.
PG - 1379-1387
LID - 10.1007/s00228-017-2309-0 [doi]
AB - PURPOSE: The reporting of suspected adverse drug reactions (ADRs) is starting to become routine to nurses. The aim of this review is to underline the role of clinical and community health nurses in pharmacovigilance and to promote their effective participation in ADR reporting in different countries and for patients of different ages. METHODS: The PubMed, Scopus and ISI Web of Science databases were searched for research articles published between January 1985 and April 2017 using the search items "pharmacovigilance" AND "nurse;" "adverse drug reaction report" AND "nurse;" "community health nurse" AND "adverse drug reaction." RESULTS: A total of 987 articles were identified using our search strategy, of which 180 articles remained over after the removal of duplicate articles. Of these 180 studies, upon full review we identified 24 which met the inclusion/exclusion criteria and included these in our review. ADR reports by clinical nurses in some countries are comparable in quality and number to those submitted by physicians or pharmacists. Data on ADRs reported by community nurses are currently not available. However, numerous publications emphasized the challenges faced by nurses in reporting ADRs and the need to include pharmacovigilance training in both clinical and community health nurse academic education. CONCLUSIONS: Nurses are central actors in pharmacovigilance activities, particularly in identifying ADRs which remain outside the reach of other healthcare providers and in being fundamental to the preservation of the health of patients and of the entire community, with attention to the more vulnerable patients, such as children and the elderly.
FAU - Bigi, Caterina
AU - Bigi C
AD - Division of Pharmacology, Department of Clinical and Experimental Medicine, Scuola Medica, University of Pisa, Via Roma 55, 56126, Pisa, Italy.
AD - Barking, Havering and Redbridge University Hospital, HNS Trust, London, UK.
FAU - Bocci, Guido
AU - Bocci G
AD - Division of Pharmacology, Department of Clinical and Experimental Medicine, Scuola Medica, University of Pisa, Via Roma 55, 56126, Pisa, Italy. guido.bocci@med.unipi.it.
LA - eng
PT - Journal Article
PT - Review
DEP - 20170802
PL - Germany
TA - Eur J Clin Pharmacol
JT - European journal of clinical pharmacology
JID - 1256165
SB - IM
MH - Drug-Related Side Effects and Adverse Reactions
MH - Humans
MH - Nurse Specialists/*statistics & numerical data
MH - Nurses, Community Health/*statistics & numerical data
MH - *Pharmacovigilance
OTO - NOTNLM
OT - Adverse drug reaction
OT - Clinical nurse
OT - Community health nurse
OT - National health systems
OT - Pharmacovigilance
EDAT- 2017/08/05 06:00
MHDA- 2018/06/19 06:00
CRDT- 2017/08/04 06:00
PHST- 2017/04/05 00:00 [received]
PHST- 2017/07/19 00:00 [accepted]
PHST- 2017/08/05 06:00 [pubmed]
PHST- 2018/06/19 06:00 [medline]
PHST- 2017/08/04 06:00 [entrez]
AID - 10.1007/s00228-017-2309-0 [pii]
AID - 10.1007/s00228-017-2309-0 [doi]
PST - ppublish
SO - Eur J Clin Pharmacol. 2017 Nov;73(11):1379-1387. doi: 10.1007/s00228-017-2309-0. Epub 2017 Aug 2.
PMID- 21698537
OWN - NLM
STAT- MEDLINE
DCOM- 20120117
LR - 20160707
IS - 1437-1588 (Electronic)
IS - 1436-9990 (Linking)
VI - 54
IP - 7
DP - 2011 Jul
TI - Participation of patients in the development of advanced therapy medicinal products.
PG - 839-42
LID - 10.1007/s00103-011-1306-1 [doi]
AB - An increasing number of advanced therapy medicinal products (ATMPs) are under development and in clinical trials. Patients are central to this progress. In research, patients have funded, catalysed, coordinated and led projects. In regulation, patient groups have contributed to the creation of the political momentum for regulation of ATMPs, contributed to the debate and now participate in the regulatory process. Once licensed, patients will have a role in the pharmacovigilance, health technology assessment and reimbursement arrangements for these products. Patient groups contribute valuably as equal stakeholders at every step of the development of an ATMP.
FAU - Bignami, F
AU - Bignami F
AD - EURORDIS (European Organisation for Rare Diseases), Paris, Frankreich.
FAU - Kent, A J
AU - Kent AJ
FAU - Lipucci di Paola, M
AU - Lipucci di Paola M
FAU - Meade, N
AU - Meade N
LA - eng
PT - Journal Article
PT - Review
PL - Germany
TA - Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
JT - Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
JID - 101181368
SB - IM
MH - Clinical Trials as Topic
MH - Consumer Organizations
MH - Europe
MH - Genetic Therapy
MH - Humans
MH - *Patient Participation
MH - Politics
MH - Stem Cell Transplantation
MH - *Therapies, Investigational
MH - Tissue Transplantation
EDAT- 2011/06/24 06:00
MHDA- 2012/01/18 06:00
CRDT- 2011/06/24 06:00
PHST- 2011/06/24 06:00 [entrez]
PHST- 2011/06/24 06:00 [pubmed]
PHST- 2012/01/18 06:00 [medline]
AID - 10.1007/s00103-011-1306-1 [doi]
PST - ppublish
SO - Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jul;54(7):839-42. doi: 10.1007/s00103-011-1306-1.
PMID- 36008634
OWN - NLM
STAT- MEDLINE
DCOM- 20220923
LR - 20221018
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Print)
IS - 0114-5916 (Linking)
VI - 45
IP - 10
DP - 2022 Oct
TI - Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis.
PG - 1083-1098
LID - 10.1007/s40264-022-01222-y [doi]
AB - INTRODUCTION: Involving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems for adverse drug reactions. However, there is a gap between allowing patients to report and actual patient involvement. Views regarding best practices from regulators, patient organizations and pharmaceutical companies could help increase and improve patient involvement in PV. OBJECTIVE: The aim of this study was to investigate the factors contributing to best practices for patient involvement in PV and to develop a definition of patient involvement based on a qualitative multistakeholder study across Europe. METHODS: A literature review was conducted to map the field of study and obtain insights for the elaboration of an interview guide. Subsequently, patient representatives, members of the pharmaceutical industry and regulators were invited to participate in interviews. These interviews were analyzed using NVIVO(®) software and employing reflective thematic analysis. RESULTS: A total of 20 interviews were conducted with representatives at both the national and European levels. The best practices identified were engagement from the start, face-to-face communication, a full circle of feedback, same-level partners, structured involvement and guidelines, establishing common goals, patient education and empowerment, and developing trust and balance. These activities can be implemented via deep collaboration among stakeholders. A definition of patient involvement was constructed in accordance with the input of all stakeholder groups, which reflects the involvement of all types of patients at all levels of the decision-making process. CONCLUSION: In this study, we developed a definition for patient involvement based on qualitative interviews. The factors contributing to best practices for patient involvement were mentioned across stakeholder groups and aimed to stimulate patient involvement in PV. Patients are eager to become equal partners and to engage effortlessly in the same manner as other stakeholders.
CI - © 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - van Hoof, Monica
AU - van Hoof M
AD - Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
AD - Centro Nacional de Información de Medicamentos, Instituto de Investigaciones Farmacéuticas, Facultad de Farmacia, Universidad de Costa Rica, San José, Costa Rica.
FAU - Chinchilla, Katherine
AU - Chinchilla K
AD - Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
FAU - Härmark, Linda
AU - Härmark L
AUID- ORCID: 0000-0002-9314-9298
AD - Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
FAU - Matos, Cristiano
AU - Matos C
AUID- ORCID: 0000-0002-6279-1421
AD - Instituto Politécnico De Coimbra, ESTESC-Coimbra Health School, Farmácia, Coimbra, Portugal.
FAU - Inácio, Pedro
AU - Inácio P
AUID- ORCID: 0000-0002-6541-8112
AD - Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
FAU - van Hunsel, Florence
AU - van Hunsel F
AUID- ORCID: 0000-0001-8965-3224
AD - Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl.
LA - eng
PT - Journal Article
PT - Review
DEP - 20220825
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
RN - 0 (Pharmaceutical Preparations)
SB - IM
MH - Europe
MH - Humans
MH - *Patient Participation
MH - Pharmaceutical Preparations
MH - *Pharmacovigilance
MH - Qualitative Research
PMC - PMC9409619
COIS- Monica van Hoof, Katherine Chinchilla, Linda Härmark, Cristiano Matos, Pedro Inácio, and Florence van Hunsel declare no relevant conflicts of interest.
EDAT- 2022/08/26 06:00
MHDA- 2022/09/24 06:00
CRDT- 2022/08/25 23:34
PHST- 2022/08/04 00:00 [accepted]
PHST- 2022/08/26 06:00 [pubmed]
PHST- 2022/09/24 06:00 [medline]
PHST- 2022/08/25 23:34 [entrez]
AID - 10.1007/s40264-022-01222-y [pii]
AID - 1222 [pii]
AID - 10.1007/s40264-022-01222-y [doi]
PST - ppublish
SO - Drug Saf. 2022 Oct;45(10):1083-1098. doi: 10.1007/s40264-022-01222-y. Epub 2022 Aug 25.
PMID- 35457375
OWN - NLM
STAT- MEDLINE
DCOM- 20220426
LR - 20220716
IS - 1660-4601 (Electronic)
IS - 1661-7827 (Print)
IS - 1660-4601 (Linking)
VI - 19
IP - 8
DP - 2022 Apr 8
TI - Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs.
LID - 10.3390/ijerph19084509 [doi]
LID - 4509
AB - OBJECTIVE: To investigate the occurrence of adverse effects of antiepileptic drugs (AEDs) in pediatric epileptic patients on mono- or polytherapy. METHOD: We evaluated eighty consecutive patients that met the following inclusion criteria: aged ≤18 years; diagnosed with epilepsy for at least one year; a stable dose of AED for at least three months; verbal consent to participation in the study. Patients were asked if they had experienced any adverse drug reaction (ADR) related to the AED. Afterward, regardless of the answer, they were interviewed based on a detailed semi-structured questionnaire about the presence of ADRs associated with the AED. The data were analyzed regarding the use of monotherapy or polytherapy. RESULTS: Ninety-seven percent of the patients reported having experienced ADRs related to AEDs. The greatest number of seizures affected the group of patients treated with monotherapy (both at baseline and at followup), but the greatest number of ADRs were observed among patients treated with polytherapy. In patients on monotherapy, the most frequent ADRs reported at baseline included fatigue and somnolence, and among patients with polytherapy, it was fatigue and hair loss. CONCLUSION: Children on polytherapy were significantly more likely to develop ADRs compared to those on monotherapy, but a statistically significant improvement in seizure frequency was also observed in the group of patients on polytherapy. Pharmacovigilance is very important in children with AEDs, so that ADRs can be identified early and managed appropriately.
FAU - Kopciuch, Dorota
AU - Kopciuch D
AUID- ORCID: 0000-0001-6547-6112
AD - Department of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.
FAU - Kus, Krzysztof
AU - Kus K
AD - Department of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.
FAU - Fliciński, Jędrzej
AU - Fliciński J
AD - Department of Developmental Neurology, Karol Marcinkowski University of Medical Sciences, Przybyszewskiego 49, 60-355 Poznan, Poland.
FAU - Steinborn, Barbara
AU - Steinborn B
AUID- ORCID: 0000-0002-9839-8162
AD - Department of Developmental Neurology, Karol Marcinkowski University of Medical Sciences, Przybyszewskiego 49, 60-355 Poznan, Poland.
FAU - Winczewska-Wiktor, Anna
AU - Winczewska-Wiktor A
AUID- ORCID: 0000-0001-8551-3419
AD - Department of Developmental Neurology, Karol Marcinkowski University of Medical Sciences, Przybyszewskiego 49, 60-355 Poznan, Poland.
FAU - Paczkowska, Anna
AU - Paczkowska A
AUID- ORCID: 0000-0002-0058-2632
AD - Department of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.
FAU - Zaprutko, Tomasz
AU - Zaprutko T
AUID- ORCID: 0000-0001-9737-9624
AD - Department of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.
FAU - Ratajczak, Piotr
AU - Ratajczak P
AUID- ORCID: 0000-0001-9118-2222
AD - Department of Pharmacoeconomics and Social Pharmacy, Karol Marcinkowski University of Medical Sciences, Rokietnicka 7, 60-806 Poznan, Poland.
FAU - Nowakowska, Elżbieta
AU - Nowakowska E
AD - Department of Pharmacology and Toxicology, Institute of Health Sciences, Collegium Medicum, University of Zielona Gora, Licealna 9 Street, 65-417 Zielona Góra, Poland.
LA - eng
PT - Journal Article
DEP - 20220408
PL - Switzerland
TA - Int J Environ Res Public Health
JT - International journal of environmental research and public health
JID - 101238455
RN - 0 (Anticonvulsants)
SB - IM
MH - Anticonvulsants/adverse effects
MH - Child
MH - *Drug-Related Side Effects and Adverse Reactions
MH - *Epilepsy/epidemiology
MH - Fatigue
MH - Humans
MH - Pharmacovigilance
MH - Seizures/chemically induced
PMC - PMC9028571
OTO - NOTNLM
OT - adverse drug reactions
OT - adverse events
OT - antiepileptic drugs
OT - children
OT - epilepsy
OT - pediatric population
OT - pharmacovigilance
COIS- The authors declare no conflict of interest.
EDAT- 2022/04/24 06:00
MHDA- 2022/04/27 06:00
CRDT- 2022/04/23 01:12
PHST- 2022/03/09 00:00 [received]
PHST- 2022/04/07 00:00 [revised]
PHST- 2022/04/08 00:00 [accepted]
PHST- 2022/04/23 01:12 [entrez]
PHST- 2022/04/24 06:00 [pubmed]
PHST- 2022/04/27 06:00 [medline]
AID - ijerph19084509 [pii]
AID - ijerph-19-04509 [pii]
AID - 10.3390/ijerph19084509 [doi]
PST - epublish
SO - Int J Environ Res Public Health. 2022 Apr 8;19(8):4509. doi: 10.3390/ijerph19084509.
PMID- 31072735
OWN - NLM
STAT- MEDLINE
DCOM- 20200928
LR - 20200928
IS - 1873-2518 (Electronic)
IS - 0264-410X (Linking)
VI - 37
IP - 25
DP - 2019 May 31
TI - Guidance for the governance of public-private collaborations in vaccine post-marketing settings in Europe.
PG - 3278-3289
LID - S0264-410X(19)30561-4 [pii]
LID - 10.1016/j.vaccine.2019.04.073 [doi]
AB - INTRODUCTION: The 2009 influenza pandemic highlighted challenges for vaccine post-marketing monitoring in Europe, particularly the need to have appropriate infrastructures to strengthen public-private collaborations (PPCs) with suitable processes to improve stakeholder interactions and collection and analysis of safety and effectiveness data. The ADVANCE consortium comprises public and private stakeholders who have worked together to build and test new system components for vaccine post-marketing projects, one component being a governance framework for efficient, transparent and trustworthy PPCs. METHODS: Based on the results of a landscape analysis and screening of formalised existing governance structures, we identified the elements of a governance framework and developed recommendations to support stakeholders willing and able to implement collaborative projects. These proposals and their implementation were discussed by 70 experts during a workshop to gain from their experience. RESULTS: We identified core governance principles and defined five fundamental functions (decision-making, scientific advice, quality control and audit, implementation and management, and financial administration) that can be attributed to individual partner organisations or to a committee with representatives from more than one partner organisation. We propose a generic governance model with options for its adaptation to specific contexts and projects. The advantages and disadvantages of PPCs were also examined. Stakeholders' concerns (e.g. scientific integrity and public trust) were addressed through recommendations about transparent decision-making rules and conflict of interest management. CONCLUSIONS: No one-size-fits-all solution for PPC governance exists but our recommendations could be used to set-up a tailored-made and fully transparent governance structure supporting collaborative projects in the European vaccine post-marketing environment. To allow the rapid establishment of robust projects, the next steps will involve this guidance being used by real-world collaborations to assess what works and what does not work and what added-value can be obtained from these collaborations.
CI - Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Torcel-Pagnon, Laurence
AU - Torcel-Pagnon L
AD - Vaccine Epidemiology and Modelling (VEM), Sanofi Pasteur, Lyon, France. Electronic address: laurence.pagnon@sanofi.com.
FAU - Bauchau, Vincent
AU - Bauchau V
AD - Vaccine Clinical Safety and Pharmacovigilance, GSK, Wavre, Belgium. Electronic address: vincent.g.bauchau@gsk.com.
FAU - Mahy, Patrick
AU - Mahy P
AD - Expertise, Service Provision and Customer Relations, Sciensano, Brussels, Belgium. Electronic address: Patrick.Mahy@sciensano.be.
FAU - Tin Tin Htar, Myint
AU - Tin Tin Htar M
AD - Clinical Epidemiology, Pfizer Inc, Paris, France. Electronic address: Myint.TinTinHtar@pfizer.com.
FAU - van der Sande, Marianne
AU - van der Sande M
AD - Centre for Infectious Disease Control, National Institute of Public Health and the Environment, Bilthoven, Netherlands; Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands. Electronic address: mvandersande@itg.be.
FAU - Mahé, Cédric
AU - Mahé C
AD - Vaccine Epidemiology and Modelling (VEM), Sanofi Pasteur, Lyon, France. Electronic address: cedric.mahe@sanofi.com.
FAU - Krause, Tyra Grove
AU - Krause TG
AD - Department of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Denmark. Electronic address: TGV@ssi.dk.
FAU - Charrat, Anne
AU - Charrat A
AD - Vaccine Epidemiology and Modelling (VEM), Sanofi Pasteur, Lyon, France. Electronic address: anne.charrat@sanofi.com.
FAU - Simondon, François
AU - Simondon F
AD - MERIT Research Unit, IRD, Paris, France; Paris Descartes University, Paris, France. Electronic address: francois.simondon@ird.fr.
FAU - Kurz, Xavier
AU - Kurz X
AD - Pharmacovigilance & Epidemiology Department, European Medicines Agency, London, UK. Electronic address: xavier.kurz@ema.europa.eu.
CN - ADVANCE Consortium
LA - eng
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PT - Review
DEP - 20190506
PL - Netherlands
TA - Vaccine
JT - Vaccine
JID - 8406899
RN - 0 (Influenza Vaccines)
SB - IM
MH - Europe
MH - Humans
MH - Influenza Vaccines/*administration & dosage
MH - Influenza, Human
MH - Marketing/*methods/organization & administration
MH - Organizations
MH - Pandemics/prevention & control
MH - Public-Private Sector Partnerships/*legislation & jurisprudence/organization & administration
MH - Stakeholder Participation
OTO - NOTNLM
OT - Governance model
OT - Multi-stakeholders collaboration
OT - Post-marketing studies
OT - Public-private partnership
OT - Vaccine benefit-risk
EDAT- 2019/05/11 06:00
MHDA- 2020/09/29 06:00
CRDT- 2019/05/11 06:00
PHST- 2018/07/30 00:00 [received]
PHST- 2019/04/19 00:00 [revised]
PHST- 2019/04/24 00:00 [accepted]
PHST- 2019/05/11 06:00 [pubmed]
PHST- 2020/09/29 06:00 [medline]
PHST- 2019/05/11 06:00 [entrez]
AID - S0264-410X(19)30561-4 [pii]
AID - 10.1016/j.vaccine.2019.04.073 [doi]
PST - ppublish
SO - Vaccine. 2019 May 31;37(25):3278-3289. doi: 10.1016/j.vaccine.2019.04.073. Epub 2019 May 6.
PMID- 30357648
OWN - NLM
STAT- MEDLINE
DCOM- 20200102
LR - 20200309
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Linking)
VI - 42
IP - 4
DP - 2019 Apr
TI - The Role of European Patient Organizations in Pharmacovigilance.
PG - 547-557
LID - 10.1007/s40264-018-0748-x [doi]
AB - INTRODUCTION: Patient organizations have a privileged position to be active agents for promoting pharmacovigilance and patient engagement, encouraging direct patient reporting and improving the awareness of pharmacovigilance. AIM: The objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance. METHODS: A descriptive correlational study was conducted to investigate the opinions and attitudes of patient organizations regarding general patient involvement in pharmacovigilance, and their initiatives to support drug safety through a web-based questionnaire during the months of March and April 2018. RESULTS: A total of 1898 patient organizations were invited to participate in the survey, including 89 pan-European organizations. In total, 337 questionnaires (17.76%) were collected from 31 countries, including 297 complete answers (88.31%). A large number of organizations stated that they would like to increase the awareness of patients regarding specific adverse drug reactions (ADRs) related to their medicines (43.19%, n = 130); however, 38.54% (n = 116) declared they do not have any pharmacovigilance goals. Barriers to supporting pharmacovigilance activities include low budget to promote pharmacovigilance among members (45.45%, n = 135), lack of resources to participate in pharmacovigilance activities (43.77%, n = 130), or lack of support from the National Competent Authorities (33.33%, n = 99). Organizations inform patients to report ADRs (40.40%; n = 120), information regarding new ADRs related to their medicines (40.07%; n = 119), or when a new drug is marketed (30.98%; n = 92); however, more than one-third indicated that they never had any involvement in pharmacovigilance (34.68%; n = 103). CONCLUSION: Bringing pharmacovigilance stakeholders and patient organizations together could create a more optimal reporting culture. Patient organizations appear to have an important role in encouraging patients to talk with their doctors/pharmacists about ADRs experienced, or to help him/her report the ADRs to the pharmacovigilance systems. Lack of resources, budget, and support from NCAs are seen as the main barriers to being involved in pharmacovigilance awareness.
FAU - Matos, Cristiano
AU - Matos C
AUID- ORCID: 0000-0002-6279-1421
AD - Department of Pharmacology, Faculty of Pharmacy, University of Seville, Seville, Spain. cristiano.r.matos@gmail.com.
AD - Instituto Politécnico De Coimbra, ESTESC-Coimbra Health School, Farmácia, Coimbra, Portugal. cristiano.r.matos@gmail.com.
FAU - Weits, Gerda
AU - Weits G
AD - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
FAU - van Hunsel, Florence
AU - van Hunsel F
AD - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
LA - eng
PT - Journal Article
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH - Drug-Related Side Effects and Adverse Reactions/prevention & control
MH - Europe
MH - Female
MH - Humans
MH - Male
MH - Patient Participation/*statistics & numerical data
MH - Pharmacists/statistics & numerical data
MH - Pharmacovigilance
MH - Surveys and Questionnaires
EDAT- 2018/10/26 06:00
MHDA- 2020/01/03 06:00
CRDT- 2018/10/26 06:00
PHST- 2018/10/26 06:00 [pubmed]
PHST- 2020/01/03 06:00 [medline]
PHST- 2018/10/26 06:00 [entrez]
AID - 10.1007/s40264-018-0748-x [pii]
AID - 10.1007/s40264-018-0748-x [doi]
PST - ppublish
SO - Drug Saf. 2019 Apr;42(4):547-557. doi: 10.1007/s40264-018-0748-x.
PMID- 22905902
OWN - NLM
STAT- MEDLINE
DCOM- 20130920
LR - 20220318
IS - 1365-2125 (Electronic)
IS - 0306-5251 (Print)
IS - 0306-5251 (Linking)
VI - 75
IP - 4
DP - 2013 Apr
TI - What can we learn from parents about enhancing participation in pharmacovigilance?
PG - 1109-17
LID - 10.1111/j.1365-2125.2012.04441.x [doi]
AB - AIMS: To investigate parents' views and experiences of direct reporting of a suspected ADR in their child. METHODS: We audio-recorded semi-structured qualitative interviews with parents of children with suspected ADRs. Our sample included parents with (n = 17) and without (n = 27) previous experience of submitting a Yellow Card. RESULTS: Parents in both groups described poor awareness of the Yellow Card Scheme. Parents who had participated in the Yellow Card Scheme were generally happy to report their child's ADR via the Scheme and valued the opportunity to report concerns independently of health practitioners. They expressed motivations for reporting that have not previously been described linked to the parental role, including how registering a concern about a medicine helped to resolve uncomfortable feelings about their child's ADR. Parents who had not previously submitted a Yellow Card expressed uncertainty about the legitimacy of their involvement in reporting and doubts about the value of the information that they could provide. CONCLUSION: Promoting wider participation in pharmacovigilance schemes will depend on raising public awareness. Additionally, our findings point to the need to empower lay people to submitting reports and to reassure them about the value of their reports.
CI - © 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.
FAU - Arnott, Janine
AU - Arnott J
AD - Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
FAU - Hesselgreaves, Hannah
AU - Hesselgreaves H
FAU - Nunn, Anthony J
AU - Nunn AJ
FAU - Peak, Matthew
AU - Peak M
FAU - Pirmohamed, Munir
AU - Pirmohamed M
FAU - Smyth, Rosalind L
AU - Smyth RL
FAU - Turner, Mark A
AU - Turner MA
FAU - Young, Bridget
AU - Young B
LA - eng
GR - RP-PG-0606-1170/DH_/Department of Health/United Kingdom
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PL - England
TA - Br J Clin Pharmacol
JT - British journal of clinical pharmacology
JID - 7503323
SB - IM
MH - Adolescent
MH - Adult
MH - Child
MH - Child, Preschool
MH - Female
MH - *Health Knowledge, Attitudes, Practice
MH - Humans
MH - Infant
MH - Male
MH - Parents/*psychology
MH - *Pharmacovigilance
MH - Professional-Family Relations
PMC - PMC3612729
EDAT- 2012/08/22 06:00
MHDA- 2013/09/21 06:00
CRDT- 2012/08/22 06:00
PHST- 2012/05/25 00:00 [received]
PHST- 2012/08/15 00:00 [accepted]
PHST- 2012/08/22 06:00 [entrez]
PHST- 2012/08/22 06:00 [pubmed]
PHST- 2013/09/21 06:00 [medline]
AID - 10.1111/j.1365-2125.2012.04441.x [doi]
PST - ppublish
SO - Br J Clin Pharmacol. 2013 Apr;75(4):1109-17. doi: 10.1111/j.1365-2125.2012.04441.x.
PMID- 22867653
OWN - NLM
STAT- MEDLINE
DCOM- 20121210
LR - 20211021
IS - 1478-5242 (Electronic)
IS - 0960-1643 (Print)
IS - 0960-1643 (Linking)
VI - 62
IP - 601
DP - 2012 Aug
TI - Pharmacovigilance on the turn? Adverse reactions methods in 2012.
PG - 400-1
LID - 10.3399/bjgp12X653453 [doi]
FAU - Herxheimer, Andrew
AU - Herxheimer A
LA - eng
PT - Editorial
PL - England
TA - Br J Gen Pract
JT - The British journal of general practice : the journal of the Royal College of General Practitioners
JID - 9005323
SB - IM
CIN - Br J Gen Pract. 2012 Oct;62(603):518. PMID: 23265207
MH - Adverse Drug Reaction Reporting Systems/legislation & jurisprudence/*organization & administration/standards
MH - Drug Evaluation
MH - European Union
MH - Humans
MH - Patient Participation
PMC - PMC3404307
EDAT- 2012/08/08 06:00
MHDA- 2012/12/12 06:00
CRDT- 2012/08/08 06:00
PHST- 2012/08/08 06:00 [entrez]
PHST- 2012/08/08 06:00 [pubmed]
PHST- 2012/12/12 06:00 [medline]
AID - 10.3399/bjgp12X653453 [doi]
PST - ppublish
SO - Br J Gen Pract. 2012 Aug;62(601):400-1. doi: 10.3399/bjgp12X653453.
PMID- 31030578
OWN - NLM
STAT- MEDLINE
DCOM- 20190605
LR - 20190723
IS - 1744-764X (Electronic)
IS - 1474-0338 (Linking)
VI - 18
IP - 6
DP - 2019 Jun
TI - Fifteen years of patient reporting -what have we learned and where are we heading to?
PG - 477-484
LID - 10.1080/14740338.2019.1613373 [doi]
AB - INTRODUCTION: In April 2003, the Netherlands Pharmacovigilance Centre Lareb successfully implemented patient reporting to their spontaneous reporting system. The number of reports by patients rapidly grew, prompting the need to evaluate the value of the patient reporting scheme and to compare experiences with other countries. The aim of this article is to summarize our 15-year experience of working with direct patient reporting in pharmacovigilance and to discuss necessary steps in order to optimize the use of patient reports in the future. AREAS COVERED: This article is based on Lareb studies on patient reporting from 2004 onwards and covers the evolution of the Dutch patient reporting system, the value of patient participation in pharmacovigilance, the impact of patient reporting on the spontaneous reporting system and future steps to strengthen patient reporting. EXPERT OPINION: After 15 years of experience with patient reporting we conclude that patients can add value to pharmacovigilance. We recognize that there is a big leap between allowing patients to report and actual patient involvement in pharmacovigilance. It is our belief that increased patient involvement in pharmacovigilance is a way to improve pharmacovigilance, enhancing the general public's trust in medicines.
FAU - van Hunsel, Florence
AU - van Hunsel F
AD - a WHO Collaborating Centre For Pharmacovigilance In Education And Patient Reporting , the Netherlands Pharmacovigilance Centre Lareb , 's-Hertogenbosch , the Netherlands.
FAU - Härmark, Linda
AU - Härmark L
AD - a WHO Collaborating Centre For Pharmacovigilance In Education And Patient Reporting , the Netherlands Pharmacovigilance Centre Lareb , 's-Hertogenbosch , the Netherlands.
FAU - Rolfes, Leàn
AU - Rolfes L
AD - a WHO Collaborating Centre For Pharmacovigilance In Education And Patient Reporting , the Netherlands Pharmacovigilance Centre Lareb , 's-Hertogenbosch , the Netherlands.
LA - eng
PT - Journal Article
PT - Review
DEP - 20190516
PL - England
TA - Expert Opin Drug Saf
JT - Expert opinion on drug safety
JID - 101163027
SB - IM
MH - Adverse Drug Reaction Reporting Systems/*trends
MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH - Humans
MH - Netherlands
MH - *Pharmacovigilance
MH - Self Report
OTO - NOTNLM
OT - Patient reporting
OT - patient participation
OT - pharmacovigilance
OT - signal detection
OT - spontaneous reporting system
EDAT- 2019/04/30 06:00
MHDA- 2019/06/06 06:00
CRDT- 2019/04/30 06:00
PHST- 2019/04/30 06:00 [pubmed]
PHST- 2019/06/06 06:00 [medline]
PHST- 2019/04/30 06:00 [entrez]
AID - 10.1080/14740338.2019.1613373 [doi]
PST - ppublish
SO - Expert Opin Drug Saf. 2019 Jun;18(6):477-484. doi: 10.1080/14740338.2019.1613373. Epub 2019 May 16.
PMID- 31240364
OWN - NLM
STAT- MEDLINE
DCOM- 20200116
LR - 20200225
IS - 1432-1041 (Electronic)
IS - 0031-6970 (Linking)
VI - 75
IP - 9
DP - 2019 Sep
TI - 'Engagement' of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework.
PG - 1181-1192
LID - 10.1007/s00228-019-02705-1 [doi]
AB - BACKGROUND: Engagement of patients and healthcare professionals is increasingly considered as fundamental to pharmacovigilance and risk minimisation activities. Few empirical studies of engagement exist and a lack of explicit conceptualisations impedes effective measurement, research and the development of evidence-based engagement interventions. AIMS: This article (1) develops a widely applicable conceptualisation, (2) considers various methodological challenges to researching engagement, proposing some solutions, and (3) outlines a basis for converting the conceptualisation into specific measures and indicators of engagement among stakeholders. METHOD: We synthesise social science work on risk governance and public understandings of science with insights from studies in the pharmacovigilance field. FINDINGS: This leads us to define engagement as an ongoing process of knowledge exchange among stakeholders, with the adoption of this knowledge as the outcome which may feed back into engagement processes over time. We conceptualise this process via three dimensions; breadth, depth and texture. In addressing challenges to capturing each dimension, we emphasise the importance of combining survey approaches with qualitative studies and secondary data on medicines use, prescribing, adverse reaction reporting and health outcomes. A framework for evaluating engagement intervention processes and outcomes is proposed. Alongside measuring engagement via breadth and depth, we highlight the need to research the engagement process through attentiveness to texture-what engagement feels like, what it means to people, and how this shapes motivations based on values, emotions, trust and rationales. CONCLUSION: Capturing all three dimensions of engagement is vital to develop valid understandings of what works and why, thus informing engagement interventions of patients and healthcare professionals to given regulatory pharmacovigilance scenarios.
FAU - Brown, Patrick
AU - Brown P
AUID- ORCID: 0000-0001-6392-1630
AD - University of Amsterdam, Nieuwe Achtergracht 166, 1018 WV, Amsterdam, The Netherlands. p.r.brown@uva.nl.
FAU - Bahri, Priya
AU - Bahri P
AD - European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam, 1083 HS, The Netherlands.
LA - eng
PT - Journal Article
PT - Review
DEP - 20190625
PL - Germany
TA - Eur J Clin Pharmacol
JT - European journal of clinical pharmacology
JID - 1256165
SB - IM
MH - Drug-Related Side Effects and Adverse Reactions
MH - Health Personnel
MH - Humans
MH - Legislation, Drug
MH - *Pharmacovigilance
MH - *Stakeholder Participation
OTO - NOTNLM
OT - Patient engagement
OT - Pharmacovigilance
OT - Regulation
OT - Risk governance
OT - Stakeholder engagement
EDAT- 2019/06/27 06:00
MHDA- 2020/01/17 06:00
CRDT- 2019/06/27 06:00
PHST- 2019/02/11 00:00 [received]
PHST- 2019/06/04 00:00 [accepted]
PHST- 2019/06/27 06:00 [pubmed]
PHST- 2020/01/17 06:00 [medline]
PHST- 2019/06/27 06:00 [entrez]
AID - 10.1007/s00228-019-02705-1 [pii]
AID - 10.1007/s00228-019-02705-1 [doi]
PST - ppublish
SO - Eur J Clin Pharmacol. 2019 Sep;75(9):1181-1192. doi: 10.1007/s00228-019-02705-1. Epub 2019 Jun 25.
PMID- 20182797
OWN - NLM
STAT- MEDLINE
DCOM- 20110126
LR - 20211020
IS - 1573-739X (Electronic)
IS - 0928-1231 (Linking)
VI - 32
IP - 3
DP - 2010 Jun
TI - Views of parents and pharmacists following participation in a paediatric pharmacovigilance study.
PG - 334-8
LID - 10.1007/s11096-010-9374-0 [doi]
AB - OBJECTIVE: To explore the experiences and views of community pharmacists and parents participating in a prospective paediatric pharmacovigilance study. METHOD: Twenty-five pharmacists and 32 parents were approached for telephone interview. Interviews were audio-recorded, transcribed and analysed thematically to identify recurring issues and themes. RESULTS: Seventeen pharmacists and 22 parents were interviewed. Parents and pharmacists agreed that more information about the side effects of medicines in children was required. Both groups reported willingness to participate in future prospective pharmacovigilance studies, although pharmacists expressed concerns about the lack of financial incentives. Pharmacists reported that parents had concerns regarding the confidentiality of their child's ADR data and the study data collection process. CONCLUSION: This study highlighted positive and negative opinions of parents and pharmacists regarding their experiences in this research project. Maintaining confidentiality in relation to indication and medicines prescribed were important issues for parents whereas time constraints and lack of financial incentives were key issues influencing participation by community pharmacists.
FAU - Tobaiqy, Mansour
AU - Tobaiqy M
AD - Division of Applied Health Sciences, The Aberdeen Medical School, The University of Aberdeen, Aberdeen, Scotland, UK.
FAU - Stewart, Derek
AU - Stewart D
FAU - Helms, Peter J
AU - Helms PJ
FAU - Bond, Christine M
AU - Bond CM
FAU - Lee, Amanda Jane
AU - Lee AJ
FAU - McLay, James
AU - McLay J
LA - eng
GR - CZG/2/267/CSO_/Chief Scientist Office/United Kingdom
PT - Comparative Study
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
DEP - 20100225
PL - Germany
TA - Pharm World Sci
JT - Pharmacy world & science : PWS
JID - 9307352
SB - IM
MH - *Attitude of Health Personnel
MH - Community Pharmacy Services/*standards
MH - *Drug-Related Side Effects and Adverse Reactions
MH - Humans
MH - Interviews as Topic/standards
MH - *Parents
MH - *Pharmacists
MH - Prospective Studies
EDAT- 2010/02/26 06:00
MHDA- 2011/01/28 06:00
CRDT- 2010/02/26 06:00
PHST- 2009/10/27 00:00 [received]
PHST- 2010/02/15 00:00 [accepted]
PHST- 2010/02/26 06:00 [entrez]
PHST- 2010/02/26 06:00 [pubmed]
PHST- 2011/01/28 06:00 [medline]
AID - 10.1007/s11096-010-9374-0 [doi]
PST - ppublish
SO - Pharm World Sci. 2010 Jun;32(3):334-8. doi: 10.1007/s11096-010-9374-0. Epub 2010 Feb 25.
PMID- 30736467
OWN - NLM
STAT- PubMed-not-MEDLINE
LR - 20200930
IS - 2226-4787 (Electronic)
IS - 2226-4787 (Linking)
VI - 7
IP - 1
DP - 2019 Feb 7
TI - General Public Views, Attitudes, and Experiences toward Drug Safety in Dubai, United Arab Emirates: A Qualitative Approach.
LID - 10.3390/pharmacy7010019 [doi]
LID - 19
AB - Ensuring drug safety among the patients is the main domain of pharmacovigilance activities worldwide. A pharmacovigilance system was established in the United Arab Emirates (UAE) in 2008. Research evidence reflects that the current system is lacking in active participation from patients, and also, the inadequate role of healthcare professionals is anticipated. In this context, it is pertinent to know the general public's understandings and their patterns of safe use of medication, which are unexplored areas in Dubai, UAE. The current study aimed to explore the public views, attitudes, and experiences toward medication safety, and to explore key factors enhancing the safe use of medications among the public in Dubai. This study adopted a qualitative approach and face-to-face, 14 in-depth interviews with public individuals, selected purposively using the snowball sampling technique. The interviews were conducted in different places in Dubai recorded and transcribed verbatim and thematically analyzed for data analysis. Reporting of adverse drug reaction was not well-known among all the participants. Public views towards safe use of medicines were limited to the side effects of the consumed medicines only, and to a lesser extent to the inappropriate indication and dosage. Most of the participants mentioned that gaining knowledge about the side effects of the prescribed drug was the main reason for reading the patient information leaflet. Quite a few participants have experienced side effects while consuming their medicines and they were unsure of how to deal with the situation. The current research also reflected the lack of proper communication between pharmacists and physicians in managing drug safety issues. Conclusively, the current research revealed gaps in public views regarding medication's safety, which consequently may impact their attitudes during the course of medication use. Efforts need to be strengthened to enhance positive views and attitudes of the public towards medication safety and ADR reporting in the UAE.
FAU - Alkhalidi, Doaa
AU - Alkhalidi D
AD - Department of Pharmacy Practice, Kulliyyah of Pharmacy, IIUM, Kuantan, Pahang 25200, Malaysia. dr.doaakamal@dpc.edu.
FAU - Jamshed, Shazia Qasim
AU - Jamshed SQ
AD - Department of Pharmacy Practice, Kulliyyah of Pharmacy, IIUM, Kuantan, Pahang 25200, Malaysia. pharmacist1992@live.com.
FAU - Elkalmi, Ramadan Mohamed
AU - Elkalmi RM
AD - Department of Pharmacy Practice, Faculty of Pharmacy, Universiti Teknologi Mara, Shah Alam, Selangor 42300, Malaysia. edriph@gmail.com.
FAU - Baig, Mirza Rafi
AU - Baig MR
AD - Department of Clinical Pharmacy & Pharmacotherapeutics, Dubai Pharmacy College, Dubai, UAE. dr.mirzabaig@dpc.edu.
FAU - Aslam, Adeel
AU - Aslam A
AD - Department of Pharmacy Practice, Kulliyyah of Pharmacy, IIUM, Kuantan, Pahang 25200, Malaysia. adeelaslam224@gmail.com.
FAU - Hassali, Mohamed Azmi
AU - Hassali MA
AD - Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang 11800, Malaysia. azmihassali@usm.my.
LA - eng
PT - Journal Article
DEP - 20190207
PL - Switzerland
TA - Pharmacy (Basel)
JT - Pharmacy (Basel, Switzerland)
JID - 101678532
PMC - PMC6473663
OTO - NOTNLM
OT - ADR reporting
OT - Dubai
OT - drug safety
OT - public
COIS- The authors declare no conflict of interest.
EDAT- 2019/02/10 06:00
MHDA- 2019/02/10 06:01
CRDT- 2019/02/10 06:00
PHST- 2018/11/30 00:00 [received]
PHST- 2019/01/21 00:00 [revised]
PHST- 2019/01/30 00:00 [accepted]
PHST- 2019/02/10 06:00 [entrez]
PHST- 2019/02/10 06:00 [pubmed]
PHST- 2019/02/10 06:01 [medline]
AID - pharmacy7010019 [pii]
AID - pharmacy-07-00019 [pii]
AID - 10.3390/pharmacy7010019 [doi]
PST - epublish
SO - Pharmacy (Basel). 2019 Feb 7;7(1):19. doi: 10.3390/pharmacy7010019.
PMID- 24155840
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20131024
LR - 20220409
IS - 1885-642X (Print)
IS - 1886-3655 (Electronic)
IS - 1885-642X (Linking)
VI - 10
IP - 4
DP - 2012 Oct
TI - Knowledge, perception and practice of pharmacovigilance among community pharmacists in South India.
PG - 222-6
AB - Pharmacovigilance has not progressed well in India and the concept is still in its infancy. India rates below 1% in pharmacovigilance as against the world rate of 5%. OBJECTIVE: The aim of our study was to evaluate the knowledge, perception and practice of pharmacovigilance among registered community pharmacists in Hyderabad, India. METHODS: This was a prospective study to find out the knowledge, perception and practice of adverse drug reaction reporting among community pharmacists. It was conducted by a face to face questionnaire and the convenience factor of the pharmacist was taken into consideration. RESULTS: From the 650 questionnaire administered to community pharmacists, 347 (53.3%) were returned completely filled questionnaires. A number of 120 (34.6%) pharmacists could define the term 'pharmacovigilance' to an acceptable extent and 119 (34.3%) knew about the National Pharmacovigilance Programme in India. 96 (27.7%) had good knowledge, 36(10.4%) had fair knowledge and 215(61.9%) had poor knowledge about pharmacovigilance. We have found that 196 (56.5%) had good perception, 94(27.1%) had fair perception and 57(16.4%) had poor perception. Only 41(11.8%) pharmacists ever reported an ADR and the other never reported ADR. The majority of pharmacists 223(64.3%) felt that the AE is very simple and non-serious and hence did not report. Pharmacists have poor knowledge, good perception and negligibly low reporting rates. CONCLUSIONS: Incorporation of ADR reporting concepts in education curriculum, training of pharmacists and voluntary participation of pharmacists in ADR reporting is very crucial in achieving the safety goals and safeguarding public health.
FAU - Prakasam, Arul
AU - Prakasam A
AD - Department of Pharmacy Practice, JKK Munirajah Medical Research Foundation, College of Pharmacy, B. Komarapalyam, Namakkal. Tamil Nadu ( India ).
FAU - Nidamanuri, Anitha
AU - Nidamanuri A
FAU - Kumar, Senthil
AU - Kumar S
LA - eng
PT - Journal Article
DEP - 20121231
PL - Spain
TA - Pharm Pract (Granada)
JT - Pharmacy practice
JID - 101530029
PMC - PMC3780499
OTO - NOTNLM
OT - Adverse Drug Reaction Reporting Systems
OT - Attitude of Health Personnel
OT - India
OT - Pharmacists
OT - Professional Practice
EDAT- 2013/10/25 06:00
MHDA- 2013/10/25 06:01
CRDT- 2013/10/25 06:00
PHST- 2012/06/01 00:00 [received]
PHST- 2012/12/06 00:00 [accepted]
PHST- 2013/10/25 06:00 [entrez]
PHST- 2013/10/25 06:00 [pubmed]
PHST- 2013/10/25 06:01 [medline]
AID - PhP-483 [pii]
AID - 10.4321/s1886-36552012000400006 [doi]
PST - ppublish
SO - Pharm Pract (Granada). 2012 Oct;10(4):222-6. doi: 10.4321/s1886-36552012000400006. Epub 2012 Dec 31.
PMID- 36861041
OWN - NLM
STAT- PubMed-not-MEDLINE
LR - 20230303
IS - 2042-0986 (Print)
IS - 2042-0994 (Electronic)
IS - 2042-0986 (Linking)
VI - 14
DP - 2023
TI - Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community.
PG - 20420986221146418
LID - 10.1177/20420986221146418 [doi]
LID - 20420986221146418
AB - Pharmacovigilance, the science and practice of monitoring the effects of medicinals and their safety, is the responsibility of all stakeholders involved in the development, manufacture, regulation, distribution, prescription, and use of drugs and devices. The patient is the stakeholder most impacted by and the greatest source of information on safety issues. It is rare, however, for the patient to take a central role and exert leadership in the design and execution of pharmacovigilance. Patient organizations in the inherited bleeding disorders community are among the most established and empowered, particularly in the rare disorders. In this review, two of the largest bleeding disorders patient organizations, Hemophilia Federation of America (HFA) and National Hemophilia Foundation (NHF), offer insights into the priority actions required of all stakeholders to improve pharmacovigilance. The recent and ongoing increase in incidents raising safety concerns and a therapeutic landscape on the cusp of unprecedented expansion heighten the urgency of a recommitment to the primacy of patient safety and well-being in drug development and distribution. PLAIN LANGUAGE SUMMARY: Patients at the center of product safety Every medical device and therapeutic product has potential benefits and harms. The pharmaceutical and biomedical companies that develop them must demonstrate that they are effective, and the safety risks are limited or manageable, for regulators to approve them for use and sale. After the product has been approved and people are using it in their daily lives, it is important to continue to collect information about any negative side effects or adverse events; this is called pharmacovigilance. Regulators, like the United States (US) Food and Drug Administration, the companies that sell and distribute the products, and healthcare professionals who prescribe them are all required to participate in collecting, reporting, analyzing, and communicating this information. The people with the most firsthand knowledge of the benefits and harms of the drug or device are the patients who use them. They have an important responsibility to learn how to recognize adverse events, how to report them, and to stay informed of any news about the product from the other partners in the pharmacovigilance network. Those partners have a crucial responsibility to provide clear, easy-to-understand information to patients about any new safety concerns that come to light. The community of people with inherited bleeding disorders has recently encountered problems with poor communication of product safety issues, prompting two large US patient organizations, National Hemophilia Foundation and Hemophilia Federation of America, to hold a Safety Summit with all the pharmacovigilance network partners. Together they developed recommendations to improve the collection and communication of information about product safety so that patients can make well-informed, timely decisions about their use of drugs and devices. This article presents these recommendations in the context of how pharmacovigilance is supposed to work and some of the challenges encountered by the community.
CI - © The Author(s), 2023.
FAU - Robinson, Fiona
AU - Robinson F
AUID- ORCID: 0000-0003-4286-271X
AD - Communications, Montréal, QC, Canada.
FAU - Wilkes, Sonji
AU - Wilkes S
AD - Hemophilia Federation of America, Washington, DC, USA.
FAU - Schaefer, Nathan
AU - Schaefer N
AD - National Hemophilia Foundation, New York, NY, USA.
FAU - Goldstein, Miriam
AU - Goldstein M
AD - Hemophilia Federation of America, Washington, DC, USA.
FAU - Rice, Michelle
AU - Rice M
AD - National Hemophilia Foundation, New York, NY, USA.
FAU - Gray, Johanna
AU - Gray J
AD - Artemis Policy Group, Washington, DC, USA.
FAU - Meyers, Sharon
AU - Meyers S
AD - Hemophilia Federation of America, Washington, DC, USA.
FAU - Valentino, Leonard A
AU - Valentino LA
AD - National Hemophilia Foundation, 7 Penn Plaza, Suite 102, New York, NY 1001, USA.
AD - Internal Medicine and Pediatrics, Rush University, Chicago, IL, USA.
LA - eng
PT - Journal Article
PT - Review
DEP - 20230225
PL - England
TA - Ther Adv Drug Saf
JT - Therapeutic advances in drug safety
JID - 101549074
PMC - PMC9969430
OTO - NOTNLM
OT - advocacy
OT - community
OT - drug safety
OT - inherited bleeding disorders
OT - patient safety
OT - pharmacovigilance
OT - postmarketing surveillance
COIS- The authors declared the following potential conflict of interest with respect to the research, authorship, and/or publication of this article: HFA and the NHF, co-leaders of the 2020 Product Safety Summit, sought participation in and support of the Safety Summit from all manufacturers of bleeding disorders medications. HFA and NHF contributed equally to the development and deployment of the Safety Summit and subsequent work and materials; all funding supporting was split equally between the two nonprofit organizations. S.W. is employed by HFA as VP for Public Affairs. S.M. is employed by HFA as President & CEO. HFA receives honoraria for their participation on patient advocacy advisory boards for Takeda, BioMarin, and Sanofi. M.G. is employed by HFA as a director of policy. HFA is a national nonprofit organization that assists, educates, and advocates for the bleeding disorders community. HFA receives funding in the form of donations from individuals, philanthropic foundations, drug/biotech manufacturers, and specialty pharmacies; a cooperative grant from the US Centers for Disease Control; an engagement award from the Patient-Centered Outcomes Research Institute; sponsorship income from a symposium it holds annually. A list of corporate supporters can be found at https://www.hemophiliafed.org/home/our-role-and-programs/what-is-hfa/our-supporters/. F.R. is a consultant and was paid by NHF/HFA to contribute her expertise to this article. She has received consulting fees from F. Hoffmann-La Roche Ltd for speaking at a symposium, and for work with the World Federation of Hemophilia, American Thrombosis and Hemostasis Network, and European Haemophilia Consortium. The opinions expressed in this article by N.S. and L.A.V. are their own and not necessarily reflective of those of the NHF or its Board of Directors. The other authors have no conflicts of interest relevant to this article.
EDAT- 2023/03/03 06:00
MHDA- 2023/03/03 06:01
CRDT- 2023/03/02 02:17
PHST- 2022/05/07 00:00 [received]
PHST- 2022/12/01 00:00 [accepted]
PHST- 2023/03/02 02:17 [entrez]
PHST- 2023/03/03 06:00 [pubmed]
PHST- 2023/03/03 06:01 [medline]
AID - 10.1177_20420986221146418 [pii]
AID - 10.1177/20420986221146418 [doi]
PST - epublish
SO - Ther Adv Drug Saf. 2023 Feb 25;14:20420986221146418. doi: 10.1177/20420986221146418. eCollection 2023.
PMID- 36520575
OWN - NLM
STAT- MEDLINE
DCOM- 20221220
LR - 20221228
IS - 2171-8695 (Electronic)
IS - 1130-6343 (Linking)
VI - 46
IP - 6
DP - 2022 Sep 27
TI - Processes implemented and activities carried out by the pharmacists during the COVID‑19 pandemic: A scoping review.
PG - 350-358
AB - OBJECTIVE: To identify and summarize the processes implemented and the activities performed by community and hospital-based pharmacists during the COVID‑19 pandemic. METHOD: A scoping review was carried out of the PubMed/Medline database with the aim of identifying articles published until 30 June 2021. The PRISMA recommendations for this type of review were followed. The articles included were reviewed and classified according to their main characteristics and outcomes, according to population, concept and context. The processes and activities identified were grouped into three categories: those performed in community and hospital pharmacies, those performed essentially in community pharmacies, and those performed essentially in hospital pharmacies. RESULTS: A total of 629 articles were identified, of which 454 were excluded because they were unrelated to the object of the review and 81 due to meeting the exclusion criteria. So, 94 articles were included in the analysis. Most studies were conducted in Europe and the United States. During the COVID‑19 pandemic, the processes implemented and the activities carried out in both community and hospital-based pharmacies included pharmaceutical care, efficient and timely management of services, information and education, psychological support, pharmacovigilance and telepharmacy. Processes implemented and activities carried out essentially in community pharmacies were those related to the detection recommendations, and drug indications. Finally, processes and activities essentially occurring in hospital pharmacies included those related to participation in drug treatment research, drug evaluation and guidelines development, and to managing off-label drugs. CONCLUSIONS: During the COVID‑19 crisis, pharmacists have led and implemented processes aimed at mitigating the impact of the pandemic on the population´s health. Pharmaceutical care, efficient and timely management of services, information and education, psychological support, pharmacovigilance and telepharmacy, both in community and hospital pharmacies, are the main processes implemented by pharmacists during the COVID‑19 pandemic. These processes and activities, in addition to contributing to the control, prevention and effective and safe treatment of COVID‑19; have ensured the implementation of biosecurity measures, proper dispensing of medication, the drug rational use, and the provision of evidence- based information and education.
CI - Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
FAU - Amariles, Pedro
AU - Amariles P
AD - Grupo de Investigación, Promoción y Prevención Farmacéutica. Universidad de Antioquia. Medellín, Colombia.. pedro.amariles@udea.edu.co.
FAU - Monsalve, Mauricio
AU - Monsalve M
AD - Grupo de Investigación, Promoción y Prevención Farmacéutica. Universidad de Antioquia. Medellín, Colombia.. mauricio.monsalve@udea.edu.co.
FAU - Rivera-Cadavid, Mónica
AU - Rivera-Cadavid M
AD - Grupo de Investigación, Promoción y Prevención Farmacéutica. Universidad de Antioquia. Medellín, Colombia.. mpatricia.rivera@udea.edu.co.
FAU - Ceballos, Mauricio
AU - Ceballos M
AD - Grupo de Investigación, Promoción y Prevención Farmacéutica. Universidad de Antioquia. Medellín, Colombia.. javier.ceballos@udea.edu.co.
FAU - Ledezma-Morales, Mónica
AU - Ledezma-Morales M
AD - Grupo de Investigación, Promoción y Prevención Farmacéutica. Universidad de Antioquia. Medellín, Colombia.. monica.ledezma@udea.edu.co.
FAU - Salazar-Ospina, Andrea
AU - Salazar-Ospina A
AD - Grupo de Investigación, Promoción y Prevención Farmacéutica. Universidad de Antioquia. Medellín, Colombia.. andrea.salazaro@udea.edu.co.
LA - eng
PT - Journal Article
PT - Review
TT - Procesos y actividades realizados por el farmacéutico en la pandemia por COVID‑19: Revisión sistemática exploratoria.
DEP - 20220927
PL - Spain
TA - Farm Hosp
JT - Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria
JID - 9440679
SB - IM
MH - Humans
MH - *Community Pharmacy Services
MH - *COVID-19
MH - Pandemics
MH - *Pharmacies
MH - Pharmacists
MH - United States
EDAT- 2022/12/16 06:00
MHDA- 2022/12/20 06:00
CRDT- 2022/12/15 12:13
PHST- 2022/12/15 12:13 [entrez]
PHST- 2022/12/16 06:00 [pubmed]
PHST- 2022/12/20 06:00 [medline]
PST - epublish
SO - Farm Hosp. 2022 Sep 27;46(6):350-358.
PMID- 21077698
OWN - NLM
STAT- MEDLINE
DCOM- 20110304
LR - 20211020
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Linking)
VI - 33
IP - 12
DP - 2010 Dec 1
TI - Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.
PG - 1065-79
LID - 10.2165/11539040-000000000-00000 [doi]
AB - As a contribution to the debate on how best to communicate information on the effective and safe use of medicines to patients, healthcare professionals and the general public, this article proposes to distinguish between communication and transparency purposes, and to test a strategic health communication approach. Any organization aiming to improve medicines use could adapt this approach to its remits and legal obligations. The approach includes agreeing measurable communication objectives through shared problem ownership of all concerned parties, evidence-based design and a cyclic process for planning, implementation and evaluation of communication as a public health intervention. The evidence base, which supplements risk assessment for product- and situation-specific communication on safety concerns, would be derived from research into drug utilization, medical decision making and risk perception, as well as from the participation of patients and healthcare professionals. It is crucial to address the practical questions and concerns of medicine users and to find out why unfavourable patterns of medicine use persist, in order to develop behaviour change models for overcoming these obstacles. For this purpose, appropriate models for facilitating the participation of medicine users in the risk management process will need to be explored. Such two-way communication would inform risk assessment as well as the analysis of risk minimization options, allow for agreement upon communication objectives and enable understandable, attractive communication materials to be designed. The communication programme should use mixed media and repetition of messages for long-term success. This would require cooperation within healthcare and medical information systems. An evaluation of the effectiveness of the communication should support the sustainability of the programme and provide lessons for the future. Given its mission, the pharmacovigilance community has the standing and duty to expand its scale of action and take the initiative in advancing risk management through a scientific approach to improving public communication for the safety of patients.
FAU - Bahri, Priya
AU - Bahri P
AD - European Medicines Agency, London, UK. priya.bahri@ema.europa.eu
LA - eng
PT - Journal Article
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - *Drug Information Services
MH - *Drug-Related Side Effects and Adverse Reactions
MH - Evidence-Based Practice
MH - Health Communication/*methods
MH - Humans
MH - Organizational Objectives
MH - Pharmacoepidemiology/*education
MH - *Product Surveillance, Postmarketing
MH - Professional Role
EDAT- 2010/11/17 06:00
MHDA- 2011/03/05 06:00
CRDT- 2010/11/17 06:00
PHST- 2010/11/17 06:00 [entrez]
PHST- 2010/11/17 06:00 [pubmed]
PHST- 2011/03/05 06:00 [medline]
AID - 3 [pii]
AID - 10.2165/11539040-000000000-00000 [doi]
PST - ppublish
SO - Drug Saf. 2010 Dec 1;33(12):1065-79. doi: 10.2165/11539040-000000000-00000.
PMID- 27558545
OWN - NLM
STAT- MEDLINE
DCOM- 20171128
LR - 20210109
IS - 1365-2125 (Electronic)
IS - 0306-5251 (Print)
IS - 0306-5251 (Linking)
VI - 83
IP - 2
DP - 2017 Feb
TI - The value of patient reporting to the pharmacovigilance system: a systematic review.
PG - 227-246
LID - 10.1111/bcp.13098 [doi]
AB - AIMS: Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. METHODS: A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid and the Cochrane Library. Studies were included if they contained: (i) reviews about patient reporting; (ii) evaluation of patient reports to national or supranational pharmacovigilance authorities; (iii) a comparison between patient and healthcare professional (HCP) reports submitted to pharmacovigilance authorities; and (iv) surveys of patient experiences, opinions and awareness about reporting ADRs. The methodological quality of the studies was assessed according to principles of Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTS: A total of thirty four studies were included. Five of the studies were reviews (two of which systematic reviews), fourteen retrospective observational studies, nine surveys and six applied mixed research methods. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with HCP reporting. In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is relatively rare in most countries. CONCLUSIONS: Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting.
CI - © 2016 The British Pharmacological Society.
FAU - Inácio, Pedro
AU - Inácio P
AUID- ORCID: 0000-0002-6541-8112
AD - Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
FAU - Cavaco, Afonso
AU - Cavaco A
AD - iMed.ULisboa Research Institute for Medicines and Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.
FAU - Airaksinen, Marja
AU - Airaksinen M
AD - Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
LA - eng
PT - Journal Article
PT - Review
PT - Systematic Review
DEP - 20161012
PL - England
TA - Br J Clin Pharmacol
JT - British journal of clinical pharmacology
JID - 7503323
SB - IM
MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH - Health Personnel/statistics & numerical data
MH - Humans
MH - Patient Participation
MH - *Pharmacovigilance
MH - Self Report
PMC - PMC5237689
OTO - NOTNLM
OT - adverse drug reaction reporting systems
OT - drug monitoring
OT - drug-related side effects and adverse reactions
OT - patients
OT - pharmacovigilance
EDAT- 2016/08/26 06:00
MHDA- 2017/11/29 06:00
CRDT- 2016/08/26 06:00
PHST- 2016/02/02 00:00 [received]
PHST- 2016/08/07 00:00 [revised]
PHST- 2016/08/15 00:00 [accepted]
PHST- 2016/08/26 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
PHST- 2016/08/26 06:00 [entrez]
AID - BCP13098 [pii]
AID - 10.1111/bcp.13098 [doi]
PST - ppublish
SO - Br J Clin Pharmacol. 2017 Feb;83(2):227-246. doi: 10.1111/bcp.13098. Epub 2016 Oct 12.
PMID- 37231322
OWN - NLM
STAT- MEDLINE
DCOM- 20230621
LR - 20230624
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Print)
IS - 0114-5916 (Linking)
VI - 46
IP - 7
DP - 2023 Jul
TI - The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed.
PG - 619-623
LID - 10.1007/s40264-023-01313-4 [doi]
FAU - Younus, Manal M
AU - Younus MM
AUID- ORCID: 0000-0001-9475-5700
AD - Iraqi Pharmacovigilance Center, Ministry of Health, Baghdad, Iraq.
AD - International Society of Pharmacovigilance Patient Engagement Special Interest Group, London, UK.
FAU - Alkhakany, Mayada
AU - Alkhakany M
AUID- ORCID: 0000-0002-1634-2246
AD - International Society of Pharmacovigilance Patient Engagement Special Interest Group, London, UK.
AD - Healthcare Affair, Boehringer Ingelheim, Dubai, United Arab Emirates.
FAU - Bahri, Priya
AU - Bahri P
AUID- ORCID: 0000-0002-7798-6117
AD - International Society of Pharmacovigilance (ISoP)-Special Interest Group on Medicinal Product Risk Communication, European Medicines Agency, Pharmacovigilance Office, Amsterdam, The Netherlands.
FAU - Caro, Angela
AU - Caro A
AUID- ORCID: 0000-0001-9773-7188
AD - International Society of Pharmacovigilance (ISoP), Pharmacy Career Director of Pontificia Universidad Javeriana, Bogotá, Colombia.
FAU - Rostom, Hadir
AU - Rostom H
AUID- ORCID: 0000-0003-3872-0540
AD - International Society of Pharmacovigilance (ISoP)-Egypt Chapter, Cairo, Egypt.
AD - Faculty of Pharmacy, MSA University, 6th of October City, Giza, Egypt.
FAU - Ndagije, Helen Byomire
AU - Ndagije HB
AUID- ORCID: 0000-0001-5802-4791
AD - National Drug Authority, Directorate of Product Safety, Kampala, Uganda.
FAU - Elhawary, Mohamed A
AU - Elhawary MA
AUID- ORCID: 0000-0002-4043-6867
AD - Egyptian Ministry of Health and Population, Central Administration for Pharmaceutical Affairs, Cairo, Egypt. mohamed.ahmed.elhawary19@gmail.com.
AD - Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. mohamed.ahmed.elhawary19@gmail.com.
LA - eng
PT - Journal Article
DEP - 20230525
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - Humans
MH - *Pharmacovigilance
MH - Patient Participation
MH - *Drug-Related Side Effects and Adverse Reactions
PMC - PMC10212217
COIS- Not applicable.
EDAT- 2023/05/26 01:05
MHDA- 2023/06/21 06:42
CRDT- 2023/05/25 23:34
PHST- 2023/04/19 00:00 [accepted]
PHST- 2023/06/21 06:42 [medline]
PHST- 2023/05/26 01:05 [pubmed]
PHST- 2023/05/25 23:34 [entrez]
AID - 10.1007/s40264-023-01313-4 [pii]
AID - 1313 [pii]
AID - 10.1007/s40264-023-01313-4 [doi]
PST - ppublish
SO - Drug Saf. 2023 Jul;46(7):619-623. doi: 10.1007/s40264-023-01313-4. Epub 2023 May 25.
PMID- 12608885
OWN - NLM
STAT- MEDLINE
DCOM- 20030708
LR - 20181113
IS - 0114-5916 (Print)
IS - 0114-5916 (Linking)
VI - 26
IP - 4
DP - 2003
TI - Consumer adverse drug reaction reporting: a new step in pharmacovigilance?
PG - 211-7
AB - The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the world. The potential contribution of patient reports of adverse drug reactions is discussed, both in terms of their qualitative and quantitative contribution. The crucial question is one of whether patient reports will increase the number and quality of the reports submitted and/or lead to a more timely detection of signals of possible adverse reactions, thus contributing to an enhancement of the existing methods of drug safety monitoring. To date, the data available are insufficient to establish such added value.
FAU - van Grootheest, Kees
AU - van Grootheest K
AD - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands. ac.vangrootheest@lareb.nl
FAU - de Graaf, Linda
AU - de Graaf L
FAU - de Jong-van den Berg, Lolkje T W
AU - de Jong-van den Berg LT
LA - eng
PT - Journal Article
PT - Review
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - Adverse Drug Reaction Reporting Systems/*trends
MH - Animals
MH - Community Participation/*methods/*trends
MH - Humans
RF - 25
EDAT- 2003/03/01 04:00
MHDA- 2003/07/09 05:00
CRDT- 2003/03/01 04:00
PHST- 2003/03/01 04:00 [pubmed]
PHST- 2003/07/09 05:00 [medline]
PHST- 2003/03/01 04:00 [entrez]
AID - 260401 [pii]
AID - 10.2165/00002018-200326040-00001 [doi]
PST - ppublish
SO - Drug Saf. 2003;26(4):211-7. doi: 10.2165/00002018-200326040-00001.
PMID- 29573274
OWN - NLM
STAT- MEDLINE
DCOM- 20190924
LR - 20210109
IS - 1365-2125 (Electronic)
IS - 0306-5251 (Print)
IS - 0306-5251 (Linking)
VI - 84
IP - 8
DP - 2018 Aug
TI - Listen to the public and fulfil their information interests - translating vaccine communication research findings into guidance for regulators.
PG - 1696-1705
LID - 10.1111/bcp.13587 [doi]
AB - Regulatory authorities have a crucial role in communicating about the vaccines they license. In terms of content and timing, their communication to the public is usually driven by data on quality, safety and efficacy. However, concerns over safety and vaccine hesitancy have emerged in some communities in various countries, and this demands a new approach to communication, starting with listening to the public debate. Reviewing communication research findings, coming in particular from the cognitive, decision-making and media sciences, constitutes one mechanism of listening and has led the European Union (EU) regulatory network to developing guidance about which common concerns and information needs of the public to address through proactive and prepared communication. The guidance has been welcomed by EU and international fora. The current article summarizes the recommendations and shares the underlying research findings, as well as a proof of concept that communication research can be valuable for regulators. It is critical that regulators integrate the communication process with product risk assessment in the framework of pharmacovigilance, to ensure that public concerns are addressed in the assessments and that information about evidence and uncertainty relating to safety is provided to the public and vaccination policy makers in a specific, clear and accurate manner. Additionally, information from regulatory authorities should support healthcare professionals in their communication with patients. Meeting the information interests of the public is the principal prerequisite for informed decisions as well as safe and effective use of vaccines and medicines overall. This is also fundamental for trust in the authorities' commitment to patient and population health.
CI - © 2018 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.
FAU - Bahri, Priya
AU - Bahri P
AUID- ORCID: 0000-0002-7798-6117
AD - Surveillance & Epidemiology Service, Pharmacovigilance Department, European Medicines Agency, London, UK.
FAU - Castillon Melero, Mireia
AU - Castillon Melero M
AD - Surveillance & Epidemiology Service, Pharmacovigilance Department, European Medicines Agency, London, UK.
LA - eng
PT - Journal Article
PT - Review
DEP - 20180531
PL - England
TA - Br J Clin Pharmacol
JT - British journal of clinical pharmacology
JID - 7503323
RN - 0 (Vaccines)
SB - IM
MH - Communication
MH - *Community Participation
MH - *Decision Making
MH - European Union
MH - Guidelines as Topic
MH - Health Personnel
MH - Humans
MH - *Information Dissemination
MH - Vaccination/adverse effects/*legislation & jurisprudence/methods
MH - Vaccines/administration & dosage/adverse effects
PMC - PMC6046478
OTO - NOTNLM
OT - drug regulation
OT - health policy
OT - patient safety
OT - vaccines
EDAT- 2018/03/25 06:00
MHDA- 2019/09/26 06:00
CRDT- 2018/03/25 06:00
PHST- 2017/09/22 00:00 [received]
PHST- 2018/03/05 00:00 [revised]
PHST- 2018/03/13 00:00 [accepted]
PHST- 2018/03/25 06:00 [pubmed]
PHST- 2019/09/26 06:00 [medline]
PHST- 2018/03/25 06:00 [entrez]
AID - BCP13587 [pii]
AID - 10.1111/bcp.13587 [doi]
PST - ppublish
SO - Br J Clin Pharmacol. 2018 Aug;84(8):1696-1705. doi: 10.1111/bcp.13587. Epub 2018 May 31.
PMID- 20635819
OWN - NLM
STAT- MEDLINE
DCOM- 20110421
LR - 20160909
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Linking)
VI - 33
IP - 8
DP - 2010 Aug 1
TI - What do stakeholders think about pharmacovigilance?
PG - 619-21
LID - 10.2165/11539210-000000000-00000 [doi]
FAU - Edwards, I Ralph
AU - Edwards IR
FAU - Graedon, Teresa
AU - Graedon T
LA - eng
PT - Editorial
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
RN - 0 (Pharmaceutical Preparations)
SB - IM
MH - Adverse Drug Reaction Reporting Systems/standards
MH - Drug Industry/methods/*standards
MH - Drug-Related Side Effects and Adverse Reactions
MH - Humans
MH - *Patient Participation/methods
MH - *Pharmaceutical Preparations
MH - *Physician-Patient Relations
MH - Product Surveillance, Postmarketing/methods/standards
EDAT- 2010/07/20 06:00
MHDA- 2011/04/22 06:00
CRDT- 2010/07/20 06:00
PHST- 2010/07/20 06:00 [entrez]
PHST- 2010/07/20 06:00 [pubmed]
PHST- 2011/04/22 06:00 [medline]
AID - 1 [pii]
AID - 10.2165/11539210-000000000-00000 [doi]
PST - ppublish
SO - Drug Saf. 2010 Aug 1;33(8):619-21. doi: 10.2165/11539210-000000000-00000.
PMID- 18631312
OWN - NLM
STAT- MEDLINE
DCOM- 20081016
LR - 20081008
IS - 1365-3156 (Electronic)
IS - 1360-2276 (Linking)
VI - 13
IP - 9
DP - 2008 Sep
TI - Pharmacovigilance of antimalarial treatment in Uganda: community perceptions and suggestions for reporting adverse events.
PG - 1143-52
LID - 10.1111/j.1365-3156.2008.02119.x [doi]
AB - OBJECTIVES: The deployment of new antimalarials in Africa provides an important opportunity to develop systems for pharmacovigilance. To inform strategies for reporting adverse events in Uganda, we investigated local perceptions and experiences with antimalarial treatment, and evaluated existing and potential systems for pharmacovigilance. METHODS: Focus group discussions (FGD) were conducted with community members and health workers from urban and rural Uganda exploring knowledge of fever/malaria, perceptions and expectations of treatment, understanding of adverse effects, and experiences with adverse events. Sessions were recorded, transcribed into English, and analysed using a coding scheme developed from pre-defined topics together with themes emerging from the data. RESULTS: Between April and July 2006, we conducted 25 FGDs; 16 with community members and nine with health workers. All respondents had extensive experience with malaria and its treatment. Community members commonly recognized adverse effects of antimalarial therapy. However, events were uncommonly reported, and certain events were often interpreted as signs of successful treatment. Community members often felt that the costs of reporting or seeking additional care outweighed the potential benefits. Health workers were unfamiliar with formal pathways for reporting, and were deterred by the additional work of reporting and fear of incrimination. Respondents provided suggestions for incentives and methods of reporting, emphasizing that pharmacovigilance should ideally encompass the public and private sector, and the community. CONCLUSIONS: To be successful, pharmacovigilance relying on voluntary reporting will require active participation of patients and health workers. Addressing the costs and benefits of reporting, and providing sensitization, training and feedback will be important.
FAU - Bukirwa, Hasifa
AU - Bukirwa H
AD - Uganda Malaria Surveillance Project, Kampala, Uganda.
FAU - Nayiga, Susan
AU - Nayiga S
FAU - Lubanga, Rosalind
AU - Lubanga R
FAU - Mwebaza, Norah
AU - Mwebaza N
FAU - Chandler, Clare
AU - Chandler C
FAU - Hopkins, Heidi
AU - Hopkins H
FAU - Talisuna, Ambrose O
AU - Talisuna AO
FAU - Staedke, Sarah G
AU - Staedke SG
LA - eng
PT - Journal Article
DEP - 20080708
PL - England
TA - Trop Med Int Health
JT - Tropical medicine & international health : TM & IH
JID - 9610576
RN - 0 (Antimalarials)
SB - IM
MH - Adverse Drug Reaction Reporting Systems
MH - Antimalarials/*adverse effects
MH - Cross-Sectional Studies
MH - Female
MH - Fever/drug therapy
MH - Focus Groups
MH - *Health Knowledge, Attitudes, Practice
MH - Humans
MH - Malaria/*drug therapy/epidemiology
MH - Male
MH - *Patient Acceptance of Health Care
MH - Retrospective Studies
MH - Rural Health
MH - Uganda/epidemiology
MH - Urban Health
EDAT- 2008/07/18 09:00
MHDA- 2008/10/17 09:00
CRDT- 2008/07/18 09:00
PHST- 2008/07/18 09:00 [pubmed]
PHST- 2008/10/17 09:00 [medline]
PHST- 2008/07/18 09:00 [entrez]
AID - TMI2119 [pii]
AID - 10.1111/j.1365-3156.2008.02119.x [doi]
PST - ppublish
SO - Trop Med Int Health. 2008 Sep;13(9):1143-52. doi: 10.1111/j.1365-3156.2008.02119.x. Epub 2008 Jul 8.
PMID- 32670594
OWN - NLM
STAT- PubMed-not-MEDLINE
LR - 20220415
IS - 2052-3211 (Print)
IS - 2052-3211 (Electronic)
IS - 2052-3211 (Linking)
VI - 13
DP - 2020
TI - Tackling the blind spot of poor-quality medicines in Universal Health Coverage.
PG - 40
LID - 10.1186/s40545-020-00208-4 [doi]
LID - 40
AB - BACKGROUND: Universal Health Coverage (UHC) is challenged by the prevalence of poor-quality medicines, those that either do not meet required specifications (substandard) or are outrightly fraudulent (falsified), especially in Low- and Middle-Income Countries, LMICs. Whereas poor-quality medicines are a significant burden in these countries, medicine quality still remains a neglected component of UHC programs. This article describes key barriers to quality medicines and presents five select approaches leveraging the scale-up of UHC for medicine quality assurance. MAIN BODY: Barriers to medicine quality assurance, while numerous, are described in five key inter-related domains as: low political priority, weak regulatory systems capacity, poor access to accredited facilities and licensed outlets, medicine manufacturing and other supply-chain challenges, and lack of public awareness. Five select approaches for leveraging the scale-up of UHC for medicine quality assurance in LMICs are (1): political commitment (2) strengthening the capacity of regulatory authorities and investment in detection technologies as part of national security (3); licensing of medicines outlets and expanding pharmacovigilance (4); strengthening the supply-chain; and (5) public awareness and participation. CONCLUSIONS: Unchecked, poor-quality medicines can jeopardize UHC. National governments in LMICs need to prioritize medicine quality assurance through enforcing policies, regulatory strengthening and investments in technologies. Healthcare facilities and insurance schemes under UHC also play critical roles through incorporating medicine quality assurance into procurement practices and by promoting awareness among beneficiaries. Tackling medicine quality with a committed systems approach will enhance progress towards UHC implementation.
CI - © The Author(s) 2020.
FAU - Orubu, E S F
AU - Orubu ESF
AD - Institute for Health System Innovation & Policy, Boston University, Boston, MA USA. GRID: grid.189504.1. ISNI: 0000 0004 1936 7558
AD - Department of Biomedical Engineering, Boston University, Boston, MA USA. GRID: grid.189504.1. ISNI: 0000 0004 1936 7558
FAU - Ching, C
AU - Ching C
AD - Department of Biomedical Engineering, Boston University, Boston, MA USA. GRID: grid.189504.1. ISNI: 0000 0004 1936 7558
FAU - Zaman, M H
AU - Zaman MH
AD - Department of Biomedical Engineering, Boston University, Boston, MA USA. GRID: grid.189504.1. ISNI: 0000 0004 1936 7558
FAU - Wirtz, V J
AU - Wirtz VJ
AD - Department of Global Health, Boston University School of Public Health, Boston, MA USA. GRID: grid.189504.1. ISNI: 0000 0004 1936 7558
LA - eng
PT - Journal Article
PT - Review
DEP - 20200511
PL - England
TA - J Pharm Policy Pract
JT - Journal of pharmaceutical policy and practice
JID - 101627192
PMC - PMC7350647
OTO - NOTNLM
OT - Falsified
OT - Medicine
OT - Poor-quality
OT - Quality assurance
OT - Substandard
OT - Universal Health Coverage
COIS- Competing interestsThe authors declare that they have no competing interests.
EDAT- 2020/07/17 06:00
MHDA- 2020/07/17 06:01
CRDT- 2020/07/17 06:00
PHST- 2019/11/12 00:00 [received]
PHST- 2020/04/08 00:00 [accepted]
PHST- 2020/07/17 06:00 [entrez]
PHST- 2020/07/17 06:00 [pubmed]
PHST- 2020/07/17 06:01 [medline]
AID - 208 [pii]
AID - 10.1186/s40545-020-00208-4 [doi]
PST - epublish
SO - J Pharm Policy Pract. 2020 May 11;13:40. doi: 10.1186/s40545-020-00208-4. eCollection 2020.
PMID- 15899105
OWN - NLM
STAT- MEDLINE
DCOM- 20050719
LR - 20161124
IS - 0300-7995 (Print)
IS - 0300-7995 (Linking)
VI - 21
IP - 4
DP - 2005 Apr
TI - Post-marketing surveillance: a UK/European perspective.
PG - 565-70
AB - The granting of regulatory approval allows medical practitioners to prescribe a drug in a controlled way to a group of patients defined within the licence. Prior to this, the new product may have been evaluated often in less than 5000 patients and usually in a selected environment in which many patients have been excluded, including for example, women of childbearing potential, the elderly and children. Co-existent disease and the concomitant use of a number of common drug treatments also frequently exclude patients from pre-licensing trials. It is hardly surprising, therefore, that many adverse drug reactions are only detected once the product has been prescribed to the general population. National and international regulatory bodies, therefore, provide systems for post-marketing pharmacosurveillance, although participation in these by clinicians is generally voluntary and under-reporting is widespread. Post-marketing surveillance (PMS) studies are not generally an integral component to launching a new drug and many clinicians are sceptical over data generated in trials which do not conform to the 'gold standard' randomised control trial (RCT) design. However, in dismissing such studies, a great opportunity to obtain information, often from many thousands of subjects, is being missed. This article discusses post-marketing pharmacovigilance and the role of PMS studies in the context of current UK and European legislation.
FAU - Gough, Stephen
AU - Gough S
AD - Division of Medical Sciences, University of Birmingham, Birmingham, UK. s.c.gough@bham.ac.uk
LA - eng
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PT - Review
PL - England
TA - Curr Med Res Opin
JT - Current medical research and opinion
JID - 0351014
SB - IM
CIN - Curr Med Res Opin. 2005 Sep;21(9):1401-2. PMID: 16197658
MH - Drug-Related Side Effects and Adverse Reactions
MH - Europe
MH - Humans
MH - *Product Surveillance, Postmarketing
MH - *Public Policy
MH - Randomized Controlled Trials as Topic
MH - United Kingdom
RF - 22
EDAT- 2005/05/19 09:00
MHDA- 2005/07/20 09:00
CRDT- 2005/05/19 09:00
PHST- 2005/05/19 09:00 [pubmed]
PHST- 2005/07/20 09:00 [medline]
PHST- 2005/05/19 09:00 [entrez]
AID - 10.1185/030079905X41426 [doi]
PST - ppublish
SO - Curr Med Res Opin. 2005 Apr;21(4):565-70. doi: 10.1185/030079905X41426.
PMID- 29921459
OWN - NLM
STAT- MEDLINE
DCOM- 20190927
LR - 20190927
IS - 0040-5957 (Print)
IS - 0040-5957 (Linking)
VI - 73
IP - 6
DP - 2018 Dec
TI - [Satisfaction of a pharmacovigilance declaration support network in general practice].
PG - 483-493
LID - S0040-5957(18)30073-8 [pii]
LID - 10.1016/j.therap.2018.04.003 [doi]
AB - OBJECTIVE: General practitioners (GPs) report little adverse drug reactions (ADR), although it is mandatory in France. The objective was to evaluate the satisfaction of the GPs who participated to a pharmacovigilance ADR declaration support network via a clinical research assistant (CRA) moving to their GP office in the French South-West region of Midi-Pyrénées. STUDY DESIGN: A satisfaction questionnaire was sent to the 59 active GPs of this network in November 2016. RESULTS: A total number of 44 GPs responded to the survey (mean age 44±11years; 48% of women). The overall satisfaction grade was rated 9/10 (SD±1). The personalized help from a CRA was highly appreciated (n=39; 89%), reduced time-loss (n=35; 90%), and facilitated communication with the local pharmacovigilance department (n=33; 85%). Most GP (95%; n=35) stated that they would keep reporting ADRs, 83% (n=35) stated to declare ADRs via the CRA, the others stated to declare ADRs directly to the Regional Pharmacovigilance Center, mainly via numerical or online tools. For 59% (n=26) their participation to the network had a positive impact on their relationship with patients through the improvement of their vigilance to ADR. DISCUSSION: Most of the active GP answered. They were very satisfied of the pharmacovigilance CRA network helping ADR reports. It may corroborate the increase of ADRs reporting in Midi-Pyrénées since this network was set up.
CI - Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.
FAU - Driot, Damien
AU - Driot D
AD - Département universitaire de médecine générale, faculté de médecine de Toulouse, université Paul Sabatier, 133, route de Narbonne, 31062 Toulouse, France. Electronic address: damien.driot@univ-tlse3.fr.
FAU - Figuet, Lucile
AU - Figuet L
AD - Département universitaire de médecine générale, faculté de médecine de Toulouse, université Paul Sabatier, 133, route de Narbonne, 31062 Toulouse, France.
FAU - Birebent, Jordan
AU - Birebent J
AD - Département universitaire de médecine générale, faculté de médecine de Toulouse, université Paul Sabatier, 133, route de Narbonne, 31062 Toulouse, France.
FAU - Coste, Sandra
AU - Coste S
AD - Département universitaire de médecine générale, faculté de médecine de Toulouse, université Paul Sabatier, 133, route de Narbonne, 31062 Toulouse, France.
FAU - Durrieu, Geneviève
AU - Durrieu G
AD - Centre régional Midi-Pyrénées de pharmacovigilance, faculté de médecine de Toulouse, université Paul-Sabatier, 31000 Toulouse, France.
FAU - Jacquot, Julien
AU - Jacquot J
AD - Centre régional Midi-Pyrénées de pharmacovigilance, faculté de médecine de Toulouse, université Paul-Sabatier, 31000 Toulouse, France.
FAU - Bismuth, Michel
AU - Bismuth M
AD - Département universitaire de médecine générale, faculté de médecine de Toulouse, université Paul Sabatier, 133, route de Narbonne, 31062 Toulouse, France.
LA - fre
PT - Journal Article
TT - Satisfaction des médecins généralistes d’un réseau d’aide à la déclaration de pharmacovigilance PharmacoMIP-MG.
DEP - 20180428
PL - France
TA - Therapie
JT - Therapie
JID - 0420544
SB - IM
MH - Adult
MH - *Adverse Drug Reaction Reporting Systems/organization & administration/standards
MH - *Community Networks/organization & administration/standards/statistics & numerical data
MH - Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology
MH - Female
MH - France/epidemiology
MH - General Practice/methods/organization & administration/standards/statistics & numerical data
MH - *General Practitioners/psychology/statistics & numerical data
MH - Humans
MH - Male
MH - Middle Aged
MH - *Personal Satisfaction
MH - *Pharmacovigilance
MH - Primary Health Care/organization & administration/standards/statistics & numerical data
MH - Surveys and Questionnaires
OTO - NOTNLM
OT - Adverse effects
OT - Community networks
OT - Effets indésirables
OT - General practice
OT - Médecine générale
OT - Pharmacovigilance
OT - Primary health care
OT - Réseaux communautaires
OT - Soins de santé primaires
EDAT- 2018/06/21 06:00
MHDA- 2019/09/29 06:00
CRDT- 2018/06/21 06:00
PHST- 2017/11/07 00:00 [received]
PHST- 2018/01/25 00:00 [revised]
PHST- 2018/04/06 00:00 [accepted]
PHST- 2018/06/21 06:00 [pubmed]
PHST- 2019/09/29 06:00 [medline]
PHST- 2018/06/21 06:00 [entrez]
AID - S0040-5957(18)30073-8 [pii]
AID - 10.1016/j.therap.2018.04.003 [doi]
PST - ppublish
SO - Therapie. 2018 Dec;73(6):483-493. doi: 10.1016/j.therap.2018.04.003. Epub 2018 Apr 28.
PMID- 22149419
OWN - NLM
STAT- MEDLINE
DCOM- 20120315
LR - 20220410
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Linking)
VI - 35
IP - 1
DP - 2012 Jan 1
TI - Experiences with adverse drug reaction reporting by patients: an 11-country survey.
PG - 45-60
LID - 10.2165/11594320-000000000-00000 [doi]
AB - BACKGROUND: Patients are important stakeholders in pharmacovigilance; however, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe. If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted. OBJECTIVE: This study aims to review the methods of patient reporting of adverse drug reactions (ADRs) in 11 countries worldwide and to compare different aspects of their experiences. METHODS: A survey based on telephone interviews, e-mail discussions and field visits of existing practices in consumer and patient reporting of ADRs was performed in the second half of 2010. RESULTS: The start dates of the patient reporting schemes vary from 1964 (Australia) to 2010 (Norway). The number of patient reports per country varies widely. Most countries would ideally spend more resources on making the public aware of the possibility that patients can report ADRs. Most countries have three different ways for patients to report ADRs - a paper form, an electronic form on a website or by telephone. The level of sophistication of the electronic forms varies. The route of handling of patients' and healthcare professionals' ADR reports is the same for most countries. Personalized feedback on the reported association for each report is only given by four organizations. All countries have guidelines for the identification of patients in the database and most undertake checks for duplicate reports. In all countries, with the exception of Norway, it is possible to ask patients for follow-up. None of the organizations seek medical confirmation for each patient report. There is a difference between countries that do a causality assessment for each incoming ADR report and countries that only do a causality assessment of reports when they are looking at a potential signal. All countries assess the seriousness of reports, mostly by using the criteria of the CIOMS committee. In all countries, patient reports are used for signal detection purposes and in publications about ADRs. The Netherlands and the UK are actively evaluating their patient reporting schemes. None of the organizations hired additional staff when they started with patient reporting. CONCLUSIONS: This study provides a comprehensive review on the methods used in patient reporting of ADRs. Although there are some differences in the way various countries handle patient reports of ADRs, the importance of giving the public the opportunity to report and the additional scientific value of the collected data is widely recognized by the countries who participated in this survey.
FAU - van Hunsel, Florence
AU - van Hunsel F
AD - Netherlands Pharmacovigilance Centre Lareb, s-Hertogenbosch, the Netherlands. f.vanhunsel@lareb.nl
FAU - Härmark, Linda
AU - Härmark L
FAU - Pal, Shanthi
AU - Pal S
FAU - Olsson, Sten
AU - Olsson S
FAU - van Grootheest, Kees
AU - van Grootheest K
LA - eng
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PT - Review
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - Adverse Drug Reaction Reporting Systems/standards/*statistics & numerical data
MH - *Databases, Factual
MH - Health Surveys
MH - Humans
MH - Patient Participation/methods
EDAT- 2011/12/14 06:00
MHDA- 2012/03/16 06:00
CRDT- 2011/12/14 06:00
PHST- 2011/12/14 06:00 [entrez]
PHST- 2011/12/14 06:00 [pubmed]
PHST- 2012/03/16 06:00 [medline]
AID - 10.2165/11594320-000000000-00000 [doi]
PST - ppublish
SO - Drug Saf. 2012 Jan 1;35(1):45-60. doi: 10.2165/11594320-000000000-00000.
PMID- 19894139
OWN - NLM
STAT- MEDLINE
DCOM- 20100413
LR - 20211020
IS - 1573-739X (Electronic)
IS - 0928-1231 (Linking)
VI - 32
IP - 1
DP - 2010 Feb
TI - Developing a consumer reporting program in Malaysia: a novel initiative to improve pharmacovigilance.
PG - 2-6
LID - 10.1007/s11096-009-9342-8 [doi]
AB - The national pharmacovigilance program in Malaysia is limited to very few centers and under-reporting of adverse drug reactions (ADRs) is a major limitation. Studies from developed countries have documented the importance and usefulness of consumer reporting of ADRs. Involving consumers in ADR reporting can be very useful in improving the reporting rates in Malaysia. The present article highlights the proposed plan of initiating a consumer based pharmacovigilance program in University Wellness Center located inside the campus of the Universiti Sains Malaysia, Penang, Malaysia.
FAU - Palaian, Subish
AU - Palaian S
AD - Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, Penang, Malaysia. subishpalaian@yahoo.co.in
FAU - Alshakka, Mohammed
AU - Alshakka M
FAU - Mohamed Izham
AU - Mohamed Izham
LA - eng
PT - Journal Article
DEP - 20091106
PL - Germany
TA - Pharm World Sci
JT - Pharmacy world & science : PWS
JID - 9307352
SB - IM
MH - Adverse Drug Reaction Reporting Systems/*organization & administration
MH - *Community Participation
MH - Developing Countries
MH - Humans
MH - Malaysia
MH - Pilot Projects
MH - Product Surveillance, Postmarketing/*methods
EDAT- 2009/11/07 06:00
MHDA- 2010/04/14 06:00
CRDT- 2009/11/07 06:00
PHST- 2009/02/04 00:00 [received]
PHST- 2009/10/12 00:00 [accepted]
PHST- 2009/11/07 06:00 [entrez]
PHST- 2009/11/07 06:00 [pubmed]
PHST- 2010/04/14 06:00 [medline]
AID - 10.1007/s11096-009-9342-8 [doi]
PST - ppublish
SO - Pharm World Sci. 2010 Feb;32(1):2-6. doi: 10.1007/s11096-009-9342-8. Epub 2009 Nov 6.
PMID- 36467063
OWN - NLM
STAT- PubMed-not-MEDLINE
LR - 20221206
IS - 1663-9812 (Print)
IS - 1663-9812 (Electronic)
IS - 1663-9812 (Linking)
VI - 13
DP - 2022
TI - Patients' perception of the pharmacovigilance system: A pre-diagnostic and post-interventional cross-sectional survey.
PG - 936124
LID - 10.3389/fphar.2022.936124 [doi]
LID - 936124
AB - Background and objective: The risk of adverse reactions necessitated the pharmacovigilance system for patient safety. A literature search documented better health literacy of patients through intervention. This investigation aims to assess the perception and the effect of an intervention on patients regarding adverse reactions caused by drugs. Methods: A pre-diagnostic and post-interventional cross-sectional investigation was designed with a sample size of 423 patients in hospitals of Islamabad. The proportion of patients was selected based on a stratified probability technique. A prevalidated tool was used to collect the response twice through a health promotion brochure with counseling, which was applied as an intervention. Results: The outcome of the investigation revealed that the prerequisite of the pharmacovigilance center in the hospital among respondents was improved significantly by 41.2% after intervention. Knowledge, communication, and practice were significantly different with respect to gender. There was a moderate Pearson correlation between diagnostic and interventional responses of patient's knowledge of adverse reactions by drugs (r = 0.66, p < 0.01) and patient's communication in pharmacovigilance (r = 0.62, p < 0.01) and a strong correlation between diagnostic and interventional responses of patient's practice in the pharmacovigilance system (r = 0.72, p < 0.01). Conclusion: The finding of the investigation provided evidence that patient awareness was significantly improved by the health promotion model. Patient participation in the reporting of adverse reactions of drugs will complement the hospital staff reporting. These reports will construct an authentic, cross-checked database for rational drug safety practices in Pakistan.
CI - Copyright © 2022 Rehman, Khalid, Zakar, Hani, Zakria Zakar and Fischer.
FAU - Rehman, Atta Ur
AU - Rehman AU
AD - Health Services Academy, Quaid e Azam University, Islamabad, Pakistan.
AD - Department of Public Health, Institute of Social and Cultural Studies, University of the Punjab, Lahore, Pakistan.
FAU - Khalid, Samina Naeem
AU - Khalid SN
AD - Health Services Academy, Quaid e Azam University, Islamabad, Pakistan.
FAU - Zakar, Rubeena
AU - Zakar R
AD - Department of Public Health, Institute of Social and Cultural Studies, University of the Punjab, Lahore, Pakistan.
FAU - Hani, Ume
AU - Hani U
AD - Holy Family Hospital, Rawalpindi Medical University, Rawalpindi, Pakistan.
FAU - Zakria Zakar, Muhammad
AU - Zakria Zakar M
AD - Vice Chancellor Office, University of Poonch, Rawalakot, Pakistan.
FAU - Fischer, Florian
AU - Fischer F
AD - Institute of Public Health, Charité-Universitätsmedizin Berlin, Berlin, Germany.
LA - eng
PT - Journal Article
DEP - 20221117
PL - Switzerland
TA - Front Pharmacol
JT - Frontiers in pharmacology
JID - 101548923
PMC - PMC9712721
OTO - NOTNLM
OT - health promotion
OT - intervention
OT - patients
OT - perception
OT - pharmacovigilance
COIS- The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
EDAT- 2022/12/06 06:00
MHDA- 2022/12/06 06:01
CRDT- 2022/12/05 04:17
PHST- 2022/05/04 00:00 [received]
PHST- 2022/10/11 00:00 [accepted]
PHST- 2022/12/05 04:17 [entrez]
PHST- 2022/12/06 06:00 [pubmed]
PHST- 2022/12/06 06:01 [medline]
AID - 936124 [pii]
AID - 10.3389/fphar.2022.936124 [doi]
PST - epublish
SO - Front Pharmacol. 2022 Nov 17;13:936124. doi: 10.3389/fphar.2022.936124. eCollection 2022.
PMID- 21507783
OWN - NLM
STAT- MEDLINE
DCOM- 20110926
LR - 20110421
IS - 1878-6847 (Electronic)
IS - 0924-6479 (Linking)
VI - 23
IP - 1
DP - 2011
TI - The involvement of Pharmacovigilance Centres in medication errors detection: a questionnaire-based analysis.
PG - 17-29
LID - 10.3233/JRS-2011-0513 [doi]
AB - OBJECTIVES: This study assesses the ability of Pharmacovigilance Centres (PVCs) to detect medication errors (ME) and to proceed to building Patient Safety (PS) via their information networks and to underline the limits for this challenge. METHODS: This was an exploratory study conducted in PVCs members of the World Health Organization International Drug Monitoring network. A questionnaire specifically designed for the needs of the study was sent to a network via a confidential email system. The questionnaire asked for information, progress and improvement made by PVCs in PS and ME. RESULTS: Among the 88 countries, 21 answered. Reporting of Adverse Drug Reactions (ADRs) by health care professionals (HCP) is mandatory for 42% of PVCs. 100% of countries receive reports from HCP, 66% from patients and 24% from PCCs. ADRs reports are received by all communications means. There is an heterogeneity between countries regarding PVCs and PS activities. Among them, 4 PVCs have the prime activity of PS organization. CONCLUSION: PVCs are able to detect and analyze ME. There is a need to coordinate efforts between countries to optimize ME detection, and its analysis. Bridges need to be built linking PVCs, PCCs and PS organizations in order to avoid duplication of workload.
FAU - Benabdallah, Ghita
AU - Benabdallah G
AD - Moroccan Poison Control and Pharmacovigilance Centre, Rabat, Morocco. ritabenabdallah@gmail.com
FAU - Benkirane, Raja
AU - Benkirane R
FAU - Khattabi, Asmae
AU - Khattabi A
FAU - Edwards, I Ralph
AU - Edwards IR
FAU - Bencheikh, Rachida Soulaymani
AU - Bencheikh RS
LA - eng
PT - Journal Article
PL - Netherlands
TA - Int J Risk Saf Med
JT - The International journal of risk & safety in medicine
JID - 9100907
SB - IM
MH - Adverse Drug Reaction Reporting Systems/*standards
MH - Computer Communication Networks/*organization & administration
MH - Drug Monitoring/*methods
MH - Drug and Narcotic Control/*organization & administration
MH - Humans
MH - International Cooperation
MH - Mandatory Reporting
MH - Medication Errors/*prevention & control
MH - Patient Participation
MH - Poison Control Centers/organization & administration
MH - Self Report
MH - World Health Organization
EDAT- 2011/04/22 06:00
MHDA- 2011/09/29 06:00
CRDT- 2011/04/22 06:00
PHST- 2011/04/22 06:00 [entrez]
PHST- 2011/04/22 06:00 [pubmed]
PHST- 2011/09/29 06:00 [medline]
AID - 1616N43U375W2464 [pii]
AID - 10.3233/JRS-2011-0513 [doi]
PST - ppublish
SO - Int J Risk Saf Med. 2011;23(1):17-29. doi: 10.3233/JRS-2011-0513.
PMID- 33146896
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR - 20211124
IS - 1099-1557 (Electronic)
IS - 1053-8569 (Linking)
VI - 29
IP - 12
DP - 2020 Dec
TI - Incorporating patient generated health data into pharmacoepidemiological research.
PG - 1540-1549
LID - 10.1002/pds.5169 [doi]
AB - Epidemiology and pharmacoepidemiology frequently employ Real-World Data (RWD) from healthcare teams to inform research. These data sources usually include signs, symptoms, tests, and treatments, but may lack important information such as the patient's diet or adherence or quality of life. By harnessing digital tools a new fount of evidence, Patient (or Citizen/Person) Generated Health Data (PGHD), is becoming more readily available. This review focusses on the advantages and considerations in using PGHD for pharmacoepidemiological research. New and corroborative types of data can be collected directly from patients using digital devices, both passively and actively. Practical issues such as patient engagement, data linking, validation, and analysis are among important considerations in the use of PGHD. In our ever increasingly patient-centric world, PGHD incorporated into more traditional Real-Word data sources offers innovative opportunities to expand our understanding of the complex factors involved in health and the safety and effectiveness of disease treatments. Pharmacoepidemiologists have a unique role in realizing the potential of PGHD by ensuring that robust methodology, governance, and analytical techniques underpin its use to generate meaningful research results.
CI - © 2020 John Wiley & Sons Ltd.
FAU - Bourke, Alison
AU - Bourke A
AUID- ORCID: 0000-0002-0005-9016
AD - Real World Solutions, IQVIA, London, UK.
FAU - Dixon, William G
AU - Dixon WG
AD - Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, UK.
FAU - Roddam, Andrew
AU - Roddam A
AD - Data & Computational Sciences, GSK, London, UK.
FAU - Lin, Kueiyu Joshua
AU - Lin KJ
AD - Brigham and Women's & Department of Medicine, Boston, Massachusetts, USA.
FAU - Hall, Gillian C
AU - Hall GC
AUID- ORCID: 0000-0002-6357-1770
AD - Gillian Hall Epidemiology Ltd, London, UK.
FAU - Curtis, Jeffrey R
AU - Curtis JR
AD - Division of Clinical Immunology & Rheumatology, The University of Birmingham, Birmingham, Alabama, USA.
FAU - van der Veer, Sabine N
AU - van der Veer SN
AD - Centre for Health Informatics, Division of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
FAU - Soriano-Gabarró, Montse
AU - Soriano-Gabarró M
AD - Bayer AG, Berlin, Germany.
FAU - Mills, Juliane K
AU - Mills JK
AD - PRA Health Sciences, Raleigh, North Carolina, USA.
FAU - Major, Jacqueline M
AU - Major JM
AD - Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Verstraeten, Thomas
AU - Verstraeten T
AD - P95 Pharmacovigilance and Epidemiology, Leuven, Belgium.
FAU - Francis, Matthew J
AU - Francis MJ
AD - The Procter & Gamble Company, Cincinnati, Ohio, USA.
FAU - Bartels, Dorothee B
AU - Bartels DB
AD - UCB Pharma, Anderlecht, Belgium.
LA - eng
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PT - Review
DEP - 20201113
PL - England
TA - Pharmacoepidemiol Drug Saf
JT - Pharmacoepidemiology and drug safety
JID - 9208369
SB - IM
MH - Humans
MH - *Patient Generated Health Data
MH - Patient Participation
MH - *Pharmacoepidemiology
MH - Quality of Life
OTO - NOTNLM
OT - big data
OT - data privacy
OT - digital epidemiology
OT - mobile apps
OT - mobile health
OT - patient generated health data
OT - patient reported outcomes
OT - pharmacoepidemiology
OT - real world data
OT - real world evidence
OT - social media
EDAT- 2020/11/05 06:00
MHDA- 2021/11/25 06:00
CRDT- 2020/11/04 12:15
PHST- 2020/03/12 00:00 [received]
PHST- 2020/09/17 00:00 [revised]
PHST- 2020/10/31 00:00 [accepted]
PHST- 2020/11/05 06:00 [pubmed]
PHST- 2021/11/25 06:00 [medline]
PHST- 2020/11/04 12:15 [entrez]
AID - 10.1002/pds.5169 [doi]
PST - ppublish
SO - Pharmacoepidemiol Drug Saf. 2020 Dec;29(12):1540-1549. doi: 10.1002/pds.5169. Epub 2020 Nov 13.
PMID- 26004569
OWN - NLM
STAT- MEDLINE
DCOM- 20160310
LR - 20220318
IS - 1432-1041 (Electronic)
IS - 0031-6970 (Linking)
VI - 71
IP - 7
DP - 2015 Jul
TI - Are consumers ready to take part in the Pharmacovigilance System?--a Portuguese preliminary study concerning ADR reporting.
PG - 883-90
LID - 10.1007/s00228-015-1867-2 [doi]
AB - BACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.
FAU - Matos, Cristiano
AU - Matos C
AD - Instituto Politécnico de Coimbra, Coimbra Health School-ESTESC, Farmácia, Coimbra, Portugal, cristiano.r.matos@gmail.com.
FAU - van Hunsel, Florence
AU - van Hunsel F
FAU - Joaquim, João
AU - Joaquim J
LA - eng
PT - Journal Article
DEP - 20150526
PL - Germany
TA - Eur J Clin Pharmacol
JT - European journal of clinical pharmacology
JID - 1256165
SB - IM
MH - Adolescent
MH - Adult
MH - *Adverse Drug Reaction Reporting Systems
MH - Aged
MH - Chi-Square Distribution
MH - *Community Participation
MH - Consumer Behavior
MH - Consumer Health Information
MH - Drug-Related Side Effects and Adverse Reactions/diagnosis/*etiology
MH - Female
MH - Health Care Surveys
MH - *Health Knowledge, Attitudes, Practice
MH - Humans
MH - Interviews as Topic
MH - Male
MH - Middle Aged
MH - Motivation
MH - *Pharmacovigilance
MH - Portugal
MH - *Public Opinion
MH - Severity of Illness Index
MH - Surveys and Questionnaires
MH - Volition
MH - Young Adult
EDAT- 2015/05/26 06:00
MHDA- 2016/03/11 06:00
CRDT- 2015/05/26 06:00
PHST- 2015/01/27 00:00 [received]
PHST- 2015/05/12 00:00 [accepted]
PHST- 2015/05/26 06:00 [entrez]
PHST- 2015/05/26 06:00 [pubmed]
PHST- 2016/03/11 06:00 [medline]
AID - 10.1007/s00228-015-1867-2 [doi]
PST - ppublish
SO - Eur J Clin Pharmacol. 2015 Jul;71(7):883-90. doi: 10.1007/s00228-015-1867-2. Epub 2015 May 26.
PMID- 23715802
OWN - NLM
STAT- MEDLINE
DCOM- 20140313
LR - 20220129
IS - 1527-974X (Electronic)
IS - 1067-5027 (Print)
IS - 1067-5027 (Linking)
VI - 21
IP - e1
DP - 2014 Feb
TI - Views of healthcare professionals to linkage of routinely collected healthcare data: a systematic literature review.
PG - e6-10
LID - 10.1136/amiajnl-2012-001575 [doi]
AB - OBJECTIVE: To review the literature on the views of healthcare professionals to the linkage of healthcare data and to identify any potential barriers and/or facilitators to participation in a data linkage system. METHODS: Published papers describing the views of healthcare professionals (HCPs) to data sharing and linkage were identified by searches of Medline, EMBASE, SCOPUS, CINAHL, and PsychINFO. The searches were limited to papers published in the English language from 2001 to 2011. RESULTS: A total of 2917 titles were screened. From these, 18 papers describing the views of HCPs about data linkage or data sharing of routinely collected healthcare data at an individual patient level were included. Views were generally positive, and potential benefits were reported. Facilitators included having trust in the system including data governance, reliability, and feedback. Some negative views, identified as barriers were also expressed including costs, data governance, technical issues, and privacy concerns. Effects on the physician-patient relationship, and workload were also identified as deterrent. DISCUSSION: From the published literature included in this review, the views of HCPs were in general positive towards data sharing for public health purposes. The identification of barriers to contributing to a data linkage system allows these to be addressed in a planned data linkage project for pharmacovigilance. The main barriers identified were concerns about costs, governance and interference with the prescriber-patient relationship. These would have to be addressed if healthcare professionals are to support a data linkage system to improve patient safety.
FAU - Hopf, Y M
AU - Hopf YM
AD - Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK.
FAU - Bond, C
AU - Bond C
FAU - Francis, J
AU - Francis J
FAU - Haughney, J
AU - Haughney J
FAU - Helms, P J
AU - Helms PJ
LA - eng
GR - ARPG/07/04/CSO_/Chief Scientist Office/United Kingdom
GR - ARPG/07/4/CSO_/Chief Scientist Office/United Kingdom
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PT - Review
PT - Systematic Review
DEP - 20130528
PL - England
TA - J Am Med Inform Assoc
JT - Journal of the American Medical Informatics Association : JAMIA
JID - 9430800
SB - IM
MH - *Attitude of Health Personnel
MH - Drug-Related Side Effects and Adverse Reactions
MH - Electronic Health Records
MH - *Health Personnel
MH - Humans
MH - *Information Dissemination
MH - *Medical Record Linkage
PMC - PMC3957379
OTO - NOTNLM
OT - data linkage
OT - pharmacovigilance
OT - routine data
EDAT- 2013/05/30 06:00
MHDA- 2014/03/14 06:00
CRDT- 2013/05/30 06:00
PHST- 2013/05/30 06:00 [entrez]
PHST- 2013/05/30 06:00 [pubmed]
PHST- 2014/03/14 06:00 [medline]
AID - amiajnl-2012-001575 [pii]
AID - 10.1136/amiajnl-2012-001575 [doi]
PST - ppublish
SO - J Am Med Inform Assoc. 2014 Feb;21(e1):e6-10. doi: 10.1136/amiajnl-2012-001575. Epub 2013 May 28.
PMID- 25190178
OWN - NLM
STAT- MEDLINE
DCOM- 20150915
LR - 20211021
IS - 2210-7711 (Electronic)
VI - 36
IP - 5
DP - 2014 Oct
TI - Pharmacovigilance: empowering healthcare professionals and patients.
PG - 859-62
LID - 10.1007/s11096-014-0004-0 [doi]
AB - The European Union has thoroughly reformed its pharmacovigilance legislation in July 2012. Despite the changes, underreporting of adverse drug reactions remains a concern. This underreporting seems to be partially associated with incorrect customs and beliefs by healthcare professionals. Therefore, strengthening teaching and training in drug safety monitoring and reporting are essential. Sustained campaigns and education on pharmacovigilance are key elements to enhance its performance and effectiveness. In general, all healthcare professionals as well as patients should be more sensitized and empowered to contribute to pharmacovigilance programmes in order to improve drug safety.
FAU - Steurbaut, Stephane
AU - Steurbaut S
AD - Department of Clinical Pharmacology and Pharmacotherapy, UZ Brussel and Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090, Jette, Brussels, Belgium.
FAU - Hanssens, Yolande
AU - Hanssens Y
LA - eng
PT - Journal Article
DEP - 20140905
PL - Netherlands
TA - Int J Clin Pharm
JT - International journal of clinical pharmacy
JID - 101554912
SB - IM
MH - European Union
MH - Health Personnel/*psychology
MH - Humans
MH - *Patient Participation
MH - *Pharmacovigilance
MH - *Power, Psychological
EDAT- 2014/09/06 06:00
MHDA- 2015/09/16 06:00
CRDT- 2014/09/06 06:00
PHST- 2013/02/25 00:00 [received]
PHST- 2014/08/12 00:00 [accepted]
PHST- 2014/09/06 06:00 [entrez]
PHST- 2014/09/06 06:00 [pubmed]
PHST- 2015/09/16 06:00 [medline]
AID - 10.1007/s11096-014-0004-0 [doi]
PST - ppublish
SO - Int J Clin Pharm. 2014 Oct;36(5):859-62. doi: 10.1007/s11096-014-0004-0. Epub 2014 Sep 5.
PMID- 23941932
OWN - NLM
STAT- MEDLINE
DCOM- 20140526
LR - 20181202
IS - 1879-8365 (Electronic)
IS - 0926-9630 (Linking)
VI - 194
DP - 2013
TI - Using patient-reported experiences for pharmacovigilance?
PG - 63-8
AB - Recent international guidelines encourage more prominent placement of patient-generated information about medications on the pharmacovigilance information landscape. Online platforms where patients share medication experiences with one another and with healthcare professionals are one possible avenue to accomplishing this goal. Public reports of medication-related events posted on the web, however, are under-utilized in the pharmacovigilance community. Moreover, little is known about who writes such reviews, what information is shared and how this information can be used by authorities. This paper reports the first results of a study of user and comment characteristics on a European-based platform.
FAU - Adams, Samantha A
AU - Adams SA
AD - Institute of Health Policy and Management, Erasmus University Rotterdam.
LA - eng
PT - Journal Article
PL - Netherlands
TA - Stud Health Technol Inform
JT - Studies in health technology and informatics
JID - 9214582
MH - Crowdsourcing/*statistics & numerical data
MH - Data Mining/*statistics & numerical data
MH - Europe
MH - Humans
MH - Information Dissemination/*methods
MH - Internet/*statistics & numerical data
MH - Netherlands
MH - Patient Participation/*statistics & numerical data
MH - Patient Satisfaction/*statistics & numerical data
MH - *Pharmacovigilance
MH - Web Browser/statistics & numerical data
EDAT- 2013/08/15 06:00
MHDA- 2014/05/27 06:00
CRDT- 2013/08/15 06:00
PHST- 2013/08/15 06:00 [entrez]
PHST- 2013/08/15 06:00 [pubmed]
PHST- 2014/05/27 06:00 [medline]
PST - ppublish
SO - Stud Health Technol Inform. 2013;194:63-8.
PMID- 25627832
OWN - NLM
STAT- MEDLINE
DCOM- 20160125
LR - 20220318
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Linking)
VI - 38
IP - 4
DP - 2015 Apr
TI - ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems.
PG - 337-47
LID - 10.1007/s40264-015-0264-1 [doi]
AB - Consumer reporting of adverse drug reactions (ADRs) has existed in several countries for decades, but throughout Europe the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the EU. Consumer reporting is an integral part of the spontaneous reporting systems in both The Netherlands and Sweden, with yearly numbers of reports constantly increasing. Consumer reporting forms and handling procedures are essentially the same as for healthcare professional reporting; the message in the reports, not the type of messenger, is what is of importance. Studies have established the significant contribution of consumer reporting to ADR signal detection. Combining all reports regardless of reporter type is recommended since it yields the largest critical mass of reports for signal detection. Examples of signals where consumer reports have been of crucial importance for signal detection are electric shock-like sensations associated with the use of duloxetine, and persistent sexual dysfunction after discontinuation of selective serotonin reuptake inhibitors. An example of consumer reporting significantly strengthening a detected signal is Pandemrix(®) (influenza H1N1 vaccine)-induced narcolepsy. Raising public awareness of ADR reporting is important, but time- and resource-consuming. The minimum effort taken should be to passively inform consumers, e.g. via stakeholders' homepages and via drug product information leaflets. Another possibility of reaching out to this target group could be through co-operation with other (non-government) organizations. Information from consumer reports may give a new perspective on ADRs via the consumers' unfiltered experiences. Consumers' views may change the way the benefit-harm balance of drugs is perceived and assessed today, and, being the ultimate users of drugs, consumers could have a relevant influence in the regulatory decision-making processes for drugs. All stakeholders in pharmacovigilance should embrace this new valuable source of information.
FAU - Härmark, Linda
AU - Härmark L
AD - Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre in Pharmacovigilance for Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands, l.harmark@lareb.nl.
FAU - van Hunsel, Florence
AU - van Hunsel F
FAU - Grundmark, Birgitta
AU - Grundmark B
LA - eng
PT - Journal Article
PT - Review
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - *Community Participation
MH - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH - Humans
MH - Netherlands
MH - *Pharmacovigilance
MH - Product Surveillance, Postmarketing/*methods
MH - Sweden
EDAT- 2015/01/30 06:00
MHDA- 2016/01/26 06:00
CRDT- 2015/01/29 06:00
PHST- 2015/01/29 06:00 [entrez]
PHST- 2015/01/30 06:00 [pubmed]
PHST- 2016/01/26 06:00 [medline]
AID - 10.1007/s40264-015-0264-1 [doi]
PST - ppublish
SO - Drug Saf. 2015 Apr;38(4):337-47. doi: 10.1007/s40264-015-0264-1.
PMID- 28924350
OWN - NLM
STAT- PubMed-not-MEDLINE
LR - 20201001
IS - 1176-6336 (Print)
IS - 1178-203X (Electronic)
IS - 1176-6336 (Linking)
VI - 13
DP - 2017
TI - Pharmacovigilance and adverse drug reaction reporting: a perspective of community pharmacists and pharmacy technicians in Sana'a, Yemen.
PG - 1175-1181
LID - 10.2147/TCRM.S140674 [doi]
AB - OBJECTIVE: The aim of this study was to compare the knowledge, attitude and barriers of pharmacy technicians and pharmacists toward pharmacovigilance, adverse drug reactions (ADRs) and ADR reporting in community pharmacies in Yemen. METHODS: This cross-sectional survey was conducted among community pharmacists and pharmacy technicians in the capital of Yemen, Sana'a. A total of 289 community pharmacies were randomly selected. The validated and pilot-tested questionnaire consisted of six sections: demographic data, knowledge about pharmacovigilance, experience with ADR reporting, attitudes toward ADR reporting, and the facilitators to improve ADR reporting. RESULTS: A total of 428 pharmacy technicians and pharmacists were contacted and 179 went on to complete a questionnaire (response rate: 41.8%). Of the 179 respondents, 21 (11.7%) were pharmacists and 158 (88.3%) were pharmacy technicians, of which, 176 (98.3%) were male and 3 (1.7%) were female. The mean age of the respondents was 25.87±2.63 years. There was a significant difference between the pharmacists and pharmacy technicians in terms of knowledge scores (P<0.05). The mean knowledge scores for pharmacists was 3.33±2.852 compared to 0.15±0.666 for pharmacy technicians. With regard to attitudes toward ADR reporting, all pharmacists (100%) showed a positive attitude, while only 43% of pharmacy technicians showed a positive attitude. CONCLUSION: Pharmacists have a significantly better knowledge than pharmacy technicians with regard to pharmacovigilance. More than half of pharmacy technicians showed a negative attitude toward ADR reporting. Therefore, educational interventions and training is very important for community pharmacists and pharmacy technicians in Yemen to increase their awareness and participation in ADR reporting.
FAU - Al-Worafi, Yaser Mohammed
AU - Al-Worafi YM
AD - Faculty of Pharmacy, University of Science and Technology, Sana'a, Yemen.
AD - Clinical Pharmacy Department, College of Pharmacy, Ajman University, Ajman, United Arab Emirates.
FAU - Kassab, Yaman Walid
AU - Kassab YW
AD - Hospital and Clinical Pharmacy Department, Faculty of Pharmacy, Cyberjaya University College of Medical Sciences, Selangor, Malaysia.
FAU - Alseragi, Wafa Mohammed
AU - Alseragi WM
AD - Faculty of Arts, Ibb University, Ibb, Yemen.
FAU - Almutairi, Masaad Saeed
AU - Almutairi MS
AD - College of Pharmacy, Qassim University, Qassim, Saudi Arabia.
FAU - Ahmed, Ali
AU - Ahmed A
AD - Unit for Medication Outcomes Research and Education (UMORE), Pharmacy, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.
FAU - Ming, Long Chiau
AU - Ming LC
AD - School of Pharmacy, KPJ Healthcare University College, Nilai, Negeri Sembilan, Malaysia.
FAU - Alkhoshaiban, Ali Saleh
AU - Alkhoshaiban AS
AD - College of Medicine, Qassim University, Qassim, Saudi Arabia.
AD - Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia.
FAU - Hadi, Muhammad Abdul
AU - Hadi MA
AD - Leicester School of Pharmacy, De Montfort University, Leicester, UK.
LA - eng
PT - Journal Article
DEP - 20170907
PL - New Zealand
TA - Ther Clin Risk Manag
JT - Therapeutics and clinical risk management
JID - 101253281
PMC - PMC5595359
OTO - NOTNLM
OT - Yemen
OT - adverse drug reactions
OT - attitude
OT - community pharmacy
OT - knowledge
OT - pharmacovigilance
COIS- Disclosure The authors report no conflicts of interest in this work.
EDAT- 2017/09/20 06:00
MHDA- 2017/09/20 06:01
CRDT- 2017/09/20 06:00
PHST- 2017/09/20 06:00 [entrez]
PHST- 2017/09/20 06:00 [pubmed]
PHST- 2017/09/20 06:01 [medline]
AID - tcrm-13-1175 [pii]
AID - 10.2147/TCRM.S140674 [doi]
PST - epublish
SO - Ther Clin Risk Manag. 2017 Sep 7;13:1175-1181. doi: 10.2147/TCRM.S140674. eCollection 2017.
PMID- 23461502
OWN - NLM
STAT- MEDLINE
DCOM- 20140806
LR - 20130306
IS - 2171-8695 (Electronic)
IS - 1130-6343 (Linking)
VI - 37
IP - 1
DP - 2013 Jan-Feb
TI - [Direct reporting by patients of adverse drug reactions in Spain].
PG - 65-71
LID - 10.7399/FH.2013.37.1.121 [doi]
AB - The Spanish Pharmacovigilance System for Medicinal Products for Human Use, integrated by regional centers of pharmacovigilance coordinated by the Spanish Agency for Medicines and Health Products, is responsible for developing the Program of Spontaneous Reporting of Suspected Adverse Drug Reactions in our country. Although, until now, reports were only requesting to health professionals, the current understanding of the role of patients in the clinical setting and the experience gained in other countries of our environment, have demonstrated the convenience of developing active participation systems to patients in the reporting of suspected adverse drug reactions. In addition, this is taking into account in the new European legislation on pharmacovigilance.
CI - Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.
FAU - Esther Salgueiro, M
AU - Esther Salgueiro M
FAU - Jimeno, Francisco J
AU - Jimeno FJ
FAU - Aguirre, Carmelo
AU - Aguirre C
FAU - García, Montserrat
AU - García M
FAU - Ordóñez, Lucía
AU - Ordóñez L
FAU - Manso, Gloria
AU - Manso G
LA - spa
PT - English Abstract
PT - Journal Article
PT - Review
TT - La notificación directa por los pacientes de reacciones adversas a medicamentos en España.
PL - Spain
TA - Farm Hosp
JT - Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria
JID - 9440679
SB - IM
MH - Adverse Drug Reaction Reporting Systems/legislation & jurisprudence/*organization & administration
MH - Drug Labeling/legislation & jurisprudence
MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH - Europe
MH - Government Agencies/economics/legislation & jurisprudence/organization & administration
MH - Humans
MH - Internet
MH - *Patient Participation/legislation & jurisprudence
MH - *Pharmacovigilance
MH - Postal Service
MH - Safety-Based Drug Withdrawals/legislation & jurisprudence
MH - Self Report
MH - Spain/epidemiology
MH - Telephone
MH - World Health Organization
EDAT- 2013/03/07 06:00
MHDA- 2014/08/07 06:00
CRDT- 2013/03/07 06:00
PHST- 2013/03/07 06:00 [entrez]
PHST- 2013/03/07 06:00 [pubmed]
PHST- 2014/08/07 06:00 [medline]
AID - 10.7399/FH.2013.37.1.121 [doi]
PST - ppublish
SO - Farm Hosp. 2013 Jan-Feb;37(1):65-71. doi: 10.7399/FH.2013.37.1.121.
PMID- 23705134
OWN - NLM
STAT- MEDLINE
DCOM- 20140203
LR - 20191112
IS - 1833-3575 (Electronic)
IS - 1833-3583 (Linking)
VI - 41
IP - 3
DP - 2012
TI - Capture and documentation of coded data on adverse drug reactions: an overview.
PG - 27-36
AB - Allergic responses to prescription drugs are largely preventable, and incur significant cost to the community both financially and in terms of healthcare outcomes. The capacity to minimise the effects of repeated events rests predominantly with the reliability of allergy documentation in medical records and computerised physician order entry systems (CPOES) with decision support such as allergy alerts. This paper presents an overview of the nature and extent of adverse drug reactions (ADRs) in Australia and other developed countries, a discussion and evaluation of strategies which have been devised to address this issue, and a commentary on the role of coded data in informing this patient safety issue. It is not concerned with pharmacovigilance systems that monitor ADRs on a global scale. There are conflicting reports regarding the efficacy of these strategies. Although in many cases allergy alerts are effective, lack of sensitivity and contextual relevance can often induce doctors to override alerts. Human factors such as user fatigue and inadequate adverse drug event reporting, including ADRs, are commonplace. The quality of and response to allergy documentation can be enhanced by the participation of nurses and pharmacists, particularly in medication reconciliation. The International Classification of Diseases (ICD) coding of drug allergies potentially yields valuable evidence, but the quality of local and national level coded data is hampered by under-documenting and under-coding.
FAU - Paul, Lindsay
AU - Paul L
AD - School of Public Health, Faculty of Health Sciences, La Trobe University, Bundoora VIC 3086, Australia. lindsay1645@bigpond.com
FAU - Robinson, Kerin M
AU - Robinson KM
LA - eng
PT - Journal Article
PT - Review
PL - Australia
TA - Health Inf Manag
JT - Health information management : journal of the Health Information Management Association of Australia
JID - 9438200
MH - Adverse Drug Reaction Reporting Systems/statistics & numerical data
MH - Australia
MH - Clinical Coding/standards/trends
MH - Documentation/standards
MH - Drug Hypersensitivity/diagnosis/immunology/prevention & control
MH - Drug-Related Side Effects and Adverse Reactions/etiology/immunology/*prevention & control
MH - Electronic Health Records/*standards
MH - Humans
MH - International Classification of Diseases
MH - Medical Order Entry Systems/*organization & administration/standards
MH - Medication Errors/*prevention & control
EDAT- 2012/01/01 00:00
MHDA- 2014/02/04 06:00
CRDT- 2013/05/25 06:00
PHST- 2013/05/25 06:00 [entrez]
PHST- 2012/01/01 00:00 [pubmed]
PHST- 2014/02/04 06:00 [medline]
AID - 10.1177/183335831204100304 [doi]
PST - ppublish
SO - Health Inf Manag. 2012;41(3):27-36. doi: 10.1177/183335831204100304.
PMID- 28758813
OWN - NLM
STAT- MEDLINE
DCOM- 20180613
LR - 20220408
IS - 1473-4877 (Electronic)
IS - 0300-7995 (Linking)
VI - 34
IP - 1
DP - 2018 Jan
TI - Medication safety knowledge, attitudes and practices among community pharmacists in Lebanon.
PG - 149-156
LID - 10.1080/03007995.2017.1361916 [doi]
AB - BACKGROUND: The effectiveness of a national post-marketing surveillance program depends directly on the active participation of all health professionals. There is no current comprehensive and active pharmacovigilance program available in Lebanon. OBJECTIVES: To assess the knowledge, attitudes, and practices (KAP) among community pharmacists in Lebanon with respect to potential pharmacovigilance and adverse-drug-reaction reporting in Lebanon. METHODS: A cross-sectional descriptive study, using a self-administered KAP questionnaire and conducted between March and July 2016, included 1857 pharmacists practicing in community settings. Statistical analysis included χ(2) test for dichotomous or multinomial qualitative variables, and Wilcoxon test for quantitative variables with non-homogeneous variances or non-normal distribution. RESULTS: The majority of responders had good knowledge concerning the concept and purpose of pharmacovigilance as well as adverse drug reactions (how to report these/the importance of reporting adverse events/the definition of an adverse event and pharmacovigilance). Concerning community pharmacists' attitudes and practice towards pharmacovigilance, the majority described having a positive attitude towards their role in adverse drug reaction reporting and this activity was even seen as one of their core duties. The questionnaire revealed a lack of practice and training regarding pharmacovigilance. Nonetheless, the pharmacists agreed on the Order of Pharmacists in Lebanon and the Ministry of Health's role in promoting this practice and helping them be more involved in reporting adverse drug reactions (ADRs). The pharmacists thought that they are well positioned regarding patient-safety practice in their pharmacies and the results were not statistically different between pharmacy employers and employees. CONCLUSION: Lebanese pharmacists have the required knowledge and positive attitude to start reporting ADRs, were aware of ADRs occurring with various medicines post-marketing, yet were currently not able to disseminate this information widely or to record it centrally, emphasizing the importance of establishing a national ADR reporting system.
FAU - Hajj, Aline
AU - Hajj A
AUID- ORCID: 0000-0003-0826-6033
AD - a Laboratoire de Pharmacologie, Pharmacie clinique et Contrôle de Qualité des médicaments, Pôle Technologie- Santé (PTS), Faculty of Pharmacy , Saint-Joseph University , Beirut , Lebanon.
FAU - Hallit, Souheil
AU - Hallit S
AUID- ORCID: 0000-0001-6918-5689
AD - b Saint-Joseph University , School of Pharmacy , Beirut , Lebanon.
AD - c Lebanese University , School of Pharmacy , Beirut , Lebanon.
AD - d Universite Saint-Esprit Kaslik , Faculty of Medicine , Kaslik , Lebanon.
AD - e Psychiatric Hospital of the Cross , Jal Eddib , Lebanon.
FAU - Ramia, Elsy
AU - Ramia E
AUID- ORCID: 0000-0001-6447-4377
AD - f Lebanese American University , School of Pharmacy , Byblos , Lebanon.
FAU - Salameh, Pascale
AU - Salameh P
AUID- ORCID: 0000-0002-4780-0772
AD - c Lebanese University , School of Pharmacy , Beirut , Lebanon.
AD - g Lebanese University , Faculty of Medicine , Beirut , Lebanon.
CN - Order of Pharmacists Scientific Committee – Medication Safety Subcommittee
LA - eng
PT - Journal Article
DEP - 20170830
PL - England
TA - Curr Med Res Opin
JT - Current medical research and opinion
JID - 0351014
SB - IM
MH - Adult
MH - Adverse Drug Reaction Reporting Systems
MH - Attitude of Health Personnel
MH - *Community Pharmacy Services
MH - Cross-Sectional Studies
MH - *Drug-Related Side Effects and Adverse Reactions
MH - Female
MH - *Health Knowledge, Attitudes, Practice
MH - Humans
MH - Lebanon
MH - Male
MH - Middle Aged
MH - Pharmacists/*statistics & numerical data
MH - Pharmacovigilance
MH - Surveys and Questionnaires
MH - Young Adult
OTO - NOTNLM
OT - Adverse drug effects
OT - community pharmacists
OT - medication safety
OT - pharmacovigilance
EDAT- 2017/08/02 06:00
MHDA- 2018/06/14 06:00
CRDT- 2017/08/01 06:00
PHST- 2017/08/02 06:00 [pubmed]
PHST- 2018/06/14 06:00 [medline]
PHST- 2017/08/01 06:00 [entrez]
AID - 10.1080/03007995.2017.1361916 [doi]
PST - ppublish
SO - Curr Med Res Opin. 2018 Jan;34(1):149-156. doi: 10.1080/03007995.2017.1361916. Epub 2017 Aug 30.
PMID- 20635820
OWN - NLM
STAT- MEDLINE
DCOM- 20110421
LR - 20220330
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Print)
IS - 0114-5916 (Linking)
VI - 33
IP - 8
DP - 2010 Aug 1
TI - Discourse on safe drug use: symbolic logics and ethical aspects.
PG - 623-9
LID - 10.2165/11538320-000000000-00000 [doi]
AB - Drug safety is not a matter for healthcare professionals alone. Patients are also involved, at three different levels: (i) in the behaviours patients adopt to reduce the adverse effects of the drugs; (ii) in regard to what some doctors say to their patients about drug risks; and (iii) in what the pharmaceutical industry says about self-medication and risks. This article will examine these aspects on the basis of information gathered in France during anthropological studies on drug use. (i) Patients' concerns about reducing adverse effects give rise to a series of behaviours relating to drug use. Patients start with the identification of what they regard as a risk inherent in the substances or linked to the uncontrolled use of drugs, and try to neutralize the risk by modifying or modulating the prescriptions in line with various parameters. Dimensions as varied as the nature of the prescribed drugs, the quantity, the dosage and the preservation of certain functions or organs are taken into account, and patients follow their own rules of conduct in order to reduce risks. These dimensions bring into play characteristics of both the drug and the individual, and take into account the effects or the risks of drugs in their physical, psychic, behavioural and social aspects. (ii) Doctors' discourse towards patients regarding the risks and possible effects of drugs is examined, in particular the discourse of those who choose to hide the undesirable effects of drugs from their patients with the aim of not jeopardizing the patient's compliance. This situation involves comparing two logics: ethics of care versus ethics of information. (iii) Regarding the pharmaceutical industry's discourse on self-medication and risks, although on the one hand it promotes self-medication on the basis of patients' growing desire for autonomy and competency, on the other hand it discourages the use of the home medicine cabinet for reasons of safety, which questions the ability of patients to use drugs properly. This article aims to demonstrate that the various behaviours and discourses relating to the risks of drugs are embedded with symbolic, ethical and cultural logics. As a consequence, above and beyond work carried out on the question of pharmacovigilance, examining the issue of safe drug use involves studying the human - social and cultural - aspects that govern part of the behaviours and practices relating to drug safety.
FAU - Fainzang, Sylvie
AU - Fainzang S
AD - CERMES, INSERM (National Institute of Health and Medical Research in France), Paris, France. sylvie.fainzang@orange.fr
LA - eng
PT - Journal Article
PT - Review
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - Drug Industry/*ethics
MH - Drug Therapy/ethics
MH - *Drug-Related Side Effects and Adverse Reactions
MH - Humans
MH - *Patient Participation/methods
MH - Physician-Patient Relations/*ethics
PMC - PMC3168863
MID - HALMS508397
OID - NLM: HALMS508397
EDAT- 2010/07/20 06:00
MHDA- 2011/04/22 06:00
CRDT- 2010/07/20 06:00
PHST- 2010/07/20 06:00 [entrez]
PHST- 2010/07/20 06:00 [pubmed]
PHST- 2011/04/22 06:00 [medline]
AID - 2 [pii]
AID - 10.2165/11538320-000000000-00000 [doi]
PST - ppublish
SO - Drug Saf. 2010 Aug 1;33(8):623-9. doi: 10.2165/11538320-000000000-00000.
PMID- 33739854
OWN - NLM
STAT- MEDLINE
DCOM- 20210805
LR - 20210805
IS - 2687-8941 (Electronic)
IS - 2687-8941 (Linking)
VI - 7
DP - 2021 Mar
TI - Building a Sustainable Comprehensive Multiple Myeloma Program in Western Kenya.
PG - 400-407
LID - 10.1200/GO.20.00572 [doi]
LID - GO.20.00572
AB - Despite improved treatment strategies for multiple myeloma (MM), patient outcomes in low- and middle-income countries remain poor, unlike high-income countries. Scarcity of specialized human resources and diagnostic, treatment, and survivorship infrastructure are some of the barriers that patients with MM, clinicians, and policymakers have to overcome in the former setting. To improve outcomes of patients with MM in Western Kenya, the Academic Model Providing Access to Healthcare (AMPATH) MM Program was set up in 2012. In this article, the program's activities, challenges, and future plans are described distilling important lessons that can be replicated in similar settings. Through the program, training on diagnosis and treatment of MM was offered to healthcare professionals from 35 peripheral health facilities across Western Kenya in 2018 and 2019. Access to antimyeloma drugs including novel agents was secured, and pharmacovigilance systems were developed. Finally, patients were supported to obtain health insurance in addition to receiving peer support through participation in support group meetings. This article provides an implementation blueprint for similar initiatives aimed at increasing access to care for patients with MM in underserved areas.
FAU - Oduor, Mercy A
AU - Oduor MA
AUID- ORCID: 0000-0003-1645-8924
AD - AMPATH Oncology Institute, Eldoret, Kenya.
FAU - Lotodo, Teresa C
AU - Lotodo TC
AD - Moi University, Eldoret, Kenya.
FAU - Vik, Terry A
AU - Vik TA
AD - Moi University, Eldoret, Kenya.
AD - Indiana University School of Medicine, Indianapolis, IN.
FAU - Manyega, Kelvin M
AU - Manyega KM
AUID- ORCID: 0000-0002-2944-6757
AD - AMPATH Oncology Institute, Eldoret, Kenya.
AD - Directorate of Pharmacy & Nutrition, Moi Teaching & Referral Hospital, Eldoret, Kenya.
FAU - Loehrer, Patrick
AU - Loehrer P
AUID- ORCID: 0000-0002-1532-4660
AD - Indiana University School of Medicine, Indianapolis, IN.
FAU - Omondi, Austin A
AU - Omondi AA
AD - AMPATH Oncology Institute, Eldoret, Kenya.
FAU - Oguda, John O
AU - Oguda JO
AD - AMPATH Oncology Institute, Eldoret, Kenya.
AD - Indiana University School of Medicine, Indianapolis, IN.
FAU - Asirwa, Fredrick C
AU - Asirwa FC
AD - International Cancer Institute, Eldoret, Kenya.
LA - eng
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PL - United States
TA - JCO Glob Oncol
JT - JCO global oncology
JID - 101760170
SB - IM
MH - Delivery of Health Care
MH - Humans
MH - Income
MH - Kenya/epidemiology
MH - *Multiple Myeloma/diagnosis/epidemiology/therapy
PMC - PMC8081545
COIS- The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/go/authors/author-center. Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments). TERRY A. VIK: Research Funding: Takeda, Bristol-Myers Squibb Foundation KELVIN M. MANYEGA: Research Funding: Celgene PATRICK LOEHRER: Research Funding: Novartis, Lilly Foundation, Taiho Pharmaceutical Patents, Royalties, Other Intellectual Property: US PPA/61/499,988 Gene Expression Analysis of Thymic Neoplasms Inventors: Sunil Badve, Yesim Gokmen-Polar, Patrick Loehrer FREDRICK C. ASIRWA: Research Funding: Celgene, Takeda, Lilly, Bristol-Myers Squibb, Takeda No other potential conflicts of interest were reported.
EDAT- 2021/03/20 06:00
MHDA- 2021/08/06 06:00
CRDT- 2021/03/19 17:14
PHST- 2021/03/19 17:14 [entrez]
PHST- 2021/03/20 06:00 [pubmed]
PHST- 2021/08/06 06:00 [medline]
AID - GO.20.00572 [pii]
AID - 10.1200/GO.20.00572 [doi]
PST - ppublish
SO - JCO Glob Oncol. 2021 Mar;7:400-407. doi: 10.1200/GO.20.00572.
PMID- 25096955
OWN - NLM
STAT- MEDLINE
DCOM- 20150703
LR - 20211021
IS - 1179-1942 (Electronic)
IS - 0114-5916 (Linking)
VI - 37
IP - 10
DP - 2014 Oct
TI - Pharmacovigilance for a revolving world: prospects of patient-generated data on the internet.
PG - 761-4
LID - 10.1007/s40264-014-0205-4 [doi]
FAU - Norén, G Niklas
AU - Norén GN
AD - Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Box 1051, 751 40, Uppsala, Sweden, niklas.noren@who-umc.org.
LA - eng
PT - Editorial
PT - Research Support, Non-U.S. Gov't
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
SB - IM
MH - Data Collection/*methods
MH - Humans
MH - Internet/*statistics & numerical data
MH - *Patient Participation
MH - *Pharmacovigilance
EDAT- 2014/08/07 06:00
MHDA- 2015/07/04 06:00
CRDT- 2014/08/07 06:00
PHST- 2014/08/07 06:00 [entrez]
PHST- 2014/08/07 06:00 [pubmed]
PHST- 2015/07/04 06:00 [medline]
AID - 10.1007/s40264-014-0205-4 [doi]
PST - ppublish
SO - Drug Saf. 2014 Oct;37(10):761-4. doi: 10.1007/s40264-014-0205-4.
PMID- 28460730
OWN - NLM
STAT- MEDLINE
DCOM- 20170727
LR - 20170727
IS - 1293-8505 (Print)
IS - 1293-8505 (Linking)
VI - 66
IP - 231
DP - 2017 May
TI - [My eReport, an application for the benefit of public health].
PG - 35-36
LID - S1293-8505(17)30092-1 [pii]
LID - 10.1016/j.revinf.2017.02.031 [doi]
AB - Positioning themselves more and more as players in their own health care alongside health professionals, citizens demand reliable, transparent and safe health information. The eVeDrug application now enables them to contribute to the practice of pharmacovigilance by reporting side effects of medication, while also keeping themselves informed of these same effects.
CI - Copyright © 2017 Elsevier Masson SAS. All rights reserved.
FAU - Touche, Claude
AU - Touche C
AD - Institut du cerveau et de la moelle épinière, Hôpital de la Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital, 75013 Paris, France. Electronic address: claude.touche@evedrug.eu.
LA - fre
PT - Journal Article
PT - Review
TT - My eReport(©), une application au service de la santé publique.
PL - France
TA - Rev Infirm
JT - Revue de l'infirmiere
JID - 1267175
MH - *Drug-Related Side Effects and Adverse Reactions
MH - France
MH - Humans
MH - *Mobile Applications
MH - *Patient Participation
MH - Pharmacovigilance
OTO - NOTNLM
OT - adverse effect
OT - application
OT - effet indésirable
OT - medication
OT - médicament
OT - pharmacovigilance
OT - security
OT - sécurité
EDAT- 2017/05/04 06:00
MHDA- 2017/07/28 06:00
CRDT- 2017/05/03 06:00
PHST- 2017/05/03 06:00 [entrez]
PHST- 2017/05/04 06:00 [pubmed]
PHST- 2017/07/28 06:00 [medline]
AID - S1293-8505(17)30092-1 [pii]
AID - 10.1016/j.revinf.2017.02.031 [doi]
PST - ppublish
SO - Rev Infirm. 2017 May;66(231):35-36. doi: 10.1016/j.revinf.2017.02.031.
PMID- 17967159
OWN - NLM
STAT- MEDLINE
DCOM- 20071220
LR - 20191110
IS - 1744-764X (Electronic)
IS - 1474-0338 (Linking)
VI - 6
IP - 6
DP - 2007 Nov
TI - Effect of consumer reporting on signal detection: using disproportionality analysis.
PG - 705-12
AB - Pharmacovigilance objectives and activities are designed to protect the health of consumers and are generally based on data acquisition from spontaneous adverse event reports (SADRs). SADRs come from different sources, including healthcare professionals, consumers, lawyers, other pharmaceutical companies, regulatory agencies and so on. Pharmacovigilance activities derived from SADRs include signal detection and description of the safety profile of the drug. Consumers are the most frequent source of most SADRs, even though the system was originally designed to receive reports from healthcare professionals. Most spontaneous adverse event reports are received from the US. GlaxoSmithKline (GSK) conducts monthly signal detection on all marketed compounds in its global database using disproportionality analysis, the empirical Bayesian algorithm known as a multiple-item gamma-Poisson shrinker. There are no systematic survey data or reviews of actual experiences within existing safety surveillance databases of how pharmaceutical companies handle consumer reports. Thus, a study was undertaken to determine the impact of consumer reports on signal detection using MGPS disproportionality analysis. Two data sets were created for four randomly selected GSK marketed compounds; one data set included reports from both consumer and healthcare providers and the second included only reports from healthcare providers. Disproportionality analysis was then used to evaluate the two data sets. A total of 23 signals were identified with a mean difference in time to signal detection of 1.8 years. The difference was in the range of -8-10 years. In 52.2% of events (12/23), the signal was identified earlier when consumer reports were included in the data. In 34.8% of events (8/23), the signal was identified in the same year in both data sets and, in 13% of the events (3/23), the signal was identified later when consumer reports were included in the data. It was concluded from this study that adverse event reports submitted directly to pharmaceutical companies by consumers can help significantly in the early detection of safety signals.
FAU - Hammond, Isaac W
AU - Hammond IW
AD - GlaxoSmithKline, Global Clinical Safety & Pharmacovigilance, 1250 South Collegeville Road, UP-4340, Collegeville, PA 19426, USA.
FAU - Rich, Donna S
AU - Rich DS
FAU - Gibbs, Trevor G
AU - Gibbs TG
LA - eng
PT - Journal Article
PT - Review
PL - England
TA - Expert Opin Drug Saf
JT - Expert opinion on drug safety
JID - 101163027
SB - IM
MH - Adverse Drug Reaction Reporting Systems
MH - Community Participation/*methods
MH - *Drug-Related Side Effects and Adverse Reactions
MH - Humans
MH - Product Surveillance, Postmarketing/*methods
MH - *Signal Detection, Psychological
RF - 37
EDAT- 2007/10/31 09:00
MHDA- 2007/12/21 09:00
CRDT- 2007/10/31 09:00
PHST- 2007/10/31 09:00 [pubmed]
PHST- 2007/12/21 09:00 [medline]
PHST- 2007/10/31 09:00 [entrez]
AID - 10.1517/14740338.6.6.705 [doi]
PST - ppublish
SO - Expert Opin Drug Saf. 2007 Nov;6(6):705-12. doi: 10.1517/14740338.6.6.705.
PMID- 15268652
OWN - NLM
STAT- MEDLINE
DCOM- 20050104
LR - 20191108
IS - 1744-764X (Electronic)
IS - 1474-0338 (Linking)
VI - 3
IP - 4
DP - 2004 Jul
TI - Patients' role in reporting adverse drug reactions.
PG - 363-8
AB - This review discusses the involvement of patients in the reporting of adverse drug reactions (ADRs). Patients benefit from drugs but also experience their adverse effects. Since concerns about the safety of drugs are also patients' concerns, the patient could also play a part in decreasing the risks of drug therapy. Patient interest in the safety aspects of drugs is evident. At an international level, the merits of patient reports are being considered. To date, the literature does not yet provide any actual results in relation to the detection of ADRs by patients. Different considerations regarding ADR reporting by patients are discussed. The authors conclude that we should positively value patients' involvement in drug therapy and their concern regarding possible adverse effects. As a consequence, patients' reports on ADRs should be accepted.
FAU - van Grootheest, Kees
AU - van Grootheest K
AD - The Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands. ac.vangrootheest@lareb.nl
FAU - de Jong-van den Berg, Lolkje
AU - de Jong-van den Berg L
LA - eng
PT - Journal Article
PT - Review
PL - England
TA - Expert Opin Drug Saf
JT - Expert opinion on drug safety
JID - 101163027
SB - IM
MH - Adverse Drug Reaction Reporting Systems
MH - *Drug-Related Side Effects and Adverse Reactions
MH - Humans
MH - *Patient Participation
MH - Product Surveillance, Postmarketing/*methods
RF - 30
EDAT- 2004/07/23 05:00
MHDA- 2005/01/05 09:00
CRDT- 2004/07/23 05:00
PHST- 2004/07/23 05:00 [pubmed]
PHST- 2005/01/05 09:00 [medline]
PHST- 2004/07/23 05:00 [entrez]
AID - EDS030409 [pii]
AID - 10.1517/14740338.3.4.363 [doi]
PST - ppublish
SO - Expert Opin Drug Saf. 2004 Jul;3(4):363-8. doi: 10.1517/14740338.3.4.363.
PMID- 35470747
OWN - NLM
STAT- MEDLINE
DCOM- 20220707
LR - 20220909
IS - 1473-4877 (Electronic)
IS - 0300-7995 (Linking)
VI - 38
IP - 7
DP - 2022 Jul
TI - Community pharmacists' challenges regarding adverse drug reaction reporting: a cross-sectional study.
PG - 1229-1236
LID - 10.1080/03007995.2022.2070380 [doi]
AB - OBJECTIVE: The effectiveness of the national drug safety monitoring program directly depends on the active participation of healthcare professionals in reporting suspected adverse drug reactions (ADRs). The aim of the study was to explore community pharmacists' comprehension of pharmacovigilance, their perspectives toward reporting ADRs and investigate the current practice of ADR reporting among pharmacists in Serbia. METHODS: This descriptive cross-sectional study was performed on a sample of pharmacists in Serbia between November 2019 and March 2020 using a pre-tested questionnaire distributed online. Eligible participants were community pharmacists in Serbia who were willing to participate in the study during the data collection period. Non-parametric statistical tests were performed in the analysis of knowledge, perspectives and ADR reporting. The validity and reliability of the survey were measured by exploratory factor analysis. RESULTS: The median knowledge score was 6 out of 10 (interquartile range 5-7, range 2-10). No significant differences in the knowledge scores of pharmacists were found based on weekly working hours (U = 24,805, p = .374), working experience (χ(2) = 4.011, DF = 2, p = .135), being a member of a professional organization (U = 24,312, p = .209), or highest level of pharmacy qualification obtained (χ(2) = 3.233, DF = 3, p = .506). Only 28.8% of pharmacists reported ADR at least once a year, while the majority of them have never reported any ADRs. CONCLUSIONS: Despite the community pharmacists' positive attitude toward adverse drug reporting and their role in the process, they show limited knowledge regarding the issue and highly prevalent under-reporting of ADRs. Educational programs are necessary to increase ADRs reporting.
FAU - Paut Kusturica, Milica
AU - Paut Kusturica M
AUID- ORCID: 0000-0003-0972-5115
AD - Faculty of Medicine Novi Sad, Department of Pharmacology, Toxicology and Clinical Pharmacology, University of Novi Sad, Novi Sad, Serbia.
FAU - Tomas, Ana
AU - Tomas A
AD - Faculty of Medicine Novi Sad, Department of Pharmacology, Toxicology and Clinical Pharmacology, University of Novi Sad, Novi Sad, Serbia.
FAU - Rašković, Aleksandar
AU - Rašković A
AD - Faculty of Medicine Novi Sad, Department of Pharmacology, Toxicology and Clinical Pharmacology, University of Novi Sad, Novi Sad, Serbia.
FAU - Gigov, Slobodan
AU - Gigov S
AD - Faculty of Pharmacy, University Business Academy in Novi Sad, Novi Sad, Serbia.
FAU - Crnobrnja, Veljko
AU - Crnobrnja V
AD - Faculty of Medicine Novi Sad, Department of Pathophysiology, University of Novi Sad, Novi Sad, Serbia.
FAU - Jevtić, Marija
AU - Jevtić M
AD - Faculty of Medicine Novi Sad, Department of Hygiene, University of Novi Sad, Novi Sad, Serbia.
FAU - Stilinović, Nebojša
AU - Stilinović N
AD - Faculty of Medicine Novi Sad, Department of Pharmacology, Toxicology and Clinical Pharmacology, University of Novi Sad, Novi Sad, Serbia.
LA - eng
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
DEP - 20220506
PL - England
TA - Curr Med Res Opin
JT - Current medical research and opinion
JID - 0351014
SB - IM
MH - Adverse Drug Reaction Reporting Systems
MH - Attitude of Health Personnel
MH - Cross-Sectional Studies
MH - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH - Health Knowledge, Attitudes, Practice
MH - Humans
MH - *Pharmacists
MH - Pharmacovigilance
MH - Reproducibility of Results
MH - Surveys and Questionnaires
OTO - NOTNLM
OT - Pharmacovigilance
OT - Serbia
OT - adverse drug reaction reporting systems
OT - knowledge
OT - pharmacists
EDAT- 2022/04/27 06:00
MHDA- 2022/07/08 06:00
CRDT- 2022/04/26 08:51
PHST- 2022/04/27 06:00 [pubmed]
PHST- 2022/07/08 06:00 [medline]
PHST- 2022/04/26 08:51 [entrez]
AID - 10.1080/03007995.2022.2070380 [doi]
PST - ppublish
SO - Curr Med Res Opin. 2022 Jul;38(7):1229-1236. doi: 10.1080/03007995.2022.2070380. Epub 2022 May 6.
PMID- 37269068
OWN - NLM
STAT- MEDLINE
DCOM- 20230605
LR - 20230613
IS - 2052-1707 (Electronic)
IS - 2052-1707 (Linking)
VI - 11
IP - 3
DP - 2023 Jun
TI - Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial.
PG - e01072
LID - 10.1002/prp2.1072 [doi]
LID - e01072
AB - The current COVID-19 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different drug candidates were proposed. In this article, we present the challenges for an academic Safety Department to manage the global safety of a European trial during the pandemic. The National Institute for Health and Medical Research (Inserm) conducted a European multicenter, open-label, randomized, controlled trial involving three repurposed and one-in development drugs (lopinavir/ritonavir, IFN-β1a, hydroxychloroquine, and remdesivir) in adults hospitalized with COVID-19. From 25 March 2020 to 29 May 2020, the Inserm Safety Department had to manage 585 Serious Adverse Events (SAEs) initial notification and 396 follow-up reports. The Inserm Safety Department's staff was mobilized to manage these SAEs and to report Expedited safety reports to the competent authorities within the legal timeframes. More than 500 queries were sent to the investigators due to a lack of or incoherent information on SAE forms. At the same time, the investigators were overwhelmed by the management of patients suffering from COVID-19 infection. These particular conditions of missing data and lack of accurate description of adverse events made evaluation of the SAEs very difficult, particularly the assessment of the causal role of each investigational medicinal product. In parallel, working difficulties were accentuated by the national lockdown, frequent IT tool dysfunctions, delayed implementation of monitoring and the absence of automatic alerts for SAE form modification. Although COVID-19 is a confounding factor per se, the delay in and quality of SAE form completion and the real-time medical analysis by the Inserm Safety Department were major issues in the quick identification of potential safety signals. To conduct a high-quality clinical trial and ensure patient safety, all stakeholders must take their roles and responsibilities.
CI - © 2023 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.
FAU - Mercier, Noémie
AU - Mercier N
AD - ANRS, Maladies Infectieuses Emergentes, Paris, France.
AD - Institut National de la Santé et de la Recherche Médicale, INSERM, Paris, France.
FAU - Belhadi, Drifa
AU - Belhadi D
AD - AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, Paris, France.
FAU - DeChanet, Aline
AU - DeChanet A
AD - Department of Pharmacology, Inserm CIC 1414 and Rennes University Hospital, Rennes, France.
FAU - Delmas, Christelle
AU - Delmas C
AD - Institut de Santé Publique, Pôle Recherche Clinique, INSERM, Paris, France.
FAU - Saillard, Juliette
AU - Saillard J
AD - ANRS, Maladies Infectieuses Emergentes, Paris, France.
FAU - Dumousseaux, Marina
AU - Dumousseaux M
AD - Institut de Santé Publique, Pôle Recherche Clinique, INSERM, Paris, France.
FAU - Le Mestre, Soizic
AU - Le Mestre S
AD - ANRS, Maladies Infectieuses Emergentes, Paris, France.
FAU - Fougerou-Leurent, Claire
AU - Fougerou-Leurent C
AD - Department of Pharmacology, Inserm CIC 1414 and Rennes University Hospital, Rennes, France.
FAU - Ferrane, Assia
AU - Ferrane A
AD - Institut de Santé Publique, Pôle Recherche Clinique, INSERM, Paris, France.
FAU - Burdet, Charles
AU - Burdet C
AD - AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, Paris, France.
AD - AP-HP, Hôpital Bichat, Unité de Recherche Clinique, Paris, France.
AD - Université de Paris, IAME, INSERM, Paris, France.
AD - AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, Paris, France.
FAU - Espérou, Hélène
AU - Espérou H
AD - Institut National de la Santé et de la Recherche Médicale, INSERM, Paris, France.
FAU - Ader, Florence
AU - Ader F
AD - Hospices Civils de Lyon, Département des Maladies Infectieuses et Tropicales, Lyon, France.
AD - Centre International de Recherche en Infectiologie (CIRI), Inserm 1111, Université Claude Bernard Lyon 1, CNRS, UMR5308, École Normale Supérieure de Lyon, Univ Lyon, Lyon, France.
FAU - Hites, Maya
AU - Hites M
AD - L'Hôpital Universitaire de Bruxelles-Hôpital Érasme, Université Libre de Bruxelles, Clinique des Maladies Infectieuses, Brussels, Belgium.
FAU - Peiffer-Smadja, Nathan
AU - Peiffer-Smadja N
AD - Université de Paris, IAME, INSERM, Paris, France.
AD - AP-HP, Hôpital Bichat, Service de Maladies Infectieuses et Tropicales, Paris, France.
FAU - Poissy, Julien
AU - Poissy J
AD - Université de Lille, Inserm U1285, CHU Lille, Pôle de Réanimation, CNRS, UMR 8576 - UGSF - Unité de Glycobiologie Structurale et Fonctionnelle, Lille, France.
FAU - Andrejak, Claire
AU - Andrejak C
AD - CHU d'Amiens, Département de Pneumologie, UR4294 AGIR Picardie Jules Verne University, Amiens, France.
FAU - Paiva, José Artur
AU - Paiva JA
AD - Department of Critical Care Medicine, Centro Hospitalar Universitário de São João, Porto, Portugal.
FAU - Tacconelli, Evelina
AU - Tacconelli E
AD - Division of Infectious Diseases, Diagnostic and Public Health, University of Verona, Verona, Italy.
FAU - Staub, Thérèse
AU - Staub T
AD - Centre Hospitalier de Luxembourg, Maladies Infectieuses, Luxembourg City, Luxembourg.
FAU - Greil, Richard
AU - Greil R
AD - Paracelsus Medical University Salzburg, Laboratory of Immunological and Molecular Cancer Research, Salzburg, Austria.
FAU - Costagliola, Dominique
AU - Costagliola D
AD - Sorbonne Université, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, INSERM, Paris, France.
FAU - Mentre, France
AU - Mentre F
AD - AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, Paris, France.
AD - AP-HP, Hôpital Bichat, Unité de Recherche Clinique, Paris, France.
AD - Université de Paris, IAME, INSERM, Paris, France.
FAU - Yazdanpanah, Yazdan
AU - Yazdanpanah Y
AD - ANRS, Maladies Infectieuses Emergentes, Paris, France.
AD - Université de Paris, IAME, INSERM, Paris, France.
AD - AP-HP, Hôpital Bichat, Service de Maladies Infectieuses et Tropicales, Paris, France.
FAU - Diallo, Alpha
AU - Diallo A
AUID- ORCID: 0000-0001-9642-0584
AD - ANRS, Maladies Infectieuses Emergentes, Paris, France.
AD - Institut National de la Santé et de la Recherche Médicale, INSERM, Paris, France.
CN - DisCoVeRy Safety Working group
LA - eng
SI - ClinicalTrials.gov/NCT 04315948
SI - EudraCT/EudraCT 2020-000936-23
PT - Journal Article
PT - Research Support, Non-U.S. Gov't
PT - Review
PL - United States
TA - Pharmacol Res Perspect
JT - Pharmacology research & perspectives
JID - 101626369
RN - 4QWG6N8QKH (Hydroxychloroquine)
SB - IM
MH - Adult
MH - Humans
MH - *COVID-19
MH - Pandemics
MH - Pharmacovigilance
MH - Communicable Disease Control
MH - Hydroxychloroquine/adverse effects
MH - Randomized Controlled Trials as Topic
MH - Multicenter Studies as Topic
PMC - PMC10238756
OTO - NOTNLM
OT - COVID-19
OT - EU-RESPONSE
OT - adverse event
OT - pandemic crisis
OT - pharmacovigilance
COIS- No author declared a conflict of interest in relation to the submitted work. C. Delmas reports receipt of drugs from Gilead Sciences, Inc., Sanofi, Merck Group, AbbVie for Inserm, outside the submitted work. J. Saillard reports receipt of drugs from Gilead Sciences, Inc., Sanofi, Merck Group, AbbVie for Inserm, outside the submitted work. M. Dumousseaux reports receipt of drugs from Gilead Sciences, Inc., Sanofi, Merck Group, AbbVie for Inserm, outside the submitted work. S. Le Mestre reports receipt of drugs from Gilead Sciences, Inc., Sanofi, Merck Group, AbbVie for Inserm, outside the submitted work. A. Ferrane reports receipt of drugs from Gilead Sciences, Inc., Sanofi, Merck Group, AbbVie for Inserm, outside the submitted work. C. Burdet reports consulting fees from Mylan, Da Volterra, outside the submitted work; participation on a Data Safety Monitoring Board or Advisory Board for 4Living Biotech, outside the submitted work. F. Ader reports grants from The French Health Ministry, European Community, outside the submitted work. M. Hites reports grants from the Belgian Centre for Knowledge (KCE), the Fonds Erasme‐COVID‐Université Libre de Bruxelles, outside the submitted work; grants from the EU‐Horizon program, outside the submitted work; support for ECCMID congress 2021 from Pfizer, outside the submitted work; working as co‐leader of the Belgian Guidelines on Therapeutics for COVID‐19, outside the submitted work; acting as a president for the Belgian Society of Clinical Microbiology and Infectious Diseases, outside the submitted work. J. Poissy reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Gilead, outside the submitted work; patents planned, issued or pending from Gilead, outside the submitted work. C. Andrejak reports grants from the FEDER, outside the submitted work; support for ERS Conference from Homeperf, outside the submitted work; acting as member of Covid group for the French High council of Public Health and acting as responsible of the Scientific council for the French Society of Respiratory Diseases, outside the submitted work. J.A. Paiva reports consulting fees from MSD, Jansen, Pfizer, Astra‐Zeneca, outside the submitted work; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Gilead, Cepheid, AOP Orphan Pharmaceuticals, outside the submitted work. R. Greil reports consulting fees from Celgene, Novartis, Roche, BMS, Takeda, Abbvie, MSD, Janssen, Astra‐Zeneca, Merck, Gilead, Daiichi Sankyo, Sanofi, outside the submitted work; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Celgene, Roche, BMS, Takeda, Abbvie, Sandoz, MSD, Novartis, Astra‐Zeneca, Merck, Gilead, Daiichi Sankyo, Sanofi, Amgen, outside the submitted work; support for attending meeting and/or travel from Celgene, Roche, BMS, Abbvie, MSD, Novartis, Astra‐Zeneca, Gilead, Daiichi Sankyo, Amgen, Janssen, outside the submitted work; participation on a Data Safety Monitoring Board or Advisory Board for Celgene, Novartis, Roche, BMS, Takeda, Abbvie, Astra‐Zeneca, MSD, Janssen, Merck, Gilead, Daiichi Sankyo, Sanofi, outside the submitted work; research funding from Celgene, Roche, Merck, Takeda, Astra‐Zeneca, Novartis, Amgen, BMS, MSD, Sandoz, Abbvie, Gilead, Daiichi Sankyo, outside the submitted work. D. Costagliola reports grants or contracts from any entity from Janssen for Inserm, outside the submitted work; lectures fees from Janssen and Gilead, outside the submitted work; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Gilead, outside the submitted work. All other authors declare no competing interests.
FIR - Gibowski, Séverine
IR - Gibowski S
FIR - Paul, Christelle
IR - Paul C
FIR - Balssa, Joséphine
IR - Balssa J
FIR - Landry, Elise
IR - Landry E
FIR - Le-Goff, Anaïs
IR - Le-Goff A
FIR - Lancrey-Javal, Solange
IR - Lancrey-Javal S
FIR - Levoyer, Lea
IR - Levoyer L
FIR - Moachon, Laurence
IR - Moachon L
FIR - Terzic, Vida
IR - Terzic V
FIR - Figarella, Mélanie
IR - Figarella M
FIR - Pittoni-Minvielle, Nicolas
IR - Pittoni-Minvielle N
FIR - Boston, Anaïs
IR - Boston A
FIR - Miantezila-Basilua, Joe
IR - Miantezila-Basilua J
FIR - Ginoux, Pauline
IR - Ginoux P
FIR - Gautier, Blandine
IR - Gautier B
FIR - Wegang-Nzeufo, Adele
IR - Wegang-Nzeufo A
FIR - Caro, Alain
IR - Caro A
FIR - De Lemos, Alexandra
IR - De Lemos A
FIR - Seux, Alexandra
IR - Seux A
FIR - Verdier, Alice
IR - Verdier A
FIR - Champougny, Ambre
IR - Champougny A
FIR - Martineau, Anne Sophie
IR - Martineau AS
FIR - Varnier, Anne-Lise
IR - Varnier AL
FIR - Le Breton, Aude
IR - Le Breton A
FIR - Langlois, Audrey
IR - Langlois A
FIR - Duquenoy, Axel
IR - Duquenoy A
FIR - Mizejewski, Beatrice
IR - Mizejewski B
FIR - Assia, Benlakhryfa
IR - Assia B
FIR - Zonzeka, Bercelin Maniangou
IR - Zonzeka BM
FIR - El Houda, Boudjoghra Nour
IR - El Houda BN
FIR - Mugnier, Brigitte
IR - Mugnier B
FIR - Risse, Brigitte
IR - Risse B
FIR - Chevalier, Camille
IR - Chevalier C
FIR - Harpon, Camille
IR - Harpon C
FIR - Jourdan, Camille
IR - Jourdan C
FIR - Dubois-Gache, Caroline
IR - Dubois-Gache C
FIR - Pruvost, Celina
IR - Pruvost C
FIR - Cameli, Charlotte
IR - Cameli C
FIR - Asma, Cherifi
IR - Asma C
FIR - Bureau, Chloe
IR - Bureau C
FIR - Back-Laufenburger, Christelle
IR - Back-Laufenburger C
FIR - Lucas, Christelle
IR - Lucas C
FIR - Schiano, Christina
IR - Schiano C
FIR - Pintaric, Christine
IR - Pintaric C
FIR - Perrier, Coline
IR - Perrier C
FIR - Camille, Collette
IR - Camille C
FIR - Simo, David
IR - Simo D
FIR - Lagarde, Dominique
IR - Lagarde D
FIR - Faillet, Edit
IR - Faillet E
FIR - Haerrel, Elina
IR - Haerrel E
FIR - Donet, Elodie
IR - Donet E
FIR - Marquis, Eric
IR - Marquis E
FIR - Lopes, Euma Fortes
IR - Lopes EF
FIR - Bouhet, Fabrice
IR - Bouhet F
FIR - Le Cerf, Florence
IR - Le Cerf F
FIR - Huguenin, Gabriel
IR - Huguenin G
FIR - Quention, Gerome
IR - Quention G
FIR - Madiot, Hend
IR - Madiot H
FIR - Calmont, Isabelle
IR - Calmont I
FIR - Gaudin, Isabelle
IR - Gaudin I
FIR - Pacaud, Isabelle
IR - Pacaud I
FIR - Osman, Issraa
IR - Osman I
FIR - Devassine, Jean-Loup
IR - Devassine JL
FIR - Tobia, Jeremy
IR - Tobia J
FIR - Rousseaux, Justine
IR - Rousseaux J
FIR - Reyrolle, Leslie
IR - Reyrolle L
FIR - Lafuente, Lorrie
IR - Lafuente L
FIR - Antoine, Lydie
IR - Antoine L
FIR - Gouichiche, Lyna
IR - Gouichiche L
FIR - Djoudi, Malek Ait
IR - Djoudi MA
FIR - Pelkowski, Manon
IR - Pelkowski M
FIR - Bellonet, Marcellin
IR - Bellonet M
FIR - Maillet, Marianne
IR - Maillet M
FIR - Diesel, Marie
IR - Diesel M
FIR - Granjon, Marie
IR - Granjon M
FIR - Stupien, Marie Laure
IR - Stupien ML
FIR - Aroulanda, Marie-Jose
IR - Aroulanda MJ
FIR - Tegue, Marie-Jose Ngo Um
IR - Tegue MNU
FIR - Simon, Marielle
IR - Simon M
FIR - Bou, Marine
IR - Bou M
FIR - Douillet, Marine
IR - Douillet M
FIR - Ghidi, Marion
IR - Ghidi M
FIR - Passageon, Maxence
IR - Passageon M
FIR - Grubner, Melanie
IR - Grubner M
FIR - Heberle, Morgane
IR - Heberle M
FIR - Mejane, Murielle
IR - Mejane M
FIR - Todessayi, Pietro
IR - Todessayi P
FIR - Yatimi, Rachida
IR - Yatimi R
FIR - Pinilla, Robin
IR - Pinilla R
FIR - Camara, Sabine
IR - Camara S
FIR - Marchionni, Sandra
IR - Marchionni S
FIR - Vautrat, Sandrine
IR - Vautrat S
FIR - Fonooni, Shervin
IR - Fonooni S
FIR - Trehoux, Solange
IR - Trehoux S
FIR - Tallon, Sophie
IR - Tallon S
FIR - Flasquin, Stephanie
IR - Flasquin S
FIR - Lejeune, Stephanie
IR - Lejeune S
FIR - Byrom, Stuart
IR - Byrom S
FIR - Grandmange, Sylvie
IR - Grandmange S
FIR - Chaima, Traikia
IR - Chaima T
FIR - Opderbeck, Valerie
IR - Opderbeck V
FIR - Perimee, Veronique Pelonde
IR - Perimee VP
FIR - Mouanga, Victoria
IR - Mouanga V
FIR - Fanomezantsoa, Volanantenaina
IR - Fanomezantsoa V
FIR - Alessia, Dr Pochesci
IR - Alessia DP
FIR - Aouali, Nassera
IR - Aouali N
FIR - Keusching, Alexandra
IR - Keusching A
FIR - Elsasser, Brigitta
IR - Elsasser B
FIR - Grimaldi, Dr David
IR - Grimaldi DD
FIR - Luz, Dr Filipa
IR - Luz DF
FIR - Colban, Martha
IR - Colban M
FIR - Keane, Ruben E
IR - Keane RE
FIR - Troníčková, Radka
IR - Troníčková R
FIR - Nerušilová, Katerina
IR - Nerušilová K
FIR - Wiesner, Agnieszka
IR - Wiesner A
FIR - Garcia, Irene
IR - Garcia I
EDAT- 2023/06/03 11:42
MHDA- 2023/06/05 06:42
CRDT- 2023/06/03 00:53
PHST- 2022/11/29 00:00 [received]
PHST- 2023/02/01 00:00 [accepted]
PHST- 2023/06/05 06:42 [medline]
PHST- 2023/06/03 11:42 [pubmed]
PHST- 2023/06/03 00:53 [entrez]
AID - PRP21072 [pii]
AID - 10.1002/prp2.1072 [doi]
PST - ppublish
SO - Pharmacol Res Perspect. 2023 Jun;11(3):e01072. doi: 10.1002/prp2.1072.