Evidence map›Paper›PMID 30911975›Full record

ArticleDrug safety2019

Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR.

Carrie E Pierce, Sieta T de Vries, Stephanie Bodin-Parssinen, Linda Härmark, Phil Tregunno, David J Lewis, Simon Maskell, Raphael Van Eemeren, Alicia Ptaszynska-Neophytou, Victoria Newbould and 4 more

Abstract read
In one paragraph

Article in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Spontaneous adverse drug reaction reporting: potential facilitators perceived by community pharmacists in Egypt - a cross-sectional study.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025
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  11. The Rise and Rise of Medicinal Cannabis, What Now? Medicinal Cannabis Prescribing in Australia 2017-2022.International journal of environmental research and public health · 2022
    Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Carrie E PierceBooz Allen Hamilton (formerly Epidemico, Inc.), Boston, MA, USA.
Sieta T de VriesDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Stephanie Bodin-ParssinenUCB Pharmaceuticals, Allée de la Recherche, 60, 1070, Brussels, Belgium.
Linda HärmarkNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
Phil TregunnoVigilance, Intelligence and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA), 151 Buckingham Palace Road, Belgravia, London, SW1W 9SZ, UK.
David J LewisChief Medical Office and Patient Safety, Global Drug Development, Novartis, Basel, Switzerland.
Simon MaskellDepartment of Electrical Engineering and Electronics, University of Liverpool, Liverpool, L69 7ZX, UK.
Raphael Van EemerenAmgen Europe BV, Minervum 7061, 4817 ZK, Breda, The Netherlands.
Alicia Ptaszynska-NeophytouVigilance, Intelligence and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA), 151 Buckingham Palace Road, Belgravia, London, SW1W 9SZ, UK.
Victoria NewbouldPharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA), London, E14 5EU, UK.
Nabarun DasguptaUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.
Antoni F Z WisniewskiAstraZeneca, Global Regulatory Affairs, Patient Safety and Quality Assurance, Granta Park, Cambridge, CB21 6GH, UK.
Sara GamaChief Medical Office and Patient Safety, Global Drug Development, Novartis, Basel, Switzerland.
Peter G M MolDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. p.g.m.mol@umcg.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Over a period of 3 years, the European Union's Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions; https://web-radr.eu/ ) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety. Recommendations relating to the use of mobile apps for PV are summarised in this paper. There is a presumption amongst at least some patients and healthcare professionals that information ought to be accessed and reported from any setting, including mobile apps. WEB-RADR has focused on the use of such technology for reporting suspected adverse drug reactions and for broadcasting safety information to its users, i.e. two-way risk communication. Three apps were developed and publicly launched within Europe as part of the WEB-RADR project and subsequently assessed by a range of stakeholders to determine their value as effective tools for improving patient safety; a fourth generic app was later piloted in two African countries. The recommendations from the development and evaluation of the European apps are presented here with supporting considerations, rationales and caveats as well as suggested areas for further research.

Indexed as

Adverse Drug Reaction Reporting SystemsAfricaCommunicationData CollectionDrug-Related Side Effects and Adverse ReactionsEuropeEuropean UnionHealth PersonnelHumansMobile ApplicationsPharmaceutical PreparationsPharmacovigilanceSocial MediaPharmaceutical Preparations

Identifiers

PMID30911975
PMCPMC6450855

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.