FormalPara Key Points

It is necessary to develop new methods to improve and facilitate notifications of adverse drug reactions. Among them, the use of mobile apps was suggested for reporting adverse drug reactions.

The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app for reporting adverse drug reactions and requesting drug safety information, available on Android and Apple stores.

The mobile app is an additional tool used in pharmacovigilance, allowing the receipt of adverse drug reaction reports that are different from those usually obtained using other classical methods of reporting.

1 Introduction

The burden of adverse drug reactions (ADRs) is well established [1,2,3]. However, under-reporting is a major problem in pharmacovigilance. Thus, several new methods have been developed to improve and facilitate notifications of ADRs from healthcare practitioners or patients, such as educational interventions on healthcare professionals [4, 5], economic incentives [6], patient interviews [7], regular visits by a clinical research assistant [8, 9], online reporting via a website [10] or the use of social networks [11].

Since the use of smartphones is increasing at a phenomenal rate, medical mobile apps were developed for managing several chronic diseases such as diabetes mellitus [12]. In the field of pharmacovigilance, it was suggested that mobile apps could increase ADR reporting and improve the communication of new safety issues [13]. A recent study discussed the factors influencing the use of a mobile app for reporting ADRs and found associations with the type of feedback given on reported ADRs, how ADR reports are stored and the type of drug news. Other factors were functions of the app, ease of use, type of language, security of the app and the source of safety information provided [13].

2 Objective

The development of smartphones in pharmacovigilance is relatively new. As far as we know, no study has clearly investigated what types of ADRs are reported via a mobile app. Thus, the objective of this work was to compare the main characteristics of ADR reports received through VigiBIP® with those of the classical methods of reporting (phone, e-mail, fax, letter, website).

3 Methods

In January 2015, the Toulouse University Pharmacovigilance Center (TUPVC) developed a free smartphone app called VigiBIP®, which can receive spontaneous reports of pharmacovigilance and drug safety information requests. Currently, it is the only app that allows the reporting of ADRs to a regional pharmacovigilance center in France. For ADR reports, age, sex, past history of the patient, name, dosage and date of administration of the drug(s), and a brief history of the ADR(s) must be indicated. VigiBip® also permits photographs of the ADRs to be sent, i.e. cutaneous and tumoural imags, which is not possible with our website (http://www.BIP31.fr). VigiBIP® can be used by healthcare professionals, patients or caregivers for drug information, ADR management or potential drug–drug interactions. VigiBIP® was developed only by the TUPVC and was not supported by any grants or resources. VigiBIP® is available on Android and Apple stores and was promoted to healthcare professionals and the general public via our website (http://www.BIP31.fr).

The present study, performed between 10 January, 2015 and 1 February, 2017, compared the type of reporter, ADR seriousness, drugs involved (classified according to the Anatomical Therapeutic and Chemical classification, second level) and reported ADRs (classified according to the MedDRA® System Organ Class classification) between the two groups. Comparisons were made using the Chi squared test. Seriousness was assessed according to the World Health Organization definition [14] and only reports with a causality assessment ≥ 1 (imputability score according to the official French method [15]) were included.

4 Results

During these 25 months, a total of 4102 reports were received by the TUPVC, including 193 (4.7%) through VigiBIP® and 3909 (95.3%) through other methods (Table 1). Reports received from patients and practitioners working outside of a hospital (‘extra-hospital reporters’) were significantly more frequent with VigiBip® than other reporting methods. In contrast, during the period of the study, hospital practitioners reported more using classical methods of reporting than with VigiBIP®.

Table 1 Comparison of the main characteristics for adverse drug reactions (ADRs) reported using the mobile app VigiBIP® and the classical methods of reporting (phone, e-mail, fax, letter and website) between 10 January, 2015 and 1 February, 2017 at the Toulouse University Pharmacovigilance Center
Full size table

The most frequently reported ADRs using VigiBIP® were cutaneous disorders, followed by gastrointestinal and general disorders. Adverse drug reactions received through the classical methods were, first, general disorders followed by cutaneous and nervous system disorders. However, no statistical difference was found between the two groups of reporting. VigiBip® reports were less frequently ‘serious’ compared with classical methods of reporting. VigiBIP® also allows the reporting of data or photographs of ADRs; this feature was used in this survey in 17.6% of the VigiBIP® reports (i.e. 17 medical reports from emergency services, 15 cutaneous photographs and two X-rays).

Adverse drug reactions related to antibacterial or psycholeptic drugs were more frequently reported with VigiBIP® than with classical methods. Similar results were found with antineoplastic and antiviral drugs, but these results should be confirmed owing to the low number of reports with these drugs. During the study period, a total of 102 drug information requests were received through VigiBIP® vs. 2507 using the classical methods; they were mainly requests about a possible association between a drug (or several drugs) and an adverse reaction.

5 Discussion

This analysis shows that mobile apps (such as VigiBip®) are new tools for healthcare professionals or patients to report ADRs and also request information from their pharmacovigilance centre. Our results suggest a special interest in the mobile app for patients because, in this study, we found proportionally more reports from patients using VigiBIP® than with the classical methods. VigiBIP® is also an easy means of reporting data or photographs of ADRs; this functionality can be a great advantage to better register the clinical characteristics of the ADRs and for making a causality assessment. Finally, our study also underlines that a mobile app is a complementary method in pharmacovigilance because it allows the reporting of different ADRs from those usually received by classical methods, i.e. gastrointestinal ADRs or antibacterial or psycholeptic-related ADRs. It is also used by extra-hospital practitioners who usually report fewer ADRs than hospital practitioners [16]. Thus, VigiBip® is able to provide different information than classical methods of reporting in pharmacovigilance. Finally, the present article demonstrates that VigiBIP® allows valuable reporting of ADRs, one of the objectives of the Web-Recognizing Adverse Drug Reactions (WEB-RADR) project [13].

The present study has some limitations. First, it is possible that users reporting ADRs through a smartphone (healthcare professionals or patients) may not be fully representative of ADR reporters using classical methods. Second, reports received through VigiBIP® could be less medically informative than those from the classical methods because VigiBIP® was used more by patients than classical methods of reporting. Third, the results should be interpreted cautiously owing to the relatively low number of ADRs reported through VigiBIP® in comparison to the classical methods. In contrast, the main strength of the study, which is one of the first describing clinical characteristics of ADRs received through a mobile app, is the relatively long period of the survey (25 months).

6 Conclusion

The mobile phone app VigiBIP® launched in January 2015 in France [before other pharmacovigilance apps such as the Yellow Card app (July 2015), the LAREB app (January 2016) or the HALMED app (May 2016)] is one of the first pharmacovigilance apps in Europe. Our experience with VigiBIP® in France may help to improve mobile app solutions for the reporting of ADRs.