Post-authorisation safety studies (PASS) are either described in the risk management plan at the time of application for marketing authorisation and become post-marketing commitments for the company; or they are required by the regulatory authorities if they consider that there is a need for additional safety information after marketing. Either way the gathering, processing and reporting of PASS data can potentially impact a drugs potential.
To address this challenge new pharmacovigilance methods are needed so that reporters, whether healthcare professionals or patients, can better exchange safety information.
Web-based monitoring systems for passive and active drug surveillance have been described in the literature and whilst these offer the capability to rapidly upload data into a database they are not always convenient for the reporter to use. In contrast, smartphones and tablets together with well designed apps offer all the benefits of a web system together with the convenience of mobile technology (always on and always with you).
However, there is one problem, before deploying this mobile technology it would need to be validated, a process that ensures the combination of device and app have been developed in a controlled manner and perform as per the requirements. This is not an insignificant activity, especially for this relatively new and still evolving technology, but the potential benefits for PASS for example would far outweigh the disadvantages and include:
- the rapid quantification of potential or identified risks
- the real time evaluation of the risks
- rapid assessment of any patterns of drug utilisation
- swift evaluation of the effectiveness of any risk minimisation program
The recent publication by the FDA of the Mobile Medical Application Guidance for Industry and FDA Staff on September 25th 2013 confirms that mobile medical app manufacturers are required to validate their apps along with the mobile platform to ensure their safe and effective operation.