Consumer Mobile Apps for Potential Drug-Drug Interaction Check: Systematic Review and Content Analysis Using the Mobile App Rating Scale (MARS)

General consumers can now easily access drug information and quickly check for potential drug-drug interactions (PDDIs) through mobile health (mHealth) apps. With aging population in Canada, more people have chronic diseases and comorbidities leading to increasing numbers of medications. The use of mHealth apps for checking PDDIs can be helpful in ensuring patient safety and empowerment.The aim of this study was to review the characteristics and quality of publicly available mHealth apps that check for PDDIs.Apple App Store and Google Play were searched to identify apps with PDDI functionality. The apps' general and feature characteristics were extracted. The Mobile App Rating Scale (MARS) was used to assess the quality.A total of 23 apps were included for the review-12 from Apple App Store and 11 from Google Play. Only 5 of these were paid apps, with an average price of $7.19 CAD. The mean MARS score was 3.23 out of 5 (interquartile range 1.34). The mean MARS scores for the apps from Google Play and Apple App Store were not statistically different (P=.84). The information dimension was associated with the highest score (3.63), whereas the engagement dimension resulted in the lowest score (2.75). The total number of features per app, average rating, and price were significantly associated with the total MARS score.Some apps provided accurate and comprehensive information about potential adverse drug effects from PDDIs. Given the potentially severe consequences of incorrect drug information, there is a need for oversight to eliminate low quality and potentially harmful apps. Because managing PDDIs is complex in the absence of complete information, secondary features such as medication reminder, refill reminder, medication history tracking, and pill identification could help enhance the effectiveness of PDDI apps.

section_content: "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man… or to affect the structure or any function of the body of man. " (e. g., IUD, Pacemaker). 2 The combination of these two items creates a hybrid known as a Mobile Medical Application, which denotes a mobile application that meets the definition of a device, and is intended either: a) to be used as an accessory to a regulated medical device, or b) to transform a mobile platform into a regulated medical device. 3 understand when a mobile application crosses the line from simply being a consumer novelty to being considered a Mobile Medical Application, it is important to analyze the type of data involved, the intended use of the data, and how that data is actually used in regards to making medical decisions by either the patient, a medical professional, or the application itself. A Mobile Application that is intended for the use in the diagnosis or the cure, mitigation, treatment, or prevention of a disease, or to affect the structure or any function of the body, falls within the medical device definition and will most probably be subject to regulation, which ultimately depends on functionality. In other words, a difference must be established between mere informational data and diagnostic or prescriptive data 4 : Applications that provide for the former allow the user to read, input their own data, and gather resources to make medical decisions; applications that provide for the latter allow decision processes normally handled by medical professionals to be entirely dependent on the software, thus giving the user substantial information regarding their condition and their treatment. Industry and Food and Drug Administration Staff ("MDDS Guidance") 5 on February 9 th 2015, all medical devices and applications (intended for use to cure, mediate, prevent, treat, or diagnose a disease) which transferred, stored, converted, and/or displayed medical data, had to be in full compliance with FDA's regulatory processes and controls. At the time, there were no filters or distinctions, regardless of different intent, risk-levels and potential harms, and the amount of FDA regulation of products was overbearing. In an attempt to alleviate this overregulation and subsequent undue burden, the FDA has undertaken several measures toward a less stringent regulatory regime for medical devices and mobile applications. Beginning in 2011, the agency first reclassified Medical Device Data Systems ("MDDS") from Class III to Class I and subsequently fully deregulated them. 6 Ultimately, the FDA decided to limit the scope of its regulation by establishing a risk-based framework for the assertion of safety and effectiveness.

section_content: Four guidelines were drafted (two already approved) with that purpose: a. 

General
section_name: III. FDA Regulation

section_content: Despite the available guidelines, the FDA's regulatory process in this field still lacks certainty in some areas. Among other things, it is difficult to assess under what exact classification a Mobile Medical Application falls; there might be an application of low-risk that implicates a high-risk if used as an accessory to an existing medical device; also, an application might have a certain intended use but there is no complete control on the actual use it will be given. Therefore, there is the issue that the interoperability between a Mobile Application and a medical device can't automatically deem the former to be a medical device accessory (this would require validation from the product manufacturer). Another related issue is the lack of a clear regulatory path for innovative products. Innovators may not want to connote their applications as medical diagnosing devices in order to avoid long and costly FDA regulations, which would not necessarily guarantee success (clearance and approval). Additionally, there are terms among the guidelines, such as "risk to safety" and "treatment," that have not yet been clarified and provide no guidance in development. The FDA's risk based approach must be further tailored to create a more eclectic and comprehensive framework, which would be able to balance innovation and regulation with security and privacy, issues currently outside of its scope.
section_name: IV. Current and Future Potential Issues

section_content: Mobile technology is indisputably transforming the health care system from physician-centered to a much more patient-focused one. The development of Mobile Applications will increase in usage and complexity, which implies that FDA guidelines must be constantly revised and restructured to satisfy existing trends. 

Some critics may argue that the guidelines are not enough and that statutory measures should be analyzed and implemented; they might rely on the idea that as long as the FDA maintains the power of exercising enforcement discretion, there will always be uncertainty regarding the processes and regulations that guide the developments in these areas. 

Although a firm limit on FDA regulatory control would help establish clearer and more predictable standards, the is that an absolute regulation approach would be impractical, due to the rapid and dynamic changes in technology. In contrast, guidance regulations and periodical updates provide for the recognition that the system constantly changes and evolves, for which there will always be a need for adaptation. The biggest challenge will continue to be balancing FDA regulation for safety and effectiveness, with permitting more liberal innovation and marketing strategies. After all, only one thing is certain: the investment of time and money in the development of Mobile Medical Applications is definitely worth it; it is the price to pay to enhance the health care system, to improve health care access, and uphold quality and safety standards.
section_name: V. Conclusion

section_name: Health