Some have criticised big pharma for being slow off the mark to monopolise on the mHealth revolution. In the changing pharmaceutical landscape where the days of the block-buster drugs are fading and innovation is key, it is easy to see why momentum is now building and the industry is becoming more aware of the potential for mHealth solutions in nearly all aspects of their business practice.
There are numerous benefits for pharma companies utilising mHealth. These include the ability to increase and tailor information and access to resources and marketing materials for both patients and physicians and to cheaply increase the reach of clinical trials and marketing campaigns to more diverse demographics and geographically wider populations. Compared to the established means of targeting user groups with drug representatives and traditional advertising, smartphones offer a cheaper, data-rich and limitlessly interactive platform for information and feedback exchange. Companies are utilising apps as a means of expanding brand awareness, generating revenue and driving down costs. Some established apps deliver disease information and advice, such as Astellas interactive Get Bladderfit App. Some act as portals for patients and physicians to direct communication with representatives from the brand. Some have been developed as programs to monitor medication adherence and feedback for the reordering of prescriptions and others developed to serve as tools for monitoring side-effect profiles and therapeutic benefits during clinical trials. It won’t stop there and as the industry grows more confident with the use of smartphone app technology and mHealth it is likely to expand its use into more diverse areas of practice including, for example, drug development, the supply-chain and logistics. It is the growing diversity of these apps and the real benefits they provide to target users and business more broadly, that will ensure the continued growth of mHealth in pharma.
Although there are clear benefits to utilising mobile technologies, it doesn’t come without challenges and risks. The current regulatory guidelines from both the U.S. Food and Drugs Administration and the European Medicines Agency are poorly defined and leave many mHealth apps in a grey area between ‘novel information service’ requiring no external monitoring or safe-guarding and ‘medical device’ which requires adherence to international regulations and standards. In an industry as tightly regulated as pharma and one with a colourful history of litigation, this uncertainty has created a barrier to developing broader strategies for mHealth design and implementation. It was only 2011, when Pfizer had to recall its most successful and most downloaded healthcare app, Rheumatology Calculator which calculated patient disease-risk scores, due to inaccuracies in the information and results it provided. This highlighted the need for pharma companies to treat mHealth with as much accountability as for all other areas of product development and delivery. Creating and adopting an industry wide code of practice for mHealth app development in a dialogue with the regulatory bodies is certainly needed to ensure products are accurate and safe and that companies are accountable for any misinformation or potentially harmful apps. Another key challenge within countries governed by the European Medicines Agency is developing apps with functions and utilities that circumvent and do not break the strict ban on direct-to-customer advertising. The development of concise codes of practice alongside innovative app design and marketing will ensure this challenge is minimised.
It is clear that mHealth has a long term footing in the pharmaceuticals industry. Focus, innovation and recognising the key challenges that lie ahead are necessary steps to ensure that maximum benefit is achieved for both target users and companies within the industry.