How apps could help to improve medication adherence

Playing Games With Your Medicine

The stampede towards campaigns on social media and mobile apps designed to increase health awareness, continues.  The same media is also being used to promote patient adherence to medication regimes.  Some of the most inventive ways being employed to get patients involved have been with the use of gaming apps.  Inelegantly labelled SMAG’s which stands for Social, mobile and games, the technology is still very much a new innovation and the question is – are they just a gimmick or will they really do anything to help the adherence to medication in those that they are aimed at?

There is no doubt that medication adherence is now a multi billion dollar per year problem, and one of those working on using gaming to address the problem is Mango who have observed that the industry has tended to focus on two main areas.  The first is tracking the consumption of medicine by patients.  The second area of focus has been analysis of patient data to better identify the populations at risk in various scenarios.  However, it is now thought that the root cause of patient non adherence is likely to be due more to behavioural issues.

mango drug adherence app

With the app that Mango produce the patient can enter any supplements or medication that they need to take as well as the timing and the dosage of that medication.  The app, that is typical of the many adherence apps on the market, will advise patients of the time that they need to take their medication.  It will also alert the user to any potential reaction between medications that might prove dangerous.   But it is the gaming side that the makers are hoping will give their app the edge.  The game involves a currency that is unique to the game and the user will ‘earn’ the virtual money by being rewarded for taking medication on time, for instance.  There is a levelling up scheme that means that the users of the gaming system of adherence can progress to actual rewards from Mango’s partners. The type of rewards on offer will include items such as donations to charities and rewards that can be redeemed at retailers.  Another interesting feature of the gaming app is that the user can see how their adherence to medication compares with others suffering from the same condition. The Mango app is aimed at middle aged people diagnosed with certain conditions although in practice the makers have found that they have had users in their twenties as well as in their seventies.  Maybe it never is too late to teach an old or a young dog new tricks!

The Benefits of E-Details

There is no doubt that face-to-face promotion and presentation has been the major sales method of most medical device and pharmaceutical reps for decades. But the chance to sit down for a leisurely chat with the average over worked GP is fast diminishing.   It is an expensive and time-consuming way of getting things done and of getting the message across.  Pharma and healthcare companies are clamouring for more and more people ‘in the field’ as it has been proven that the face-to-face sales approach is inevitably the best.   But with doctors often feeling  “ambushed” by sales reps, is there a better way of making personal contact with physicians and getting information over in a way that does not have them looking at their watches every few minutes?

The Internet offers an option in its global dissemination of information, but if a rep is not sitting eyeball to eyeball with the medical professional, can they be sure they have understood or appreciated the benefit of the information being given, or will they simply move on if they have a question that does not appear in the FAQ list?

Enter the era of presenting information using tablets like the iPad and Samsung Galaxy.  A survey carried out in 2011 found that 70 per cent of the doctors polled, either already used or planned to use an iPad in their working life in some capacity.  So, if a medical rep turns up to do his presentation with an iPad along with a truly interactive e-detail aid the possibility of engaging the medical professional will be increased.

Initially it might be a good idea to hold a brainstorm meeting and ask sales reps to list what they see as the benefits of using tablets. Get feedback from friendly KOLs too and then plan the content, along with a list of all the functional requirements that will be needed.

As you plan your presentation, design your e-detail aid to work and render properly on the various platforms, i.e. iPad, Android etc. This will mean using an intuitive interface. Focus on making any tablet based presentation work fast and elegantly. Don’t try to cut corners with this, you need to make a good first impression, to engage interest from the word go and if there has been any compromise on your design or material it will be obvious.

It is definitely not a good idea to introduce strata of intricacy by cluttering up the presentation with features that are not going to be important to the users. Trying to cram too much in is likely to be the biggest mistake, under the misapprehension that: “The more features your presentation has, the better it will look.”  This doesn’t work. The simplest detail you can manage will invariably be the most successful in terms of your viewer remembering the message and prescribing his or her intent.

The benefit of developing an e-detail specifically for a tablet is that this device has been built specifically for you to interact and engage with any content. For example, one idea that makes a good visual impact is showing how a medical device might work. You can present product catalogues, or perhaps provide a dosage calculator to enable interaction with the medical professional. You could think of including videos or perhaps 3D images.  Try to devise engaging ways to present clinical data and always try to include mode of action demos, and even, for the more fun-loving professional – educational games!

There is no doubt that arriving with a sleek iPad will make your presence feel less intrusive than struggling in with abulging briefcase full of large product catalogues and other sales aids.  As technology races on at pace, it makes sense for pharma and medical device companies to take advantage of the benefits tablets and e-details offer.

Using Medical Apps for Diagnosing Patients

Using Medical Apps for Virtual DiagnosisIn May of this year Isabel Healthcare announced their new mobile application (app). The app is based on Isabel’s checklist system for diagnosis. The App allows doctors and nurses and other health care providers access to the app via iPhone, iPad or iPod touch mobiles.  Diagnosis can be established with the resulting possibility of treatment for patients being delivered faster.  And this innovative tool in the physician’s armoury has claimed a coveted top app rating in Apple’s Medical App category.  Where Isabel has gone many will follow and medical apps are beginning to make their presence felt in the medical community. Taking the Isabel App as an example it has been offered for download from Apple’s App Store with three subscription choices.  Customers can sign up for weekly, monthly or annual options, with the first level, the weekly option, pitched at just under £2.00 to attract the infrequent user.

Medical apps of the type offered by Isabel typically contain many thousand disease diagnostic markers both paediatric and adult and allow doctors instant access to the technologies that will help them make vital diagnoses.  Using a mobile diagnostic app a doctor does not even need to be in his hospital or clinic to diagnose a stroke in a patient and begin lifesaving treatment.  Using brain scan images that can be accessed via a smartphone and with an accuracy proven to be almost as reliable as the results of an ‘actual’ scan viewing, diagnosis can be made instantly.  This time saving ability is vital in the treatment of stroke victims.

Medical Apps – ‘Virtual’ Diagnosis?

Not everyone has welcomed this latest innovation in virtual diagnostics. There have been reservations concerning viewing detailed and complex anatomical images on a small 3.5-inch screen, from where critical emergency diagnoses will be made. However advances in image compression, microprocessors and wireless-data bandwidth, are likely to make this 21st century advance an essential diagnostic tool for doctors. For example, a CT scan image could be sent to a ‘cloud’ of the type that is commonly used as a storage device by PC users.  Downloaded to a mobile app or tablet, doctors could then zoom in to view images in more detail.  The use of this compression method to support any medical app is critical, in particular with the sending of high-resolution brain imagery.  Digital images are very large files to download and in a time sensitive situation such image files would take an hour to download using 3G or Wi-Fi.  Compression of the file overcomes this potential problem.

In countries where patients live in remote locations, this instant access diagnostic tool could prove invaluable.  In local or rural hospitals where medical staffing is limited, the instant access to patient’s results offered via this diagnostic tool, could also prove a lifesaver.

There is no doubt that this new application of technology will make a significant impact on the way in which doctors practice medicine both in and out of a hospital setting.   Gone will be the iconic picture of the consultant, clipboard in hand, with his entourage, visiting the wards.  In its place will be armies of medics with iPads and Android tablets that they can take home with them so that they always have a ‘virtual’ presence in their hospitals.

When is an app classed as a medical device?

Recently we’ve seen a number of apps with dosage calculator functions, some award winning, released to app stores but surprisingly these don’t seem to carry the CE mark to show that they have been registered with the MHRA as class I medical devices. There are currently over 11,000 medical apps in UK App stores aimed at HCPs which cover a huge number of disciplines from reference guides to dosage calculators. Everyday more and more are being added but how are HCPs supposed to know if the tools they are downloading have been thoroughly tested and are safe to use?

In the UK there is no official requirement to register smartphone or tablet apps either as software or devices with the MHRA and the guidelines that are available are just that, so it depends on what the app does and the level of patient risk associated with it as to whether it should be classified as a device or not.

 

The European Medical Device Directive MDD 93/42/EEC says:

‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

The inclusion of the word ‘software’ means that potentially all healthcare apps could fall under the medical device banner. However the meeting minutes from the Medical Device Technology Forum in 2010 show that the MHRA will apply further criteria to understand if ‘software’ needs to be categorised as a medical device.

  • Electronic Health Records (EHR) – while views apparently differ across Europe, the MHRA believes that if software is purely a record archiving and retrieval system it is unlikely to be considered a medical device. However if it includes a module that interprets data or performs a calculation, then it is likely that this module (or system) may be considered a medical device, depending on the claims of the manufacturer. 
  • Decision Support software will generally not be considered a medical device if it exists to provide already existing information to enable a healthcare professional to make a clinical decision. However, if it performs a calculation or the software interprets or interpolates data and the healthcare professional does not review the raw data, then this software may be considered a medical device.

Now, common sense must prevail but for example, an app that calculates BMI is highly unlikely to fall within their definition of a medical device, but a dosage calculator which produces a recommended dose based on a patients details, would.

Based on the information available and to ensure patients are not being put at risk, if you are thinking of developing an app that will use patient data to either contribute to, or make a clinical decision then you should submit a registration for the app as a class I device with the MHRA.

Notifying the MHRA

If you want your app to carry the CE mark as proof that it conforms to the Medical Device Directive, you will need to notify the MHRA as soon as it is applied to the device. This process involves producing a declaration of conformity which includes a detailed technical document that proves that the design conforms to the directive. As part of the technical documentation you will also need to have undertaken a controlled test and risk assessment to demonstrate that the app supports and improves upon any existing process used to present the same information. Once all the documentation is in place you can submit your registration with the MHRA and your fee for the registration which currently stands at £70.00.

Ultimately there is no definitive answer as to whether an app should be registered as a device and until such a time as regulation dictates that all apps are registered as medical devices, it’s down to the nature of the app and what it does, applied with common sense that will dictate if an app should carry the CE mark.

What would be interesting however is to understand that if apps carry the CE mark, would they be more likely to be seen as a trusted source by HCPs for use within their professional day?

References: d4.org.uk, mhra.gov.uk