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Pharma’s Digital Initiatives In India: A Missing Link

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An interesting study – designed to investigate the challenges that Health and Human Services (HHS) organizations face in implementing digital and data solutions, stands out today – for many reasons. One such being, this ‘multi-country survey’ project team had no inkling about the pandemic when the project was undertaken.

This study was conducted by a research team from Imperial College London’s Institute of Global Health Innovation (IGHI), and was sponsored by EY. The survey comprises of more than 2,000 global HHS professionals – from India, Australia, Italy, UAE, the UK and the US. 359 respondents were from India.

The research passed through the phase when Covid related disruptions was about to put HHS providers through the most extreme stress test in living memory. ‘While the outbreak was catastrophic in its effects, it presented the researchers with an exceptional opportunity to study the sector’s behavior during a pivotal moment,’ the paper noted.

From this perspective, today’s article will explore, from various different sources, across the world, how Covid-triggered rapid development and adoption of digital solutions are in the process of making a paradigm shift in the healthcare space. It spans across – health care service providers, its users, and practitioners – including pharma industry and the tech-solution developers.

Consequently, the question arises, would healthcare industry’s innovative spirit of 2020 is robust enough for taking a quantum leap in this space, as we move on. That space will span across – conceptualization and development of new health care products and services, alongside their consumption pattern and consumer behavioral dynamics. And, right up to the adoption of cutting-edge digital technology for commensurate delivery mechanisms. Let me start with some key findings in this area from the above report.

Some key findings – Global and India:

The findings of the Report titled, ‘Embracing digital: is COVID-19 the catalyst for lasting change?’ published on January 13, 2021, ferreted out some interesting facts, with details. These encompass both global and Indian scenario, in this area.

Some key findings – Global:

  • Pre-pandemic – just 18% of HHS providers had managed to embed digital tools in the way they work – mostly, due to lack of funds, regulatory restrictions, and risk aversion. However, the pandemic outbreak swept away many of these barriers, as 62% of organizations have now started using digital technologies and data solutions, globally.
  • 48% organizations are planning to continue investing in technology during the next three years, with 33% expecting more than 50%, and 19% more than 100% increase in investment.
  • While phone consultations are being offered by 81 % of HHS organizations (up from 39 % before the pandemic), 71 % of organizations offering video consultations (up from 22 % before the pandemic).
  • Respondents’ top objectives for future investment towards rapid adoption of digital solutionsinclude, transforming ways of working and service delivery, improving quality of care, reducing the administrative load, enabling better communications, and streamlining work processes.
  • However, 47% of respondents think, the introduction of digital and data solutions was a temporary measure to address challenges during the pandemic.

Some key findings – India:

The Covid-19 pandemic triggered fast acceleration of the adoption of digital technologies by the HHS in India, as well.

  • 51% of respondents from India reported that their respective organizations have increased the use of digital technologies and data solutions since the Covid-19 outbreak.
  • Increased staff productivity reported for 74 % of respondents’ organizations with 75% reporting that digital solutions have been effective in delivering better outcomes for patients and service users.
  • Remote consultations, such as, phone and video consultations have witnessed a greater increase in India than the global average. 86 % of Indian organizations are now offering phone consultation (up from 48 % before pandemic) and 83 % for video consultations (up from 33 % before pandemic).
  • Around three fourth of the respondents in India reported positive experiences with digital technologies and data solutions with the number of people using online consultations in India recording a threefold increase.

This encouraging trend and pattern needs to be consolidated, analyzed, and leveraged – for sharper actionable insights for the development of more contemporary products and services to delight the pharma and health care stakeholders.

A key missing link in India:

The digital health transformation of India’s healthcare system during Covid pandemic was also captured in another article, published by Elsevier Connect on February 23, 2021. It reiterated, although the pandemic has made an overall detrimental impact impacted on India, ‘it has brought about an avalanche of positive changes, including the adoption of digital health technologies and significant changes to the way care is delivered.’ Looking ahead, ‘With the launch of national public health initiatives, India has an incredible opportunity to become a digital health leader,’ the paper predicted.

However, the author also pointed out, unambiguously, that the health care crisis caused by the pandemic has also brought to the fore a key missing link – the need for updated and near real-time availability of trusted information. This observation is more relevant now than ever before, especially considering India’s National Digital Health Mission (NDHM).

National Digital Health Mission – a new ambition:

While addressing the nation on August 15, 2020, Prime Minister Narendra Modi announced the National Digital Health Mission of India. He said in his speech, “From today, the national digital health mission will begin. It will revolutionize the Indian healthcare sector. Every Indian will be issued a health ID that will act like a healthcare account, storing details of all the tests done, existing diseases, diagnoses, medicines prescribed.”

The objectives of the mission are to establish a core digital health database, creating a system of Electronic Health Records (EHR) based on international standards, establish data ownership pathways, so that patients become the owner of their health records, and promoting health data analytics and medical research. This initiative by any standard, is expected to be a game changer, as and when it comes to fruition.

Subsequently, on June 25, 2020, the Union Ministry of Health, reportedly, wrote to the principal secretaries (health) of all states and union territories, asking them to extend full support to the NHA to create four registries — doctors, health infrastructure, health IDs and personal health records of patients. It also instructed the states to send the required details within the stipulated timeline without breaching the norms of data privacy.

Need to avoid any possible missing link in the NDHM:

However, the Harvard Business Review article, published on June 12, 2020, asserted that the emergence of the COVID-19 pandemic not only presented a “mind-boggling array of challenges” exposed the limitations of the electronic health record (EHR) in helping physicians deliver care, especially in the United States.

It suggested: transformation of the EHR from an emphasis on a ‘person’s medical record’ – to an emphasis on their ‘plan for health’ and from a focus on ‘supporting clinical transactions’ to a focus on ‘delivering information’ to the provider and the patient, will be more meaningful.

Thus, it’s time for a new kind of EHR system in today’s perspective, as suggested by the HBR article, besides other domain experts. I am sure, competent authorities will take note of this transformation required in EHR initiatives to avoid any missing link in the new digital healthcare space in India.

As the above Elsevier Connect paper also observed, with the launch of national public health initiatives, such as, Ayushman Bharat and National Digital Health Mission (NDHM), India harbors an incredible opportunity to showcase its world class digital health ecosystem for all in the country.

To help fructify these projects, all key stakeholders – health care service providers, its users, and practitioners – including the pharma industry and the tech solution companies, need to get intimately involved with a common agenda in place. Falling behind may invite regrets, later.

Nonetheless, well before that – the common missing links in India - near real-time availability of credible data, trusted and verified information for adopting digital health for patients that will need to be provided by clinicians in a seamless manner, should be carefully identified and addressed.

New steps into digital healthcare are on the way:

Several new steps into digital healthcare have been taken in various countries of the world. One such initiative is ‘Internet Hospitals.’ These are basically an internet-medical-platform combining online and offline access for medical institutions to provide a variety of telehealth services directly to patients.

A Deloitte paper – ‘Internet Hospitals in China: The new step into digital healthcare,’ published on March 16, 2021 says: ‘Online hospitals are typically offshoots of offline medical organizations. The combination of Internet with health care will drive the medical industry’s transformation into a health service provider from a health care supplier, distributing resources equally and enhancing efficiency,’ moving ‘towards future smart health care.’

Conclusion:

Covid-19 has created a new focus on the digital health ecosystem in India, for accelerating the use of digital technology to radically advance health care systems and save lives. Today, many are experiencing that, big data, analytics, artificial intelligence, remote learning, and data inter-connectivity, can make a real difference to the work of HHS professionals in India.

Embracing digital with accelerated speed during the pandemic, has reportedly started making a significant positive impact on the cycle of the patient’s clinical assessment, treatment, and monitoring. With increasing use, it would reduce the cost of health care, improve patient access to affordable treatment and care services, when many patients’ journey for disease treatment will start online, and get directed to the optimal care setting either physically or virtually.

The article on health-tech, published in the Fortune India on February 20, 2021, has aptly concluded: ‘Eventually health technology infusion in the Indian healthcare ecosystem will be the route to enhance patient-centric healthcare accessibility, affordability, and sustainability. The advent of 5G technology in the country is poised to further catalyze this momentum.’ This, in turn, will facilitate ushering in more game changing steps into digital healthcare, creating a new ecosystem, greater awareness and a keen desire to remain healthy for all.

Thus, from the GIGO perspective, as defined by the Cambridge Dictionary, I reckon, in pharma’s digital initiatives, especially in India, a key factor needs to be carefully addressed. This is – fathoming existence of any missing link involving near real-time availability of trusted information and credible data generation, which could indeed be a great spoiler of any painstaking digital adoption project.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

‘One Indian, One Health Record’: Is EHR A Tentative Intent?

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The ongoing march of technology, at a scorching pace, transforming our everyday personal – working and social lives. This is palpable. In tandem, it is also making traditional processes of doing successful business less and less productive, over a period of time. The same is more than visible in the healthcare space too. One such field – although not so widely discussed just yet, is maintaining Electronic Health Record (EHR). This is so important for both patients and healthcare providers to ensure significantly better treatment outcomes at a lesser cost, and reducing disease burden of disease too, in that endeavor.

EHR being a systematic, ongoing process of maintaining health records of every individual, help provide prompt, effective and safe health care for all. It helps immensely whenever the person visits a doctor either in private clinics or in any health center for treatment of any disease condition, or even for preventive measures.

Health profession bodies in various countries have articulated what should get included in the health record of individuals. Let me draw an example from one of the BRICS nations. The Health Profession Council of South Africa (HPCSA) defines health records as “any relevant record made by a health care practitioner at the time of, or subsequent to, a consultation and/or examination or the application of health management”. Since, over any person’s lifetime a massive health data gets generated, the current trend is to capture and store such medical data electronically and is, therefore, called ‘Electronic Health Record’ or EHR.

Laudably, India also formally notified its detail intent to make EHR system work in the country. In this article, I shall deliberate on what is the current status of EHR in India, and the key barriers that need to be overcome to make the process gain momentum, in the days ahead.

What EHR can do:

Before zeroing on to India specific initiative on EHR, let me recapitulate what it entails, quoting from a credible global source. According to Health IT- the official website of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services, being real-time- patient-centered records, EHRs make health information available instantly, “whenever and wherever it is needed”. As this process brings together in one place everything about a patient’s health, EHRs can:

  • Contain information about a patient’s medical history, diagnoses, medications, immunization dates, allergies, radiology images, and lab and test results
  • Offer access to evidence-based tools that providers can use in making decisions about a patient’s care
  • Automate and streamline provider’s workflow
  • Increase organization and accuracy of patient information
  • Support key market changes in payer requirements and consumer expectations

Let me reiterate at this point, a person’ EHR can bring together all health information from all the doctors visited at private clinics, hospital, health centers, school and workplace clinics, pharmacies and diagnostic facilities. In many countries, EHRs can be created, managed, and consulted by authorized providers and staff across more than one health care organization. This process has been followed, though in a very limited way, in India, as well.

EHR initiative in India:

In sync with Prime Minister Narendra Modi’s Digital India initiative, India reconfirmed its EHR initiative, just as ‘Aadhar’. By a notification, it explained how a cloud-based hospital application system will receive real-time health data of all individuals generated during any clinical encounter or events. Interestingly, EHR standards were first notified by the Indian government in 2013.

Be that as it may, with a fresh vow to popularize EHR in the country, especially among the health care providers, the Ministry of Health and Family Welfares revised the 2013 EHR standards and notified the same on December 30, 2016. A paper titled ‘EHR Adoption in India: Potential and the Challenges’, published in the Indian Journal of Science and Technology in September 2016, presents some interesting findings. Some of these are as follows:

  • Adoption of EHR has been significantly less in India as compared to other developed nations. This is despite the government’s enhancing the budget to US$ 19.2 billion for HIT for its greater acceptance and influence returns.
  • The reason may be attributed to the fact that EHR is not yet mandatory in India. (In my personal view, this is quite unlike what was Aadhar, for a plethora of government and private services, till the Supreme Court verdict came.)
  • In many countries implementation of EHR in the health care system is working very well, benefiting both healthcare providers and the patients, immensely.

The key barriers: 

The above paper identified the following as the key barriers to EHR implementation in India:

  • Legacy System: Most of the patient records are paper based documents. It’s challenging to convert the paper-based records to an electronic format.
  • Cost: High cost of implementation.
  • Policy: Absence of coordinated policy of Government. Lack of clarity in the existing policies of HIT.
  • Funding: Current actual funding of the government for HIT is grossly inadequate, besides lack of well-trained medical informatics professionals.
  • Standards: Most systems don’t adhere to standards, besides usage of multiple local languages by patients and staff.
  • Computer Literacy: Low Computer literacy among government staff and private hospital community, and lack of adequate system training on proper usage of the HER.
  • Coordination and Infrastructure: Lack of coordination and supporting infrastructure (including the hardware and software) among both public and private sector hospitals.
  • Privacy Concerns: Privacy concern on the confidentiality of patient health record needs to be properly addressed.

That’s a 2016 report, what’s happening in 2018?

One may justifiably comment and ask – the above details are of 2016, what is happening today – in 2018?

Even after 2 years since then, EHR still remains at a nascent stage in India, with the keep barriers refusing to get dislodged. The July 16, 2018 media headline – ‘Adoption of e-medical records facing infra hurdles’ clarifies it. It says: “The government is facing serious challenges in its efforts to adopt an electronic health record (EHR) system.” This news report quotes the latest report prepared by the ministry of electronics and information technology (MeitY), titled ‘Adoption of Electronic Health Records: A Roadmap for India’.

This paper highlights that the government is still facing serious challenges in adopting (EHR) system for every Indian’s medical record that can be accessed by doctors and hospitals – transforming the speed, quality and cost of healthcare in India.  Intriguingly, the challenges, continue to range from infrastructure creation, policy and regulations, standards and interoperability to research and development.

The report also emphasized: “With more than 75 percent of outpatients and more than 60 percent of inpatients in India being treated in private health care facilities, it is necessary for the government to bring these establishments on-board for using EHR. In view of the size of the country, there is a need to take a Free and Open Source Software (FOSS) approach to make good quality software available to hospitals and individual practitioners.”

EHR in the United Staes and other countries:

According to the ASHP National Survey of Pharmacy Practice in Hospital Settings: Prescribing and Transcribing – 2016, ninety-nine percent of hospitals across the United States now use EHR systems, compared to about 31 percent in 2003. Computerized prescriber-order-entry (CPOE) systems with clinical decision support are used by 96 percent of hospitals.

As indicated in the above September 2016 article of the published in the Indian Journal of Science and Technology the EHR implementation rate in China is 96 percent, Brazil – 92 percent, France – 85 percent, and even in Russia the same is at 93 percent.

EHR, in various form is working in many other countries of the world. Let me cite an example from nearer home. As captured in the Accenture paper titled “Singapore’s Journey to Build a National Electronic Health Record System,” Singapore government has articulated the essence of EHR with its vision that is easy to understand and remember by all – “One Singaporean, One Health Record.” To improve health care quality for all residents, increase patient safety, lower health care costs and develop more effective health policies, Singapore’s MOH created this vision that enables patient health records to be shared across the nation’s healthcare ecosystem.

Conclusion:

Borrowing the concept of Singapore, I reckon, EHR should also mean to all Indians: “One Indian, One Health Record.” I fully agree that this process isn’t easy. Many barriers require to be overcome in pursuit of this pathway – successfully. No country found this process easy, neither it is expected in India.

That said, the key question is, can India do it successfully in a relatively short period of time? My answer undoubtedly will be an emphatic yes. This is because India has the world-class IT service providers, such as Infosys, TCS and Wipro, to name a few. It means, India has the capability. Does India have the financial resources, as well? Going by the incumbent government notification on the implementation of the revised EHR standards in India, together with what it says about the country’s economic robustness – I would again say – yes, the country possibly has the financial resources too.

It seems very much possible, also considering what the last two successive governments could conceptualize, structure and implement – a massive project of similar nature and magnitude for all Indians – ‘Aadhar’. When ‘Aadhar’ could so quickly be linked with all services – provided virtually by all public and private organizations, why can’t EHR be linked with all health records of every Indian, backed by appropriate infrastructure, human resources, laws and policies?

If a new law is required for addressing privacy and ownership concerns on health data generated for all, so be it! Doesn’t this initiative need to be visible to all – just as ‘Aadhar’ project, with a priority tag attached to it?

Thus, from the perspective of ‘One Indian, One Health Record’, government notification on EHR standards in 2013, and then revising and notifying the same in 2016, appears to be no more than a tentative intent. It has been happening to several important public health care initiatives for long, and continues to happen even today.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

India Needs More Integrated, High Quality E-Commerce Initiatives In Healthcare

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In the digital space of India, many startups have been actively engaged in giving shape to a good number interesting and path breaking ideas, especially since the last ten years. One such area is ‘electronic commerce’ or ‘e-commerce’.

In the e-commerce business, particularly the following business model is gaining greater ground and popularity:

Here, an e-commerce company plans to generate large revenue streams on hundreds and thousands of items without producing and warehousing any of these, or carrying any inventory, handling, packaging and shipping. It just collects, aggregates and provides detailed and reliable information on goods and/or services from several competing sources or aggregators, at its website for the consumers.

The firm’s strength primarily lies in its ability to draw visitors to its website, and creating a user-friendly digital platform for easy matching of prices and specifications, payment and delivery, as preferred by the buyers.

Growing e-commerce in India:

Today, e-commerce players in the country are not just a small few in number. The list even includes many of those who have already attained a reasonable size and scale of operation, or at least a critical mass. Among many others, some examples, such as, ‘Flipkart’, ‘Bigbasket’, ‘HomeShop18’, ‘Trukky’ and ‘Ola’ may suffice in this context.

Currently, these companies try to satisfy various needs of the consumers related to, such as, lifestyle, daily households, logistics, and other chores, at any time of the users’ convenience and choice, with requisite speed, variety and reliability.

Healthcare initiatives need to catch up:

Despite the overall encouraging scenario, every day in India a large number of the population, even those who can afford to pay, at least a modest amount, still struggle while going through the unstructured and cumbersome process of access to better and comprehensive health care services. The situation continued to linger, despite the ongoing game-changing digital leaps being taken by many startups in various other fields within the cyberspace of India.

Nevertheless, the good news is, it has now started happening in the healthcare space, as well, though most projects are still in a nascent stage. The not so good news is, many of these world class services, though available, are still not known to many.

The medical treatment process is complicated:

The medical treatment process is just not complicated; it is non-transparent too. There is hardly any scope for doing an easy-to-do personal research by common people to ascertain even a ballpark number on the treatment cost, with requisite details of the various processes, that a patient may need to undergo. 

Thus, in pursuit of quality health care at optimal cost in today’s complex scenario in India, one will require to get engaged in time-intensive and complicated research, first to find out, and then to effectively manage the multiple variables for access to comprehensive and meaningful information to facilitate patients’ decision making on the same. For most people, it’s still a challenge to easily collect all these details on a user-friendly platform of any credible and transparent online website.

The usual treatment process:

The usual process that any patient would need to follow during any serious illness is cumbersome, scattered and non-transparent. This is, of course, a natural outcome of the generally deplorable conditions and, in many cases, even absence of quality public health infrastructure in India, forget for the time being about the Universal Health Care (UHC). 

During such illness, one will first need, at least, a General Practitioner (GP), if required a secondary and a tertiary doctor, alongside well-equipped diagnostic laboratories. Then follows the medical prescriptions, or advice for any invasive procedure, buying the right medicines, as required for the treatment of the disease condition, and thereafter comes the desired relief, hopefully. 

Each of these steps being different silos, there were not many easy options available to most patients, in this tortuous quest for good health, but to go for expensive private health care. Currently, this entire process is over-dependent on word-of-mouth information, and various advice from vested interests.

Never before opportunity:

There seems to be an immense opportunity waiting in the wings for any e-commerce business in India, providing a comprehensive and well-integrated information network for the patients directly, enabling them to take well-informed decisions for reliable, cost-effective and high quality health care services.

This has been facilitated by increasing mobile phone usage in India. According to India Telecom Stat of January 2016, the number of mobile phone users in the country has now crossed one billion. Experts believe that a large section of these subscribers will soon be the users of smartphones.

Rapid growth of internet connectivity with the affordable smartphones, fueled by the world’s cheapest call tariffs, commensurate availability of various attractive packages for data usage, would empower the users avail integrated, comprehensive and high quality e-commerce services in the healthcare sector too, sooner than later.

Would it reduce health care cost?

A transparent system of integrated health care services could bring health care cost significantly.

For example, one can find out from such websites, not just a large number of doctors from any given specialty, including dentistry. Alongside will be available many other important information, such as, their location, availability time and fees charged.

This would help patients comparing the doctors from the same specialty, especially from the quality feedbacks published on the website. This would facilitate patients taking a well informed decision for disease treatment according to their individual needs and affordability. The same process could be followed for selecting diagnostic laboratories, or even to buy medicines.

Such open and transparent websites, after gaining desired confidence and credibility of the users, would also help generate enough competition between healthcare service providers, making the private health care costs more reasonable, as compared to the existing practices.

These e-commerce companies would arrange immediate appointments according to the convenience and needs of the patients, and also help in delivering the prescribed medicines at their door steps. 

Some initiatives around the world:

Many startups are now setting shops in this area, around the world. Just to give a flavor, I would cite a few examples, as follows, among many others:

Name Country Services
Doctoralia http://www.doctoralia.com Spain A global online platform that allows users to search, read ratings, and book appointments with healthcare professionals 
iMediaSante http://www.imediasante.com/ France Provides patients to make medical appointments from a mobile for free. 
DocASAP http://www.docasap.com United States An online platform enabling patients to book appointments with the doctors and dentists of their choice.
Zocdoc https://www.zocdoc.com/ United States Solves patient problems with instant online appointment booking, provides verified reviews and tailored reminders.
Lybrate.com https://www.lybrate.com/ India Provides access to a verified online doctor database of over 90,000 medical experts, including in Ayurveda and Homeopathy, for appointments and to ask any question.
Practo http://www.practo.com/ India An online platform for patients to find and book appointments with doctors. Doctors use Practo Ray software to manage their practice.  

An Indian example:

In this sphere, one of the most encouraging Indian examples would be the Bangalore based Practo Technologies Private Ltd. This startup debuted in 2008, and in a comparative yardstick, has been the country’s most successful business in this area, so far. Its key stated goal has been bringing order to India’s rather chaotic health care system.

Currently, Practo connects 60 million users, 200,000 doctors and 10,000 hospitals. According to a May 27, 2016 report of Bloomberg Technology, Practo website is used to book over 40 million appointments, every year.

This e-commerce company also offers online consultations, and home deliveries of medicine. Its software and mobile applications link people and doctors, as well as hospital systems, so that they can effectively manage the visits and billing, while helping patients find physicians and access their digital medical records.

At present, Practo offers services in 35 cities, and plans to extend that to 100 by the end of this year. The company reportedly is now expanding in Indonesia, the Philippines and Singapore, with a future expansion plan in Latin America, starting with Brazil in March 2016.

How would India shape up?

Although, these are still the early days, according to Grand View Research Inc., based in San Francisco in the United States, the global healthcare information technology market is right on track to reach US$ 104.5 billion by 2020. Increasing demand, especially from the middle income population for enhanced healthcare facilities, and introduction of technologically advanced systems, are expected to boost the growth of this industry.

Increasing rural penetration of e-commerce on integrated health care, would be a major growth booster for this industry in India.

Besides its distant competitor Lybrate, Practo does not have any tough competition in India, at present. However, the scenario may not remain the same, even in the near future. 

Keeping an eye on this fast growing market, two former top executives from India’s e-commerce leader – Flipkart are launching their own health-tech startup creating a new rival for Practo, according to the above Bloomberg report. Thus, it is a much encouraging fast ‘happening’ situation in the interesting digital space of the country. 

Conclusion:

Evolution of Indian e-commerce in health care is an encouraging development to follow. It would offer well-integrated, comprehensive and cost-effective health care services to many patients. Gradually penetration of this digital platform, even in the hinterlands of India, would help minimize quality health care related hassle of many patients, along with a significant reduction of out-of-pocket health expenditure cost.

Interestingly, there is no dearth of doomsayers against such novel initiatives, either. A few of them even say, it doesn’t make sense for the doctors to list themselves in the e-commerce directory for the patients to find them, as the patients desperately need them for any medical treatment, in any case. Others counter argue by saying that acquiring patients online should be a preferable way for doctors to maximize their income, among others, especially by eliminating the referral fees, which many specialists in India require paying for the source of referral.

However, I reckon, a larger number of credible and transparent e-commerce websites for integrated healthcare services, all in one website, would enhance competition, bring more innovation, and in that process delight many patients in India. Never before it was so promising, as the country is making a great progress in the smartphones’ usage, along with Internet access, in the country. The unique facility of free search for medical care services would also help patients immensely in choosing quality, and cost effective medical treatment interventions that would suit their pocket. 

To achieve this goal, the highly competitive digital process of integration and aggregation of requisite pre-verified latest information on different health care service providers and aggregators, in the most innovative and user-friendly way, would play a crucial role. In tandem, delivering the prescribed medicines at the patients’ door steps in strict compliance with the regulatory requirements, would really be a treat to follow in the rapidly evolving digital startup space of India.

The name of the game is ‘Idea’. The idea of offering innovative, well-integrated, comprehensive, user-friendly, and differential value delivery digital platforms for healthcare e-commerce. It shouldn’t just overwhelmingly be what the sellers want to force-feed, but where the majority of patients on their own volition can identify the differential values, and pay for these, willingly.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Marketing Off-label Use of Drugs: A Path Much Abused?

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As many would know, prescribing any medicine for disease conditions that are not approved by the drug approving authorities while granting its marketing approval, is generally termed as ‘off-label’ use of drugs.

It is also a usual practice in most of the regulated markets of the world that once the drug regulators give marketing approval of a medicine, which is indication-specific, physicians are free to prescribe these as they deem necessary. However, the drug manufacturers can seek prescription support from the doctors only for the indications as approved by the appropriate government authorities.

Even the USFDA had articulated, “the best way to address any concerns that the information about those (off-label) uses is not reaching medical practitioners is to get those uses in the labeling. We believe that the risks of allowing drug companies to distribute journal articles and other information about off label uses far outweigh any benefits.”        

Since long, most of the drug regulators across the world, including the Drug Controller General of India (DCGI) have prohibited the sales promotion for unapproved uses of drugs to doctors. Nevertheless, the practice continues ignoring its serious consequences.

Monitoring of ‘off-label’ use is challenging: 

Monitoring of off-label use of medicines is quite challenging too by the drug regulators, especially in India, where post marketing surveillance is generally just on paper.

In this regard, a recent research study that I shall refer to below in this article, has quite appropriately suggested, “Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.”

As India intends to move towards the ‘Digital’ space, this suggestion would be quite implementable by the DCGI, as the ‘Smart Cities’ start coming up.

Some examples of extensive off-label usages: 

According to the study done by a team of experts in medical information – Iodine, using the top drugs by number of monthly prescriptions, the following is a list of 4 medications with surprising off-label uses:

Drug Approved Indication Off-label Indication
Abilify (Aripiprazole) Schizophrenia, Bipolar Disorder, Major Depressive Disorder (adjunctive), Autism-related Irritability, Agitation associated with Schizophrenia or Bipolar Mania, other Insomnia
Lyrica (Pregabalin) Management of: neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury; adult patients with partial onset seizures (adjunctive) Anxiety
Namenda (Memantine) Moderate to severe dementia of the Alzheimer’s type ADHD, OCD
Synthroid (Levothyroxine) Low thyroid hormone levels, some types of goiters, management some types of thyroid cancers Depression

Off-label use and increasing risks of drug safety: 

In its November 02, 2015 online issue, JAMA Internal Medicine published an article titled, “Association of Off-Label Drug Use and Adverse Drug Events (ADE) in an Adult Population.” The objective of this study was to monitor and evaluate off-label use of prescription drugs and its effect on ADEs in an adult population.

This particular study assumes importance, as off-label use of prescription drugs without strong scientific evidence has been identified as an important contributor to preventable Adverse Drug Events (ADEs), especially in children. However, despite concerns in this regard, no systematic investigation on the effects of off-label drug use in adult populations is being performed, regularly.

The detail analysis of this study reveals that not only is the benefit of off-label prescription is uncertain, but the risks of ADEs could make the ‘risk-benefit ratio’ quite unfavorable. So much so that in a large number of cases, no drug treatment will be a much better option.

According to the authors, the risk for ADEs grew as the number of prescription drugs the patient used increased. For example, patients using eight or more drugs had more than a 5-fold increased risk for ADEs compared with patients who used one to two drugs.

The study involving 46,021 adult patients, receiving 151,305 prescriptions between January 2005 and December 2009 was done in Canada. Of those prescriptions, more than 10 percent were prescribed for off-label use. Interestingly, out of that group, more than 80 percent prescriptions were for off-label uses without any robust scientific evidence supporting the use.

Based on the findings the researchers concluded that off-label use of prescription drugs is associated with ADEs.

The article suggested:

  • Caution should be exercised in prescribing drugs for off-label uses that lack strong scientific evidence.
  • Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.

Pharma industry strongly opposes off-label use, when it suits them:

Interestingly, pharma industry vehemently opposes off-label use of drugs, when it suits them.

To give just a couple of examples, recently a new law that permits prescribing of drugs for off-label uses in France has reportedly been strongly opposed by the pharmaceutical industry in Europe.

Pharma trade associations argue, “the above move of France is directly in opposition to European Union’s laws that prohibit member states from supporting off-label use for economic purposes, and is a trend that undermines the current regulatory framework and could put patients’ health at risk.”

Besides France, they have also submitted a complaint against Italy to the European Commission over the country’s new off-label rules.

Common methods followed for off-label marketing:

The other side of the story is that, reportedly many pharma companies continue promoting off-label uses of drugs aggressively, for significant commercial gains.

According to ‘The Centers for Medicare & Medicaid Services (CMS) – a federal agency within the United States Department of Health and Human Services, some of the off-label drug promotion methods of the pharmaceutical companies are as follows:

• Paying incentives to sales representatives based on sales for off-label use

• Paying kickbacks to physicians to prescribe drugs for off-label use

• Disseminating misleading posters promoting off-label use

• Paying physicians:

- To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents

- To serve as members of “advisory boards” promoting off-label use

- To travel to resort locations to listen to promotions about off-label use

- To give promotional lectures in favor of off-label use to fellow practitioners

• Publicizing studies showing efficacy of off-label uses, while suppressing studies showing no efficacy.

Even the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) of the Government of India does not allow such sales and marketing practices. But these all continue to happen, unabatedly.

A path much abused?

Although most of the drug companies publicly advocate self regulation to avoid unethical marketing practices, the situation on the ground is much different, across the world. 

The following are just a few examples of serious business consequences faced by some of the well-known global pharma and biotech majors, besides many others, from the United States Department of Justice, for alleged off-label promotion of drugs: 

  • On November 4, 2013, Johnson & Johnson (J&J) was asked to pay more than US$ 2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promoting for uses not approved as safe and effective by the USFDA and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  
  • On July 30, 2013, Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, agreed to pay US$490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the USFDA. 
  • On December 19, 2012, Amgen Inc. pleaded guilty and paid US$762 million to resolve criminal liability and false claims allegations.
  • On July 2, 2012 GlaxoSmithKline LLC (GSK) pleaded guilty and paid US$3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. This resolution is the largest health care fraud settlement in the US history and the largest payment ever by a drug company, so far. 
  • On May 7, 2012, Abbott Laboratories Inc. pleaded guilty and agreed to pay US$1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the USFDA.  This resolution is the second largest payment by a drug company and includes a criminal fine and forfeiture totaling US$700 million and civil settlements with the federal government and the states totaling US$800 million.  Abbott also was reportedly subjected to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.
  • On October 21, 2011, Pfizer Inc. agreed to pay US$14.5 million to resolve false claims allegations related to its marketing of the drug Detrol. 
  • On June 10, 2011, Novo Nordisk was asked to pay US$25 million to resolve allegations of off-label promotion of Novoseven.
  • On September 30, 2010, Novartis agreed to pay US$422.5 million to settle criminal and civil investigations into the marketing of the anti-seizure medicine Trileptal and five other drugs. The government accused Novartis of mislabeling, paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. 

Hence, it appears that the path followed by many pharma players to inform the doctors about the judicious off-label use of drugs only in circumstances where approved treatments have failed, is being much abused. 

A conflict of interest? 

Many doctors believe that there is also a distinct upside for off-label use of drugs, as flexibility of a physician to prescribe drugs off-label offers important advantages too, especially in circumstances where approved treatments have failed. This is indeed true and indisputable.

However, the reality is, many pharma industry, in general, actively encourage off-label use of drugs for commercial benefits through expanded use of their respective brands.

Aggressive drug promotion for various off-label uses, reportedly being so widespread and indiscriminate, many physicians can’t even remember the approved indications of drugs. Hence, they do not necessarily go for off-label use only when approved treatments have failed.  In this context, on November 23, 2015, ‘The Wall Street Journal (WSJ)’ in an article titled, “Risk of Off-Label Uses for Prescription Drugs” reported as follows:

“A 2009 study published in the journal Pharmacoepidemiology and Drug Safety found that 1,199 physicians in a national survey were able to identify the FDA-approved indication of 22 drugs only about 55% of the time. The physicians surveyed included primary-care doctors and psychiatrists.” 

On the other hand, the patients generally expect that the prescribed drugs will be safe. They want to administer evidence based approved medicines. Some of them have even started expressing that these evidences must also be disclosed to them.

Hence, there seems to exist a clear conflict of interest in this matter between the patients, drug manufacturers and perhaps the doctors, as well.

Conclusion:

The magnitude of general off-label use of drugs is reportedly increasing and is likely to increase further, exposing patients to increased risks of ADEs.  Although the business consequences of getting engaged in this unwanted process indiscriminately could at times be quite adverse, in the balance of probability between slim chances of getting caught, and expected creamy return, many pharma players continue to feel that this risk is worth taking.

Therefore, the moot question that needs a pragmatic answer is, for patients’ safety, when the global and local pharma majors talk about prescriptions of only impeccable evidence based medicine, do they walk the talk?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

‘e-detailing’: The Future of Pharmaceutical Sales?

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Pharmaceutical product detailing to doctors by Medical Representatives (MRs) is believed to fetch the single largest return on marketing investments by the pharmaceutical companies globally, as on date.

At the same time, the pharma players, across the world, are increasingly experiencing that the costs of product detailing by the MRs to the doctors are not now quite commensurate to the desired return in terms of financial results, despite bringing in many new skills and other productivity improvement measures on a regular basis.

Thus, to make such interaction between the MRs and the doctors more productive and cost efficient, increasingly the global pharmaceutical industry has been exploring various models and methods with numerous state-of-art digital Internet based applications. Some pharmaceutical companies, especially, from the western world, have already started putting such innovation into practice.

Waning productivity of traditional detailing:

This is quite apparent now that due to changing market dynamics and increasingly busy schedules of the doctors, the productivity of traditional product detailing is fast waning. As a result, pharmaceutical companies are encountering huge challenges in the process of generating prescription demand for their respective products by taking commensurate share of mind of the Physicians.

This is mainly because, the number of patients is also now fast increasing and the doctors are trying to see these large numbers of patients within their limited available time. As a result each patient is getting lesser doctors’ time, while the doctors are trying to provide optimal patient care in each patient visit. At the same time, other obligations of various kinds also overcrowd physicians’ time.

As a result, increasing number of MRs, which has almost double in the past decade, is now fiercely competing to get a share of lesser and lesser available time of the doctors. Added to this, increasing inflow of new doctors not being in line with the increasing inflow of patients is making the situation even worse.

As stated earlier, significant expenditure that the pharma companies have been incurring towards product detailing, many of them feel, is not resulting into desired top and bottom line growth for the organization, any more. Even good numbers of important specialist doctors do not seem to value this traditional MR product detailing process any longer, mainly due to immense time pressure on them and also due to their easy access to other modern product information gathering tools.

What is happening today:

Today, keeping the core concept of traditional detailing unchanged a few, especially large pharmaceutical companies in India, have introduced a number of digital interventions to eliminate some important manual processes that MRs used to follow earlier like, call planning, access to other relevant information electronically, instant reporting etc. 

Such incremental improvements in the traditional detailing model, though helpful to the MRs, do not seem to be just good enough to produce desired business results in today’s highly competitive environment. The time calls for radical technological interventions.

A new report on the trend: 

According to a new study of CMI Communication Media research report, about half of physicians restrict visits from MRs in one way or another.

It reported, just half of cancer specialists (oncologists) saying that they would interact about new products with MRs, while 47% of them indicated email as a preference.

Surveys found the oncologists being the most restrictive specialists, with only 19% allowing MRs without restrictions. On the other hand, 20% of them would not see MRs at all, with the 40% in the middle either requiring appointments or limiting visits to particular hours of the day or week.

‘e-Detailing’:

The well known consulting company Mckinsey & Company in a paper titled, ‘Making sense of e-detailing in Japan’s pharmaceutical sector’ has defined e-detailing as follows:

“e-detailing or electronic detailing refers to interacting with physicians virtually rather than physically. It often takes place through a company’s own website or through a physician portal coupled with email- driven promotions and attached explanatory videos offering up-to-date pharmaceutical product information.”

Thus, in ‘e-detailing’ Internet-based communications applications are used to provide customized services to the doctors, in many times to complement the activities of MRs.

‘e-detailing’ is now evolving as a modern technological innovation in the field of communication between MRs and doctors. It is intended to be highly customized, very interactive, more effective, quite flexible and at the same cost-efficient too. Live analytics that ‘e-detailing’ would provide instantly could be of immense use in the strategizing process of pharmaceutical marketing.

Cost effectiveness of ‘e-detailing’:

In the same paper, as mentioned above, to highlight the cost advantages of ‘e-detailing’, McKinsey & company, from its Japan experience, has reported as follows:

“While accurate, apples-to-apples data is hard to come by, we estimate each    e-detail costs between 500 and 750 Yen, depending on the scope 
of audience and the sophistication 
of content. An MR costs 7,000 Yen 
to 12,000 Yen, depending on sector, region, and hospital vs clinic The ROI (return on investment) for MR detail is in the range up to ~20x, versus ~4-6x for e-detail. In other words, the cost structure allows for sustained ROI
 for e-detailing—even when extending reach beyond the top prescribing quintiles of physicians.”

In  the Japanese context, Mckinsey & Consulting further states:

“Right now, e-detailing in Japan is more often used at the beginning of a product’s lifecycle (i.e. to win attention during product launches) or at the end (i.e. to sell established products). These are what we call ‘stay in the race’ practices; necessary, but not sufficient.”

Perceived advantages of ‘e-detailing’:

The traditional way of detailing through ‘Visual Aids’ may not be good enough today when the available time with the doctor has come down drastically.  Just providing, by and large, the usual ‘one size fits all’ types of data/information to the doctors is gradually proving to be not effective and efficient enough to generate expected outcome. There is a dire need for helping these busy doctors to get access to drug information they value and trust at a time of their need and convenience.

Thus, the process of medical detailing should be made highly flexible depending on whatever time is chosen by each doctor to satisfy his/her specific needs.

In such an environment ‘e-detailing’, as discussed above, would help creating customized, more impressive, self-guided by doctors and more focused presentations with significant reduction in the detailing cost/ product with improved productivity.

Moreover, ‘e-detailing’ would:

  • Make expensive printed promotional aids redundant
  • Eliminate time required and cost involved to deliver such material
  • Have the flexibility of change at any time
  • Ordering of just required samples online, eliminating wastage

Fast increasingly number of doctors using computers and the Internet for professional purposes, especially in the urban areas, would facilitate this process.

Key success factor:

Experts believe, besides developing an effective and user-friendly tool for e-detailing, the important success factor for such initiative by a pharmaceutical company would well depend on:

  • Well planned integration of ‘e-detailing’ into the Customer Relationship Management (CRM) strategy
  • Deep understanding of physician segments
  • Efficient application of ‘e-detailing’ to support marketing goals.

The challenges:

Though there are many benefits for ‘e-detailing’, it throws some challenges too, as follows:

  • Still many doctors continue to prefer the personal touch of the MRs in traditional detailing
  • Some doctors do give prescription support to a company based on their good relationship with the concerned MRs
  • Despite hectic schedule, many busy doctors continue to take time out to interact with such MRs.

Though such relationships do not develop with all MRs, this challenge needs to be effectively overcome to make ‘e-detailing’ successful wherever possible, probably by creating an optimal mix of traditional and ‘e-detailing’.

A recent initiative:

Recent media reports highlight one such innovation, among many others. Pfizer has reportedly come out with an interesting innovation in the field of medical detailing to the primary care doctors.  This new service of the company ‘Ask Pfizer’ claims that it can provide promotional product information to the doctors at a time convenient to them. Thus the ‘digital medical representatives’ of Pfizer leave the decision as to whether they want to see them and if so, when.

‘Ask Pfizer’, featuring in the website called ‘Pfizerline’ of the company says that the system is:

  • Simple
  • Flexible
  • Convenient
  • Calls can be arranged to suit the doctors’ busy practice schedule
  • Online meeting room provides a rich multi-media interaction where the doctor can see trained country-specific’ digital representative making product presentations and also discuss the relevant subjects with them.

Pfizer is advertising this new service called ‘digital detailing’ on the British Medical Journal (BMJ) website aiming, reportedly, at the UK doctors.

This initiative is indeed innovative, as it creates an environment of direct marketing in an indirect way with the help of simple Internet applications like Skype.

Conclusion:

Like many other industries, in the pharmaceutical industry too, across the world, communication of relevant information in an interesting way is of utmost importance. Here also. Indian pharmaceutical industry is no exception.

Since ages, the pharma players in India, in general, have been continuing to follow the traditional model of product detailing, hoping to generate more and more prescriptions from the doctors by deploying a larger and larger contingent of MRs, who highlight superiority of their respective products over competition.

Some may argue, there is nothing wrong in this model, but question would arise, is it still as productive as it used to be? This is mainly because, the doctors are now giving lesser and lesser time to the MRs.

Those pharmaceutical companies of the country who sincerely believe that innovative use of technology in the digital world of today may considerably help addressing this issue, at least in the urban areas, would possibly get a head start, as they delve into the future for business excellence in this area.

With e-detailing they will be able to provide an interesting communication option to the top-prescribers having a very busy schedule for top of mind recalls of their respective brands, leading hopefully to increase in prescription generation.

It is worth noting, though ‘e-detailing’ is emerging as an important innovation in the field of product detailing, there are still some questions that need to be answered. Some of these questions could be as follows:

  • Would many doctors prefer to schedule time for this purpose after a busy day’s schedule?
  • Would the information overload from other sources not keep them away from seeking more information through such a process?

Taking all these into consideration, the question that we need to answer:             Is ‘e-detailing’ the future of pharmaceutical sales, also in India?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.