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Drug Prescription In Generic Names Only, No Branded Generics

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The World Bank Report released on April 07, 2023 highlights that patients’ Out-of-Pocket (OoP) expenses as a percentage of their total healthcare expenditure in India still accounted for as high as 50.59%. This means that patients in India generally pay for the majority of their healthcare costs themselves, rather than through insurance or government funding. The high level of OoP expenses in India has been a major problem for many patients, even today. Studies indicate it often leads to financial hardship, especially for low-income families.

A number of factors contribute to the high level of OoP in the country, as a whole, with regional variations. According to several studies, the healthcare costs in India are rising faster than inflation, making it increasingly difficult for more people to afford the care they need, especially for life threatening ailments, such as cancer.

Different union governments while in power have taken several steps to address this problem, such as, in 2018, the launch of the Pradhan Mantri Jan Arogya Yojana (PMJAY), a national health insurance scheme. It provides free coverage for poor and vulnerable families. The PMJAY is expected to have helped in reducing OoP for some patients, but it is not yet clear how much of an impact it has had overall.

On April 24, 2017, I asked on this blog – would drug ‘Prescriptions in Generic Names Be Made A Must in India?’. Interestingly, in August 2023, a new circular from the National Medical Commission (NMC) notified professional conduct regulations for Registered Medical Practitioners (RMP), including guidance to doctors on drug prescriptions.  This has raised a furor, as it were, among many medical practitioners and their associations. In this article, I shall deliberate on the pros and cons of this decision and its practicality in India. Let me start with the rationale behind such thinking, as I see it.

The rationales behind drug prescription only in generic names in India:

As I see it, there are several rationales behind doctors prescribing drugs only under generic names in India. Here are some of the most important ones:

  • Cost savings: Generic drugs are typically much cheaper than brand-name drugs. This is because generic drugs do not have to go through the same expensive clinical trials and marketing campaigns as brand-name drugs. As a result, they can be sold at a much lower price. This can save patients a significant amount of money, especially for expensive medications. 
  • Increased access to medicines: The lower cost of generic drugs can make them more accessible to people who might not otherwise be able to afford them. This is especially important in India, where a large proportion of the population lives below access, the poverty line. Generic drugs can help to ensure that everyone has access to the medicines they need. 
  • Improved competition: The availability of generic drugs can lead to increased competition in the pharmaceutical market. This can drive down prices even further and benefit patients.
  • Reduced risk of counterfeit drugs: Generic drugs are regulated by the government and must meet the same quality standards as brand-name drugs. This means that patients can be confident that they are getting a safe and effective product, regardless of whether it is a generic or brand-name drug. Counterfeit drugs, on the other hand, are often made with substandard ingredients and can be dangerous to take. By prescribing generic drugs, doctors can help to reduce the risk of patients getting counterfeit drugs. 
  • Transparency and accountability: In addition to these benefits, prescribing drugs under generic names can also help to promote transparency and accountability in the pharmaceutical industry. When doctors prescribe drugs under generic names, it is easier for patients to compare prices and choose the best option for their needs. This can help to drive down prices and improve the quality of care. 

A draft regulation was notified in 2022 for comments by all concerned:

For this purpose, a draft regulation was issued by the National Medical Commission (NMC) on May 23, 2022, for comments by all concerned, before it becomes mandatory in 2023. The NMC has also stated that it will take steps to ensure that the quality of generic drugs is maintained. The NMC will work with the Drug Controller General of India (DCGI) to ensure that generic drugs meet the required quality standards.

The final notification goes beyond drug prescription in generic names:

On August 03, 2023, The National Medical Commission (NMC) notified the professional conduct regulation for Registered Medical Practitioners (RMP). It not only provides guidance to avoid branded generic drugs and prescribing drugs with generic, non-proprietary and pharmacological names only, but also, restricts doctors from getting involved in any third-party educational activity like Continuing Professional Development, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. 

It justified its decision by saying, “India’s out-of-pocket spending on medication accounts for a major proportion of public spending on health care. Further, generic medicines are 30% to 80% cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care costs and improve access to quality care.” The notification also provided guidance on telemedicine consultation and prescriptions.  

The Indian Medical Association (IMA) Protested against it:

The Indian Medical Association (IMA) submitted a memorandum to the Indian regulator, the National Medical Commission (NMC), on February 7, 2023, protesting against the compulsory prescription of generic drugs. The memorandum argued that the regulations would harm patients and doctors, and that they were being implemented without proper consultation with stakeholders.

The IMA also stated that the regulations would violate the fundamental right to freedom of speech and expression of doctors. The memorandum said that doctors should be free to prescribe drugs based on their medical judgment, and that they should not be forced to prescribe generic drugs.

The IMA’s protest is significant because it is the first major challenge to the NMC’s regulations on compulsory prescription of generic drugs. The protest could have a significant impact on the implementation of the regulations, and it could also lead to changes in the regulations.

It is important to note that the IMA is not the only organization that has expressed concerns about the NMC’s regulations. Several other medical associations have also expressed concerns, and some doctors have also spoken out against the regulations.

The controversy over the NMC’s regulations is likely to continue for some time. It is important to note that there are valid concerns on both sides of the issue. It is also important to remember that the regulations are still in the early stages of implementation, and that it is too early to say what their long-term impact will be.

A few reasons why doctors in India may be hesitant to prescribe drugs under generic names. 

Here are some of the most common reasons:

  • Lack of awareness: Some doctors may not be aware of the benefits of generic drugs. They may believe that brand-name drugs are always better than generic drugs, even though this is not always the case. 
  • Influence from pharmaceutical companies: Pharmaceutical companies often give doctors incentives to prescribe their brand-name drugs. This can create a conflict of interest for doctors, who may be more likely to prescribe brand-name drugs even if they believe that generic drugs are just as effective.
  • Patient demand: Some patients may specifically ask for brand-name drugs, even if generic drugs are available. This can put pressure on doctors to prescribe brand-name drugs, even if they believe that generic drugs are a better option.
  • Quality concerns: There have been some cases of counterfeit generic drugs being sold in India. This can lead to doctors being hesitant to prescribe generic drugs, as they may be concerned about the quality of the drugs.

Some ways to encourage doctors to prescribe generic drugs:

  • Educate doctors about the benefits of generic drugs. Doctors need to be aware of the benefits of generic drugs in order to be willing to prescribe them. They should be taught about the cost savings, increased access, and improved quality of generic drugs.
  • Reduce the influence of pharmaceutical companies on doctors. Pharmaceutical companies should not be allowed to give doctors incentives to prescribe their brand-name drugs. This would help to ensure that doctors are prescribing drugs based on the best interests of their patients, rather than on financial considerations. 
  • Encourage patients to ask for generic drugs. Patients should be aware of the benefits of generic drugs and should ask their doctors to prescribe them whenever possible. This will help to create a demand for generic drugs and encourage doctors to prescribe them. 
  • Improve the quality control of generic drugs. The government should take steps to improve the quality control of generic drugs in India. This would help to reduce the risk of patients getting counterfeit drugs. 

By taking these steps, we can encourage doctors to prescribe generic drugs and make them more accessible to patients. This would help to save patients money, improve access to medicines, and reduce the number of counterfeit drugs in circulation.

Conclusion:

I now revert to this month’s notification of the National Medical Commission (NMC) on the professional conduct regulation for Registered Medical Practitioners (RMP), providing  new guidance for drug prescriptions in India. It clearly indicates that doctors should avoid prescribing branded generic drugs, instead prescribe drugs with generic, non-proprietary and pharmacological names only. ‘However, in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, the practice of prescribing generic names only, can be relaxed,’ it elaborated.

Weighing the pros and cons of this notification, I reckon, despite the reasons articulated by doctors and their associations, besides the branded generic manufacturers, there are many benefits to prescribing drugs under generic names only. Generic drugs are typically much cheaper than brand-name drugs, and they are just as effective. They can also help to reduce the number of counterfeit drugs in circulation, besides several other benefits, as cited above. As a result, doctors should be encouraged to prescribe generic drugs whenever possible. Let me hasten to add, changing the prescribing practices of doctors and addressing concerns about the quality of generics can be a complex and gradual process.

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.

 

Meeting India’s Unmet Biologic Drug Needs Some Global Synergy Evident – But Patients Need More

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Many reports have vindicated the rapidly growing importance of biologic drugs in the treatment of a wide range of complex ailments. These include autoimmune diseases, cancers, hormonal irregularities, anemia, and to prevent various diseases such as vaccines, have drawn healthcare experts’ attention globally.

As defined by experts, Biologics are larger, more complex molecules compared to traditional small molecule pharmaceutical drugs. Unlike traditional pharmaceuticals, they require some components from a living organism to be manufactured.

The critical importance of biologic drugs lies in their ability to provide innovative treatment options, address unmet medical needs, and significantly impact patient outcomes in various disease areas. Towards this endeavor, a clear pathway for focused initiatives is warranted, especially in countries like India.

This article will explore this domain to get a sense of how much and how fast the country is progressing in this space, having huge healthcare significance, for all. Let me start with a quick recap on the areas of seminal importance of biologic drugs – to help all to be on the same page – as I start this deliberation.

The critical importance of biologic drugs:

The critical importance of biologic drugs, I reckon, lies in their unique properties and therapeutic potential:

Targeted Therapies: Designed to interact with specific molecules or receptors in the body, allowing for targeted treatment. This specificity can enhance the efficacy of the drug while reducing potential side effects on healthy cells and tissues.

Novel Treatment Options: Offer novel treatment options for diseases that were previously difficult to manage or had limited treatment options. They have revolutionized the management of conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, and certain types of cancer.

Personalized Medicine: Paving the way for personalized medicine, as it can be tailored to individual patients based on factors like genetic profiles or specific disease characteristics. This approach allows for more precise and effective treatment strategies.

Disease Modification: Unlike some traditional drugs that primarily alleviate symptoms, biologics can often modify the underlying disease process. They can target specific pathways or molecules involved in disease progression, potentially leading to long-term benefits and improved outcomes.

Improved Quality of Life: Has the potential to significantly improve the quality of life for patients living with chronic or debilitating conditions. By effectively managing symptoms and slowing disease progression, they can reduce pain, disability, and the need for other interventions.

It is important to note that biologic drugs are complex to manufacture, often require specialized infrastructure, and can be costly. No wonder why the India specific research paper - published on January 18, 2023 commented: “Although various biologic drugs are already available, they are still not within reach of the common person due to financial constraints.”  This prompts me to explore with examples some of the key issues that Indian patients confront while meeting this health need.

Patient access to original biologic drugs in India faces several key barriers:

Patient access to original biologic drugs in India faces several key barriers, including: 

1. Cost and Affordability:

- Trastuzumab (Herceptin): The cost of a single course of Herceptin, used in the treatment of breast cancer, can range from several lakhs to crores of rupees, making it financially burdensome for many patients in India.

- Eculizumab (Soliris): Eculizumab, used in the treatment of rare blood disorders, can cost several lakhs of rupees per month, making it unaffordable for most patients.

2. Limited Healthcare Coverage:

- Many health insurance policies in India have limitations or restrictions on coverage for expensive biologic drugs, requiring patients to bear a significant portion of the cost out of pocket.

- Some government-funded healthcare schemes, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY), may have restrictions on coverage for expensive biologic therapies, limiting patient access.

3. Regulatory Barriers:

- The approval process for biosimilar versions of original biologic drugs could face delays in India. For example, the biosimilar version of Trastuzumab (Herceptin) faced delays in obtaining regulatory clearance, resulting in delayed patient access to more affordable alternatives.

- The regulatory requirements for original biologic drugs can be complex and time-consuming, leading to delays in drug approvals and subsequent patient access.

4. Limited Local Manufacturing:

- Drugs like Bevacizumab (Avastin) and Adalimumab (Humira) used in India are often imported, leading to supply chain challenges and potential delays in availability.

- Limited local manufacturing of certain original biologic drugs can result in dependence on imported versions, leading to potential pricing issues and supply disruptions.

5. Physician Awareness and Education:

- Some physicians may have limited awareness or familiarity with prescribing guidelines and clinical benefits of certain original biologic drugs. This can result in underutilization or hesitation in prescribing these therapies.

- Lack of specific training and education programs for physicians regarding the latest advancements in original biologic drugs can impact their knowledge and confidence in prescribing them.

6. Patient Education and Understanding:

- Patients may have limited knowledge about the availability and benefits of original biologic drugs. For instance, patients with chronic diseases like rheumatoid arthritis may not be aware of the benefits of newer biologic treatments over traditional therapies.

- Lack of patient education about the appropriate use and potential side effects of original biologic drugs can lead to hesitancy or misconceptions among patients, affecting their willingness to pursue these therapies.

These specific examples illustrate how cost, limited healthcare coverage, regulatory barriers, limited local manufacturing, physician awareness, and patient education can act as barriers to patient access to original biologic drugs in India.

Healthcare impact of inadequate access and availability of biologic drugs in India:

The inadequate access and availability of biologic drugs in India can have several significant healthcare impacts: 

Suboptimal Disease Management: Biologic drugs often provide highly effective and targeted treatments for complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. The lack of access to these therapies can result in suboptimal disease management, leading to poorer patient outcomes, increased disease progression, and reduced quality of life for affected individuals.

Delayed or Incomplete Treatment: Inadequate access to biologic drugs can result in delays or interruptions in treatment. For chronic or progressive diseases, timely initiation and consistent use of these therapies are critical. Delayed or incomplete treatment can compromise the effectiveness of interventions, leading to prolonged disease activity, exacerbation of symptoms, and potential irreversible damage in some cases.

Increased Healthcare Burden: Without access to appropriate biologic therapies, patients may require more frequent hospitalizations, emergency room visits, or other healthcare interventions to manage their conditions. This can place an additional burden on healthcare systems, leading to increased healthcare costs and strain on resources.

Reduced Treatment Options: Biologic drugs often represent the most advanced and effective treatments available for certain diseases. Inadequate access to these therapies limits treatment options for patients, forcing them to rely on less effective or outdated treatments. This restricts the ability of healthcare providers to offer the best available care to patients, potentially leading to compromised treatment outcomes.

Health Inequity: Inadequate access to biologic drugs can exacerbate health inequities in India. Patients from lower socioeconomic backgrounds or those without sufficient insurance coverage may face greater barriers to accessing these expensive therapies. This can result in disparities in healthcare outcomes, with some individuals being unable to afford or access the best available treatments for their conditions.

Impact on Research and Innovation: Inadequate access to biologic drugs can hinder clinical research and innovation in India. Limited availability may reduce opportunities for conducting clinical trials and studying the effectiveness of these therapies in the local population. This, in turn, can hamper the development of new treatments and advancements in healthcare.

Addressing the inadequate access and availability of biologic drugs is crucial to ensure equitable healthcare outcomes, optimize disease management, and reduce the burden of complex diseases in India.  

Increasing need for biosimilar drugs in India and issues involved:

From the above perspective, increasing the availability of biosimilar drugs in India is crucial. Fostering competition may improve affordability. Thereby, it would increase access to essential therapies – bridging treatment gaps, disease management, healthcare system sustainability and foster market competition and innovation.

However, it can ensure that patients receive appropriate and effective treatments while addressing the healthcare challenges faced by a diverse population, only when some key barriers created for biosimilar drug entry, besides patent thickets, are also adequately addressed. One such way is creating a global synergy in this space by collaborating with MNC pharma – having deep pockets and other requisite wherewithal.

Some global synergy is evident in this critical healthcare space:

The good news in this space has started flowing. There have been several collaborations between multinational pharmaceutical companies (MNCs) and domestic Indian drug companies to develop even high potential interchangeable biosimilar drugs in India. Here are a few examples:

- Biocon and Mylan: Biocon has collaborated with Mylan, a global pharmaceutical company, to develop and market biosimilar products. This collaboration has resulted in the development and approval of biosimilar drugs such as Trastuzumab (Herceptin) and Adalimumab (Humira) in India. 

- Dr. Reddy’s Laboratories and Merck: Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, entered into a collaboration with Merck & Co., a global pharmaceutical company, to develop biosimilar versions of biologic drugs. This collaboration has resulted in the development and launch of biosimilars such as Pegfilgrastim (Neulasta) and Rituximab (Rituxan) in India.

- Cadila Healthcare and Novartis: Cadila Healthcare, an Indian pharmaceutical company, collaborated with Novartis, a multinational pharmaceutical company, to develop and manufacture biosimilars. This collaboration has resulted in the development of biosimilar drugs such as Rituximab (Ritucad) and Bevacizumab (Bevatas) in India.

These are just a few examples of collaborations between MNCs and Indian drug companies in the field of interchangeable biologic drugs. The landscape of collaborations and partnerships in this area is dynamic, and there may be more ongoing collaborations between companies to develop and commercialize biosimilars in India.

Conclusion:

Overall, patient access to biosimilar drugs in India is crucial for ensuring affordable and comprehensive healthcare, improving patient outcomes, and promoting a competitive pharmaceutical market. It helps address the challenges of access and affordability of biologic drugs, ultimately benefiting the well-being of patients across the country – promoting healthcare equity, and the sustainability of the healthcare system in the country. But patients need more…much more.

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.

Changing Doctors’ Practice Dynamics With Covid-19 And Beyond

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Unexpectedly, the answer to an onerous question surfaced just around a year’s time. In my article on this blog, written on April 08, 2019, I raised a question – “Would ‘Connected Healthcare’ Catch Pharma Players Off-Guard?” Interestingly, an unexpected and abrupt turn of events in the global healthcare space, including India, triggered by Covid-19 pandemic, signals an early dawn of an evolving reality, related to ‘Connected Healthcare’, in India.

Never ever, I reckon, the Government realized so well that continuation with a fragile public healthcare infrastructure is self-defeating for the country. Allocation of financial resources, at least 2.5 percent of the country’s GDP, for its rejuvenation – powered by AI-based modern digital technology, would help avoid overburden on the healthcare system. This will mean, saving more lives and also a significant reduction of morbidity, especially in a situation, like Covid-19 pandemic. Good health can propel good economy, more effectively.

That’s why, ‘connected healthcare’ – by effectively linking requisite ingredients of all health-related information that medical professionals and the patients would need, appears to be the new reality. This process is being facilitated by rapid acceleration of usage of various digital platforms, by both healthcare consumers and providers. Thus, it is becoming increasing clear now that leveraging digital technology with innovative mindset and a fresh pair of eyes, will be the way forward, in India, as well. It seems very likely, when considered from two angles:

  • What several research data reveals about an increase in usage of digital platforms by healthcare consumers and providers, before and during Covid-19 pandemic. Especially because, this struggle appears to be for a long haul.
  • Most countries are currently struggling to navigate through highly contagious Covid-19 outbreak and simultaneously trying to chart a workable pathway for avoiding similar eventualities in the future.

In this article, I shall try to focus on Covid-19 induced changes in doctors’ practice dynamics – based on research studies, while revisiting the subject on ‘connected healthcare,’ and its relevance now – also in the years ahead.

Research studies capture a new and growing awareness: 

The recent findings from the “Digital Doctor 2020” survey, which is a ‘21-country study of Doctors’ perspectives on digital and connected health, highlight some interesting points. This study was conducted just before the global outbreak of Coronavirus. Some of its findings were also deliberated inan article published in the PharmExec.com on April 23, 2020. The paper is titled, ‘How Prepared Were Physicians for the COVID-19 Digital Upswing? Some of the key points, as reported, are worth noting:

  • Although, the awareness of drug prescribers of different digital technologies related to healthcare is high, how these technologies work in healthcare was unknown to many doctors at the time of the Digital Doctor 2020 survey. It came out that clear benefit statements, will be welcomed when there is such a steep learning curve.
  • Regardless of face-to-face interactions still remaining preferred choice before the pandemic, online channels are on the rise and accelerating with COVID-19 lockdown.
  • Benefits of using connected health devices for patient management and treatment are widely recognized and is believed to play a key role in the future. The respondents agree, even their patients are now more interested in their own health data, as they are gaining control over their weight, diet and physical activities.

Highlighting that their research data over the last few weeks showing increasing usage of digital solution to respond and adapt to the new realities of Covid-19 pandemic, the author of the article concluded: ‘For a long time, digital solutions have often been considered an option; now they have become a necessity.’ To understand the emerging scenario, let us now look at the preferred communication channels of the doctors – pre-Covid-19 outbreak. 

Preferred channels of doctors pre-Covid-19 outbreak:

According to the Ipsos survey of pre-Covid-19 outbreak, face-to-face communication with Medical Representatives (MR) used to be the most favored channel of the doctors, as follows:

Channel Med. Rep Speaker Program Conf. E-detail Journal Ads Med. Liaison E-mail Direct mail Pharma website
Pref. % 35.2 11.7 10.0 8.4 8.4 8.8 8.4 5.0 4.1

However, on April 14, 2020, Ipsos shared the results of their interim research conducted, together with M360, among doctors, conducted during Coronavirus outbreak. The preliminary findings indicate, Covid-19 will permanently alter physician practice dynamics. A clear shift in the engagement model with them – away from in-person detailing, throws several significant questions on the traditional physician engagement template of the pharma players.

It also signals another fundamental change in the physicians’ practice dynamics, as Covid-19 seems to have changed practicality of having face-to-face communication between the representatives and doctors, as before. This situation makes ‘connected healthcare’ a reality – as we move deeper into the everyday- evolving scenario.

Some unexpected and significant changes surfaced in a month: 

The above research also flagged, the following two important changes, among several others, triggered by the Coronavirus outbreak:

  • The mean number of sales representative visits dropped from 15.7 before the Coronavirus outbreak to 1.3 in just the following month, during the pandemic 
  • Overall preference and effectiveness of e-detailing also improved, significantly, where any non-personal communication and interaction with drug companies, either through sales representatives or by others, were considered as e-detailing. 

This brings me back to the question, how are doctors feeling about this never before shift in their practice dynamics?

How are doctors feeling about a never before shift in their practice dynamics?

The ongoing research on this critical area captures a new reality, where many doctors, especially those who are not directly engaged in combating the Covid-19 pandemic, are clearly feeling a shift in their practice dynamics. Curiously, the new feeling of a shift also includes, the way these doctors interact with different drug companies, mostly through their Medical Representatives.

These inklings of the doctors are expected to get translated into some fundamental changes in the real-life situation, as we all sail through the life-changing time caused by Covid-19. Especially, considering the requirements of a new normal – social distancing, wearing a mask always while on outdoor, and several other norms as prescribed from time to time.

‘Connected healthcare,’ is expected to take its place on the center stage:

In this situation, ‘connected healthcare,’ which used to be more discussed than practiced, is expected to take its place on the center stage. It is necessary in the present situation for remote consultations, primarily for chronic ailments – for effective disease management and treatment. More so, as in the current situation individual health awareness of a large population, even in India, is increasing with an accelerated speed, perhaps more than ever before.

Thus, this is the right time to focus on ‘connected healthcare’, powered by AI-based digital technology. It has immense potential to help the Indian population getting immediate medical attention at a lower cost, with an improved access, for all. Though these are early days, it appears the ball has started rolling in the right direction, as the recent draft guidelines of the Indian Council of Medical Research (ICMR) indicates: ‘Patient can WhatsApp, SMS or email consent for Covid-19 clinical trials.’

Conclusion:

Still today, there is no sign of even temporary flattening the disease progression curve in India. As on May 10, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 62,939 with 2,109 deaths, which is rising in India faster than most other countries. On May 07, 2020, AIIMS director again warned that Covid-19 pandemic is yet to peak in the country. “According to modeling data and the way our cases are increasing, it is likely that peak can come in June and July,” he added.

But is it getting worse? Despite stringent lockdown, there has been a surge in cases, which can also be attributed to higher levels of testing. However, from a doubling rate of 11.5 days on May 3, it has shortened to 10.3 days, which means that cases are doubling in quicker time. Each set of 10,000 cases is now increasing at a more rapid pace than the preceding set, highlighted an editorial of a leading news daily.

With a vaccine still elusive, the government had been banking mostly on the lockdown to break the chain of transmission of the virus. Meanwhile, the World Health Organization (WHO) has said: ‘Deliberately infecting healthy people with Coronavirus may speed Covid vaccine studies,’ reflecting more uncertainties in this area. It is also not likely that the country will cease to have any problems with its fragile public healthcare infrastructure and delivery system, even after flattening the disease progression curve.

Along with many other Covid-19 induced life-impacting changes, doctors’ practice dynamics are also expected to undergo a metamorphosis, lasting for an indefinite period. Consequently, I reckon, it’s about time, even for the pharma industry to voluntarily adopt ‘connected healthcare’ as a future way of life. One can get a glimpse of it in the Covid-19 clinical trial draft guidelines of the ICMR. Nonetheless, ‘connected healthcare’ comes with a clear signal of reducing the cost of healthcare and improved patient access, having the potential to effectively mitigate a sizeable part of the precipitated healthcare crisis, caused by Coronavirus.

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.

Gamification in Pharma: Creates Engaging Patient Experience For Better Results

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On January 03, 2019, media reports flashed – “A video game-based ‘digital medicine’ tool can help reduce symptoms in children with autism spectrum disorder (ASD) and attention/deficit-hyperactivity disorder (ADHD).” This study was published in the Journal of Autism and Developmental Disorders, confirming the feasibility and safety of the tool called Project: EVO, which delivers sensory and motor stimuli through an action video game experience.

This initiative reconfirms that technology is becoming a great enabler to provide integrated, comprehensive and cost effective approach in treating many diseases, particularly with ‘Digital Medicine.’ The above report on ‘Project EVO’ is an example of application of the concept of ‘gamification’ in digital medicine. Many consider ‘gamification’ as a game changer to create an engaging patient experience with added value. It makes patients getting involved in the disease-treatment process, especially for effective self-management of chronic disorders.

I shall focus on this area in today’s article, giving examples wherever available. However, let me start by recapitulating what is ‘gamification’ in the pharma industry.

Gamification: 

The Oxford dictionary defines ‘gamification’ as: ‘The application of typical elements of game playing (e.g. point scoring, competition with others, rules of play) to other areas of activity, typically as an online marketing technique to encourage engagement with a product or service.’ It further adds, ‘gamification is exciting because it promises to make the hard stuff in life fun.’

‘Gamification’ is assuming increasing importance, with disruptive digital innovations gradually becoming game changers in the pharma business. This is mainly because, it can deliver to a specific group of patients, doctors or other stakeholders exactly what they look for – with precision.

I suggested in my article, published in this blog on January 07, 2019 that pharma companies should facilitate self-management of chronicailments,not just for better outcomes, but also for improving the quality of patient engagement. To achieve this objective,‘gamification’ could play a remarkable role-such as disease awareness and prevention and when afflicted its desirable self-management. This has the potential to create a win-win situation between patients and a drug company.

This is so important, as ‘the old paradigm of the paternalistic model of medicine is now transforming into an equal level partnership between patients and professionals, aided and augmented by disruptive technologies. This comment was made in a study titled, ‘Digital health is a cultural transformation of traditional health care,’ published in mHealth on September 14, 2017.

‘Patient-doctor partnership is critical in the new paradigm:

One of the major ways to develop a partnership between the treating doctors along with the product/service providing pharma companies and patients is through mutually beneficial ‘patient engagement’ programs with added value.

That such programs can create a unique patient experience of better outcomes at a lesser cost, has already been established by a number of credible research studies. Taking a cue from quantum benefits that this initiative provides, many pharma companies are now making ‘patient engagement’ strategy as an integral part of their overall market access program, including the process of branding.

What does an effective patient engagement strategy involve?

An article titled, ‘Patient Engagement: A Key Element in Pharmaceutical Marketing Strategy,’ published in the IgeaHub on May 29, 2016 defines ‘patient engagement’ as a concept that combines a patient’s knowledge, skills, ability and willingness to manage his own health and care with interventions designed to increase activation and promote positive patient behaviors. This measure also involves offering relevant services to patients.

To assess the opportunity of patient services in the pharma industry, Accenture conducted a survey titled, ‘Pharma’s Growing Opportunity in Patient Services’, on 200+ pharma patient services executives, covering seven therapeutic areas – heart, lungs, brain, immune systems, bones, hormone/metabolism, and cancer. The study concluded,the future of patient services that requires patient engagement, is bright. It elaborated by saying, this approach offers pharmaceutical companies a tremendous opportunity – for those willing to invest in the right places and let patients know about them in the right way.

To move in this direction, ‘gamification’ is an efficient way for the pharma companies to follow. Let us see below how does ‘gamification’ work on the ground.

How does ‘gamification’ work?

According to the findings of Innovatemedtec, ‘gamification’ with health apps typically works in the following three ways:

  • Allowing users to share progress and results with their friends or other users of the service, creating a competitive spirit to elicit more or better use of the specific health app service.
  • Giving virtual gifts, such as badges, medals, stars during each stage of progress, generating a sense of achievement for greater patient motivation levels in disease monitoring and management.
  • Advanced medical health applications can provide real-time biofeedback with built-in sensors. Or using a storytelling approach and explaining health literature related to diagnoses, medical procedures and patient behavior.

Thus, the primary reasons for introducing ‘gamification’ in the pharma industry would be to improve the disease awareness and increasing patients’ motivation for self-management for mutual benefits.

Improves disease awareness and motivation for self-management:

The precise rationale for ‘gamification’ in the pharma industry was nicely articulated in the ‘M.Sc. Thesis titled, ‘Gamification in the Pharmaceutical Industry – Exploring how European Pharmaceutical Organizations can build and use Gamified Mobile Applications to Improve Relations with Patients.’ This was written by Nanna Birkedal and jointly delivered by the University of Stirling and Lund University.

It highlighted: “Patients and industry experts both argue that awareness is important; constant reminders about healthy habits are pivotal for an improved lifestyle. Patients furthermore need to be motivated to act upon this and actively implement the required lifestyle changes. If pharmaceutical organizations succeed in helping the patients with overcoming challenges related to their illness by motivating them to enact the needed lifestyle changes, it will increase the perceived trust towards their brand and thereby strengthen their relationship with the patients. This research argues that digital gamification is suited for this purpose, hence why it may be advantageous for organizations to incorporate digital gamification …”

Why and how to motivate patients for self-management of chronic disease?

As I said before, after proper diagnosis of a chronic ailment and charting out a medical treatment pathway, self-management of the disease by patients plays a critical role. Thus, the question arises, how to motivate patients and more importantly, keep patients motivated for engaging in self-management of such nature.

There is also a need for continuous improvement of the ‘gamification’ process for a long-term engagement of patients, leading to progressively better outcomes. Many examples of success with ‘gamification’ are available for chronic diseases, such as diabetes.

One of the metrics used in ‘gamification’ to help diabetic patients stick with a digital health platform, making it a higher priority in their daily lives, is to provide useful timely information on their disease condition. This metric may include informing the user about some tangible changes in their health risks due to the disease. For example: “Over the last month your effective glucose has reduced the risk of losing your eyesight by 10 percent.” Accordingly, the patients may earn points or badges for using the app and accomplishing certain important tasks.

In this way, gamification can immensely help self-management through behavioral changes, improving disease outcomes. As Healthcare in America also reiterates: ‘There is nothing more motivating than knowing your health is improving in real time.’

Another study, and two examples of ‘gamification’ in pharma:

Another study titled, ‘Gamification: Applications for Health Promotion And Health Information Technology Engagement’, published by ResearchGate arrived at an interesting conclusion. It reiterated: ‘Game-based approaches (gamification) can provide ideal strategies for health promotion, prevention, and self-management of chronic conditions. However, there is a need to clearly define components and uses of gamification in healthcare for increased patient engagement in health information technology.’

Elaborating the point further, the authors emphasized that many health/physical activity apps provide feedback in a clear and concise manner and in a variety of formats (e.g., graphs, text or icons). The available option to share the feedbacks on social networking sites allows for further engagement by individuals and adds additional motivation and encouragement in attaining users’ goals. However, it recommends more studies to explore and identify the suitability of ‘gamification’ for health in clinical settings.

There have been several instances of gamification efforts health care with powerful effects. Let me cite just two interesting illustrations from mobihealthnews, as follows:

Conclusion:

As available from various literature, such as Healthcare in America, there are enough well-verified testimony, indicating that patients are motivated by gamified elements.

Consequently, some major global pharmaceutical companies have started testing the water. For example, the Media Release of Roche dated June 30, 2017 announces, the company has acquired mySugr - an Austrian startup that offers gamified solutions for diabetes management in a fun way, both for children and adults. It, reportedly, has more than a million registered users in 52 countries and is available in 13 different languages. Post-acquisition, it will be an integral part of Roche’s new patient-centered digital health services in diabetes care.

Hence, ‘gamification’ in pharma carries potential to be a win-win strategy in creating engaging, motivating and a unique patient experience in self-management of chronic diseases, for better outcomes.

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.

Exigency of Cybersecurity in Digitalized Pharma

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Digitalization – as it unfolds and imbibed by most drug companies, is presumed to herald a whole new ballgame in the Indian pharma business. Equally significant is the quantum benefit that the process will deliver to pharma stakeholders – right from drug companies to patients. It has already hastened the process of new drug discovery and will also help charting newer ways to meaningfully engage with stakeholders, besides enhancing treatment outcomes for patients, appreciably.

However, the flip side is, more benefits a company accrues from digitalization, greater will be the risks of cyber-attacks. Thus, preventive measures should also be equally robust. Otherwise, hackers can bring a company’s digital system to a standstill, causing not just a temporary loss in revenue and profit, but also valuable data leak, with considerable impact on even long-term business.

Strangely, associated risks of digitalization to pharma companies are seldom outlined in any discussion, leave aside alternatives for salvaging such untoward situation, if or as and when it comes. Unless, it is felt that the scope of such discussion doesn’t cover the implementors and falls totally on cybersecurity experts.

Nonetheless, it is intriguing in the pharma space. The reason being, pharma industry believes, while talking about the efficacy of any drug, its vulnerability in terms of side-effects, contraindications or drug interactions, should also be known to its users. That’s the purpose of a packaging leaflet. It’s a different reason though, that most drug companies in India have virtually jettisoned this practice as a cost saving measure, even for drugs that are not under price control. That apart, in this article, I shall explore the relevance of cybersecurity in the digitalized pharma world.

A question that help understand its implication:

During organizational transformation through digitalization in pharma, just like any other business, all crucial documents get transferred from paper to digital formats. The key question that follows in this regard is – what happens to these digital documents post cyber-attacks, if any? Any attempt to answer this question holistically will help people realize its implication – that ‘cybersecurity must be more than an afterthought.’

‘Cybersecurity must be more than an afterthought’:

The article, ‘Cybersecurity in the Age of Digital Transformation,’ published by MIT Technology Review Insights on January 23, 2017, stressed upon this critical point. It highlighted: “As companies embrace technologies such as the Internet of Things, big data, cloud, and mobility, security must be more than an afterthought. But in the digital era, the focus needs to shift from securing network perimeters to safeguarding data spread across systems, devices, and the cloud.”

Thus, while discussing the need to digitally transform a company’s business, cybersecurity must be part of that conversation from the very start – the paper underscored in no uncertain terms. That’s exactly what we are deliberating today - ‘as companies embark on their journeys of digital transformation, they must make cybersecurity a top priority.’

The cybersecurity threat may cripple innovation and slow business:

Cisco explored the concept of Cybersecurity as a Growth Advantage by a thought leadership global study. While assessing the impact of cybersecurity on digitalization, it surveyed more than 1,000 senior finance and line-of-business executives across 10 countries. Some of the key findings, as captured in the Cisco report, may be summarized, as follows:

  • 71 percent of executives said that concerns over cybersecurity are impeding innovation in their organizations.
  • 39 percent stated that they had halted mission-critical initiatives due to cybersecurity issues.

Interestingly, 73 percent of survey respondents admitted that they often embrace new technologies and business processes, despite cybersecurity risk. However, as we shall see below, pharma executives are quite confident of cybersecurity, probably because of inadequate experience in this area, as on date.

Companies are struggling with their capabilities in cyber-risk management:

The paper published in the May 2014 issue of the McKinsey Quarterly journal, titled “The rising strategic risks of cyberattacks”, also flagged this issue. It said: “More and more business value and personal information worldwide are rapidly migrating into digital form on open and globally interconnected technology platforms. As that happens, the risks from cyberattacks become increasingly daunting. Criminals pursue financial gain through fraud and identity theft; competitors steal intellectual property or disrupt business to grab advantage; ‘hacktivists’ pierce online firewalls to make political statements.”

McKinsey’s research study on the subject, conducted in partnership with the World Economic Forum also upheld that companies are struggling with their capabilities in cyber-risk management. As highly visible breaches occur with growing regularity, most technology executives believe that they are losing ground to attackers. Its ongoing cyber-risk-maturity survey research also ferreted out the following important points:

  • Large companies reported cross-sector gaps in their risk-management capabilities.
  • 90 percent had “nascent” or “developing” ones.
  • 5 percent was rated “mature” overall across the practice areas studied.

Interestingly, the research found no correlation between spending levels and risk-management maturity. Some companies spend less, but do a comparatively good job of making risk-management decisions. Others spend vigorously, but without much sophistication. Even the largest firms had substantial room for improvement – McKinsey reiterated.

‘Corporate espionage’– a prime reason behind cyberattack on pharma:

An interesting article appeared in The Pharma Letter on July 18, 2017 on this subject. The paper is titled “Cyber-attacks: How prepared is pharma?” It said:“The pharmaceutical industry is a prime target for hackers. In 2015, a survey of Crown Records Management revealed that nearly, two-thirds of pharma firms had experienced breaches in data, and that one fourth of these same companies had been victims of hacking.”The paper also highlighted ‘corporate espionage’ as one of the prime reasons behind hacking.

In view of this, the author articulated that the need for pharma and healthcare companies to fortify their security systems has become clear in recent years. The best method of protection is to prevent cyber-attacks from happening, or at least reduce the risk of a hack, he advised.

Instances of cyber-attacks in pharma are many:

To drive home the point that when firms and other organizations fail to strengthen IT systems against attacks, they incur high costs -the above paper cited an example from the year 2016. It said: “The average global cost of data breach per stolen record was US$ 355 for healthcare groups, higher than losses in other fields such as education (US$ 246/record), transportation (US$ 129), and research (US$ 112).”

The author further emphasized that besides financial losses, pharma companies and other healthcare groups risk losing the trust of patients and other stakeholders. With the ongoing digitization in pharma, new threats may become even more pervasive and sophisticated. “Thus, investment in cybersecurity must be a priority, if pharma players are to protect their data and the data of their stakeholders”, he added.

Are pharma executives experienced enough on cybersecurity?

As reported by Pharma IQ on July 31, 2018, one of its recent surveys found that around 70 percent of senior pharma decision makers are “confident” or even “very confident” in their company’s IT security. But, digging deeper, the survey uncovered that:

  • 42 percent of respondents’ companies do not routinely follow IT security policies,
  • 49 percent said that the corporate risk profile is not firmly understood across all departments.

The survey concluded that this could potentially lead to gaps in the security process. To me it appears, this could, as well, be due to inadequate experience of pharma executives in this area.

But, investment in pharma IT is increasing:

The good news is, even in the current scenario, many pharmaceutical companieshave started making investments in IT solutions, in general. This is corroborated by the 2018 survey by Global Data. Some of its important findings are, as follows:

  • 79 percent of them are currently making investments in identity and access management (IAM) solutions
  • 72 percent are considering investment in the solutions over the next two years.
  • 75 percent of the respondents are currently deploying some form of backup, archiving, alongside content and web filtering solutions to store, as well as, preserve their online information. 

Conclusion:

In pharma perspective, digitalization of business promotes paperless culture. It radically changes the basic infrastructure of maintaining critical documents in the workplace. Digital document storage systems become the nerve center of information on the company. All data – strategic or related to operations – internally generated or acquired – right across all critical functional areas, such as IP, research, clinical trials, manufacturing, sales and marketing, finance, supply chain legal and even of the CEO’s office, find a space in this digital data sever.

Although, the benefits of digitalization are well known and much discussed, it has a contraposition, as well – related to the vulnerability of the system to cyber-attacks. This flags a demanding need for protection of digitally stored assets from cyber-attacks, or to frustrate even any misdemeanorfrom amateur hackers. Thus, creating an almost impregnable, well-firewalled digital data storage server assumes prime importance. Equally important is formulating and religiously implementing a robust digital policy for the same.

Creating strong awareness among employees and stakeholders regarding cybersecurity and involving them in tandem with a system-approach, sans an iota of complacency, is expected to mitigate such vulnerability, appreciably. Thus, a sense ofexigency for cybersecurity in the digitalized pharma world, I reckon, is very real.

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.

The top two reasons for not seeking medical treatment, across the population, are not poor ‘Access to Healthcare’ in India

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“About 1.8 million children under age of 5 die in India every year; 68,000 mothers die due to maternal causes, and 52 million children in the country are stunted”.

“With 70% people living in more than 600,000 villages across rural India, not more than an estimated 30% have access to modern medicine”.

Such sensational headlines could be fallacious at times and may tend to divert the attention of all concerned from some of the key healthcare issues in India. We are indeed too negative in our approach towards a problem solution process. All stakeholders interested in improved healthcare facilities are continuously engaged in an eternal blame game. Government blames the industry and the industry blames the government and so on. In this unfortunate logjam scenario since last several decades, any possibility of breaking it will require active interference by a ‘Cerebral Braveheart”

Moreover, taking advantage of this situation, some groups of people want to progress their vested interests by projecting a ‘Weaker India’ and pontifying with crocodile tears.

Let me now try to explore these issues with hard facts.

Access to ‘round the year’ healthcare facilities in India:

As reported by the Government of India in 2004, access to healthcare infrastructure and services for the rural villages in terms of percentages were as follows (Source:India Health Report 2010) :

  1. Primary Health Centers: 68.3
  2. Sub-Centers: 43.2
  3. Government Dispensaries: 67.9
  4. Government hospitals in urban areas: 79
  5. Private Clinics: 62.7
  6. Private Hospitals: 76.7

I reckon, after implementation of National Rural Health Mission (NRHM) and National Urban Health Mission (NRUM), this situation prevailing in 2004 has improved. However, the scope for further improvement in all these areas still remains very high.

Hence, the shrill voice highlighting around 65% of population of India does not have access to healthcare or medicines seem to be motivated and highly misplaced.

‘Access to Modern Medicines’ is improving in India:

In addition to the above facts, CAGR (volume) of the pharmaceutical industry since the last ten years has been over 10%, leaving aside another robust growth factor being contributed through the introduction of new products, every year. Encouraging growth of the Indian Pharmaceutical Market (IPM), since the last decade, both from the urban and the rural areas certainly signals towards significant increase in the domestic consumption of medicines in India.

IPM maintained a scorching pace of 16.5% growth in 2010. A recent forecast of IMS highlights similar growth trend in 2011, as well.

In addition, extension of focus of the Indian pharmaceutical Industry, in general, to the fast growing rural markets clearly supports the argument of increasing ‘Access to Modern Medicines’ in India. The improvement in access may not exactly be commensurate to the volume growth of the industry during this period, but a major part of the industry growth could certainly be attributed towards increase in access to medicines in India.

For arguments sake, out of this rapid growth of the IPM, year after year consistently, if I attribute just 5% growth per year, for the last nine years over the base year, to improved access to medicines, it will indicate, at least, 57% of the population of India is currently having access to modern medicines and NOT just 35%, as I wrote in this blog earlier.

Unfortunately, even the Government of India does not seem to be aware of this gradually improving trend. Official communications of the government still quote the outdated statistics, which states that 65% of the population of India does not have ‘Access to Modern Medicines’ even today. No wonder, why many of us still prefer to live on to our past.

Be that as it may, around 43% of the population will still not have ‘Access to Modern Medicines’ in India. This issue needs immediate attention of the policy makers and can be resolved with a holistic approach. A robust model of healthcare financing for all socio-economic strata of the population, further improvement of healthcare infrastructure and healthcare delivery systems are the needs of the hour.

So called ‘Diseases of the Poor’ are no longer the ‘Leading Causes of Death’ in India:

Unlike popular belief that diseases of the poor are the leading causes of death in India. The office of the Registrar General of India (2009) highlights a totally different scenario, where the top five leading causes of death in terms of percentage, have been reported as follows:

  1. Cardiovascular diseases: 24.8
  2. Chronic Obstructive Pulmonary Disease (COPD): 10.2
  3. Tuberculosis: 10.1
  4. Cancer: 9.4
  5. Ill-defined conditions: 5.3

Thus the diseases of the developed world like cardiovascular diseases, COPD and Cancer cause over 45% of the total deaths in India, whereas Tuberculosis, Malaria, Diarrheal and digestive diseases cause around 23% deaths in the country.

The key reasons for not seeking medical treatment are not poor ‘Access to Healthcare’:

As I wrote before, the key reasons for not seeking medical treatment across socio-economic status in the country are not predominantly ‘Poor Access to Healthcare ‘. The following data will vindicate this point:

Reason Rural Poorest 20% Rural Richest 20% Urban Poorest 20% Urban Richest 20%
Financial Reasons 39.7 21.2 37.2 2.3
Ailments not considered serious 27.2 45.6 44.3 84.4
No Medical facilities 12.8 10.0 1.6 _
Others 20.3 23.2 16.9 13.3
Total 100 100 100 100

(Source: India Health Report 2010)

Conclusion:

Thus even if the government ensures ‘Access to Healthcare’ to 100% of the population of India by taking all drastic infrastructural, policy and delivery measures, still a large section of the population both rich and poor and from urban as well as rural India will not seek medical treatment assuming many of their ailments are not serious enough. Such a situation will definitely not materially improve the healthcare scenario of India, adversely affecting the economic progress of the country by a robust productive population.

This necessitates continuous disease awareness campaigns with active participation of all stakeholders, including the civil society across the country, sooner rather than later, in tandem with all measures as will deem necessary.

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.