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Aptness Of Pharma Marketing Audit In Covid Days And Beyond

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That, Covid-19 pandemic has changed the operational dynamics of many areas of the pharma industry, as compared to the old normal, is being felt by many. These changes generally fall into two categories. Some are broad industry specific changes, giving rise to a new normal. Whereas, a lot more could often be specific changes required by individual companies in the changing times – depending on how these companies were operating in pre-Covid days. The good news is, the industry specific ones are being well deliberated by many domain experts, almost on an ongoing basis.

Most experts are suggesting digital solutions, for a number of problem areas in the pharma industry as a whole. But, the reality is, for rapid adaptation of the new normal, there is also a crucial need to dovetail the Company specific solutions, with the industry specific generic ones. This effort will call for effective use of robust, well-structured and time-tested systems. However, not as many discussions seem to be taking place in this area, as on date.

As I see around, one such comprehensive and well proven approach is ‘Marketing Audit’. This can be effectively used to ascertain Company specific changes, required for successful pharma business operation during the Coronavirus triggered paradigm shift. It may not sound as zesty as a ‘digital approach,’ but remains fundamentally important for pharma marketers, nonetheless.

In this article, I shall discuss the relevance and the key importance of a comprehensive pharma Marketing Audit, in this trying time for business. Its key purpose is to give shape to a cutting-edge strategy in today’s unfamiliar order. Let me begin with a brief background of the same, for better understanding of all.

Marketing Audit demonstrated its perennial importance over decades:

To put it in perspective, let me refer to a landmark article by Philip Kotler, titled ‘‘The Marketing Audit Comes of Age.’ It was published by the MIT Sloan Management Review, on January 15, 1989. In his review of the need for Marketing Audit, one can get a sense of perennial importance of Marketing Audit, proven over decades.

In Kotler’s own words: ‘The marketing audit as an idea, dates back to the early 1950s.’ An executive at Booz Allen & Hamilton, conducted marketing audits as early as 1952. Its importance of improving business results, was captured by an excellent set of papers under the title ‘Analyzing and Improving Marketing Performance,’ published by the American Management Association, in 1959.  

Covid-19 Surveys highlight general trends, not any Company specific:

We all are witnessing these days, how the Coronavirus pandemic is changing the pharma consumers. In my June 22, 2020 article in this blog on ‘Enhancing Pharma Brand Experience in The New Normal,’ I highlighted some of the basic changes required in the traditional pharma sales and marketing practices.’ These were the generic changes in the marketplace involving the stakeholders. To illustrate this point better, let me cite some recent examples.

The pandemic has suddenly accelerated certain trends:

The lockdowns have brought to the fore certain shortcomings of the pharma industry, more than ever before. Consequently, its serious fallout compelled almost all players ‘to evaluate and adapt its roles and responsibilities almost overnight.’ This point was captured in the ‘Survey results: Accelerating digital transformation during COVID-19,’ published by Reuters Events– Pharma on September 04, 2020. Some of the survey findings included the following:

  • Although, adoption of digital engagement has accelerated, pharma’s ability to deliver exceptional virtual engagement and content is being put to test.
  • Customer Relationship Management (CRM), Content Management Systems (CMS) and customer engagement platforms were found wanting and not fully exploited.
  • There will be a greater emphasis on the Connected healthcare customer journey.
  • Providing a unique customer experience will emerge as a competitive edge.
  • The industry must re-direct resources accordingly, and re-tool to make the most of them.

Let’s now examine some India specific findings from another survey in this space.

Some India specific survey findings:

To explore the impact of COVID-19 on the Indian pharmaceutical industry, another survey, conducted by C Com Digital of India, came out with some interesting findings, some of which are as follows:

  • The new normal warrants a strategic shift in the business operation, besides engagement with doctors and patients.
  • Increasingly, drug companies are moving into online business operations from mostly offline operations of pre-Covid days.
  • Many companies are considering dedicating about 5 percent to 10 percent of their marketing budget towards creating webinars and online communications.
  • Teleconsultations and online consultations are steadily increasing and around 42 percent patients are getting their prescriptions in this way.
  • Doctor visits dropped by 5 percent only during March-April 2020 period.
  • Companies are expanding in online patient education, and online field staff training through custom made e-Learning modules.

As we find above, the emerging new trends are all generic in nature – not enough to prepare any comprehensive company specific strategy for success in the prevailing situation. This brings us to the question: What exactly is Marketing Audit and its relevance during pandemic days?

Relevance of Marketing Audit during pandemic days and beyond:

Thus, the extent of changes required on all sales and marketing related areas, during the pandemic period and beyond, has to be carefully and productively evaluated by each Company, separately. No wonder, why a comprehensive ‘Marketing Audit,’ is also considered “a marketing mirror” - so appropriately.

Without going into the theoretical details, let me first try to explain this terminology in simple terms. It has clearly been established that a Marketing Audit helps understanding, both internal and external marketing environments of an organization, in a comprehensive way. Mainly because, it involves an in-depth and data analysis of the concerned company’s business domain, not just to accurately diagnose the new areas of problems, but also to work out a contemporary – cutting edge marketing strategy.

Thus, I reckon, this tool should be effectively used by pharma marketers, as a high potential mechanism in the marketing warfare, especially during the global pandemic and beyond. Still, some can raise the question, what exactly pharma industry surveys will tell you and what those won’t, – and what gaps company specific surveys will help bridge.

The gaps that Marketing Audit will help bridge:

Industry specific surveys on Covid-19 pandemic would tell the Companies where they should aim to reach. However, each Company would still need to figure out where they currently are in those areas, and most importantly how to reach the target point. An effective Marketing Audit will help the Companies get exact information on where they currently are, and how to reach where they want to reach.

As the new normal is changing, it needs to be done periodically: 

The information obtained through a robust Marketing Audit will help address both customer and market needs – on the one hand and honing or reorganizing the company’s internal value delivery systems commensurately, on the other. However, when an unprecedented or a disruptive change, such as the Covid-19 pandemic keeps striking all conceivable entities, very hard, ‘the new normal’ keeps changing. In this situation, most of the past success ingredients will no longer yield results. Thus, to realign the business with changing market demand, pre-Covid strategic blueprint needs to be redrawn, alongside the necessary wherewithal required for the same.

Marketing Audit, therefore, becomes a periodic requirement for all organizations, assuming the importance of a key business success imperative, if not for survival in the new normal. Any delay in this area may lead to significant loss of Company business.

Conclusion:

According to Covid-19 update of Evaluate Pharma, ‘seemingly uncontrollable advance of Covid-19 in India,’ is perturbing. As on September 20 morning, the country had recorded a staggering figure of 5,400,619 of Coronavirus cases with 86,774 deaths, overtaking Brazil the week before.

The above report points out the potential danger of ‘the country’s health care system to buckle under the weight of hospital admissions for the virus.’ However disturbing this trend may be, from the pharma industry perspective, it sends, at least, four clear signals:

  • It’s a long-haul struggle for the business, as Covid-19 is not going to vanish any time soon.
  • The barriers to in-person interaction will continue for an indefinite period.
  • The market dynamics will keep changing, mostly based on Government’s new guidelines.
  • A robust, flexible, contemporary and comprehensive marketing strategy needs to be supported by stronger and time-tested marketing systems for all times.

From the above perspective, one such time-tested mechanism still remains – ‘the Marketing Audit.’ For business excellence during Covid times, it carries a game changing potential, by dovetailing the industry specific generic problems with company specific strategic solutions.

The criticality of ‘Marketing Audit’ does not remain limited just to bright pharma marketers. It also provides an equally critical top management decision support tool, especially for risk-benefit analysis of the corporate business. Thus, relevance and importance of ‘Marketing Audit’, would remain undiluted, not just during the Covid pandemic – but much beyond.

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.

Multichannel Marketing: Two Important Pharma Trends

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On September 6, 2018, Reuters reported the announcement of GlaxoSmithKline (GSK) that it would cut about 650 positions in the United States related to a global restructuring program. This includes 450 Medical (sales) Representatives (MR). Similar announcements on job cuts for MRs by other pharma companies are being made since the last several years. Last week’s GSK announcement was the continuation of the same process. This prompts me to use the aforementioned global news while focusing on two important emerging trends in the pharma industry, as we witness today.

In the rapidly digitalized world, several broader questions are often raised today. These include whether or not e-detailing in the pharma industry will eliminate the role of MRs, or for that matter will digital marketing replace the pharma print media? As the concept of ‘multichannel marketing’ (MCM) gains momentum, finding right answers to these questions or at least the right trends are assuming as much importance for business success. As I don’t have any specific answers to these queries, in this article, let me discuss just two of these emerging trends, as appears to me.

Importance of multichannel marketing in pharma:

Many pharma companies are fast realizing that their customers, such as doctors, patients and others, are showing increasing interest in getting the requisite product or treatment related information from multiple readily available channels or sources. These are accessible both in digital and print platforms, which are often of independent origin. Such behavioral preferences of pharma customers are contrary to what was mostly happening in the past, globally. However, in the pharma world of contemporary India the same old traditional path of product information flow, from drug companies through Medical Representatives to doctors, continues, by and large.

Looking ahead, ‘multichannel marketing’ for pharmaceutical and biologic products is being generally considered as the recipe for commercial success of brands. Thus, pharma players are trying to engage their customers more through multiple channels, both directly or indirectly. This is happening in many countries of the world. It is a matter of time, I reckon, that majority of large to medium Indian drug manufacturers will also follow suit.

Two interesting trends:  

As multichannel marketing in pharma catches up, I find some interesting developments. These are outcomes of different channels getting balanced, based on customer preferences. Let me underscore, these are customers’ perceptions in the real world and not what the drug companies and their associates usually think, hence are worth considering. The two emerging trends, in my view, are as follows:

1. Although, the role of Medical Representatives is still important, but not as indispensable as was in the past.

2. Despite high decibel discussion over digital media, print media is still very relevant.

1. Impact on the role of Medical Representatives (MR): 

“There is an ongoing debate about the effectiveness and impact of the traditional sales representative, with some arguing to discontinue the role while others sense an opportunity to improve both rep productivity and efficiency.” This was articulated in a McKinsey & McKinsey paper titled, “Death of a sales model or not.” The same article also says, even those who champion the role, point out that using richer analytics, better leadership and aligned incentives to deliver stellar results in many geographies.

To comprehend what is really happening in this area, I would quote below from two important global survey reports, with a sincere wish that similar surveys are carried out in India too. Although, these two surveys are different in nature, but address the same basic issue.

A. ZS’s Access Monitor 2014 survey:

According to this survey, “Representatives access to physicians continues to decline, particularly in certain specialties and areas of the country. Overall, close to half of all doctors in the United States are now considered “access restricted” to varying degrees.” It further says: “Since the initial ‘Access Monitor’survey in 2008, access has steadily fallen, with 77 percent of physicians considered “accessible” that year, compared with 65 percent in 2012, 55 percent in 2013 and 51 percent in 2014.

In another important finding the same study captured that “the pharmaceutical and biotech industry wastes approximately USD 1.4 billion in infeasible calls. (A call is considered infeasible if a best-in-class sales rep can’t deliver it.) The cost of infeasible calls appears to have plateaued, as companies have largely squeezed out sales force inefficiencies— making alternative channels the best path to improving access and customer engagement.”

B. CMI/Compas Media Vitals research 2018:

Despite such debate, doctors still value face to face interaction with MR, across the world. However, the digital tools and platforms of various types are increasingly used as the source of both new and existing product information, including updates.

According to CMI/Compas Media Vitals research 2018, as shown in the Table I below, doctors’ dependence on MR for information on new and existing products now stands at 51 percent and 46 percent, respectively. Similarly, for product updates their dependence stands at just 39 percent. The above McKinsey & McKinsey paper also predicts that the number of MR will gradually decline as the multichannel marketing initiatives pick up.

That said, in Table I – dinner meeting ranks seven and peer to peer information comes in the third place. Digital sources when put together now occupy a significant part of the doctors’ preferences for obtaining product information.This is also clear from the Table I that the doctors have started showing interest e-detailing, as well.

Table I:  How do you want to receive information from pharma companies, for:

In % New Products Existing Products Product Update
E-detailing

15

16

13
EHR

16

16

26
Reps’ Email

21

7

27
Medical Journal

22

19

12
MSL

24

23

14
Pharma Brand E-Mail

24

21

28
Direct Mail

32

29

29
Peer-to-peer

47

40

21
Dinner Meetings

49

45

24
Representatives

51

46

39

(Source CMI/Compass Media Vitals 2018)

Dinner Meetings:

As I said before, “Dinner Meetings” were rated as the second most preferred choice of the doctors for getting new and existing product information, in the above Table I. This is interesting, especially when one reads it along with the findings of the research paper, published in the August 2016 issue of JAMA Internal Medicine. The study concluded with: “The receipt of industry-sponsored meals was associated with an increased rate of prescribing the promoted brand-name medication relative to alternatives within the drug class.” The paper also clarified that “the findings represent an association, not a cause-and-effect relationship.”

2. Print media remains relevant despite digital push:

The research by CMI/Compass Media Vitals 2018 has also shown that despite the abundant availability of online versions of various medical publications, many doctors still prefer to read the print format of the same Journal, as shown below in the Table II:

Table II. How do doctors read medical Journals? 

Online/Digital format (%)

Print format (%)

47

53

(Source CMI/Compass Media Vitals 2018)

Although, the professional portals are the most used to get the requisite information by the doctors, print journals still rank number three, after peer-to-peer information.

That print media is still relevant for the doctors to know about drugs, was confirmed by another study, as shown in Table III:

Table III. Print media is still relevant:

Professional Portal Colleagues Print Journals CME Meetings Online Journals Drug Ref. App In Person Speaker program
72% 67% 66% 66% 53% 53% 53% 53%

(Source :Kantar Sources & Interactions report from September 2017)

It is noteworthy that ‘online journals’ rank number 5, after ‘CME meeting’.

Conclusion:

Despite Millennials in India mostly prefer reading news online through digital media, print media has still remained relevant and growing too. So are the television channels, regardless of easy availability of anytime streaming of all types of news, videos, TV serials and even movies.

Moreover, with increasing preference of digital media by an increasing number of populations, reliance of many industries such as Fast-Moving Consumer Goods (FMCG) haven’t totally shifted from magazine and newspaper advertisements, alongside targeting their customers through digital platforms. The same is expected to happen with various print formats in multichannel pharma marketing, where the physical presence of MRs still play an important role. Thus, to create a greater impact on doctors, patients and other stakeholders, pharma marketers are expected to leverage the best of both print and digital world in the form of comprehensive MCM initiatives. It could well be more on digital platforms and less with print materials, as we move on.

The new role of MRs was epitomized in an interview of the Sales Director, Roche, UK, published in the eyeforpharma on January 26, 2018. In the words of the sales director: “For us, in our market, the traditional showing a visual aid and some messages with the HCP is dead… But the face to face meeting is certainly not. Its role, however, will be more about adding value, about finding the right patients for the right drug.” He further highlighted, “the clear challenge that stands before the pharmaceutical industry’s sales organizations; a world where access to physicians is diminishing, trust in the information the industry provides is dwindling, and having a costly sales force is increasingly hard to defend.”

Against this backdrop, regardless of MCM, the role of those MRs who will be in sync with the requisite applications of technology in their focus areas of work, will continue to remain relevant, though they will be lesser in number. A few of them will also stand out and shoulder higher and higher professional responsibilities in the industry.  Be that as it may, in my view, these two emerging trends are expected to gather a strong tailwind, at least in the medium to long term, heralding the dawn of a new era in the Indian pharma industry.

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 importance of ‘Supply Chain Integrity’ in ‘Global Supply Chain Management (GSCM)’ process

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Since the last decade with increasing pace of change, mostly in the western world has accelerated the globalization process in the Pharmaceutical Industry across the world. The key drivers to these changes are as follows:

1. A large number of patent expiration hugely impacting the top-line growth
2. Research pipeline is drying-up
3. The cost of bringing a new molecule from ‘the mind to market’ has now touched around US $ 1.75 billion
4. Regulatory requirement to get the marketing approval is getting more and more stringent, basically for patients’ safety, making clinical development more expensive and time consuming
5. Cost containment measures of various governments around the world is putting an immense pressure on product price, significantly affecting the profit margin

Changing Business Process:

All these factors are triggering other sets of consequential strategic events of enormous significance. Among those, following key corporate strategic steps indeed stand out:

1. More mergers and acquisitions of various size and scale to achieve both revenue and cost synergy, with new products and newer types of resources

2. Transformation in the fundamental operating models, e.g. R&D focused companies like Pfizer, GSK, sanofi aventis are extending their business interest in the pharmaceutical generics space, as well

3. Increasing globalization process and more focus on the emerging markets of the world like, Brazil, Russia, India, China, Turkey, Mexico

4. Growing emphasis on partnering, as we see in India, like for example, between Pfizer and Aurobindo, Claris and Biocon, GSK with Dr. Reddy’s Lab (DRL), AstraZeneca with Torrent, sanofi aventis with Zydus Cadila etc.

5. Global outsourcing in the ‘Contract Research and Manufacturing Services (CRAMs)’’ space

Increasing importance of GSCM:

In today’s evolving scenario, Global Supply Chain Management (GSCM) process has assumed a key importance. The need to reduce costs significantly and minimize the risks associated with the procurement activities of the business, have compelled many innovator companies to extend the activities of their Supply Chain management process to the Global arena, instead of just confining to the local space.

The changing requirements of all hues and types in various areas of the business, like in sales and marketing, manufacturing, research and development etc., have created a challenging, if not a rather volatile operating environment.

Such an evolving scenario will make the GSCM to increasingly play a key role in the overall business process of an organization to ensure that the right products are available at the right place, at the right time, at a right price and following the right processes…Always.

Emerging GSCM hubs:

There is at the same time, a new trend emerging to provide world class outsourcing services, especially from countries like India and China. These initiatives, which in turn will make these two countries the key global outsourcing hubs, are definitely not due to just cost arbitrage. It encompasses increased integrated value proposition for the overseas customers. Cost is just one of the key factors, others being quality, speed and suppliers’ integrity and reliability. Nothing in this value chain is mutually exclusive. GSCM will need to go through a set of complex algorithms to strike a right balance between all these vital parameters.

Importance of GSCM integrity:

In the days to come by, one of the greatest challenges in GSCM will be to improve the supply chain integrity and security. An appropriate definition of integrity for supply chains could be:

“…the requirement that the system performs its intended function in an unimpaired manner, free from deliberate or inadvertent manipulation.”

A safe and secure supply chain is definitely not a new requirement. However, in the list of priority of importance, it has now come up significantly, compared to what it was just a few years back. Though the issue of improving supply chain integrity and security has now assumed global importance, unfortunately, any uniformity in national regulatory requirements for this vital parameter is glaringly missing. Such a lack of regulatory uniformity clearly highlights that the pharmaceutical companies, engaged in manufacturing, are still not aligned with each other on what will be the right way to ensure absolute integrity, safety and security in the supply chain operating process to guarantee patients’ safety.

Globally, many Pharmaceutical Companies are getting engaged in improving supply chain integrity, security and patients’ safety with the introduction RFID. This, as many may know, is an inventory tracking system for improved product traceability, which in turn extends some protection to its customers with genuine products from the genuine pharmaceutical manufacturers. It is worth noting that RFID is just one component of overall patients’ safety initiative.

Along with high tech measures like RFID, to improve supply chain integrity, I reckon, pharmaceutical companies will need to further enhance their respective ‘supplier qualification process’. The process of supplier audits should include all important and critical areas of manufacturing, testing and quality, related to each individual product.

Stringent supplier qualification standard is of prime importance:

Only a stringent supplier qualification process will be able to guarantee integrity, safety and the quality of outsourced products from the suppliers.

An example of a GSCM related tragedy:

Before I conclude, I would like reinforce my recommendation with the example of the ‘Heparin tragedy’ where the supply chain integrity was violated and seriously challenged thereafter.

In the beginning of 2008, there were media reports on serious adverse drug events, some even fatal, with Heparin, a highly-sulfated glycosaminoglycan of Baxter International. Heparin is widely used as an injectable anticoagulant. Baxter voluntarily recalled almost all their Heparin products in the U.S. Around 80 people died from contaminated Heparin products in the U.S. The US FDA reported that such contaminated Heparin was detected from at least 12 other countries.

A joint investigation conducted by Baxter and the US FDA ascertained that the Heparin used in batches associated with the serious adverse drug events was contaminated with over sulfated chondroitin sulfate (OSCS). It was reported that his Heparin was supplied to Baxter by Scientific Protein Laboratories, Changzhou, China.

The cost of OSCS is just a fraction of the ingredient used in Heparin. Being driven by the criminal profiteering motive the manufacturers in Changzhou, China had reportedly used OSCS for highly-sulfated glycosaminoglycan as the former could not be detected by the pharmacopeia test in use, until 2008. This is because OSCS mimics Heparin in the pharmacopeia test. Post this criminal event, at present, all over the world more specific pharmacopeia test methods have been adopted for Heparin.

Conclusion:

Let us all ensure that such a tragedy does not get repeated in future due to a breach in the supply chain integrity, anywhere in the world…for the patients’ sake.

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.

To avoid “Heparin” like tragedy in future, a robust “supply chain integrity and security” system is of critical importance

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Globally the pharmaceutical industry is going through a metamorphosis. The types of changes that are taking place today globally, perhaps has no precedence..

The key drivers of these changes are mainly the following:

1. A large number of patent expiration hugely impacting the top-line growth
2. Research pipeline is drying-up
3. The cost of bringing a new molecule from the ‘mind to market’ has now touched around U.S$ 1.75 billion
4. Regulatory requirement to get the marketing approval is getting more and more stringent, basically for patients’ safety, making clinical development more expensive and time consuming
5. Cost containment measures of various governments around the world is putting an immense pressure on product price, adversely affecting the profit margin

Strategic measures of enormous significance:

All these are triggering other sets of consequential events of enormous significance. Among those following key corporate strategic measures indeed stand out:

1. More mergers and acquisitions of various sizes and scales to achieve both revenue and cost synergy, with new products and newer types of resources
2. Transformation in the fundamental operating models, e.g. R&D focused companies like Pfizer, GSK, sanofi aventis are extending their business interest to the pharmaceutical generics space
3. Increasing globalization and greater focus on the emerging markets of the world like, Brazil, Russia, India, China, Turkey, Mexico
4. Growing emphasis on partnering, as we see in India, like for example, between Pfizer and Aurobindo, Claris, GSK with Dr. Reddy’s Lab (DRL)
5. Global outsourcing in the ‘Contract Research and Manufacturing Services (CRAMs)’’space, mainly to rationalize costs and deliver the bottom lines, when the top line is under immense pressure.

Demand on all round effectiveness of the “Supply Chain”:
The changing requirements of all types, in sales and marketing, manufacturing and research and development have created a challenging, if not a rather volatile operating environment. In this situation supply chain will increasingly play a key role to ensure that the right product is available at the right place, at the right time, at a right price and following the right process…always.

Outsourcing initiative is not just about cost:
There is at the same time, a new trend emerging for increased outsourcing initiative, especially from countries like India and China. This initiative, which in turn is in the process of making these two countries the key global outsourcing hubs, is definitely not all due to just cost advantages. It encompasses increased integrated value proposition for the customers. Cost is just one of the key factors, others being quality, speed and suppliers’ reliability. Nothing in this value chain is mutually exclusive. Supply Chain will need to go through a set of complex algorithms to strike a right balance between all these vital parameters.

Robust “supply chain integrity and security’ will assume critical importance:
In the days to come by one of the greatest challenges in supply chain management will be to improve the supply chain integrity and security.
An appropriate definition of integrity for supply chains is:

“the requirement that the system performs its intended function in an unimpaired manner, free from deliberate or inadvertent manipulation.”
A safe and secure supply chain is definitely not a new requirement. However, in the list of priority of importance, it has now come up significantly compared to what it was just a few years back.

Are the pharmaceutical companies aligned on this issue?
Though the issue of improving the supply chain integrity and security has now assumed global importance, unfortunately, any uniformity in national regulatory requirements for this vital parameter is glaringly missing. Such a lack of regulatory uniformity clearly highlights that the pharmaceutical companies, engaged in manufacturing, are still not aligned with each other on what will be the right way to ensure absolute integrity, safety and security in the supply chain operating process to guarantee patients’ safety.

RFID is just one component of supply chain integrity:
Globally many Pharmaceutical Companies are getting engaged in improving supply chain integrity, security and patient safety with the introduction RFID. This, as many may know, is an inventory tracking system for improved product traceability, which in turn extends some protection to its customers with genuine products from the genuine pharmaceutical manufacturers. It is worth noting that RFID is just one component of overall patients’ safety initiative.

Suppliers’ qualification process through stringent ‘supplier audit’ is of critical importance:
Along with high tech measures like RFID, to improve supply chain integrity, I reckon, pharmaceutical companies will need to further enhance their respective supplier qualification process.
The process of supplier audits should include all important and critical areas of manufacturing, testing and quality, related to each individual product. Only a stringent supplier qualification process will be able to guarantee integrity, safety and the quality of products from the suppliers.

Heparin tragedy, where the supply chain integrity was grossly violated:
Before I conclude, I would like reinforce my recommendation with the example of Heparin tragedy where the supply chain integrity was violated and seriously challenged thereafter.

In the beginning of 2008, there were media reports on serious adverse drug events, some even fatal, with Heparin, a highly-sulfated glycosaminoglycan of Baxter International. Heparin is widely used as an injectable anticoagulant. Baxter voluntarily recalled almost all their Heparin products in the U.S. Around 80 people died from contaminated Heparin products in the U.S. The US FDA reported that such contaminated Heparin was detected from at least 12 other countries.

A joint investigation conducted by Baxter and the US FDA ascertained that the Heparin used in batches associated with the serious adverse drug events was contaminated with over sulfated chondroitin sulfate (OSCS). It was reported that his Heparin was supplied to Baxter by Scientific Protein Laboratories, Changzhou, China.

The cost of OSCS is just a fraction of the ingredient used in Heparin. Being driven by the criminal profiteering motive the manufacturers in Changzhou, China had reportedly used OSCS for highly-sulfated glycosaminoglycan as the former could not be detected by the pharmacopeia test in use, until 2008. This is because OSCS mimics Heparin in the pharmacopeia test and thus could not be detected in the case in question.
Post this criminal event, at present, all over the world more specific pharmacopeia test methods have been adopted for Heparin.

Conclusion:
Let us all ensure that such a tragedy does not get repeated in future due to a breach in the supply chain integrity, anywhere in the world…for the patients’ sake.
In today’s deliberations I am sure this issue will be touched upon to ponder over the possible implementable steps to address such future threats effectively.

By Tapan 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.