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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.

Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India

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“Bottle Of Lies Exposes The Dark Side Of The Generic-Drug Boom” – re-emphasized the book, released in May 2019.  This confirms, the raging debate on the questionable quality of many generic drugs manufactured in India and involving several top domestic pharma companies, is a never-ending one. Numerous articles also ascribe many different reasons to this saga, leaving an overall impression – as if, blindfolded persons are trying to describe an elephant, touching and feeling different parts of the animal’s body, each at a time.

Let me illustrate the point with the Bloomberg article of January 31, 2019. It reported, “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency.” And further commented: ‘The FDA confronts creative improvisation in the world’s largest generic-drug exporter.’ Curiously, according to the above report it seems to be a general belief among many, even within India.

This article will take into account the above apprehension – specifically raised against Indian drug manufacturers of both branded and non-branded generics. Accordingly, my focus will be on just three points – as possible causative factors for this critical issue:

  • Is it an India specific concern – thus related to ‘Indian cultural mindset’? or it’s a global issue, involving both Indian multinational drug manufacturers.
  • Is it a systematic attempt to create a perception bias against low-cost generic drugs, worldwide?
  • Are generic drug makers resorting to such unacceptable shortcuts due to increasing margin pressure?

Having deliberated these points, I shall try to outline a set possible remedial measures to address this issue in a holistic way, ensuring a win-win outcome. Let me first explore, whether or not this issue is specific to India, involving Indian drug manufacturers.

Is the issue India specific?

Is the issue of questionable quality of generic drugs, irrespective of whether they carry a brand name or not restricted to the shores of India? One can find its answer in the same report, as quoted above. A yearlong investigation by Bloomberg News into the generic-drug industry concluded, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’

One possible reason for such perception could be, since India is predominantly a branded generic market, voices decrying ‘questionable’ safety and efficacy of cheaper non-branded generic drugs, are too loud. Nevertheless, amidst all this, who’s who of branded generic manufacturers continue getting caught on the wrong foot by overseas regulators in the quality quagmire. Ironically, multinationals are also included in it.

Multinationals are also included in such quality quagmire:

There are several examples of non-compliance to requisite drug quality standards by multinational drug companies. Let me illustrate the point with an example that involves a top global pharma player.

The March 04, 2019 ‘Warning Letter’ of US-FDA for the Irungattukottai (Tamil Nadu) plant of Pfizer in India, clearly said: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

This is not a solitary example of Pfizer’s generic hospital injectables manufactured in this plant. According to a media report dated July 17, 2018, twice before US-FDA had cited manufacturing and testing issues in this facility, containing 11 observations of the regulator, such as, workers “manipulated test sample weights to obtain passing results” for both batches of raw materials and finished product. It is a different matter that the company, later on, decided to close this plant for commercial reasons. Be that as it may, negative perception of generic drug quality is indeed an issue that needs to be addressed without further delay, holistically.

Studies have captured negative perception of generic drugs:

That this is a perception, has been well – elucidated along with its implications, in several studies. A few of which are as below:

A BMJ article concluded: “A significant proportion of doctors, pharmacists and lay people hold negative perceptions of generic medicines. It is likely these attitudes present barriers to the wider use of generics.” It further added, “Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector.”

Endorsing this point, yet another BMJ article inferred: “Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behavior and affect trust in healthcare provided in public services. To succeed, access to medicine programs need to systematically invest in information on the quality of medicines and develop strategies to build trust in healthcare offered in government health services.”

Again, in a separate survey of over 2700 physicians on perceptions of generic drugs, more than 23 percent of respondents expressed negative perceptions about their efficacy and nearly 50 percent. reported negative perceptions of generic drug quality. In the same survey, patients also expressed concerns that the lower cost of generics is associated with reduced medication quality.

Although, the above survey was conducted in the United States, the current situation in India, I reckon, is no different, but with one caveat. Here, preferential promotion of branded generic medicines over cheaper non-branded equivalents, by the respective drug manufacturers, could significantly influence prescriber behavior. Therefore, the question that follows: Is this perception-creation based on facts?

Is the negative perception fact-based?

Although, even the US-FDA clearly states that: ‘A generic medicine works in the same way and provides the same clinical benefit as its brand-name version”, I did try to find some conclusive evidence depicting brand name drugs are superior to their cheaper generic equivalents. While doing literature searches, two types of results emerged – there are studies that do not find any significant difference between generic drugs and their branded equivalents. At the same time, a few other studies do suggest that there is a difference between these two, but admitting that these studies are not conclusive. Let me give below examples of each.

No quality difference found between generic drugs and the branded variants: 

I shall quote here three studies, out of which one is India specific. The analysis reported in the above BMJ article, found that ‘the generic and branded variants of the medicines tested were of comparable quality.’

Another study, published by PLOS Medicine on March 13, 2019 also said, “In this study of 8 drug products conducted using 2 large US commercial insurance databases, we observed that use of generics provided comparable clinical outcomes as the brand products.”

An India specific researchon the same also reported, most generic and branded drug users believed that their drugs were effective in controlling their ailments with no significant difference in reported adverse effects and drug adherence.

Slightly different results were also reported with generics, but not conclusive:

One such study questioned, whether generic drugs are truly equivalent to the brand-name versions.This article was published on January 2019 by Harvard Health Publishing with the title, “Do generic drugs compromise on quality?”

This article quoted a Canadian study, published in the October 2017 issue of ‘Circulation: Cardiovascular Quality and Outcomes’, which found that patients who took generic versions of three different blood pressure medications in the months after the generic drugs became available saw increased rates of drug-related side effects.

Was it due to a perception bias?

To ascertain whether or not there is a perception bias, let us look into the following details of the same study along with its conclusion.

In this study, the researchers ‘looked at the numbers of emergency room visits and hospitalizations for 136,177 individuals ages 66 and over (60% of them women) who used any of three blood pressure medications: losartan (U.S. brand name Cozaar), valsartan (Diovan), and candesartan (Atacand). The investigators examined data for the periods 24 months before and 12 months after the generic versions of these medications went on the market. And found that before the generic versions became available, about one in 10 people taking the blood pressure drugs had to go to the emergency room or be hospitalized each month. In the month after each of the generics went into use, the rates of these adverse events went up: 8% for losartan, almost 12% for valsartan, and 14% for candesartan.’ The study authors commented, this might suggest performance differences between the brand-name and generic drugs.

However, analyzing this study, the Harvard article suggested further probe on the question: Did it result from quality problems with the generic versions of these medications or were there other factors that occurred in this time frame?

Another research, aimed at finding, whether patients are more adherent to generic statins than brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes, also concluded, “An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group.” This also wasn’t a conclusive one, either.

Nevertheless, the key point of a ‘perception bias’, is captured in a separate study, where the researchers did find higher rates of psychiatric hospitalization for patients taking generic and AG escitalopram and sertraline, compared with those who initiated the brand-name product. Importantly, they noted that these outcomes were likely due to either residual confounding or generic perception bias.

No quality difference also found between branded and non-branded generics in India:

There are studies, which captured no quality difference between branded generics and non-branded generics in the country. One such India specific study concluded: “Quality of branded-generics is same as for their branded version. The study highlights the need to modify the drug price policy, regulate the markups in the generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders.”

Thus, so far, we have seen in this article that concern on quality of generic drugs is neither India specific, nor is it related to ‘Indian cultural mindset.’ And this is, undoubtedly, a global issue, involving both Indian and multinational drug manufacturers. There are also ample evidences available that a systematic attempt is being made to create a perception bias against low-cost generic drugs, worldwide. Let us now look at the third possible causative factor, as I listed above.

Is it due to margin pressure on generic drugs?

The answer to this question was deliberated in an article titled, ‘Generic drug makers feel pinch as prices crumble,’ published in the Financial Times on August 17, 2017. Quoting a top global financial analyst, it reported – global generic drug industry, where Indian manufacturers are major players,has maintained roughly 30 per cent operating margins over a long period of time, with improvements year on year. But, since last few years, there has been a margin degradation, which may possibly further go down – even lower than what it is today.

The article further highlighted, a round of consolidation among their main customers in the US: the wholesalers, have escalated the problem.  Many of these groups have clubbed together to form “mega buyers”, known as general purchasing organizations, that can command large discounts. Moreover, for the US market, another area of ‘concern’ is that the US-FDA has identified boosting competition in the generics market as one of its main priorities. As this reform opens up, it could squeeze the generic drug margins further.

Many envisage that intense cost cutting measures, could have transgressed in the drug quality assurance area, aggravating this issue. Although, it needs to be verified through credible studies, curiously, some signs of improvement in this area has recently been reported.

That said, there appears to be a strange coincidence between recent reports on Indian drug makers showing improvement in USFDA inspection outcomes and attempts to increase generic drug companies and some of their top executives slapped with price-fixing lawsuits in the U.S.This needs to be studied further.

The way forward:

The negative perception of generic drugs, in general, and non-branded generic drugs, in particular, is most likely a well-crafted business issue, rather than a genuine patient safety concern. It calls for an immediate two-pronged approach:

  • Vigorous awareness and educational campaigns on safety and efficacy of generic drugs targeted to patients, medical and paramedical professionals.
  • New regulatory measures, especially the following five:

- No pricing pressure or price control in any form of generic drugs

- Abolish brand names for generic drugs

- Make generic prescription compulsory to boost intense competition and thereby     reducing the price.

- Restrict the number of ingredients in FDC not more than two or three

- Make Uniform Code of Pharmaceutical Marketing Practices (UCPMP) mandatory.

Conclusion:

Thus, the questionable quality of generic drugs is not an India specific concern and involves both Indian multinational drug manufacturers. This is also evident from the analysis, as quoted above, that underscores, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’ Many studies have revealed that there is a systematic attempt to create a perception bias against low-cost generic drugs, worldwide.

A sequence of remedial measures, as described above, also include fostering competition, instead of introducing government controls on prices of generic drugs with stringent regulatory oversight being in place.

Thus, the so called ‘belief’ that the ‘culture of bending Rules’ is culpable for dubious generic drug quality in India, is more akin to a strong perception, prevailing in India, rather than based on any scientific analysis related to this issue. This ought to change with a well-coordinated intervention – for patients’ health interest sake.

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.

Should Pharma-Doctor Communication Be Also Gender-Specific?

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Regardless of situations, while selecting a suitable doctor for patients, or for that matter, pharma companies engage with them for commercial reasons, their gender doesn’t matter much to many.

What one generally looks for is, whether they are General Practitioners (GPs), General Surgeons (GSs) or Specialists in various disease areas, such as cardiac, metabolic, bones and joints, cancer and so on. This has been happening, despite several research studies pointing out a number of important gender-based behavioral differences between most male and female doctors, often leading to a significant difference in patient outcomes.

Before proceeding further, let me admit up front that there may be some exceptions to this general scenario. For example, certain female patients may prefer being examined by the female doctors only. Similarly, a few drug companies may be tailoring the content and the process of their communication based on the target doctors’ age.

In this article, I shall try to focus on this area based on a number of important research findings. The objective being whether medical communications of pharma players should also factor-in the gender-specific nuances among male and female doctors. This is because, such differences impact clinical outcomes and happens irrespective of whether they are GPs or specialists. Let me kick-start the discussion with the following question:

“Does gender matter when choosing a doctor?”

This interesting point was raised in an article, titled “Should You Choose a Female Doctor?”, appeared in ‘The New York Times (NYT)’ on August 14, 2018. Let me put across the essence of it, quoting from some large research findings.

The August 21, 2018 study, titled “Patient–physician gender concordance and increased mortality among female heart attack patients,” published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS). This study covered more than 580,000 heart patients admitted to emergency rooms in Florida between 1991 and 2010. After a thorough scrutiny, the researchers noted that:

  • The mortality rates for both women and men were lower when the treating physician was female.

Consequently, it appears, gender does matter, while choosing a doctor for better treatment outcomes. Nevertheless, just one illustration in this regard may not possibly be enough to drive home this point. Thus, let me quote from another important study. This one is a Harvard study that included more than 1.5 million hospitalized Medicare patients and arrived at similar conclusions, with the finding as stated hereunder.

Lower 30-day mortality under female internists than male counterparts:

This large study, published in JAMA Internal Medicine on February 2017 also concludes:Hospitalized patients who receive care from female general internists have lower 30-day mortality and readmission rates than those patients cared for by male internists.

“The difference in mortality was slight – about half a percentage point – but when applied to the entire Medicare population, it translates to 32,000 fewer deaths,” reported the above NYT article while commenting on this subject. I shall come to this finding in just a bit.

Why patient outcomes are different under the care of male and female doctors? 

To get an answer to this question, just as several other previous studies, the findings of the above issue of JAMA Internal Medicine also suggest more studies in this area. The aim is to zero-in on the key differences in practice patterns between male and female physicians, which may have important clinical implications for patient outcomes.

The researchers observed, understanding exactly why these differences in care quality and practice patterns exist may provide valuable insights into improving quality of care for all patients, irrespective of who provides their care.

Curiously, this question was answered in a 2002 study published in the JAMA that found female doctors spend more times with patients.

Female doctors spend more times with patients:

The paper, titled “Physician gender effects in medical communication: a meta-analytic review” wanted to find out why patient outcomes are different under the care of male and female doctors?This study was published in the August 14, 2002 issue of JAMA. It found, “Female primary care physicians engage in more communication that can be considered patient centered and have longer visits than their male colleagues.”The average difference in time spent with patients between male and female physicians is about 2 minutes, or 10 percent, per visit.

The researchers also found that female physicians engage in communication that mostly relates to the larger life context of patient conditions. It includes addressing psychosocial issues through related questions and counseling, greater use of emotional talk, more positive talk, and more active enlistment of patient input. From this perspective, they commented: When taken together, these elements comprise a pattern that can be broadly considered ‘patient-centered’ interviewing.

Would tailoring pharma communication accordingly fetch better dividend? 

Such highly similar findings, as evidenced by many reports, over a considerable period of time, add much credence to an important fact. These vindicate the concept that ‘patient-outcomes are better when cared by female doctors as compared to their male counterparts.’ In the pharma context, the subsequent question that surfaces: Can this finding be put to use while developing a tailor-made communication strategy with appropriate content for female doctors, harvesting a rich commercial dividend?

No doubt, before doing so, more data need to be generated and analyzed to corroborate the utility of the same in the pharma business. That said, the good news is, the work has already started in this area.

Some interesting recent findings on pharma-doctor interactions:

As reported by Fierce Pharma on October 26, 2018, moving towards this direction, CMI/Compas ventured into testing the water. It planned to find out whether drug companies should develop male and female doctor-specific communication strategy and content for more productive engagement with them. After an elaborate data analysis, CMI/Compas found the following:

  • As the most important source of new product information 59 percent of older-male-doctors rank pharma sales reps much higher. Whereas, only 46 percent of older-female-doctors’ think so.
  • 47 percent of older-male-doctors were most likely to see sales reps without any restrictions. Whereas, less than 40 percent of the other group saw reps without placing any hurdles to their visits.
  • Female physicians of all generations were found more likely to rank medical websites and online drug reference guides as more important tools than their male counterparts.
  • Women doctors are also likely to encourage patients using websites, electronic medical records and patient support programs more frequently than their male counterparts.
  • After receiving requisite information from pharma source, especially younger women doctors, are more likely:

- To change a patient’s treatment (20 percent).

- Try a new product (22 percent).

- Conduct more research using other sources (40 percent).

Conclusion:

These research findings do provide a fresh food for thought for the pharma strategists to ascertain whether a new ground exists to further hone the conversation between drug companies and the doctors. More specific point to ponder is, whether an avant-garde, as it were, customer-segmentation strategy be put to use, while devising a sharply focused communication and content for the male and female doctors, separately for each.

Coming back to where I started from: Should pharma-doctor communication be gender-specific? In my view, enough credible evidences, as captured in several large studies, send a clear signal towards an affirmative answer. Nevertheless, individual company would still be required to meticulously vet it out internally, for the best possible results.

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.