World Pharmacists’ Day 2020: Role of pharmacy professionals in transforming global health

World Pharmacist Day is celebrated every year on September 25^th worldwide under the aegis of International Pharmaceutical Federation (FIP) which is an international body representing over four million pharmacists, educators and pharmaceutical scientists. FIP is a non-governmental organization that was established on this day in 1912 and has been collaborating with the World Health Organization since 1948. This year’s theme for the day has been chosen to be “Transforming global health”. While describing the main aim behind these celebrations, President of FIP, Dominique Jordan has stated that “We aim to show how pharmacists contribute to a world where everyone benefits from access to safe, effective, quality and affordable medicines and health technologies, as well as from pharmaceutical care services”. The purpose of World Pharmacists Day, which was brought to life at the FIP Council 2009 in Istanbul, was to encourage activities that promote and advocate the role of the pharmacist in improving health in every corner of the world. Main objective of the World Pharmacist Day campaign is to raise awareness about the professional activities of a qualified pharmacist and to educate the public on their significant role and crucial responsibilities in healthcare system and also to inculcate a sense of pride, solidarity and awareness among the pharmacy professionals on a global level. Pharmacists represent the third largest healthcare professional group in the world and India too is home to more than ten lakh registered pharmacists. After bringing out Pharmaceutical Workforce Development Goals in 2016, FIP has unveiled its “FIP Development Goals” this year on September 21 outlining measures needed to develop this profession in consonance with Sustainable Development Goals of the United Nations. 

International Pharmaceutical Federation (FIP) has selected the theme of “transforming global health” primarily with a view to lay a roadmap on how to make progress on its twenty one FIP Development Goals in the coming years so that substantial headway could be made in improving global health in sync with UN Sustainable Development Goals. Though this might seem to be an attainable goal in the global context owing to their considerable progress already made in their respective healthcare sectors, it is being perceived by many as a far-fetched dream back home in the national backdrop. Looking at the situation vis-à-vis pharmacy workforce, education and science within India it appears that the country is lagging far behind than developed nations whose FIP members have coined this theme for this year’s world pharmacist day in light of their own regional contexts. In a country where almost 65% population is believed to lack access to medicines as per World Medicines Situation report of WHO, standards of healthcare continue to be quite low that was duly accepted by the government at the onset of this year’s pandemic, quality and effectiveness of medicines is doubtful and their safety is not monitored systematically in all the healthcare facilities. Further prescribing and dispensing practices are flawed and drug use patterns among patients are not up to the mark. Pharmacy workforce though qualified is not empowered and integrated with the healthcare team mainly comprising of doctors and nurses. Clinical pharmacy departments and services within government hospitals are almost non-existent and other good practices with respect to drug selection, procurement, tendering, quantification, storage, distribution and use are rarely followed. As such primary responsibility and challenge before the pharmacists within India continues to be the service delivery to the utmost satisfaction of the system as well as the patients. Continuation and upgradation of their services amid severe financial, logistic and systemic constraints are their immediate concerns before they could think about transformation of the national health scenario let alone global health. Nevertheless pharmacists can contribute in their own modest and feasible way in improving the healthcare system and maximizing the therapeutic, clinical, economic and humanistic outcomes of patients through their concerted education, scientific research and practice-based initiatives. A sizeable number of qualified pharmacists have already been contributing substantially in these spheres all across the country in spite of all their limitations and there is no doubt that well-qualified and professionally trained pharmacists can contribute significantly towards improving as well as transforming national health that in turn will automatically contribute to the global health owing to the fact that India is home to more than 138 crore human beings. 

Need of the hour is to re-orient our pharmacy education and profession in India towards hospital and clinical pharmacy, enhance competencies, clinical skills, motivation and efficiency levels of pharmacy graduates and work towards their capacity building for making them an integral part of the health care system where they can assist the medical practitioners in providing optimal evidence-based care to the patients. Our pharmacists should be well-equipped, professionally trained and legally empowered to participate in medical ward rounds and give assistance to doctors in selection of an ideal drug therapies and their dosage. They should master the art and skill of drug therapy and disease-state monitoring for rational therapeutics as well as rational diagnostics. Our pharmacists need to be professionally fit to render adverse drug reaction and therapeutic drug monitoring services, detection of medication errors and other drug-related problems, patient counseling, drug and poison information services, pharmaco-economic and pharmaceutical care services, detection of drug interactions besides other hospital and community pharmacy services. Additionally they should be in a position to contribute towards formulation of hospital formularies, drugs and therapeutics committees, standard treatment guidelines and medicines management in hospitals. Pharmacists must be capable of evaluating the effectiveness and rationality of medication therapy, in improving patient safety, in stimulating improvements and standardization in medication-use processes, in minimizing costs of medication therapy and in meeting or exceeding internal and external quality standards. They should also be competent to suggest policy measures and interventions for the improved use of medicines both within and outside the hospitals. 

Once our pharmacists become well-equipped, professionally trained and technically competent to render all these kinds of services there ought to be adequate administrative structures and legal statutory framework in place to empower them to deliver those services. Pharmacy Practice Regulations of 2015 that have already been notified by the Pharmacy Council of India in concurrence with the Govt. of India on January 15^th, 2016. These regulations need to be adopted by all the state and UT governments and implemented in all district and divisional level secondary and tertiary care hospitals. Every such hospital should have a full-fledged clinical pharmacy department with adequate workforce, infrastructure, budget and statutory powers for making necessary interventions as and when required. Roles and responsibilities of clinical pharmacists within the hospital settings should be very well defined and there should be necessary supervision and monitoring to ensure compliance with the duties assigned to them. Coronavirus pandemic has exposed the chinks in some of the best healthcare systems of the world besides leaving healthcare systems of developing nations grappling with their inadequate workforce, infrastructure and other facilities in the face of an unprecedented outbreak of the disease. Simultaneously it has underscored the need to revisit, review and revive healthcare policies, settings, facilities and the procedures with a view to carve adequate space for the professionally qualified and well-trained people like pharmacists to contribute towards confronting such challenges and unforeseen circumstances. During this pandemic we have seen even nursing orderlies and multi-purpose health workers being employed to combat the consequences of the outbreak at the spur of the moment whereas there should have been proper disaster management rules in places to allow only qualified and well-trained personnel to step in at such occasions. Now the whole world must strive to develop human resource for any such eventuality in future and pharmacists are a force to reckon with in this direction.

NDMA impurity in medicines: A source of bewilderment for the patients

 A potentially carcinogenic impurity detected in medicines used for hypertension and diabetes is shaking the faith and confidence of patients and making them apprehensive about their safety

A potentially carcinogenic impurity namely NDMA (N-nitrosodimethylamine) has been found in a few medicines that are being widely used worldwide for the treatment of common ailments like hypertension, diabetes and acid-peptic disease. First time this contamination was detected by the US Food and Drug Administration (USFDA) as well as European Medicines Agency (EMA) in July, 2018 in an anti-hypertensive drug called valsartan. Subsequently it was also found in other anti-hypertensive medicines like amlodipine, losartan, irbesartan, hydrochlorthiazide, gastric ulcer prevention drugs like ranitidine, nizatidine and very recently even in anti-diabetic drug metformin. This has caused considerable anxiety and bewilderment among patients taking these medicines owing to the serious consequences of the dreaded disease cancer that this impurity is likely to cause. Since July 2018, USFDA has issued as many as 53 drug recall notices, 16 of them this year alone as a result of the detection of this possibly carcinogenic impurity and drug companies have recalled thousands of batches of such drugs after testing revealed presence of small amounts of cancer-causing chemicals in them. 

Probability of causing cancer 

The International Agency for Research on Cancer has classified NDMA as a “probable carcinogen”, with animal studies revealing tumor formation predominantly in the gastrointestinal tract and liver but also in lungs and kidneys. It has also been shown to cause liver damage and fibrosis in animal models. This has considerably shaken the faith and confidence of patients consuming these drugs and made them apprehensive about their safety. However it is believed that the trace amounts of carcinogens found in these drugs can increase the risk of cancer if people are exposed to them at above acceptable levels over long periods of time whereas short-term exposure at levels above the acceptable intake limit has not been established as yet to lead to an increase in the risk of cancer in humans. The EMA update on 2 August, 2018 revealed that the average level of NDMA detected was 60 parts per million which could result in one extra case of cancer for every 5000 patients taking the affected medicines at their highest dose every day for 7 years (Farrukh MJ et al, 2019). 

Drugs involved 

A recall is a voluntary action taken by a pharmaceutical company on its own or on the advice of the regulatory agency at any time to remove a defective drug product from the market. A drug recall is the most effective way to protect the public from a defective or potentially harmful product (USFDA). Valsartan was the first drug to be recalled from the shelves in July 2018, followed by its analogues irbesartan in October and losartan in November, 2018. Till September 23rd, 2019, a total of 1159 batches of valsartan, losartan and irbesartan had been recalled from US markets (White CM, 2019). In September 2019, USFDA alerted the world about the presence of NDMA in some batches of ranitidine, available as Zantac and manufacturers pulled it out from the shelves during the next few months. The USFDA alert came on a day when a US-based online pharmacy, Valisure petitioned the USFDA requesting a recall of all products containing ranitidine, saying its own laboratory tests had revealed high levels of NDMA, above USFDA’s daily limit. Subsequently USFDA recommended that manufacturers of ranitidine must recall all lots and types of these medications. Another heartburn medication, Nizatidine was recalled by its manufacturer Mylan Labs in January 2020. 

Companies involved 

Many manufacturers including Apotex Corporation, Sandoz, Sanofi, Aurobindo and Dr Reddy Labs had to recall products containing ranitidine because of the high levels of the contaminant. This year NDMA has also been found in Metformin, a diabetes drug taken by over 15.8 million people worldwide. In July this year several leading Indian drug manufacturing companies including Lupin, Marksans Pharma, Aurobindo Pharma and Alembic Pharmaceuticals recalled their pharmaceutical products from the US markets. As per the latest USFDA report, Lupin and Granules India recalled around 9.71 lakh bottles of diabetes drug from the US market whereas Marksans Pharma recalled 11,279 bottles of Metformin tablets. On May 22, 2020 GlaxoSmithKline Pharmaceuticals announced that the company made a decision to discontinue the manufacture and supply of ranitidine tablets manufactured in India after it was contacted by regulatory authorities regarding the detection of NDMA in its products. Dr Reddy’s Laboratories Ltd also initiated a voluntary nationwide recall in October, 2019 of all its ranitidine medications sold in US due to confirmed contamination with NDMA above levels established by the USFDA (Expresspharma, July 5, 2020). All these voluntary recalls have been classified as class II recalls. As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a medicinal product may cause temporary or medically reversible adverse health consequences. 

Origin of NDMA 

Apart from NDMA, two other nitrosamines namely N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and N-nitrosodiethylamine (NDEA) have also been detected in at least six more drugs that are consumed by tens of millions of people each year. NDMA and NDEA are "probable human carcinogens" whereas NMBA is a "possible human carcinogen," according to the USFDA. Origin of NDMA contaminated bulk drugs has been traced back to a Chinese drug manufacturing firm Zhejian Huahai Pharmaceuticals by the European Medicines Agency (EMA) and began recalling medicines containing valsartan manufactured by this company. According to European regulators, the problem likely dates back to 2012 when changes in manufacturing processes were made at this unit, further suggesting that many patients could potentially have been exposed to the cancer risk (Pharmabiz May 30, 2020). Subsequently Drugs Controller General of India (DCGI) ordered its drug inspectors at port offices to closely monitor the import of valsartan bulk drug manufactured by this Chinese firm and draw the samples from every batch of imported consignment of the drug for laboratory testing including test for NDMA impurity. However it is not clear from DCGI’s official website as to how many drugs have been recalled or withdrawn from the Indian markets on account of this contamination over the past two years. 

Source of contamination 

Interestingly NDMA is also believed to be present in many processed foods and alcoholic beverages including smoked fish, broiled meat, bacon, cereals, dairy products, some fruits and vegetables. Levels of NDMA in these foods are typically much higher than levels of NDMA found in treated drinking water. This NDMA contamination could arise from the water the plants and animals utilize, soil contamination of the food or the food that animals eat, or during processing before sale. Pertinently a study from Kashmir, published in 1988 had found 1,010 nanograms (ng) of NDMA in every kilogram of smoked fish sold in the local markets. There are two main sources of NDMA contamination in medicines. The first source is the use of material like solvents or catalysts contaminated with NDMA in the manufacturing process. The second source of contamination occurs when NDMA is created from an intermediate or from the active ingredient itself. The FDA has set an interim acceptable level of NDMA in a medication tablet or capsule at 96 nanograms/day. Although this is below the 190 ng dose of NDMA that the WHO would find acceptable, it is estimated that senior citizens (above 65 years of age) who take a median number of 4 medications daily, so there could be a multiple risk of NDMA exposure over time in these patients (White CM, 2019). 

Advice for patients 

Worldwide in 2017, about 10 million people took losartan, over 2.3 million took irbesartan and around 1.8 million people took valsartan, according to the Agency for Healthcare Research and Quality. Many medical professionals have warned against unnecessary panic regarding these medicines. They have urged that the patients should not abruptly stop taking their blood pressure medications because that can lead to a rebound increase in blood pressure, which could put such patients at risk of experiencing a cardiovascular event. USFDA has also advised that the patients taking recalled metformin should continue taking it until a doctor prescribes them a replacement or a different treatment option since it could be dangerous for patients with Type-2 diabetes to abruptly stop taking their metformin without first talking to their health care professionals (Boerner LK, 2020). Then there are many other medications in the market that can be used alternatively by blood pressure and diabetes patients on their doctor’s advice. It is pertinent to mention that other metformin products have not been recalled from the markets.  

Measures to be taken 

Vigorous testing of all the bulk drugs as well as finished drug formulations for these impurities is the need of the hour since their implications could be devastating to a patient taking these medicines on long-term basis. It is quite possible that these contaminants may have been present in our drugs for several years, but nobody was so far aware of it. Before it is too late Govt. of India must issue necessary guidelines on testing of all such medicines for NDMA contamination, both for drugs presently circulating in the markets as well as those yet to be released. Active pharmaceutical ingredients (APIs) as well as any inactive ingredients prone to NDMA formation should be tested under different environmental conditions to determine how product storage, especially heating, light exposure and time since manufacture, can affect NDMA incorporation. Data regarding drug recalls within Indian markets on this account should also be made public because there is every possibility that drugs withdrawn from American and European markets by the Indian companies could have been resold and circulated in the domestic markets by certain unscrupulous elements as a result of lax quality assurance and drug regulatory system that could lead to a surge in cancer cases in future. Government needs to wake up to this alarming situation well in time and take adequate measures not to allow it to spiral out of control. Further the sources of these impurities need to be plugged and suitable changes need to be made in the manufacturing processes of these drugs. 

(Author is a pharmacologist teaching at the Department of Pharmaceutical Sciences, University of Kashmir)

Transforming student-teacher relationship amid COVID times

Let students be the masters of their own choices and destiny; let teachers be the torch-bearers and path-finders of their bright future

For long there has been a sustained advocacy campaign going on around the world to transform student-teacher engagement into a mentor-mentee relationship. Coronavirus pandemic has made these voices and demands even shriller.  A teacher just teaches and delivers content whereas a mentor's role is to guide and to inspire; to give advice and to support the mentee. A mentor can help his student improve his or her abilities and skills through observation, continuous assessment, monitoring and counseling. Online teaching amid lockdown has thrown enormous challenges before teachers in terms of retaining interest and attention span of students and getting them fully involved in the teaching-learning process in absence of a real classroom situation that allows physical interaction and live one-to-one exchanges between teachers and their students. It has also posed several challenges to the online examination system in terms of bridging the trust deficit and ensuring a credible student evaluation sans any copying or mutual consultation. It has turned out to be truly a herculean task to ensure full presence as well as involvement of all the students in almost six hour long online sessions on daily basis. While initially out of sheer excitement and enthusiasm for the new system students were quite curious to attend their classes online, with the passage of time exhaustion and fatigue appears to have gradually set in forcing the teachers to look for novel, innovative and creative means to sustain this exercise and retain student interest and involvement in their classes.

David Shulman, President of the Carnige Foundation for the Advancement of Teaching defines good teaching as the one during which “students are visible, engaged, attentive, involved and participating”. He further adds that “good teaching is passionate and it induces an emotional response among the students”. Good mentorship evokes and engages practical and analytical thinking, critical evaluation, constructive mindset and problem‐solving skills that can be applied in a variety of settings and perspectives. It leaves a positive impact upon students’ values, commitments, ideals and mindsets. In times of coronavirus pandemic when most of the conventional practices have been disrupted and age-old stereotypes have been shaken up we need to introspect whether we have assimilated these basic principles of good teaching and mentorship and accordingly improvised our teaching methods or we have continued with our redundant and obsolete methods even in our online teaching. As per Morgan and Reinhart, “empathy is critical to good teaching, especially to teaching emotionally disturbed/stressed/conflict-affected/behaviorally disordered students. Empathy provides the ability to know the students’ world in the way that they live it, to interpret that understanding back to the pupil, and then provide boundaries of reality so that they may function more competently”. Question is do we harness and exhibit empathy in our day-to-day teaching or does it fail to inspire awe or for that matter even touch the hearts and minds of our students in a manner that is essential to foster a positive change.

In the present day context, teachers have to play an enabling role in the holistic development of the students. This involves not only imparting knowledge and skills, but also developing critical and innovative thinking, engaging them in research and extension activities, furnishing instructional material with the aid of information technology tools and above all counseling them for their personalized educational needs. Modern day teacher has to be a friend, a philosopher, a guide, a counselor, a mentor and sometimes a caregiver too. Last one might in all likelihood surprise you a bit. Teachers as caregivers can serve as rich and powerful resources for those students who feel frustrated, helpless, rebellious and agitated amid stressful times. As suggested by Deiro (1996), “Students value adults who value them”. Thus, students who are living in seemingly intolerable situations but have a pro-social adult outside their home environs who cares about them will adjust their behavior to carefully safeguard that relationship. Noddings (1984) articulates that student–teacher relationships provide a rich arena in which students are transformed by an ethic of care. Care translates into interventions that are in the best educational, emotional and psychological interests of the students (Morgan, 1987). When students fail to receive care within their classroom, they are often reduced to a ‘case’ or a mere ‘Roll Number.’

Martin Heidegger says, “What is most thought-provoking in these thought-provoking times is that we are still not thinking”. It is high time when we should think how best we can reach out to our students during these stressful times of lockdown and social distancing and provide the best possible learning solutions to them in a very comfortable and acceptable manner. Merely completing the formality of holding an online class and covering some portion of the prescribed syllabus might not suffice anymore. We may have to go an extra mile in making our online teaching experience more refreshing, motivating, inspiring and interesting. This can be made possible by making our content as applied as possible, by citing more and more examples from real life situations, by involving students in an open discourse with full freedom to express their viewpoints, by using case studies embedded with cartoons, animations, illustrations and similar stuff to draw our point home, by keeping the atmosphere light with a bit of decent and dignified humour, by engaging students in lucrative and healthy mutual competitions, by bringing the best out of non-responsive and reclusive students, by helping the students explore their potential and by acting more like one of them than the one on top of them. By innovative and creative thinking teachers can turn their online classes into the most sought after hangouts for their students.

‘Thinking’ includes a set of cognitive activities that we use to process information, make connections, solve problems, take decisions and create new ideas. It will be prudent to take a pledge on the teachers’ day today to transform our students into thinkers - creative and analytical thinkers. Only when they become good thinkers, they can be creative innovators and credible nation builders. Creative thinking refers to the ability to conceive new and innovative ideas by breaking from established thoughts, theories, norms and procedures. It involves putting things together in new and imaginative ways. It is often referred to as “thinking out-of-the-box.” Analytical thinking on the other hand refers to the ability to separate a whole into its basic parts in order to examine the parts and their mutual relationships. It involves thinking in a logical, step-wise manner to break down a larger system of information into its contiguous parts. By way of analytical and creative thinking we actually need to promote critical thinking among our students that refers to the ability to exercise careful evaluation or judgment in order to determine the authenticity, accuracy, worth, validity or value of something. In addition to precise, objective analysis, critical thinking involves synthesis, evaluation, reflection, and reconstruction. Rather than strictly breaking down the information, critical thinking explores other elements that could have an influence on the conclusions. Once we succeed in our mission of evoking creative, analytical and critical thinking among our students goals of our education will be met in their real sense. Positive, constructive, sequential, convergent as well as divergent thinking will automatically fall into the place. At present we are not allowing thinking of any kind, we are only spoon feeding and storing information in their brains without allowing them to process it.

Teachers’ Day celebration should mark the beginning of an irrevocable transformation of student-teacher relationship into the one that encourages questioning and critical analysis, that fosters creative thinking and helps build constructive insights; one that dwells into different perspectives on every topic of discussion, that explores new possibilities and evokes innovative solutions to our intriguing problems; one that is based on empathy and compassion, care and companionship rather than being a whip-wielding master. Let students be the masters of their own choices and destiny. Let teachers be the torch-bearers and path-finders of their bright and magnificent future. Let us transform students’ yearning for marks and grades into their quest for knowledge and learning. On this day let us think about ways and means how to break the shackles of marks and certificates and make our students effective contributors of the knowledge society who can contribute significantly towards nation building. A minor shake-up will be of no avail, a massive restructuring is needed for the same.