DRUG PIPELINES: TOGETHER FOR THE HEALTHIER

The most recent pandemic spread has got the most of us to ponder on the clinical the aspect of the development of a vaccine or effective treatment to encounter the current scenario because this wildfire outspread has not only weakened the global health but also is a threat to the economy and mental well-being of the population. Here is the role of the contributions and continuous efforts of a group of individuals with the unacquainted term: the drug pipelines.

They are the team of individuals assigned by a pharmaceutical company who are involved in the process of discovery and development through various clinical trials and marketing. In other words they revolutionize the health sector of the planet. These research and progress in the involves the identification of the target, the lead compound discovery, dealing with the chemistry of the lead, pre-clinical and clinical trials through various in vitro and in vivo studies and finally approval by FDA. Maximum input and energy from the professionals and scientist in these drug pipelines over these years has led to a healthier society.

The accelerated efforts of these teams have to be acknowledged and brought into the spotlight along with the various healthcare professionals for their incomparable battle against the big and small elements that threaten our wellbeing. Together are them for healthier and happier tomorrow.

-Krupamol Joy, 3rd Pharm.D

The Synergistic Revolution – India as a Generic Hub

“Generic Drugs are an important component in the Pharmaceutical ecosystem”

Affordable medicines are favourably accessible and come down to the promise of providing treatments within the budget of patients. Every rupee saved at the pharmacy store can be spent on life essentials and other basic requirements.  The need of the hour is to pave a reliable way in order to bring down the cost of medicines which can help the patients and at the same time boost the economic development of a country like India.

Among the developing nations of the world, India has already carved out a unique position for itself in many business grounds of the pharmaceutical industry and is presently being recognized as the ‘pharmacy of the world’ for the generic drug products. The Indian generics market is growing day by day with Indian pharmaceutical companies seeking more Abbreviated New Drug Application approvals (ANDAs) in the US. Indian Pharma market is growing at a very fast pace making Indian pharmaceutical industry rank third all over the world in terms of volume. Generic medicines are formulated when patent and other exclusivity rights expire. The birth of generics in the US took place through the enactment of the Drug Price Competition and Patent Restoration Act of 1984, public law 98-417 popularly known as “The Hatch- Waxman Act” which created a chance for the development and marketing of generics for 180 days. Under ANDAs a pharmaceutical manufacturer can develop and market low price generic version of previously approved innovator drugs, thus providing the same product to the patient which is economically feasible, safe and efficient. To ensure the therapeutic efficacy of generic products, it must be pharmaceutically interchangeable and bioequivalent to the originator product. The contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high i.e. about to 35%. To sustain competition from developed world Indian generic manufacturer should plan the market strategy and regulatory requirement needed, very quickly because for generics production a large number of application will be filed and competition from domestic market will also be there. It is seen that there is an upward swing in the generic market. It has reached 100 billion dollars in the past and is estimated to be three times higher than the overall growth of drugs. The current trend exhibits that blockbuster drugs are scheduled to lose their patent protection, opening the doors to cheaper generic drugs in the near future. To make the situation more favourable the Indian government has also introduced a scheme of providing generic drugs to a patient in hospitals with various Jan-aushadhi Kendra. Thus future prospects of generics in India is very high as they are the next big thing in health care scenario. Fortunately, India has the best subject skills to galvanize foreign investors. High R&D cost and investment in research is also a major stumbling block in this direction. In situations where demand for medicines exceeds supply, and cost-effective drug in demand with minimum expenditure, generic drug are the best choice fulfilling this demand.

Generic Drugs will help more people live healthier and longer by- driving down the cost of existing drugs & increasing competition means the payers also have a choice in the market place. Resources invested from the savings created by generic copies can provide a platform for the innovation of newer drugs for the most dreaded diseases in a country like India. An important aspect also lies within the uncompromised quality of generic drugs and that they are at par with the brand drugs. In order to ensure a continuous flow of generic drugs to the public, there should also exist a stage for the generic competitors. Generic drugs are, therefore, the sleek answer to this thick and burdensome rising prescription drug costs. Promoting timely access to quality standard generic drugs, understanding the dynamics of a brand and generic markets, providing a platform for generic drug development and advocating the use of these generic drugs are also the crucial links to affordable drugs. An important cornerstone of disease improvement is patient compliance, generics could be a key reason for increased patient compliance. In the therapeutic areas, the maintenance of chronic illnesses and diseases through generic drugs provide tremendous savings and valuable relief for people nationwide. Hence, a possible solution to this booming explosion of prescription costs could be the evolution of a generic drug.

-Janice Jacson, 3rd PharmD

COST EFFECTIVE ANALYSIS

COST EFFECTIVE ANALYSIS is a form of economic analysis that compares relative cost and health outcomes of one or more interventions. It provides information on cost impact and effect of an intervention compared to an alternative intervention, as this allows the decision-makers to consider whether an innovation is better than the status quo. The objective of CEA to determine if the outcome of an intervention justifies its cost. It helps to identify the opportunities that are relatively inexpensive but have the potential to reduce the burden of disease substantially. It involves the basic calculation of dividing the cost of intervention into monetary units by the expected health outcome measured in natural units such as a number of lives saved. Some studies use the years of life lost in natural units for measuring the effect of the interventions. DALY is a comprehensive measure of population health which compares different interventions against a common standard. While comparing with cost-benefit analysis of the main advantage of cost-effectiveness ratios is that they avoid some ethical dilemmas and analytical difficulties.
Example: CEA of metformin+dipeptidyl peptidase-4 inhibitors compared to metformin+ sulfonylurea for treatment of type 2 diabetes.   

- Maria James, Pharm.D Intern

SUPERIOR HUMAN VS TINY VIRUSES

From the ancient time, the human race has probably died more from the infectious disease than all other causes combined. In the past 100 years or more, despite nutritional and medical advancement, have we come forward from living in constant worry that merely a cough or fever might be a death sentence? Despite all our medical and technological breakthroughs, when dealt with the prospect of an epidemic or a warlike disease states, we are not that different from prehistoric.

A very thoughtful lookout is needed to view the sequential attacks of the different tiny viruses and engulf millions of life. The whole world is prepared at how to deal with the Atomic attacks, but we fail to protect ourselves from these tiny cells. Right now the entire world is threatened and witnessed millions of deaths by the COVID-19 pandemic. But the history of deaths by viruses are not new there were pandemics and epidemics in past and recent past. The past ten years alone have seen major outbreaks of swine flu, the Ebola, Nipah and Zika viruses, and even a resurgence of plague in some regions. Even today, along with Novel Corona outbreak there are serious threats of Ebola and Zika viruses are co-existing in some part of the world. There are four stages of epidemic grief: denial, panic, fear, and if all goes well rational response. From last three months, the whole world is still in a panic.

From the last time there were millions of death by various deadly viruses, importantly mention, HIV/AIDS pandemic (at its peak, 2005-2012), the number of deaths: 36 million. First identified in the Democratic Republic of the Congo in 1976. Between 2005 and 2012 the annual global deaths from HIV/AIDS dropped from 2.2 million to 1.6 million. Flu pandemic (1968), number of deaths: 1 million, cause: Influenza a category 2 flu pandemic sometimes referred to as “the Hong Kong flu,” the 1968 flu pandemic was caused by the H3N2 strain of influenza a virus, while the 1968 pandemic had a comparatively low mortality rate (0.5%) it still resulted in the deaths of more than a million people, including 500,000 residents of Hong Kong, approximately 15% of its population at the time. Asian flu (1956-1958) number of deaths: 2 million, cause: Influenza. Asian flu was a pandemic outbreak of influenza a of the H2N2 subtype, that originated in china in 1956 and lasted until 1958. Estimates for the death toll of the Asian flu vary depending on the source, but the world health organization places the final tally at approximately 2 million deaths, 69,800 of those in us alone. Flu pandemic (1918) number of deaths: 20 -50 million cause: Influenza, between 1918 and 1920 a disturbingly deadly outbreak of influenza tore across the globe, infecting over a third of the world’s population and ending the lives of 20 – 50 million people. Out of the 500 million people infected in the 1918 pandemic, the mortality rate was estimated at 10% to 20%, with up to 25 million deaths in the first 25 weeks alone. Sixth cholera pandemic (1910-1911), number of deaths: 800,000+, cause: cholera-like. Its five previous appearances, the sixth cholera pandemic originated in India where it killed over 800,000, before spreading to the Middle East, North Africa, Eastern Europe and Russia. The sixth cholera pandemic was also the source of the last American outbreak of cholera (1910–1911). Flu pandemic (1889-1890), death toll: 1 million, cause: Influenza. originally the “Asiatic Flu” or “Russian Flu” as it was called, this strain was thought to be an outbreak of influenza a virus subtype H2N2, though recent discoveries have instead found the cause to be influenza a virus subtype H3N8. Third cholera pandemic (1852–1860), death toll: 1 million, cause: cholera. in which 23,000 people died in Great Britain. The Black Death (1346-1353), number of deaths: 75-200 million, cause: bubonic plague from 1346 to 1353 an outbreak of the plague ravaged Europe, Africa, and Asia, with an estimated death toll between 75 and 200 million people. Plague of Justinian (541-542), number of deaths: 25 million, cause: bubonic plague, thought to have killed perhaps half the population of Europe, the plague of Justinian was an outbreak of the bubonic plague that afflicted the byzantine empire and Mediterranean port cities, killing up to 25 million people in its year-long reign of terror. Antonine plague (165 ads) death toll: 5 million cause: unknown, also known as the plague of Galen. The Antonine plague was an ancient pandemic that affected Asia Minor, Egypt, Greece, and Italy and is thought to have been either smallpox or measles, though the true cause is still unknown. Other than these there are the number of deadly viruses who have attacked us time to time and killed millions in resent past as Chikungunya, Crimean-Congo Haemorrhagic Fever, Hendra Virus Infection, Lassa Fever, Nipah Virus Infection, Novel Coronavirus (COVID-2019), Marburg Virus Disease, Mers-Cov, Monkeypox, Sars, Mers, Yellow Fever Etc.

The question is, will the most superior humans be dying in millions, whenever these novel microbes attack us? Can we do something to prevent these situations before they arrive or at least to deal effectively and quickly to minimize our loss of lives? Can we find out some kind of pattern or environmental similarity for these viral attacks to crack them down before they appear? Are we prepared or preparing enough? 

‘If you want to panic, go right ahead. It’s what we do. It’s what our ancestors did. Then be afraid. Eventually, however, roll up your sleeves and get to work, scrubbing this bug back to whatever its host species happens to be. We’ll get there. Humanity has so far survived every microbe that has jumped the species barrier, and we will survive this one.’-Sintia Radu, 

Source:

https://www.who.int/health-topics/crimean-congo-haemorrhagic-fever/#tab=tab_1

https://www.usnews.com/news/best-countries/slideshows/20-pandemic-and-epidemic-diseases-according-to-who?slide=6

https://www.mphonline.org/worst-pandemics-in-history/

         Authored by:  Dr. Bharat Misra     Professor & Head, Department of Pharmacology 

                                Nirmala College of Pharmacy, Muvattupuzha

PASS – A new pass for outcome research

Patient acceptable symptom state (PASS) is defined as the highest level of symptom beyond which the patient considers themselves in a state of well-being.

Research methodology for PASS:

Step 1: Selection of an outcome measuring tools related to the desired outcome (Pain VAS, BASDAI for ankylosing spondylitis, womac for osteoarthritis)

The criteria for selecting an outcome measuring tools should that 

• Its output should be a numerical variable
• It should be able to appropriately measure the disease activity according to the required outcome

Step 2: The patient should be taught to fill the above outcome measuring tool and they should be also asked the yes or no question that is mentioning their satisfaction in continuing in the current symptom scale in the future period. 

The score of the outcome measuring tool will be correlated with the yes or no reply of the patient. A yes by the patient defines the patient to be in remission and the associated score of the outcome measuring tool is defined as the remission score of the patient. A no by the patient defines the patient to be in flare and the associated score of the outcome measuring tool is defined as the flare score of the patient.

The statistical approach used to derive the PASS scores for disease state

The 75th percentage approach: The cut-point corresponding the 75th percentile of the score for improvement in the patient who reported improvement by the anchoring question.Receiver operating characteristic (ROC) curve method: This method allows for choosing the threshold that is the best compromise between sensitivity and specificity for each outcome criterion.

Outcome expected: We could define a disease state-wise scores for an outcome measuring tool.

Application of PASS:

• Used in clinical trials to define their endpoints in terms of PASS scores.
• The development of PASS scores can be used in clinical practice guidelines to taper the drug dose modifications and other interventions.

PASS scores can be used to define the state of diseases in health economics 

• modelling

The disadvantage of PASS: huge sample sizes have to be used to ensure the robustness of the PASS cut points.

-Mr. Aby Paul

Principal's Message

Welcome All

I am very glad to be joining this amazing learning community, the blog of "Nirmala Infobliss", initiated by the KUHS ISPOR Student Chapter under the affiliation of 'ISPOR', 'The Professional Society for Health Economics and Outcomes Research (HEOR) globally'. I hope this blog will take part actively in the mission of promoting HEOR excellence to improve decision making for health globally. Since the health care protocols are very dynamic day in and day out in the present world the participation of our fellow pharmacists are expected to be significantly contributing, where we play a major role in the decision of the cost-effectiveness of each and every newer and existing drug treatment protocol. This may be the reason that ISPOR (International Society for Pharmacoeconomics and Outcomes Research) now being focused to be a Society for Health Economics and Outcomes Research because pharmacoeconomics invigorate the mission of the health economics in a bigger logic.  

At this juncture, I congratulate the student chapter for receiving an award from ISPOR for the year 2020 and inaugurating such a blog would be good commemoration. At the outset, I wish all office bearers of ISPOR student chapter and Dr. Suja Abraham for steering this blog in the right direction to achieve its mission and to create greater student and professional networks globally.

I am excited to note that ISPOR is organizing many virtual conferences due to universal lockdown caused by COVID-19 about this pandemic disease. This blog and chapter can also pay participative roles in such world demanding activities.

With best wishes

Prof. Dr S A Dhanaraj

Principal & Director, Nirmala College of Pharmacy, Muvattupuzha

Kerala, India- 686661

What’s next? Digital eye strain!!!!!!!!!

As you know the world is under threat of a small virus. Many countries announced lockdown. The same can lead to an increase in Computer vision syndrome or digital screen syndrome. All of us are at home and spending most of the time on a screen. The CVS or DES is a group of Vision or eye-related problem arising from continues and extended use of digital screens. Presently, many individuals experience eye discomfort and vision problems when viewing digital screens and it’s a common problem today.

The most common symptoms of this are Dry, itchy, or burning eyes, Blurred vision at near (or in the distance after long periods of near work), Eyestrain, Headaches, Aching of the Neck and Shoulders. Based on individuals, the time of using the visual abilities other symptoms also can be generated. Actually, the CVS is temporary, that means it will decline when the frequency of usage reduced. But in some, it can lead to permanent damage of visual abilities. The major causes are uncorrected vision problems, improper lighting, glare on the computer screen, incorrect working distance from or position of screen, poor seating posture. When compared to other focus, when we focus on digital screen our eyes will work harder and high demand. Some of us are using glass or contact lens, but they are more prone to the syndrome because the glass or contact lens is not suitable for digital screen use. There is anti-glare glass for digital screen usage.

Precautions that helps to prevent the problems are 

Monitor distance & position– The computer the screen should be 20 to 28 inches from the ey inches from eyes, phones should be allowing you to read the screen without leaning your head, neck or trunk forward or backwards. The screen should be directly in front of you and 15 to 20 degrees below eye level (about 4 or 5 inches) as measured from the centre of the screen so you don’t have to twist your head or neck.

For multifocal lenses, wearers – You should be able to view the screen without bending the head or neck backwards.

Glare – (for example, from windows, lights): Minimize glare from light sources,

Document holder – Position at about the same height and distance as the monitor screen so there is little head movement and need to re-focus when you look from the document to the screen.

Lighting – Use bright lights with a large lighted area when working with printed materials. Limit and focus light on computer tasks.

Let your eyes take a break – Try the 20/20/20 rule to avoid eye strain during long periods.

Don’t let the problem get in your way. The visual problem will greatly affect your life. It can only save by proper caring. It’s your choice whether you need it or not. Be caution! Be a responsible person during the lockdown. Hope the crisis will end soon.Have a nice day😀😀😀

                                                                                                                             - Mr. Johnson V. Babu

Preface

NIRMALA-INFOBLISS

I am privileged to be a part of ISPOR student chapter, KUHS, blog “NIRMALA- INFOBLISS.”

Healthcare providers are facing problems in deciding the cost effective treatment due to numerous brands of medicines and because of this pharma companies are instructed to perform pharmacoeconomic analysis before introducing a product into the market. The purpose of this blog is to discuss the issues faced by healthcare providers and patients and the possible research in this field to be undertaken. Also the concept of pharmacoeconomics can be strengthened among student community and encourage them to participate in outcome based research. This forum can be utilized to discuss case studies related to pharmacoeconomics, newer concepts and applications in real world scenario especially focusing on Indian healthcare settings.

I acknowledge the efforts and dedication of ISPOR student chapter President Mr. Aby Paul (Pharm D intern), Vice president Mr. Johnson V Babu (Pharm D V^th year), Secretary Ms. Akhila John (Pharm D IV^th year) and Treasurer Mr. Tomson (B-Pharm IV^th year) and all other students who actively participated in ISPOR activities. Also I would like to acknowledge Dr. Bharat Mishra, Head of R&D Cell, Members of R&D team, all faculty members of Dept. of Pharmacy Practice, Principal and Administrator of Nirmala College of Pharmacy, Muvattupuzha for their constant support and encouragement for this new venture.

I wish all success for this blog and believe that this will enlighten your thoughts.

Dr. Suja Abraham

Faculty-in-charge

ISPOR student Chapter

Nirmala College of Pharmacy

Muvattupuzha