Source: Data as uploaded by States-UTs on HMIS portal, status as of 20 July 2018.
\\n\\n
More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:{caption:"IntechOpen Maintains",originalUrl:"/media/original/113"}},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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\r\n\tIn the past years, dogs have become family members and with this, there is an increased interest from pet owners in treating different diseases and the advances in animal nutrition providing increased life expectancy. Therefore, Veterinary Medicine experienced an increased incidence of different diseases, such as endocrine diseases, cancer, and degenerative diseases. Infectious, degenerative, and inflammatory diseases are common in dogs and early diagnosis is essential for the best patient care. For the best diagnosis, it is important to recognize the patient’s symptoms and associate them with proper complementary tools. Due to the introduction of new technologies in veterinary diagnosis and treatment, it is important to be up-to-date.
\r\n\r\n\tThis book intends to provide the reader with a comprehensive overview of the current state-of-the-art in diagnosis and treatment of several diseases in dogs, including congenital, inflammatory, infectious, and neoplastic diseases.
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During the pandemic, healthcare workers, particularly pharmacy professionals (PPs) in India, continued to deliver medication, supplies, and services. In India, the public-private healthcare system is complex and of variable quality. Gaps in pharmacy practice education and training, as well as a lack of understanding about pharmacists\' roles, cause complications for patients. This lack of difference complicates job requirements and successful placement of healthcare professionals in patient care, EP&R task forces, and policy representation. During this unprecedented pandemic situation, we have also observed malpractice and bogus distribution in the healthcare and pharmaceutical arena in terms of personal protective kits, medications, injectable, life-saving oxygen, and other products. The following are a few of the incidents. The central division police in Bangalore (India’s Global BPO & IT Hub) filed a complaint of bed-blocking at a private hospital and arrested three people, one of whom is an Arogya Mitra (primary contact for beneficiaries at every empaneled hospital care provider), for allegedly extorting Rs. 1.20 lakh from the son of a COVID-19 patient who later died. In the last few weeks, at least 178 COVID-19 patients in India have died due to a lack of oxygen. Another 70 deaths have been linked by patients’ families to a lack of oxygen, though this has been refuted by authorities. “Death of COVID patients due to non-supply of oxygen not less than genocide,” the Allahabad High Court ruled in response to reports spreading on social media regarding the death of COVID-19 patients in Lucknow and Meerut due to a shortage of oxygen [1]. Five persons were arrested after the Delhi police raided an industrial manufacturing site in Uttarakhand\'s Kotdwar, where duplicate Remdesivir injections were being made. This reflects the reality of Good Pharmacy Practice in this country, as well as the ethical norms that apply to it. It is critical to re-evaluate and re-establish pharmacy practice standards in healthcare settings throughout the country, in accordance with World Health Organization (WHO) and International Pharmaceutical Federation (FIP) principles. As a result, healthcare workers have a great deal of reliance and responsibility, especially in current pandemic circumstances. The pharmacy zone is adaptive, growing, and becoming more diverse, providing a comprehensive range of job and management opportunities [2]. PPs are human service professionals tasked with keeping people safe by distributing drugs according to prescriptions. In India, there are about 1,000,000 (1 million) enrolled PPs working in diverse capacities and contributing to the country\'s well-being, making it the world\'s third-largest medical service with active gathering. In its real definition, pharmacy practice, which encompasses clinical, community, and hospital pharmacy, is referred to as overall healthcare. PPs form a crucial link between physicians, nurses, and patients in the social community group through the adaptation and application of GPP in healthcare settings, with the ultimate emphasis on patient well-being and protection. In order to instill quality and elevate the standard in this chaotic scenario, the country must take stringent steps. Good pharmacy practice (GPP) is defined by the International Pharmaceutical Federation and the World Health Organization as practices that fulfill the individual requirements of patients or people who use pharmacy services by providing adequate evidence-based care. Pharmaceutical assistance is defined in developed countries as a pharmaceutical practice model that includes attitudes, ethical values, behaviors, skills, appointments, and co-responsibility to prevent diseases, promote, and recover health in an integrated manner as part of the healthcare process, highlighting, among other requirements, the institution\'s full adoption of the GPP. In the context of the Indian healthcare system and adopting a "new normal" due to the unprecedented event of COVID-19, there is a need for a GPP program designed by the Indian Government or its stakeholders, as well as raising the standard and importance of GPP for healthcare professionals in the current scenario.
India is a developing country in southern Asia with 29 states and seven union territories, 22 nationally recognized languages, and a population of 1.38 billion. India is a rural country with an agriculture-based economy, with rural areas accounting for over 75% of the population. In recent decades, India\'s average income has risen dramatically, resulting in growing urbanization, improved middle-class access to a better lifestyle, and increasing awareness of health insurance. Male and female literacy rates have climbed to 82% and 65%, respectively. According to reports, the average life expectancy is 69.9 years [3]. According to World Bank research from 2020, about 400 million Indians live on less than $1.25 a day, and 44% of children are hungry. Even though the government has taken attempts to reduce baby and maternal death rates, they remain high. Ancient Hindus acknowledged pharmacy as a complementary healing profession, and they specialized in vegetable treatments. Vedic and Brahmanic medicine were the two periods of Hindu medicine. The Vedic period or Vedic age (c. 1500–c. 500 BCE), and was a rudimentary period. During the Vedic period, sin was thought to be a major source of disease. Between 800 BC and 1000 AD, the Brahmanic period was a high-quality time for Hindu medical education. The works of Charaka, Susruta, and Vagbhat, which are based on ancient Vedic themes, are the three great masterpieces of Brahmanic medicine [4]. The origins of pharmacy in India can be traced back to Ayurveda, which dates to 5000 BC. Lord Brahma initially taught Ayurveda, or "life science," which was further transmitted by Charaka and Sushruta [5]. The Charaka Samhita, early work on Ayurveda, focuses on vegetable goods as well as some animal and earth goods. The classification of medications in this book is based on how they affect different bodily parts [4]. In 900 AD, Tamilnadu established a hospital to treat piles, jaundice, bleeding, and tuberculosis [5]. Tantrism was a prominent philosophical and religious movement that emerged in India after the downfall of Buddhism; it brought the art and science of the production of metallic compounds, particularly mercury and sulfur, to the fore [4]. In 1811, Scotch M. Bathgate built the first chemist shop in Calcutta, which is regarded as the birthplace of pharmacy practice in India. In December 1860, Madras Medical School began pharmacy instruction, enrolling students with only middle school education; the pharmacy degree was 2 years long. Madras Medical College (MMC), Chennai, established the diploma course in pharmacy in 1874. The Bengal Chemists and Druggists Association was founded in 1926 after the Calcutta Chemists and Druggists Association was founded in 1920. The first issue of the official
Many issues face India\'s healthcare system, including the need to lower mortality rates, enhance physical infrastructure, provide health insurance, and train healthcare experts and workers. A rise in communicable diseases, lifestyle diseases, and noncommunicable diseases has been recorded. Diseases such as poliomyelitis, leprosy, and newborn tetanus will be eradicated; nevertheless, certain previously controlled infectious diseases, such as dengue fever, viral hepatitis, tuberculosis, malaria, and pneumonia, have resurfaced or developed medication resistance.
Even though Indians are now more affluent as a result of the rise of the middle class, their eating habits have shifted dramatically to unhealthy, high-sugar, high-fat diets, leading to an increase in lifestyle diseases such as hypertension, cancer, and diabetes. Furthermore, India\'s healthcare institutions and services would be burdened by the expanding older population.
Due to a dearth of hospital beds and skilled medical personnel such as doctors, nurses, and pharmacists, the people do not have access to their medical needs. In comparison to urban areas, healthcare services are much scarcer in rural communities. Females have an adversely skewed proportion in the healthcare workforce when compared to males. In the 11th five-year plan, total healthcare expenditure (comprising state funds, private funds, and external flows) accounted for 4.1% of GDP (GDP). The 12th five-year plan (2012–2017) intends to raise public health spending from 1.1% of GDP to 2–3% of GDP [6].
The state is responsible for the healthcare system. This system is currently managed by both public and private (for profit and nonprofit) groups. Policymaking, planning, guiding, aiding, reviewing, and coordinating the activities of various provincial health authorities are all responsibilities of the federal government, as is providing financing to implement national healthcare initiatives [7]. Allopathic hospitals, hospital beds, Indian System of Medicine and Homeopathy hospitals, subcenters, Pharmacy Health Care (PHC), Community Health Center (CHC), blood banks, Eye Bank, psychiatric hospitals, and cancer hospitals are all part of India\'s healthcare infrastructure [7]. The Department of Ayurveda, Yoga, and Naturopathy, as well as Unani, Siddha, and Homeopathy, provide medical and healthcare services (AYUSH). The ownership of the public sector is split between the federal and state governments, municipalities, and panchayats (local governments). Dispensaries, primary health centers, subcenters, and health posts are among the facilities. Teaching hospitals, secondary-level hospitals, first-level referral hospitals (community health centers/rural hospitals), dispensaries, primary health centers, subcenters, and health posts are among the facilities. Public facilities for specific occupational groups are also included, including organized labor (Employees State Insurance Scheme), defense, government employees (Central Government Health Scheme), railways, post and telegraph, and mining, to name a few. The private sector (profit/nonprofit) is the most prevalent, with services ranging from >1000 beds to two beds. Health-related facilities are available through the federal government healthcare program in 25 cities, with 246 allopathic dispensaries [7]. Private healthcare providers are currently treating 78% of outpatients and 60% of inpatients in India. Private healthcare providers range from world-class hospitals that promote medical tourism by providing world-class treatments to international clients and Indians who can afford it to private doctors who have minimal medical expertise or formal training on the other end of the spectrum. Furthermore, the private sector controls 80% of doctors, 26% of nurses, and 49% of hospital beds, demonstrating its power.
In contrast to India, the number of hospitals in other nations is not given. However, according to World Bank statistics, available at https://data.worldbank.org/indicator/SH.MED.BEDS.ZS India\'s accessible beds per 1000 population is lower than that of a lot of other countries. As a state of concern, public health and hospitals are largely responsible for the upkeep, providing health treatment to individuals, and maintaining hospital information. However, the following details are provided below:
Number of Primary Health Centers (PHCs), Community Health Centers (CHCs), Sub-District/Divisional Hospitals (SDHs), District Hospitals (DHs), and beds in India, by State/UT, as uploaded by the States/UTs on the Ministry\'s Health Management Information System (HMIS) portal.
Number of government hospitals and beds in rural and urban areas in India, broken down by state/UT, as published in National Health Portal 2018.
The Ministry of AYUSH provides information on the number of AYUSH hospitals and beds in each state/UT.
Total and state-by-state number of hospitals and beds maintained by the Ministry of Defense.
Number of railway hospitals and beds, as reported in the National Health Portal 2018 publication.
Number of State Insurance Corporation employees, hospitals, and beds, per state/UT, and total, as published in the National Health Portal 2018.
State/UT | No. of public facilities | No. of beds available in public facilities | ||||
---|---|---|---|---|---|---|
PHC | CHC | SDH | DH | Total | ||
Andaman & Nicobar Islands | 27 | 4 | 3 | 34 | 1246 | |
Andhra Pradesh | 1417 | 198 | 31 | 20 | 1666 | 60,799 |
Arunachal Pradesh | 122 | 62 | 15 | 199 | 2320 | |
Assam | 1007 | 166 | 14 | 33 | 1220 | 19,115 |
Bihar | 2007 | 63 | 33 | 43 | 2146 | 17,796 |
Chandigarh | 40 | 2 | 1 | 4 | 47 | 3756 |
Chhattisgarh | 813 | 166 | 12 | 32 | 1023 | 14,354 |
Dadra & Nagar Haveli | 9 | 2 | 1 | 1 | 13 | 568 |
Daman & Diu | 4 | 2 | 2 | 8 | 298 | |
Delhi | 534 | 25 | 9 | 47 | 615 | 20,572 |
Goa | 31 | 4 | 2 | 3 | 40 | 2666 |
Gujarat | 1770 | 385 | 44 | 37 | 2236 | 41,129 |
Haryana | 500 | 131 | 24 | 28 | 683 | 13,841 |
Himachal Pradesh | 516 | 79 | 61 | 15 | 671 | 8706 |
Jammu & Kashmir | 702 | 87 | 29 | 818 | 11,342 | |
Jharkhand | 343 | 179 | 13 | 23 | 558 | 7404 |
Karnataka | 2547 | 207 | 147 | 42 | 2943 | 56,333 |
Kerala | 933 | 229 | 82 | 53 | 1297 | 39,511 |
Lakshadweep | 4 | 3 | 2 | 1 | 10 | 250 |
Madhya Pradesh | 1420 | 324 | 72 | 51 | 1867 | 38,140 |
Maharashtra | 2638 | 430 | 101 | 70 | 3239 | 68,998 |
Manipur | 87 | 17 | 1 | 9 | 114 | 2562 |
Meghalaya | 138 | 29 | 13 | 180 | 4585 | |
Mizoram | 65 | 10 | 3 | 9 | 87 | 2312 |
Nagaland | 134 | 21 | 11 | 166 | 1944 | |
Odisha | 1360 | 377 | 27 | 35 | 1799 | 16,497 |
Puducherry | 40 | 4 | 5 | 4 | 53 | 4462 |
Punjab | 521 | 146 | 47 | 28 | 742 | 13,527 |
Rajasthan | 2463 | 579 | 64 | 33 | 3139 | 51,844 |
Sikkim | 25 | 2 | 1 | 4 | 32 | 1145 |
Tamil Nadu | 1854 | 385 | 310 | 32 | 2581 | 72,616 |
Telangana | 788 | 82 | 47 | 15 | 932 | 17,358 |
Tripura | 114 | 22 | 12 | 9 | 157 | 4895 |
Uttar Pradesh | 3277 | 671 | 174 | 4122 | 58,310 | |
Uttarakhand | 275 | 69 | 19 | 20 | 383 | 6660 |
West Bengal | 1374 | 406 | 70 | 55 | 1905 | 51,163 |
Source: Data as uploaded by States-UTs on HMIS portal, status as of 20 July 2018.
States/UTs | Rural hospitals | Urban hospitals | As on | ||
---|---|---|---|---|---|
No. | Beds | No. | Beds | ||
Andhra Pradesh | 193 | 6480 | 65 | 16,658 | 01.01.2017 |
Arunachal Pradesh* | 208 | 2136 | 10 | 268 | 31.12.2017 |
Assam | 1176 | 10,944 | 50 | 6198 | 31.12.2017 |
Bihar | 930 | 6083 | 103 | 5936 | 31.12.2016 |
Chhattisgarh | 169 | 5070 | 45 | 4342 | 01.01.2016 |
Goa* | 17 | 1405 | 25 | 1608 | 31.12.2017 |
Gujarat | 364 | 11,715 | 122 | 20,565 | 31.12.2016 |
Haryana* | 609 | 6690 | 59 | 4550 | 31.12.2016 |
Himachal Pradesh* | 705 | 5665 | 96 | 6734 | 31.12.2017 |
Jammu & Kashmir | 56 | 7234 | 76 | 4417 | 30.12.2016 |
Jharkhand | 519 | 5842 | 36 | 4942 | 31.12.2015 |
Karnataka* | 2471 | 21,072 | 374 | 49,093 | 31.12.2017 |
Kerala | 981 | 16,865 | 299 | 21,139 | 01.01.2017 |
Madhya Pradesh | 334 | 10,020 | 117 | 18,819 | 01.01.2016 |
Maharashtra | 273 | 12,398 | 438 | 39,048 | 31.12.2015 |
Manipur | 23 | 730 | 7 | 697 | 01.01.2014 |
Meghalaya* | 143 | 1970 | 14 | 2487 | 31.12.2017 |
Mizoram* | 56 | 604 | 34 | 1393 | 31.12.2017 |
Nagaland | 21 | 630 | 15 | 1250 | 31.12.2015 |
Odisha* | 1655 | 6339 | 149 | 12,180 | 31.12.2017 |
Punjab* | 510 | 5805 | 172 | 12,128 | 31.12.2017 |
Rajasthan | 602 | 21,088 | 150 | 10,760 | 31.12.2016 |
Sikkim* | 24 | 260 | 9 | 1300 | 31.12.2017 |
Tamil Nadu* | 692 | 40,179 | 525 | 37,353 | 31.12.2017 |
Telangana* | 802 | 7668 | 61 | 13,315 | 31.12.2017 |
Tripura* | 99 | 1140 | 56 | 3277 | 31.12.2017 |
Uttar Pradesh* | 4442 | 39,104 | 193 | 37,156 | 31.12.2017 |
Uttarakhand | 410 | 3284 | 50 | 5228 | 31.12.2015 |
West Bengal | 1272 | 19,684 | 294 | 58,882 | 01.01.2015 |
Andaman & Nicobar Islands | 27 | 575 | 3 | 500 | 31.12.2016 |
Chandigarh | 0 | 0 | 4 | 778 | 31.12.2016 |
Dadra & Nagar Haveli* | 10 | 273 | 1 | 316 | 31.12.2017 |
Daman & Diu | 5 | 240 | 0 | 0 | 31.12.2015 |
Delhi | 0 | 0 | 109 | 24,383 | 01.01.2015 |
Lakshadweep | 9 | 300 | 0 | 0 | 01.01.2016 |
Puducherry | 3 | 96 | 11 | 3473 | 01.01.2016 |
INDIA | 19,810 | 279,588 | 3772 | 431,173 |
States/UTs provided information for the year 2017 and PHCs are also included in the number of hospitals.
Source: National Health Profile 2018/Directorate General of State Health Services.
Notes: Government hospitals include central government, state government, and local govt. bodies. Figures are provisional.
Srl no. | State/UT | Number of hospitals | Number of beds | ||||||
---|---|---|---|---|---|---|---|---|---|
Govt. | Local Body | Others | Total | Govt. | Local Body | Others | Total | ||
1 | Andhra Pradesh | 8 | 0 | 0 | 8 | 365 | 0 | 0 | 365 |
2 | Arunachal Pradesh | 11 | 0 | 1 | 12 | 100 | 0 | 25 | 125 |
3 | Assam | 4 | 0 | 0 | 4 | 205 | 0 | 0 | 205 |
4 | Bihar | 8 | 0 | 0 | 8 | 950 | 0 | 0 | 950 |
5 | Chhattisgarh | 7 | 0 | 8 | 15 | 370 | 0 | 470 | 840 |
6 | Delhi | 4 | 0 | 1 | 5 | 390 | 0 | 210 | 600 |
7 | Goa | 0 | 2 | 0 | 2 | 0 | 150 | 0 | 150 |
8 | Gujarat | 35 | 29 | 0 | 64 | 1495 | 1763 | 0 | 3258 |
9 | Haryana | 4 | 0 | 7 | 11 | 145 | 0 | 600 | 745 |
10 | Himachal Pradesh | 34 | 0 | 0 | 34 | 710 | 0 | 0 | 710 |
11 | Jammu & Kashmir | 2 | 0 | 0 | 2 | 75 | 0 | 0 | 75 |
12 | Jharkhand | 1 | 4 | 0 | 5 | 50 | 300 | 0 | 350 |
13 | Karnataka | 156 | 0 | 57 | 213 | 2455 | 0 | 7740 | 10,195 |
14 | Kerala | 162 | 0 | 0 | 162 | 4054 | 0 | 0 | 4054 |
15 | Madhya Pradesh | 23 | 0 | 0 | 23 | 690 | 0 | 0 | 690 |
16 | Maharashtra | 5 | 0 | 66 | 71 | 812 | 0 | 8024 | 8836 |
17 | Manipur | 10 | 0 | 0 | 10 | 0 | 0 | 0 | 0 |
18 | Meghalaya | 10 | 0 | 0 | 10 | 100 | 0 | 0 | 100 |
19 | Mizoram | 2 | 0 | 0 | 2 | 100 | 0 | 0 | 100 |
20 | Nagaland | 2 | 0 | 0 | 2 | 10 | 0 | 0 | 10 |
21 | Odisha | 9 | 0 | 5 | 14 | 593 | 0 | 310 | 903 |
22 | Punjab | 5 | 0 | 4 | 9 | 100 | 0 | 108 | 208 |
23 | Rajasthan | 137 | 0 | 0 | 137 | 1391 | 0 | 0 | 1391 |
24 | Sikkim | 1 | 0 | 0 | 1 | 10 | 0 | 0 | 10 |
25 | Tamil Nadu | 293 | 0 | 0 | 293 | 2381 | 0 | 0 | 2381 |
26 | Tripura | 4 | 0 | 0 | 4 | 60 | 0 | 0 | 60 |
27 | Uttar Pradesh | 2315 | 0 | 1 | 2316 | 11,361 | 0 | 100 | 11,461 |
28 | Uttarakhand | 404 | 0 | 1 | 405 | 2023 | 0 | 50 | 2073 |
29 | West Bengal | 11 | 0 | 11 | 22 | 530 | 0 | 620 | 1150 |
30 | Andaman & Nicobar Islands | 5 | 0 | 0 | 5 | 90 | 0 | 0 | 90 |
31 | Chandigarh | 0 | 0 | 2 | 2 | 0 | 0 | 80 | 80 |
32 | Dadra &Nagar Haveli | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
33 | Daman &Diu | 2 | 0 | 0 | 2 | 20 | 0 | 0 | 20 |
34 | Lakshdweep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
35 | Puducherry | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
36 | Telangana | 20 | 0 | 0 | 20 | 841 | 0 | 0 | 841 |
Total (A) | 3694 | 35 | 164 | 3893 | 32,476 | 2213 | 18,337 | 53,026 | |
B. CGHS & central government organizations | 50 | 0 | 0 | 50 | 2216 | 0 | 0 | 2216 | |
Total (A+B) | 3744 | 35 | 164 | 3943 | 34,692 | 2213 | 18,337 | 55,242 |
Source: Ministry of AYUSH.
S. no. | Name of state | No. of hospitals | No. of beds |
---|---|---|---|
1 | Assam | 8 | 2357 |
2 | Andhra Pradesh | 1 | 306 |
3 | Andaman & Nicobar Islands | 1 | 107 |
4 | Arunachal Pradesh | 1 | 198 |
5 | Bihar | 2 | 348 |
6 | Delhi | 2 | 1993 |
7 | Goa | 2 | 175 |
8 | Gujarat | 5 | 666 |
9 | Haryana | 3 | 1458 |
10 | Himachal Pradesh | 6 | 699 |
11 | Jammu & Kashmir | 11 | 2643 |
12 | Jharkhand | 2 | 649 |
13 | Karnataka | 3 | 1090 |
14 | Kerala | 5 | 744 |
15 | Madhya Pradesh | 7 | 1402 |
16 | Maharastra | 11 | 4202 |
17 | Manipur | 1 | 74 |
18 | Meghalaya | 1 | 247 |
19 | Nagaland | 2 | 398 |
20 | Odisha | 2 | 147 |
21 | Punjab | 10 | 2990 |
22 | Rajasthan | 11 | 2115 |
23 | Sikkim | 2 | 247 |
24 | Tamil Nadu | 3 | 373 |
25 | Telangana | 3 | 764 |
26 | Tripura | 1 | 49 |
27 | Uttarakhand | 5 | 1402 |
28 | Uttar Pradesh | 15 | 4570 |
29 | West Bengal | 7 | 2107 |
Total | 133 | 34,520 |
Source: Ministry of Defense
S. no. | Zone/PU | Total no. of hospitals | Total no. of indoor beds |
---|---|---|---|
1 | Central Railway | 11 | 1164 |
2 | Eastern Railway | 8 | 1587 |
3 | East central Railway | 9 | 819 |
4 | East coast Railway | 4 | 339 |
5 | Northern Railway | 9 | 1101 |
6 | North Central Railway | 5 | 586 |
7 | North East Railway | 6 | 927 |
8 | North East Frontier Railway | 10 | 1107 |
9 | North Western Railway | 8 | 584 |
10 | Southern Railway | 10 | 1131 |
11 | South Central Railway | 7 | 714 |
12 | South Eastern Railway | 6 | 1086 |
13 | South East Central Railway | 5 | 250 |
14 | South Western Railway | 3 | 300 |
15 | Western Railway | 9 | 976 |
16 | West Central Railway | 7 | 456 |
17 | Intergral Coach Factory | 1 | 101 |
18 | Rail Coach Factory | 1 | 60 |
19 | Chittaranjan Locomotive Works | 1 | 197 |
20 | Diesal Locomotive Works | 1 | 105 |
21 | Diesel Loco Modernisation Works | 1 | 50 |
22 | Rail Wheel Factory | 1 | 46 |
23 | Research Design and Standards Organization | 1 | 30 |
24 | Metro/Kolkata | 1 | 30 |
25 | MCF/Raibareli | 1 | 2 |
26 |
Source: National Health Profile 2018 (as on 21/3/2018).
S. no. | States/UTs | Total no. of hospital | Total no. of beds |
---|---|---|---|
1 | Andhra Pradesh | 5 | 345 |
2 | Assam | 1 | 75 |
3 | Bihar | 3 | 50 |
4 | Chandigarh [Adm.] | 1 | 70 |
5 | Chhattisgarh | 0 | 0 |
6 | Delhi | 4 | 1416 |
7 | Goa | 1 | 15 |
8 | Gujarat | 12 | 910 |
9 | Himachal Pradesh | 2 | 150 |
10 | Haryana | 7 | 781 |
11 | Jammu & Kashmir | 1 | 50 |
12 | Jharkhand | 3 | 210 |
13 | Karnataka | 11 | 1675 |
14 | Kerala | 12 | 1178 |
15 | Madhya Pradesh | 7 | 725 |
16 | Meghalaya | 0 | 0 |
17 | Maharashtra | 13 | 2390 |
18 | Nagaland | 0 | 0 |
19 | Odisha | 6 | 325 |
20 | Puducherry | 1 | 75 |
21 | Punjab | 8 | 647 |
22 | Rajasthan | 6 | 495 |
23 | Sikkim | 0 | 0 |
24 | Tamil Nadu | 10 | 1856 |
25 | Telangana | 7 | 907 |
26 | Tripura | 0 | 0 |
27 | Uttar Pradesh | 16 | 1886 |
28 | Uttarakhand | 0 | 0 |
29 | West Bengal | 14 | 3534 |
Total |
Source: National Health Profile 2018.
The hospital pharmacy is one of the most important departments in the hospital, and it is responsible for drug procurement, storage, compounding, dispensing, manufacturing, testing, packaging, and distribution. This section is also in charge of pharmaceutical science and education research, which is carried out by skilled and knowledgeable pharmacists. The hospital pharmacy has a significant impact on healthcare cost economics. In today\'s hospital pharmacy, medication monitoring and drug information services are combined. Purchasing, storing, handling, pricing, and dispensing pharmaceuticals are all skills that a hospital pharmacist possesses. In addition, pharmacists give drug information to all healthcare professionals and the public, as well as serve as a link between the patient and the doctor. The criteria for acquiring pharmaceuticals, chemical and biological medications, and other items are provided by hospital pharmacists. They are also in charge of manufacturing and distributing pharmaceuticals like transfusion fluids, parenteral goods, pills, capsules, ointments, stock combinations, and safe drug storage. Hospital pharmacists can sterilize and dispense parenteral drugs made in hospitals. They fill, label, and distribute all medicine packages. Hospital pharmacists oversee purchasing pharmaceuticals, ensuring correct drug storage conditions, keeping records, and distributing pharmaceuticals to the outpatient department. In addition, hospital pharmacists provide drug monitoring services for inpatients and participate in hospital research programs [8]. Due to low wages, the hospital parts of a pharmacist\'s job have historically been overlooked in India; also, pharmacists have never been trained for a patient-centered role. Medical practitioners have never embraced pharmacists for clinical functions, while pharmacists have been hesitant to accept their profession\'s clinical obligations. Many Indian hospitals have begun to assign pharmacists a clinical role, with encouraging outcomes, but India still lags behind other countries in this regard. In India, the concept of a hospital pharmacy is confined to the dispensing of medications at hospital pharmacies [9].
Hospital pharmacies require certain personnel.
The dispensing, manufacturing, quality assurance, and clinical pharmacy services are all integrated within the hospital pharmacy. Personnel requirements for an inpatient pharmacy are determined by the nature and scope of services supplied by the department. The number of hospital pharmacists required is determined by the workload and the number of beds in the hospital. Small hospitals typically require a minimum of three pharmacists; however, this varies depending on the number of beds. Table 1 shows the number of pharmacists necessary based on the number of beds in a hospital [8].
Pharmacist requirement | |
---|---|
Bed strength | No. of pharmacists required |
Up to 50 beds | 3 |
Up to 100 beds | 5 |
Up to 200 beds | 8 |
Up to 300 beds | 10 |
Up to 500 beds | 15 |
Pharmacist requirement in hospitals.
According to 2011 data, the number of government hospital beds in rural and urban locations is shown in Table 2.
State | Rural hospital beds (government) | Urban hospital beds (government) | Total beds (government) | Proportion of rural and urban beds |
---|---|---|---|---|
Bihar | 1830 | 16,686 | 18,516 | 10:90 |
Chhattisgarh | 3270 | 6158 | 9428 | 35:65 |
Jharkhand | N.A. | N.A. | N.A. | N.A. |
Madhya Pradesh | 10,040 | 18,493 | 28,533 | 35:65 |
Odisha | 7099 | 8715 | 15,814 | 45:55 |
Rajasthan | 13,754 | 12,236 | 25,990 | 53:47 |
Uttar Pradesh | 15,450 | 40,934 | 56,384 | 27:73 |
Uttarakhand | 3746 | 4219 | 7965 | 47:53 |
EAG states | 55,189 | 107,477 | 162,630 | 34:66 |
Non-EAG states | 114,673 | 511,187 | 622,310 | 18:82 |
All India | 169,862 | 618,664 | 784,940 | 20.5:79.5 |
State and union territory wise number hospitals and beds in rural and urban areas in India.
N.A., not available.
Source: GOI, Table 6.2.2 State/UT wise number of govt. hospitals and beds in rural and urban areas (including CHCs) in India (provisional), in “Health infrastructure” in “National Health Profile, 2011,” Central Bureau of Health Intelligence, Ministry of Health and Family Welfare, 2011.
Personnel who work in hospital pharmacies must be knowledgeable and well-trained. The director of the pharmacy must have a postgraduate degree in hospital pharmacy, pharmacology, or pharmaceutics and serves as a liaison between pharmacy and non-pharmacy personnel. The hospital pharmacy\'s structure is depicted in the Flowchart below (Figure 1).
Organization structure of hospital pharmacy. Source: Nahata [
Even we have seen the present status, there were no significant improvements.
In India, the Pharmacy Act of 1948 was passed to ensure that every practicing pharmacist had a registration certificate [11, 12, 13]. On completion of the minimum diploma in pharmacy, educational institutes authorized by the PCI can grant this credential. A pharmacy diploma involves at least 2 years of education and 500 h of practical training, including three months in a community or hospital pharmacy [11]. These pharmacists with a diploma represent most of the workforce and run most community pharmacies in India today. A bachelor\'s degree in pharmacy is designed to meet the needs of the pharmaceutical business, with most graduates working in pharmaceutical companies or regulatory agencies. In comparison to community pharmacy, many B. Pharm graduates prefer to work in the pharmaceutical business because of the higher pay scale and other benefits.
In practice, these pharmacists with a diploma or bachelor\'s degree are still unheard of in half of the community pharmacies. Most patients come to community pharmacists for help on sexually transmitted diseases, minor ailments, contraceptive options, and menstruation issues [11]. The majority of community pharmacies are administered by people with minimal awareness of health issues or medical training, and pharmacists are hired on low pay rates. Most pharmacists in community pharmacies lack counseling abilities and are simply able to deliver medications. Despite the public\'s negative opinion of pharmacists and the idea that pharmacies are like grocery stores, community pharmacies remain the principal provider of low-cost medical treatment.
In India nowadays, the average cost of a prescription per patient who visited a private clinic is around 1000–1500 rupees, and the number of prescriptions per drug has increased. The marketing efforts of pharmaceutical companies have a significant impact on doctors\' prescribing patterns. Pharmaceutical companies spend less on R&D than they do on marketing. Medical representatives are trained by pharmaceutical companies to advertise and sell pharmaceuticals utilizing printed product materials, medicine samples, and gifts. Around 80,000 medical representatives are hired by pharmaceutical companies in India, and they are paid well.
In addition to their pay, they are offered significant incentives. General practitioners have been found to prescribe new products under the influence of sales reps. Furthermore, medical representatives promote medications by stating more indications than are officially registered.
One of the main tools used by pharmaceutical firms to advertise their medication is gifts (ranging from a table-top reminder to an air conditioner), gratification, foreign excursions, pleasure excursions, and so on. From clocks to air conditioners, calendars to cars, rubber bands to refrigerators, telephone indexes to television, and office items to overseas trips, the variety of gifts includes stationery, timepieces, bags, books, folders, office desks, medical supplies, and household items—from clocks to air conditioners, calendars to cars, rubber bands to refrigerators, telephone indexes to television, and office items to overseas trips. According to Chren and associates, there is an implicit relationship between doctors and the pharmaceutical industry, which leads to a responsibility to respond to gifts [14].
Advertising has a significant role in the marketing of medicine. Pharmaceutical companies spend a lot of money to advertise in medical and pharmaceutical magazines, which are read by a lot of general practitioners and clinical specialists. Medical journals in India would perish if pharmaceutical companies did not advertise in them. The advertising of pharmaceuticals is strictly monitored, and if there is any false information, harsh action is taken. Drug information should be accurate, current, and balanced, according to the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and The Association of the British Pharmaceutical Industry (ABPI) guidelines. The IFPMA code must be followed by all members of the Organization of Pharmaceutical Producers of India (OPPI). Internal codes and promotional material for the pharmaceutical producers of India must be approved by medical advisers, according to the organization. A Promotional Quality Improvement and Assurance Committee also performs a thorough study of these promotional materials. Furthermore, this committee makes recommendations for marketing enhancements.
Irrational prescription and its consequences are heavily influenced by pharmaceutical marketing and promotional activities. The Medical Council of India has issued a new code of ethics for practitioners who receive any sort of compensation from pharmaceutical companies. New legislation in Rajasthan, India, states that a doctor must only put the generic name of a medicine on a prescription [14].
With the advent of clinical pharmacy, which provides high-quality treatment and assistance to patients, a pharmacist\'s job has been expanded. Pharmacists now provide drug and toxicity information, manage anticoagulation clinics, and administer smoking cessation programs, among other things.
The paramedic education system has been supply-driven, with no regard for industry demand. Allied healthcare providers are the most crucial because, if a patient has a hundred interactions at a hospital, allied healthcare workers account for 80 of those encounters. In India, healthcare is the third most important source of employment. It is broken down into three categories: Doctors make up 10–15% of the healthcare workforce, nurses make up 20–25% of the workforce, and paramedics, also known as allied healthcare professionals or healthcare technicians, make up the largest segment of the healthcare workforce. The doctor-to-allied healthcare-professional ratio in India is 1:4. The advanced countries, such as the United States and the United Kingdom, have a 1:20 ratio. India already employs over 10 million allied healthcare workers, but to meet the 1:20 ratio, we will need to increase this number to 40–50 million in the next few years. Diagnostic, curative, and rehabilitative allied healthcare professions are categorized into three groups. The diagnostic and therapeutic industries in India have been expanding. Allied healthcare professionals such as X-ray technicians and medical app technicians work in diagnostic. Technicians such as OT technicians and emergency medical technicians work in Curative. The difficulty is that in India, only about 7% of these allied healthcare professionals are certified because there was no centralized authority to certify them until the NSTC was established. Before NSTC, each state certified them at their own level, and the biggest problem today is for quality healthcare services, allied healthcare professionals are the most important because if a patient has a hundred interactions in a hospital, 80 of those interactions are with allied healthcare professionals, and the biggest challenge in India is that there are less than a hundred allied healthcare professionals. Until 2008, there was no centralized body. One of the most significant issues is that, in general, education in India has been supply-driven, with no connection to industry needs. As a result, when compared to worldwide norms, we are one of the least prepared for the workforce. What needs to be done is for education to be driven by demand. It must be presented from the standpoint of the company and how these individuals will work in the sector. To do so, we must recognize three factors—technical training, practical training, and soft skills and grooming training, all of which must be provided so that these individuals are prepared to fully contribute to the workforce in a productive manner when they enter the workforce. Mr. Narendra Modi, Prime Minister of India, believes that ongoing training of the workforce required to combat the COVID 19 crisis is critical. He recommended officials and doctors to hold training sessions and webinars, particularly for paramedics and doctors who work in rural areas. He also requested that the officials endeavor to reduce vaccination waste in the district. Interacting with Varanasi doctors and administrators via video chat Prime Minister Narendra Modi paid a heartfelt tribute to those who died because of COVID-19. He emphasized the necessity of ongoing training for those fighting COVID, advising officials and doctors to hold training sessions and webinars, particularly for paramedics and doctors functioning in remote areas. He also requested that the officials endeavor to reduce vaccination waste in the district. "Jahan Bimar Wahan Upchar," is the new slogan in COVID management in terms of delivering therapy to the patient\'s doorstep that will minimize the strain on the health system. The doctors from Varanasi updated the other doctors through video conference on the measures made in the last month to restrict the spread of COVID, vaccination status, and ongoing steps and strategies to prepare the district for future difficulties. They stated that they have been vigilant in their response to the threat of mucormycosis and have already taken action and established facilities to handle the condition. Our Prime Minister also praised the microcontainment zones project and praised the home distribution of medicines, and he urged health professionals to make the campaign as widespread as possible in rural areas. He praised the physicians, nurses, technicians, ward boys, ambulance drivers, and other Kashi frontline health professionals for their efforts. He praised the medical staff in Kashi for their efforts in controlling the pandemic to a large extent, but warned against complacency, urging them to fight a lengthy battle right now by focusing on the rural districts of Banaras and Purvanchal. PM emphasized the critical role of Accredited Social Health Activists (ASHAs) and Auxiliary Nursing Midwifery (ANMs) sisters in the ongoing village campaign against COVID-19 and urged health officials to use their potential and experience. The main reason is if the frontline employees had already been vaccinated, they were able to serve the people safely during the second wave. We need to encourage everyone to get the vaccine when it is their turn, that is what has currently been done.
Diverse countries and continents, including emerging, transitional, and industrialized countries, have different pharmaceutical practices. The World Health Organization (WHO)/International Pharmaceutical Federation (FIP) joint guideline of good pharmacy practice (GPP), which was updated in 2011, is meant to account for these changes in practice. The pharmacy profession is rapidly expanding, with new responsibilities being offered and announced not only by pharmacists but also by other medical professionals, national organizations, and institutions. The GPP\'s guideline is progressive and adaptable, and it must remain relevant when new positions develop. Standardizing many parts of pharmacies is one of the most important techniques of quality control for medications and pharmaceutical services for the public. The GPP Guide is a significant step toward bettering pharmacy services [12]. The GPP guideline is designed for use by national professional pharmaceutical associations, as well as national authorities and other relevant agencies responsible for drafting relevant documents and related laws and regulations in their countries, according to the WHO and FIP. It is not a clear national standard, but it does provide guidance on certain tasks, responsibilities, and actions that help pharmacists to fulfill their mission. Professional issues and attitudes are given specific attention throughout the guideline\'s content, and the patient\'s well-being is given priority. However, it should be noted that this is the first time that a legal, economic, and labor framework has been introduced in the context of the GPP structure, and it comes at an appropriate time given global debates on the economic aspects of medicines, access to quality medicines, access to skilled medical workers, the global workforce failure, the increased cost of medical care, and new models of healthcare [13]. The GPP is defined by the WHO and the FIP as a pharmacy practice that satisfies the needs of people who use pharmacists\' services to deliver optimal medical care based on evidence-based medicine principles. To support this approach, a national framework of quality standards and guidelines is required. The goal of this project is to investigate the historical stages of development of GPP requirements, as well as to examine modern normative texts proposed by FIP for use in global pharmaceutical practice, as well as to investigate the current state of this issue around the world. The study included the generalization of information material and system analysis methods. The WHO and the FIP have been working together since the late 1980s to define pharmacist duties and functions, as well as produce guidelines for the GPP as a framework for pharmacological care. The WHO amended the medicines strategy, which was accepted by the World Health Assembly in 1986, and two meetings on the function of pharmacists were held in accordance with it. The inaugural meeting was held in Delhi, India, in 1988 [15]. The FIP produced criteria for pharmaceutical services in 1992, and the WHO Information Centers disseminated the approach of good pharmaceutical practice in March 1993. The standards of pharmacy services entitled "GPP in Public and Hospital Pharmacies" were officially issued during the convention in Tokyo, Japan [15]. Under the framework of the Tokyo declaration on quality standards of pharmaceutical services, the FIP congress accepted the FIP/GPP text. The FIP has asked pharmaceutical companies and governments to work together to implement GPP standards or to amend current national standards in countries where they currently exist, according to this paper. Then, in May 1994, the World Health Assembly adopted a resolution on the role of the pharmacist in support of the WHO\'s new pharmaceuticals strategy. In 1994, a version of the GPP was also presented to the WHO Expert Committee on Pharmaceutical Medicine Specifications in Geneva. In 1999, a joint document of the WHO/FIP of the GPP was published in a series of technical reports of the WHO Expert Committee on concerns of pharmaceutical medicine specification, following the recommendations of the WHO Expert Committee and the approval of the Board of the FIP in 1997. This gave the GPP more formal standing and assured that it was widely distributed around the world [16]. A Soon after, the WHO convened two more meetings on the pharmacist\'s role, one in 1997 in Vancouver, Canada, and the other in 1998 in The Hague, Netherlands. These gatherings reinforced the necessity for reforming pharmacy education programs and highlighted the pharmacist\'s role in self-help and self-healing. The European Union\'s (EU) pharmaceutical group prepared a paper containing the GPP for Europe in 1998, with special emphasis dedicated to EU countries—"the GPP in Europe." [17]. The “GPP in the New Independent States” was established in 2001. The Copenhagen Center for Drug Policy and Development of Pharmaceutical Practice developed “Guidelines for the creation and implementation of standards” in Denmark. The document examined the state of pharmacy practice and focused on issues such as health education and morbidity prevention, the provision of prescription drugs and their use, self-treatment, the effects of prescription and use of drugs, as well as the method of implementing proper pharmacy practices in developing countries. The WHO experts recommended that European standards for pharmacies be implemented on a par with existing national standards to regulate various aspects of pharmaceutical activity, including the quality of prescription data received by the pharmacist, the development of medical forms, the building of contacts with doctors based on individual recipes, and the evaluation of data on the use of medical products [18]. There is a strategy for establishing national GPP standards, according to FIP recommendations. To begin, fundamental pharmaceutical services must be established, for which a regulatory framework and relevant standards must be created. The secondary and higher education systems in pharmacy should be revised after that because pharmacists will require a more in-depth understanding of pharmacotherapy, pharmacopeia, and communications skills. The provision of more complex professional pharmaceutical services is the ultimate stage. The FIP highlights GPP elements that demonstrate that the pharmacy provides high-quality service and adheres to strict guidelines: The presence of a zone in the pharmacy with information about healthy lifestyles; availability of a pharmacy for people with disabilities and elderly patients; availability of a comfortable waiting area; the possibility of a private conversation between a pharmacist and a patient, including those with disabilities; and the presence of a pharmacist on call. The pharmacist\'s responsibility in providing successful drug therapy, according to FIP\'s recommendations, is as follows: Management of therapy, monitoring of treatment success, and disseminating information on the safe and effective use of medications. The pharmacist should evaluate the client\'s health and needs, taking into consideration his unique qualities. Professional collaboration between the pharmacist and the doctor is an important part of GPP. Each patient\'s medical and pharmacological information (diagnosis and laboratory data) should be in the first one. It is also crucial to keep track of whether GPP standards are being followed. It can be internal and/or external; it can also be necessary or simply for accreditation/certification purposes. This will disclose the drawbacks of meeting GPP requirements as well as ideas for how to avoid them. One of the simplest ways to ensure that a pharmacy\'s work is of high quality is to assess customer satisfaction with the service. In 2006, FIP and WHO collaborated to publish the handbook "Developing Pharmacy Practice—A Patient-Centered Approach." This guide introduces the new pharmacy practice paradigm and the approach to pharmaceutical assistance. The FIP has taken the initiative to explore the possibilities of providing technical assistance to its member organizations in Cambodia, Moldova, Mongolia, Paraguay, Thailand, Uruguay, and Vietnam in developing national standards of the GPP in a pilot project to improve standards and practice of medicine distribution and use with the help of the WHO/FIP setting with the GPP as the framework. The “Bangkok declaration of the GPP in public pharmacies” was adopted across Southeast Asia in 2007, and member associations pledged to improve the quality of pharmacy services and professional practice [19]. Significant advances in practice applied science and technology, and pharmaceutical policy has happened since the GPP guideline was accepted in community and hospital settings. Despite changes that have occurred since the GPP\'s previous guidance in pharmaceutical policy, practice, and applied science was adopted in 2007, FIP was established to investigate the problem of updating the GPP\'s guiding principles to reflect current standards and professional thinking peculiarities [20]. During the 68th World Congress in Basel, Switzerland, in 2008, the FIP convened expert consultations for this aim. A total of 50 people attended the meeting, including members of the working group (WG), FIP of the GPP, WHO headquarters staff, representatives from the WHO regional office for the Eastern Mediterranean countries, medicines advisers from Ghana, Nigeria, and the United Republic of Tanzania, presidents, and secretaries of six Regional Pharmaceutical Forums, FIP member organizations, and several NGOs [21]. Following these consultations, the FIP GPP working group performed a detailed examination of current national standards for GPP in at least 37 countries and developed a time zone that could allow for adequate consultations with all 120 national associations, relevant experts, and the WHO. In October 2008, a proposal for this project was given to the WHO Expert Committee on concerns of pharmaceutical medicine specification at its 43rd meeting, and an updated report was provided to the Committee of Experts at its 44th meeting in October 2009. Simultaneously, in late 2008, the Pan-American Health Organization prepared “the guide for pharmaceutical services in primary health care” with the help of a group of experts from various pharmaceutical organizations, with the goal of highlighting the role of pharmaceutical experts in Latin America\'s health system. Following discussion with 120 national members of the FIP in 2011 and changes in the pharmaceutical industry, the GPP recommendations were adopted and updated by the approval of a joint guideline FIP/WHO titled "the GPP: Standards of the quality of pharmacy services." This general guideline was released as new standards of pharmacy service quality in the WHO Expert Committee\'s 45th report. In addition, this document encourages national pharmacy professional associations to embrace these standards and propose some GPP-specific norms [22]. The GPP establishes standards that are usually higher than the requirements of a country\'s pharmaceutical legislation. In the modified version of the GPP, pharmacists play many roles:
Medical product manufacturing, receiving, storage, security, distribution, usage, release, and disposal.
Ensuring that the pharmacological therapy is properly managed.
Continuation and enhancement of professional activity.
Encouraging the system of medical care and health to become more effective [20].
Depending on the duties that each pharmacist does, these positions may differ. Only through national pharmacy professional associations may specific GPP standards be defined. This recommendation is made in the form of a set of professional goals that must consider the needs of patients and other pharmaceutical stakeholders.
In comparison to the previously authorized concept of the GPP, the present updated version reinforces the requirements for the GPP\'s well-known primary aspects and identifies functions in each pharmacist\'s position for which minimum national standards should be established. Different countries have different versions of the GPP rules. There are holistic papers in some countries that cover both requirements for the material-technical base, infrastructure, personnel, and standards for the provision of pharmacological treatment. These rules and regulations are spelled out in numerous documents in other countries. The standards for pharmacists in France, for example, are established in several guidelines. In Austria, on the other hand, nearly all the requirements for pharmacists are encapsulated in a single piece of legislation. There is also a guideline for pharmacists\' work, which includes standards for a quality management system in addition to the typical criteria for premises, equipment, and staff. The GPP standards have a recommended status in industrialized countries. As a result, the Norwegian pharmaceutical association\'s standards of pharmacy practice, created in partnership with other professional groups, include requirements for pharmacy activities that are utilized by pharmacy owners to conduct internal quality control of pharmacy services. The government adopts legislation acts that provide the minimum standards for the functioning of pharmacies [23]. The Pharmaceutical Society of Ireland published a guideline on pharmacy practice to help pharmacists meet legal and regulatory requirements when providing pharmaceutical services [24]. In addition, the GPP is adopted in CIS countries. Belarus has implemented a pharmacy classification system. The GPP was adopted in Kazakhstan in 2006, and the provisions of the GPP of the customs union are currently approved in the Russian Federation. It should be noted that the GPP standard and guidance on the implementation of proper pharmacy practices serve as the foundation for implementing the total quality management (TQM) concept and the international standard of ISO quality management at pharmaceutical companies, both of which have been in use for more than 30 years. The understanding of the existence of an inextricable link between the quality management system and the organization\'s management system, as well as the understanding that this is an essential tool for continuous improvement and increasing the pharmacy organization\'s competitiveness in any market, is the foundation of TQM [25]. As a result, by enhancing the requirements to assure the quality of public services, the GPP standards are a significant step toward the expansion and enhancement of pharmacy operations. Despite improvements in pharmaceutical research and practice, the development and implementation of GPP criteria into pharmacy practice is a long-term and ongoing process. The standardization of pharmacists\' activity in providing people with medications and medical items receives a lot of attention in GPP guides of all years. Because national regulation of pharmacy practice differs widely among nations, the establishment of GPP standards should be handled at the level of public professional organizations. The results of the study will be used to design and apply GPP national standards around the world, according to future scientific research.
A recent countrywide survey done by final year postgraduate diploma in management students from Indian Institute of Health Management & Research, Bangalore finds that out of 107 hospitals 66 hospitals only follow the WHO/FIP GPP 2011 or Indian Pharmacy Practice Regulations 2015 which is merely 62% of the entire sample.
Students were asked to conduct a brief analysis and report on the top five hospitals or community pharmacy dept. in their area or where they did train/observer ship whether these guidelines are followed or not and where are the loopholes in following this guideline. There were two kinds of data generated, such as
The graphical representation of the quantitative survey data is illustrated as follows:
The qualitative observational/survey data is represented as follows:
Qualitative survey result | Observations |
---|---|
Narayana Health City | While working in a Pharmacy Department of the Hospital, many things are founded like:
There should be a proper space in the IP pharmacy. Pharmacists should be provided with more space with more no of counters. Expired medicine should be categorized separately. Medicine should be categorized on a monthly basis so that it may return on time. Calls should be attended properly by the staff. The pharmacy should categorize the drugs, injections, medical consumables in an order so that anyone can find it quickly. Drinking water facilities should be there. There should be proper lighting facilities. The pharmacy should be hygienic. |
Dr. Agarwal\'s Eye Hospital Chain, S V Hospital & C M N Hospital |
|
Sagar Hospital | Most common loopholes and challenges found in the hospital pharmacy. As hospitals have a pharmacy, they mostly followed the FIP guidelines but there are some challenges and loopholes faced by the hospital pharmacy. The challenges related to the pharmacist include the inadequacy of service promotion, absence of service continuity, poor DIC service, and lack of commitment, communication, and confidence among clinical pharmacists. Most respondents declared that poor attitude toward the services, conflict of interest due to the unclear scope of practice, and absence of cooperation are the challenges that radiate from health practitioners such as nurses and physicians. Some respondents also described challenges that arise from the hospital management and its set-up. The challenges they mentioned include lack of training, shortage of skilled manpower, lack of incentives, absence of facilities in the ward for clinical pharmacists, and collaboration between academics and hospital clinical pharmacists. The other challenges stated by the respondents were due to the academic policy and the curriculum itself. This encompasses some gaps of the curriculum; absence of clear job description and working guidelines; and documentation system. The major challenges for clinical pharmacy services described were a lack of support from hospital management, absence of clearly defined roles and responsibilities for the clinical pharmacists, a shortage of pharmacy workforce and staff turnover, a lack of follow-up from responsible bodies, and a lack of enough salaries and incentives for the healthcare providers. |
Aditya Netralaya |
|
Mithra Hospital |
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General | Many of the hospitals do not have an assigned clinical pharmacist, which makes the difficulty in practicing Rule number 2 of the standards of GPP. Workforce shortage during peak OPD hours there should be a training of pharmacists and associated personnel on regular basis. Updating newer guidelines. Sometimes when too much workload is there, pharmacists are unable to properly counsel the patients/attendants regarding doses, their uses, drug interactions, etc. Shortage of time for EWS pharmacy. Because medications are not always available, it is extremely inconvenient for patients to return after time. The room does not have adequate light and ventilation. There is a lack of adequate space for the storage area of the pharmacy. No trained personnel in pharmacy, that is, the staff is from nonpharmaceutical or nonmedical backgrounds. No proper support is seen in abiding by policies of government related to health outcomes as per the guidelines of Role 4. Drug availability is not meet the needs of patients. No proper record is maintained in any aspects related to dispensing or storing of drugs. |
No proper follow-up of patient turnaround time at the pharmacy | |
Narayana Health City | Missing of personnel in the pharmacy increases the patient waiting time |
Omni R K Hospital | No trained personnel in pharmacy, that is, staff from nonpharmaceutical or nonmedical background |
Gayathri Hospital | No trained personnel in pharmacy, that is, staff from non-pharmaceutical or non-medical background |
Pharmacy practice, which includes clinical, community, and hospital pharmacy, is referred to as healthcare in the true sense. PPs establish a vital link between doctors, nurses, and patients in a social community group, with the goal of improving patient welfare and safety [26]. Pharmacists must provide more than only distribution; they must also provide services to society, such as patient counseling, guidance, and the organization of drug data for human services, suppliers, and patients [27]. For example, before the product patent was implemented in India in the early 2000s, the pharma industry thrived successfully after the amendment of new monetary reforms in India in the mid-1990s until the early 2000s [28]. In terms of educational outcomes, the degree of student achievement in pharmacy has improved from 2012 to 2020 and is predicted to continue to climb due to its scope. Many pharmacy graduates have expressed an interest in medication discovery and innovation through research [29]. It has been suggested that pharmacies play an important role in strengthening social security because they work around the clock to maintain a chain of elegant integrity on drugs, particularly during the COVID-19 pandemic. From the standpoint of regulatory authorities, PPs play a variety of roles and duties in the execution of new recommendations based on situational faults [30].
It entails the implementation, evaluation, and interpretation of pharmacy orders as well as the dispensing of prescriptions. Pharmacists are responsible for providing patient counseling, legislation, and social services to promote pharmaceutical treatment as primary care in all areas of patient health [31]. They are also in charge of segregating and labeling pharmaceuticals and medical devices, as well as guaranteeing the safety of medication and device storage and maintaining adequate records [32].
The Pharmacy Act is a nonconstitutional statute.
There cannot be two regulators at the same time.
The AICTE Act is a broad statute.
The Pharmacy Act is a unique piece of legislation.
The Pharmacy Act is a comprehensive code that includes pharmacy specialists.
Only the Pharmacy Council of India (PCI) has the authority to set pharmacist qualifications.
Only PCI has the authority to set standards for pharmacies.
PCI will be solely responsible for approval and admission to institutes.
The Pharmacy Act has the power to govern not just pharmacy education but also the profession [33].
In India, there are two types of pharmacists—those who work in hospitals and those who work in
Pharmaceutical industry
Pharmacies in the community
Pharmacovigilance is a term that refers to the monitoring of pharmaceuticals.
Pharmacy schooling
Pharmacovigilance procedures
Bengal Chemical and Pharmaceuticals Ltd. was founded in 1892 as an individual initiative by the "Father of Indian Chemistry," Acharya Prafulla Chandra Ray, and is considered the country\'s first pharmaceutical enterprise. For the first time in more than six decades, Bengal chemicals and medicines Ltd. made a profit in 2016–17 [34].
For the manufacture, distribution, and sale of medications, India has the harshest rules and regulations in the world. The ability of law enforcement is not just determined by good legislation; it also requires stringent regulations and the acceptance of successful challenges. According to the Mashelkar committee\'s recommendations, one drug inspector should be assigned to every 50 manufacturing units and one to every 200 distribution outlets. In most states, 30–50% of positions are vacant, and the number of positions available is insufficient to expand the pharmaceutical sector. According to the Mashelkar committee report, one drug inspector is assigned to every 200 retailers, and the data from the All-India Organization of Chemists and Druggists (AIOCD) indicates that there are approximately 8.5 lakh pharmacies to be considered, implying that more than 4250 drug inspectors are required to manage the retail pharmacy segment [35].
CDSCO and SDRA have different roles.
Pre-manufacturing is the process of preparing a product for manufacture.
Expert panels help the Central Drugs Standard Control Organization (CDSCO) to regulate premanufacturing. The following is their primary role in dealing with the two major criteria:
Clinical studies (clinical trial registry, GCP, inspections, ethics committee, and significant adverse events)
Import and marketing license approvals for new drugs [36].
The State Drug Regulatory Authority (SDRA) oversees regulating drug product manufacturing in the states, while CDSCO oversees union territories. In some circumstances, the CDSCO and SDRAs undertake joint inspections [37]. The terms listed below are required for the manufacture of pharmaceutical products.
Permit (generic and marketing license)
GMP (good manufacturing practices) inspection
Drug testing and noncompliance penalties [31].
The SDRAs oversee regulating the distribution and sale of drugs in the states, while the CDSCO oversees the union territories. The terms listed below are required for the distribution and sale of pharmaceutical items.
Permit (sale and distribution practices)
Good Distribution Practices Inspection (GDP)
Drug testing and noncompliance penalties [38].
The current state of pharmacy education, authority functions, and future difficulties of pharmacists in all aspects was discussed, particularly considering the COVID-19 epidemic. During the development phase, it must overcome numerous obstacles, including regulations, duration, process controls, legal stumbling blocks, and situational flaws [39]. Table 3 summarized the educational updates.
Pharmacy program | Number of institutions | Annual intake |
---|---|---|
D Pharm | 3022 | 180,770 |
B Pharm | 1961 | 125,524 |
Pharm D | 267 | 8010 |
M Pharm | 792 | 24,465 |
Ph. D. in Pharmacy | 31 | 1240 |
Statistics of pharmacy education program in India.
From June 2, 2020, the PLI Scheme will be open for 4 months, allowing investors to propose the construction of Greenfield facilities for any of the 53 important drug intermediates and bulk pharmaceuticals that are now barely made in India [40]. The list contains important chemicals found in regularly given medications such as paracetamol, aspirin, metformin, atorvastatin, and others. The whole planned incentive package is worth Rs. 13,760 Crore, which is divided between bulk medicines and medical devices as shown in Figure 1.
COVID-19 PPs
Millions of people around the world are affected
Insight into no cure
Online (digital) education
Evaluate Indian strategy and tactics.
India\'s pharmaceutical industry\'s expectations in terms of global visibility
Opportunities with challenges
Across the several layers of regulatory and enforcement procedures, this industry suffers from knowledge asymmetry. Because each state has its own regulations, there is a lot of variation in the quality of drug regulation across the country [41]. India\'s drug inspectors, who are crucial players in drug regulation, should be highly qualified and adequately compensated to reflect the dignity that comes with such a large duty. The agency has a budget limit when it comes to implementing innovative methods of regulatory monitoring [39].
There is a great deal of anticipation, price pressure, and caution in the development of vaccines, particularly (Covaxin, Covishield, or Sputnik) for the treatment of COVID-19, which is still in Phase I and II clinical trials in India. There is a potential that poor data will emerge in a Phase III study, as several countries have done in the past, leading to vaccine development and outcome failure [42]. Nowadays, one of the most pressing issues in the management of process controls during the formulation of pharmaceuticals is the formation of impurities in the form of genotoxic and carcinogenic impurities, which are extremely toxic and harmful to patients taking medication for diabetes, gastric ulcers, and psychosis [43]. There is also a compensation challenge in India due to the loss of fixed-dose combination (FDC) drugs, as many of the 344 drugs in this category were banned and withdrawn because they were therapeutically irrational and caused toxicity in patients when used to treat chronic diseases like tuberculosis and HIV. As a result, there are still hopes of bringing FDCs to market for patient benefit with assurances of safety and efficacy [44]. If the financial expenditure is not increased, the quality of research, drug discovery, and development will suffer.
According to Holon IQ global education intelligence, the current $6 trillion education market will grow to $10 trillion by 2030. Digital platforms account for only 3% of worldwide education spending, and by 2025, they will account for $325 billion, or less than 5% of total spending [45, 46]. Although this will go a long way toward solving the country\'s educational challenges, the government\'s present worries include guaranteeing smooth delivery of education on the post-Covid road of digital education [47]. The UGC is now working on a game-changing regulation that will allow universities with a high “NAAC” score in the top 100 NIRF rankings to offer online programs. This will be a game-changer since educational jurisdiction will become worldwide, and only equipped universities will survive [48].
The following recommendations were implemented for the PPs based on the unique circumstance faced by each country because of COVID-19:
The pharmaceutical business must shift its focus away from COVID-19 and onto the needs of the country, as well as ideas for overcoming governmental and regulatory obstacles.
The government should provide adequate funds to PPs researchers for the development of novel drugs and the conduct of clinical trials.
To achieve the required results, the pharmaceutical business should learn to invest in quality staff and move its attention from the product to the patient [49].
Application of state and federal norms to protect public health and disease prevention.
Strengthening the regulations governing healthcare administration and professionals, requiring them to adhere to severe state-based rules.
There should not be a large reliance on API procurement from China; instead, actions should be done to ensure API supply from within the country.
Enabling workflow changes in principles while dealing with emergencies
To raise awareness and develop educational training programs to protect people\'s physical and mental health during the pandemic.
To combat COVID-19 as a naturopathy-based treatment, the pharmacognosy and phytopharmacy department should focus on herbal and ayurvedic formulation development.
Positive, credible, and evidence-based marketing to be made by PPs on the conventional way of using AYUSH-based drugs to combat COVID-19.
The general public should consume “Kapasura kudineer,” which is widely available in retail pharmacies, particularly in south India, and contains many combinations of herbs that can combat the coronavirus and other microorganisms. This has shown promising results, as many people have been benefited and relieved from COVID-19 in asymptomatic reported positive cases.
Steps to be done for e-learning/webinar programs in order to receive additional updates from the WHO and the health advisory council for pharmaceutical development and public health protection.
In the event of an emergency, the use of PPs as second-line healers or physicians to diagnose the patient\'s ailment [50].
During the COVID-19 epidemic, enabling e-prescriptions and home delivery of medicines to self-isolated individuals and older people by guaranteeing preventive steps and safety.
Advocacy with policymakers and stakeholders must be strengthened in order to create the optimal regulatory framework for the pharmaceutical industry to thrive.
The devastating second wave of the COVID-19 outbreak has brought strangers together offline and online to assist one another in any way they can. Even terrible stories of death and loss have not deterred some people from engaging in unethical and immoral actions including black-marketing medical life-saving medicines, hoarding, and defrauding in the name of COVID-19 medical supplies, and charging exorbitant prices for ambulance service. The Delhi Police recently raided a fine-dining restaurant in Lodhi Colony and seized 419 oxygen concentrators. These were being sold at an astronomical price of 69,999, complete with bogus MRP labels. About 96 oxygen concentrators were seized from Khan Chacha, owner of a famous food joint in Khan Market. When Delhi-NCR is in the midst of the biggest crisis in its history, notable figures in the city urge tough punishments for anyone who engages in such unlawful and inhumane activities. In connection with a Rs 450 crore medical equipment maintenance scam, Andhra Pradesh\'s Crime Investigation Department (CID) has filed a complaint against Bengaluru-based TBS India Telematic & Biomedical Services Private Limited, private individuals, and health department employees. The case was filed under the sections of the Indian Penal Code dealing with cheating, criminal conspiracy, and criminal breach of trust. Price increases, inflated bills for nonexisting equipment, and increased invoices for equipment in government hospitals in AP are among the irregularities. Over 300 doses of anti-COVID vaccination were taken from a hospital in Jaipur during a spike in coronavirus illness, forcing authorities to file a criminal complaint. According to agency reports citing a Centre RTI response, Tamil Nadu recorded 12.10% vaccine wastage, followed by Haryana (9.74%), Punjab (8.12%), Manipur (7.80%), and Telangana (7.80%) (7.55%). Vaccine wastage in Tamil Nadu is up to 13% for Covaxin and 9% for Covishield, according to data from the state directorate of public health, which distributes vaccines and regulates its use. Between January 16 and April 17, 7.14 lakh doses of Covaxin and 44.80 lakh doses of Covishield were sent to drug retailers, according to state authorities. A vial must be used within 4 h of being opened and stored at a temperature between 2 and 8°C. The state has used 47.05 lakh dosages by April 17, including 40.5 lakh Covishield. Health staff was under pressure to vaccinate as many individuals as possible. Even though there were not enough individuals, they opened bottles of 20 and 10 dosages. We will now be able to expand immunizations due to an increase in cases and stock. On Friday, as a new day dawned over Delhi, a somber narrative surfaced from Sir Ganga Ram Hospital, one of the capital\'s most prestigious institutions. In the last 24 h, at least 25 COVID-19 patients had perished there. Physical ventilation—occasional6manual compression of a gas-filled reservoir bag to drive the gas into a patient\'s lungs—has been used on occasion to ensure that patients on ventilator assistance survive. The burning question is how to treat patients when key supplies are not available. As per specialist doctors without oxygen, a patient who requires ventilator assistance can die in minutes. Many other hospitals were in a similar situation. The hospitals then devised a plan to have two patients share a cylinder by using connectors. But also, according to doctors, those on a ventilator can die in minutes if their oxygen supply is cut off. Doctors face a significant hurdle because of this. Despite government pledges and rules, the black market for Remdesivir, a crucial COVID-19 medicine, is thriving in Chennai, with many pharma dealers asking up to Rs 14,000 per 100-mg vial. Even though the Tamil Nadu government has promised to assist them in obtaining the drug, many private hospitals have thrown in the towel, leaving numerous COVID-19 patients in their care without treatment. A private COVID panel hospital has been charged with overbilling by the Kanpur district administration. On Monday, the complainant filed a complaint alleging that he was overcharged by Rs 3.50 lakh in the previous 7 days, and on Tuesday, the district administration issued a notice to the hospital\'s management after completing a preliminary investigation. The charges were confirmed to be accurate after a preliminary investigation by the extra city magistrate and a government doctor. When the hospital\'s management failed to respond satisfactorily, district magistrate Alok Tiwari issued an order to register an FIR against it on Tuesday. The administration has appointed static magistrates and sector magistrates to investigate overbilling issues in private panel hospitals, according to the district magistrate. Furthermore, the government has already circulated cell phone numbers for the public to use to report any overbilling complaints. Despite threats of severe consequences for overbilling, private panel hospitals are seizing every opportunity to overcharge patients. Prices of oxygen concentrators, oximeters, and nebulizers have risen by 50–100% in the last 10 days, owing to a massive demand-supply mismatch as the coronavirus epidemic enters its second wave. Even as the organized medical device sector, legal entities, and consumers pressed for enforcing pricing control over these products, e-commerce giant Amazon stated it has begun removing listings of accounts selling these products beyond MRP. Over the last 7 days, the price of oxygen concentrators, which generate oxygen from the air, has nearly doubled, while the price of oximeters has increased by Rs 1000–2000. Prices have risen in both physical businesses and online marketplaces such as Amazon and Flipkart. The government set a price cap on certain products last year, but some vendors, companies, and importers are not following it. A spokesman for Amazon India stated the business is taking urgent action to stop the surge pricing. Hundreds of tweets from customers have gone viral, claiming that they had to pay more than Rs 1 lakh for oxygen concentrators that would normally cost Rs 45,000. The device\'s monthly rentals have also increased from Rs 5000 to Rs 10,000–20,000. Many sellers and importers have boosted costs of COVID-essential medical supplies by two to four times in just a week, even on online markets like Amazon and Flipkart. The problem is large with imported products by opportunistic dealers who import these products at low costs and then continuously raise prices to profit from the scenario while blaming it on their suppliers.
Since the pharmaceutical industry\'s exponential rise, there has been a need to regulate the interaction between pharmaceutical firms and medical practitioners. The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, as revised until February 1, 2016, ("MCI Regulations") were enacted with this in mind. The MCI Regulations, Regulation 6 (Unethical Acts), establishes a code of conduct for medical practitioners in their interactions with the pharmaceutical and allied healthcare industries. The MCI Regulations, on the other hand, apply only to medical practitioners. As a result, on December 12, 2014, the Department of Pharmaceuticals ("DoP") declared the Uniform Code of Pharmaceuticals Marketing Practices ("UCPMP") effective on January 1, 2015, for a 6-month period of voluntary adoption. When the DoP announced UCPMP, it stated that it was a voluntary code for the Indian pharmaceutical industry, but warned that if it is discovered that the pharma associations/companies have not implemented it successfully, the government may consider making it a statutory code. The DoP then extended UCPMP until further orders on August 30, 2016. Despite the fact that the UCPMP was the first of its kind and contained substantial regulations, the DoP attempted to replace the voluntary code with mandatory recommendations since it was optional. As a result, the DoP transmitted the draught Essential Commodities (Control of Unethical Practices in Drug Marketing) Order, 2017 ("Order") to the Law Ministry in July 2017 for final approval. The Law Ministry, on the other hand, is concerned about the Order, which is now being sought to be issued under the Essential Commodities Act, 1955. It is worth noting that the Order is beyond the scope of the Vital Commodities Act of 1955 ("Act"), whose goals are to control the manufacture, supply, and distribution of essential commodities rather than to oversee medication marketing. In 2015, the UCPMP was expanded to include the medical devices business, which is worth more than Rs 25,000 crore annually. The Order indicates that it will not apply to medical devices because the DoP is in the process of creating and releasing a separate code of marketing practices for the medical device industry (which would be voluntary for 6 months). The Order, like the UCPMP, prohibits pharmaceutical corporations from presenting cash, gifts, or sponsorship to doctors, chemists, or pharmacists, as well as giving travel facilities or paid vacations. Any pharmaceutical firm or its representatives are prohibited from giving presents, cash cards, hampers, or any other item that may produce monetary benefit or allow profits in kind to a medical practitioner, a retail chemist, or pharmacists, or their "family members" under paragraph 3 of the Order. It does, however, allow for the financing of academic conferences organized by medical groups, as well as the organization of screening camps or awareness campaigns in government-owned healthcare institutions, with the caveat that these cannot be used as surrogate advertising. A pharmaceutical business or its agent is also prohibited from providing free samples to any medical practitioner under the terms of the Order. Allowing pharmaceutical companies to distribute free samples up to a full course of medicines for a maximum of three patients has created an exemption to this norm. Three, on the other hand, is a modest amount for any medical professional to comprehend and analyze the effects of a new drug on patients. It is important to note that the term "Agent" is defined very broadly in paragraph 2(b) of the Order, and includes any person, company, society, nongovernmental organization, or other institution who has been hired or authorized by a third party to call on any healthcare facility to promote a pharmaceutical company\'s drugs. The Order further states that a company\'s MD or CEO is accountable for ensuring that the Order is followed. All complaints involving violations of the Order shall be investigated by an Ethics Compliance Officer (ECO) designated by the Government of India, who shall not be below the rank of a Joint Secretary to the Government of India, according to paragraph 5 of the Order. It should be noted that a firm or its agent who fails to comply with the terms of subparagraphs (a) (b) (c) or (d) of paragraph 3 of the Order will face a penalty under paragraph 4 of the Order. Furthermore, paragraph 5(4) of the Order lays out the mechanism for imposing a penalty by prohibiting the breaching corporation from marketing its best-selling product for the previous 12 months for a period of three to one year. The Order also states that corporations can pay a penalty ranging from Rs 5 lakh to Rs 10 lakh to have the marketing prohibition lifted. According to the Order, the DoP Secretary will be the appellate authority, and appeals from the Appellate authority\'s orders will be handled by the court.
There is an utmost necessity to relook and re-establish the standards of pharmacy practice in healthcare setups available in each and every corner of the country in line with guidelines provided by the World Health Organization (WHO) and International Pharmaceutical Federation (FIP). For that, the dependency and responsibilities are very high on healthcare professionals, particularly in this pandemic situation. The pharmacy zone is adaptable, evolving, and increasingly diverse, offering a wide range of work and management opportunities to execute [27]. PPs are human service professionals whose responsibilities include safeguarding individuals by dispensing medications based on prescriptions [28]. Representing the world\'s third-largest medicinal services with active gathering, and in India, there are over 1,000,000 (1 million) enrolled PPs employed in various capacities and readily contributing to the country\'s well-being [51]. Pharmacy practice, which includes clinical, community, and hospital pharmacy, is referred to as total healthcare in its true sense. Through adaptation and implementation of GPP in healthcare setup, PPs form an essential link between physicians, nurses, and patients in the social community group, with an ultimate emphasis on patient well-being and protection [30].
There should be country-wise GPP training programs are specifically aimed to gain rapid insights from World Health Organization (WHO) and International Pharmaceutical Federation (FIP) joint guidelines for advancing pharmacy practice worldwide and especially in India. In the view of current COVID-19 crisis, this initiative should be the first of its kind training program being offered in India. This training program mainly focuses on experiential training while promoting the GPP concept among healthcare professionals in India. This course will help the participants to get easy access to the guidelines, provides opportunities for peer discussions, and eventually be influential in improving pharmacy practices.
There should be a very focused approach for the same as follows
To understand the roles of pharmacists, national pharmaceutical organizations, and healthcare systems in developing GPP standards.
To understand the role of the pharmacist as a part of healthcare and the requirements of this role.
To understand the methodology and principles of quality management.
Be able to set standards, measure the quality and use the principle of continual improvement in one’s own working environment.
This course mainly explores and discusses the WHO/FIP GPP guidelines, the model of GPP in the hospital setting, and aseptic preparations.
Additionally, focus on WHO, MoH & FW, ICMR & NCDC guidelines for handling, treatment, and disposal of biomedical waste at healthcare facilities.
Across the globe, pharmacy is one of the most important, dynamic, and versatile segments of the healthcare industry. The pharmacy zone has become adaptable, evolving, increasingly diverse, adhering to the quality standards. However, the importance of ensuring appropriate quality to every patient has taken a center stage in this pandemic, especially in India. In such time, it is important to understand and execute the methodology and principles of quality management and set standards, for continual improvement in one’s own working environment, while realizing the emerging roles of pharmacists, national pharmaceutical organizations, and healthcare systems in developing good pharmacy practice (GPP) standards in this pandemic era.
The International Pharmaceutical Federation and World Health Organization define good pharmacy practice (GPP) as practices that meet the personal needs of patients or those using pharmacy services by offering appropriate evidence-based care. In developed countries, pharmaceutical assistance is defined as a pharmaceutical practice model that involves attitudes, ethical values, behaviors, skills, appointments, and co-responsibility to prevent diseases, promote and recovery health in an integrated manner as part of the healthcare process, highlighting, among other, the requirement that the institution fully adopts the GPP. The program should be designed to take care of the Indian healthcare system and its context of adoption of “new normal” due to the unprecedented event of COVID 19 and the importance of GPP for the healthcare professionals in same.
This kind of training program should be opened to
Health, Health IT, Hospital & Pharma Management Students & Professionals.
Medical, Dental, Physiotherapy, Nursing, Pharma, Paramedical Students.
Any Graduate student/Professional who wants to pursue a career in healthcare.
Today, the forms of care are shifting from secondary care providers to primary care providers to patients (Figure 2). This trend has already started in developed countries, such as the behind-the-counter drug option in European countries that was already endorsed by the FDA. The FDA showed positive signs toward boosting the numbers of nonprescription drug statuses to over-the-counter statuses. The healthcare delivery system is coming closer to the patient due to knowledge and understanding, as well as better diagnostic tools and monitoring devices [52] (Figure 2).
The healthcare delivery status of 2007 and 2020. Source: PricewaterhouseCoopers.
The use of simulation and related technology in healthcare education will continue to grow in the next years, and this methodology has a collective role within the pharmacy curriculum. It is expected that increasing the quantity of simulation in pharmacy curricula will have a good impact on pharmacy student education and training, resulting in favorable outcomes for patients and the healthcare team. The obvious goal of incorporating simulation techniques into the pharmacy student training curriculum is to increase pharmacist education and training with the ultimate goal of enhancing patient care and safety. Simulation experiences will never be able to replace real-world clinical experiences, but they do have the ability to supplement clinical education and serve as a tool for developing the skills necessary for a successful pharmacist. Simulation approaches have been utilized in pharmacy education to address broad cognitive and social skills, particularly communication, decision-making, ethical dilemmas, prioritization, and teamwork, in addition to the development of technical skills such as procedural and clinical abilities. Simulated learning environments could provide a more systematic approach to both clinical skill training and pharmacy programs that aim to provide an opportunity for theoretical knowledge to be applied to a real clinical situation. Basic sciences, dispensing, and drug supply all benefit from simulation\'s constant, predictable experience. In an ideal world, simulation training would be integrated into all levels of pharmacy education and training.
Types of simulation technology used in healthcare education [53, 54].
1. | High-fidelity patient simulator or mannequin—able to mimic human actions and physiology and respond to physiologic and pharmacologic interventions |
2. | Task trainer —designed to help learners practice, specific skills and do not have the extensive programming capabilities of high-fidelity models. It can be considered as |
3. | Standardized patients—live people who are coached to portray patients, usually referred to as simulated patients |
4. | Virtual reality simulator—in which a computer display simulates the physical world and user interactions are with the computer within that simulated (virtual) world |
5. | Full environment simulation—it involves the incorporation of high-fidelity mannequins, standardized patients, healthcare professionals, and ancillary equipment to recreate a real-life clinical environment |
Serves to increase efficiency and accuracy of dispensing
Re-direct staff time away from routine technical tasks and toward more direct patient care activities
Featured Systems: ADC, place medications much closer to the user, but still allow electronic verification
Pharmacy Robot: Reduced preparation and check time for medications, minimizations of potential contamination in sterile product preparation
Bar coded medication administration
Computerized prescriber order entry systems (CPOE)
Smart pumps
Clinical decision support system (CDSS)
Predictive population risk stratification
Patient self-management tools
list of contributors in who gpp 2011/ippr 2015 regulation adherence survey | |
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Chronic myeloproliferative disorders are a group of clonal diseases of the stem cell. It is a group of several diseases with some common features. They derive from a multipotential hematopoietic stem cell. A clone of neoplastic cells in all these neoplams is characterized by a lower proliferative activity than that of acute myeloproliferative diseases. In each of these diseases, leukocytosis, thrombocythemia, and polyglobulia may appear at some stage, depending on the diagnosis [1, 2].
The research on interferon has been going on since the 1950s [3]. Then, the attention was paid to its influence on the immune system. It has been noted that it can exert an antiproliferative effect by stimulating cells of the immune system [4]. In 1987, a publication by Ludwig et al. was published, which reported the effectiveness of interferon alpha in the treatment of chronic myeloproliferative disorders [5].
More and more new studies have been showing the effectiveness of interferon alpha in reducing the number of platelets, reducing the need for phlebotomies in patients with polycythemia vera and also in reducing the number of leukocytes. Moreover, interferon reduced the symptoms of myeloproliferative disorders such as redness and itching of the skin. Additionally, it turned out to be effective in reducing the size of the spleen.
Further studies on the assessment of remission using molecular-level response assessments indicate that the interferon action in chronic myeloproliferation diseases targets cells from the mutant clone with no effect on normal bone marrow cells [6].
Over the years, interferon alpha-2a and interferon alpha-2b have been introduced into the treatment of chronic myeloproliferation, followed by their pegylated forms. The introduction of pegylated forms allowed for a reduction in the number of side effects and less frequent administration of the drug to patients. In recent years, monopegylated interferon alpha-2b has been used to further increase the interval between drug administrations while maintaining its antiproliferative efficacy.
The exact mechanism of action of interferon alpha in the treatment of chronic myeloproliferative disease is still not fully understood, but it has an impact on JAK2 (Janus Kinase) signal transducers and activates the STAT signal pathway (Janus Kinase/SignalTransducer and Activator of Transcription).
Interferon alpha binds to IFNAR1 and IFNAR2c, which are type I interferon receptors. Interferon alpha has an impact on JAK2(Janus Kinase) signal transducers and activates the STAT signal pathway. The disturbances in this signaling pathway are observed in chronic myeloproliferative disorders [7].
Interferon inhibits the JAK-STAT signaling pathway by directly inhibiting the action of thrombopoietin in this pathway [8].
So far, three driver mutations have been described in the course of chronic myeloproliferative diseases that affect the functioning of the JAK-STAT pathway.
JAK2 kinase and JAK1, JAK3, and TYK2 kinases belong to the family of non-receptor tyrosine kinases. They are involved in the intracellular signal transduction of the JAK-STAT pathway. It is a system of intracellular proteins used by growth factors and cytokines to express genes that regulate cell activation, proliferation, and differentiation. The mechanism of JAK activation is based on the autophosphorylation of tyrosine residues that occurs after ligand binds to the receptor. JAK2 kinase transmits signals from the hematopoietic cytokine receptors of the myeloid lineage (erythropoietin, granulocyte-colony stimulating factor thrombopoietin, and lymphoid lineage [9].
A somatic G/T point mutation in exon 14 of the JAK2 kinase gene converts valine to phenylalanine at position 617 (V617F) in the JAK2 pseudokinase domain, which allows constitutive, ligand-independent activation of the receptor to trigger a proliferative signal [10].
Mutation of the MPL gene, which encodes the receptor for thrombopoietin, increases the sensitivity of magekaryocytes to the action of thrombopoietin, which stimulates their proliferation [11].
Malfunction of calreticulin as a result of mutation of the CARL gene leads to the activation of the MPL-JAK/STAT signaling pathway, which is independent of the ligand, as calreticulin is responsible, for the proper formation of the MPL receptor. Consequently, there is a clonal proliferation of hematopoietic stem cells [12].
Below, we provide an overview of some clinical studies on the efficacy of interferon in chronic myeloproliferative disorders.
Polycythemia vera (PV) is characterized by an increase in the number of erythrocytes in the peripheral blood.
Polycythemia vera is caused by a clonal mutation in the multipotential hematopoietic stem cell of the bone marrow. The mutation leads to an uncontrolled proliferation of the mutated cell clone, independent of erythropoietin and other regulatory factors. As the mutation takes place at an early stage of hematopoiesis, an increase of the number of erythrocytes as well as of leukocytes and platelets is observed in the peripheral blood. The cause of proliferation in PV independent from external factors is a mutation in the Janus 2 (JAK2) tyrosine kinase gene. The V617F point mutation in the JAK2 gene is responsible for about 96% mutation, and in the remaining cases the mutation arises in exon 12. Both mutations lead to constitutive activation of the JAK-STAT signaling pathway [13].
As a result of the uncontrolled proliferation, blood viscosity increases, which generates symptoms such as headaches and dizziness, visual disturbances, or erythromelalgia. As the number of all hematopoietic cells, including the granulocytes ones, increases, the difficult to control symptoms of their hyperdegranulation may appear, among which gastric ulcer or skin itching is often observed. During the disease progression, the spleen and liver become enlarged.
The most common complication of the disease is episodes of thrombosis, especially arterial one. During the course of the disease, it can also evolve into myelofibrosis or acute myeloid leukemia.
The treatment of PV is aimed at preventing thromboembolic complications, relieving the general symptoms, the appearance of hepatosplenomegaly as well as preventing its progression.
Each patient should receive an antiplatelet drug chronically, and usually acetylsalicylic acid is the choice. Most often, the treatment is started with phlebotomy in order to rapidly lower the hematocrit level. If cytoreductive therapy is necessary, the drugs of first choice are hydroxycarbamide and interferon [2].
However, the research on the mechanism of the action of interferons is still ongoing. In vitro studies with CD34+ cells from peripheral blood of patients diagnosed with polycythemia vera showed that interferon inhibits clonal changed cells selectively. It was found that interferon alpha-2b and pegylated interferon alpha-2a reduce the percentage of cells with JAK2 V617F mutation by about 40%. Pegylated interferon alpha-2a works by activating mitogen-activated protein kinase P38. It affects CD34+ cells of patients with polycythemia vera by increasing the rate of their apoptosis [6].
A case of a patient with PV with a confirmed chromosomal translocation t(6;8) treated with interferon alpha-2b, which resulted in a reduction of the clone with translocation by 50% from the baseline value, was also described [14].
In 2019, the results of a phase II multicenter study were published, which aimed at assessing the effectiveness of recombinant pegylated interferon alpha-2a in cases of refractory to previously hydroxycarbamide therapy. The study included 65 patients with essential thrombocythemia (ET) and 50 patients with polycythemia vera. All patients had previously been treated with hydroxycarbamide and showed resistance to this drug or its intolerance.
The assessment of the response was performed after 12 months of treatment. Overall response rate to interferon was higher in patients diagnosed with ET than in patients with polycythemia vera. In essential thrombocythemia, the percentage of achieved complete remissions was 43 and 26% of partial remissions. The remission rate in ET patients was higher if calreticulin CALR gene mutation was present. Patients with polycythemia vera achieved complete remission in 22% of cases and partial remission in 38% of cases.
Treatment-related side effects that follow to discontinuation of treatment were reported in almost 14% of patients [15].
The duration of response to treatment with pegylated interferon alpha-2a and the assessment of its safety in long-term use in patients with chronic myeloproliferative disorders was the goal of a phase II of the single-center study. Forty-three adult patients with polycythemia vera and 40 patients with essential thrombocythemia were enrolled in the study. The complete hematological response was defined as a decrease in hemoglobin concentration below 15.0 g/l, without phlebotomies, a resolution of splenomegaly, and no thrombotic episodes in the case of PV, and for essential thrombocythemia—a decrease platelet count below 440,000/μl and two other conditions as above. The assessment of the hematological response was performed every 3–6 months. The median follow-up was 83 months.
The hematological response was obtained in 80% of cases for the entire group. In patients with polycythemia vera, 77% of patients achieved a complete response (CR) while 7% a partial response (PR). The duration of response averaged 65 months for CR and 35 months for PR. In the group of patients diagnosed with essential thrombocythemia, CR was achieved in 73% and PR in 3%. The durance of CR was 58 months and PR was 25 months.
The molecular response for the entire group was achieved in 63% of cases.
The overall analysis showed that the duration of hematological remission and its achievement with pegylated interferon alpha-2a treatment is not affected neither by baseline disease characteristics nor JAK2 allele burden and disease molecular status. There was also no effect on age, sex, or the presence of splenomegaly.
During the course of the study, 22% of patients discontinued the treatment, because of toxicity. Toxicity was the greatest at the beginning of treatment. The starting dose was 450 μg per week and was gradually tapered off.
Thus, on the basis of the above observations, the researchers established that pegylated interferon alpha-2a may give long-term hematological and molecular remissions [16].
The assessment of pegylated interferon alpha-2a in group of patients diagnosed with polycythemia vera only was performed. The evaluation was carried out on a group of 27 patients. Interferon decreased the JAK2 V617F allele burden in 89% of cases. In three patients who were JAK2 homozygous at baseline, after the interferon alpha-2a treatment wild-type of JAK2 reappeared. The reduction of the JAK2 allele burden was estimated from 49% to an average 27%, and additional in one patient the mutant JAK2 allele was not detectable after treatment. It can therefore be postulated that the action of pegylated interferon alpha-2a is directed to cells of the polycythemia vera clone [17].
In 2005, the results of treatment by pegylated interferon alpha-2b of 21 patients diagnosed with polycythemia vera and 21 patients diagnosed with essential thrombocythemia were published. In the case of polycythemia vera in 14 patients, PRV-1 gene mutation was initially detected. In 36% of cases, PRV-1 expression normalized after treatment with pegylated interferon alpha-2b. For the entire group of 42 patients, the remission assessment showed that complete remission was achieved in 69% cases after 6 months of treatment. However, only in 19 patients remission was still maintained 2 years after the start of the study. Pegylated interferon alpha-2b was equally effective in patients with PV and ET. The use and the type of prior therapy did not affect the achievement of remission [18].
Another study with enrolled only PV patients included 136 patients. They were divided into two arms. One group received interferon alpha-2b and the other group received hydroxycarbamide. Interferon dosage was administered in 3 million units three times a week for 2 years and then 5 million units two times a week. Hydroxycarbamide was administered at a dose between 15 and 20 mg/kg/day.
In the group of patients treated with interferon, a significantly lower percentage of patients developed erythromelalgia (9.4%) and distal parasthesia (14%) compared with the group treated with hydroxycarbamide, for whom these percentages were respectively: 29 and 37.5%. Interferon alpha-2b was found to be more effective in inducing a molecular response, which was achieved in 54.7% of cases, in comparison with hydroxycarbamide—19.4% of cases, despite the fact that the percentage of achieved general hematological responses did not differ between the groups and amounted about 70%. The 5-year progression free period in the interferon group was achieved in a higher percentage (66%) than in the hydroxycarbamide group (46.7%) [19].
The most recent form of interferon approved by the
Thanks to these changes to the structure of the molecule, it was possible to achieve a significant increase in its half-life. Ropeginterferon can be administered subcutaneously to patients every 14 days. The clinical trials conducted so far have assessed the ropeginterferon dose from 50 micrograms to a maximum dose of 500 microgams administered as standard every 2 weeks. The possible dose change in case of side effects includes not only the reduction of the drug dose itself, but also the extension of the interval between doses. The extension of the dosing interval up to 4 weeks was assessed.
Ropeginterforn was approved in 2019 by the EMA for the use in patients diagnosed with polycythemia vera without splenomegaly, as monotherapy.
Ropeginterferon, like the previous forms of interferons used in treatment, is contraindicated in patients with severe mental disorders, such as severe depression. It is also a contraindication in patients with noncompensatory standard treatment of disorders of the thyroid gland as well as severe forms of autoimmune diseases. The safety profile of ropeginterferon is similar to that of other forms of alpha interferons. The most common side effects are flu-like symptoms [20].
Ropeginterferon has been shown to exhibit in vitro activity against JAK2-mutant cells. The activity of ropeginterferon against JAK2-positive cells is similar to that of other forms of interferons used actually for standard therapy. Ropeginterferon has an inhibitory effect on erythroid progenitor cells with a mutant JAK2 gene. At the same time, it has almost no effect on progenitor cells without the mutated allele (JAK2-wile-type) and normal CD34+ cells. A gradual decrease of JAK2-positive cells was observed in patients with PV during ropeginterferon treatment. The examination was performed after 6 and 12 months of treatment. In comparison, the reduction in the percentage of JAK2 positive cells in patients treated with hydroxycarbamide was significantly lower.
These results may suggest that ropeginterferon may cause elimination of the mutant clone, but further prospective clinical trials are needed to confirm this theory. The evaluation was performed on a group of patients enrolled in the PROUD-PV study who were treated in France [21].
In 2017, a multicenter study was opened in Italy. The study was of the second phase. In total, 127 patients with polycythemia vera were included in the study. All patients enrolled on the study had low-risk PV. The clinical trial consisted of two arms. Patients received phlebotomies and low-dose aspirin in one arm and ropeginterferon in the other arm. The aim of the study was to achieve a hematocrit of 45% or lower without any evidence of disease progression. Ropeginterferon was administered every 2 weeks at a constant dose of 100 μg.
The response to the treatment was assessed after 12 months. The reduction of hematocrit to the assumed level was achieved in significantly higher percentage of patients in the ropeginterferon group than of patients who received only phlebotomies and aspirin. In addition, none of the patients treated with ropeginterferon experienced disease progression during the course of the study, while among those treated with phlebotomies, 8% of patients progressed.
Grade 4 or 5 adverse events were not observed in patients treated with ropeginterferon, and the incidence of remaining adverse event (AE) was small and comparable in both arms. The most common side effects in the ropeginterferon group were flu-like symptoms and neutropenia; however, the third-grade neutropenia was the most common (8% of cases) [22].
One of the most important clinical studies on the use of ropeginterferon was the PROUD-PV study and its continuation: the CONTINUATION-PV study. These were three-phase, multicenter studies. The aim of the study was to compare the effectiveness of ropeginterferon in relation to hydroxycarbamide. The study included adult patients diagnosed with polycythemia vera treated with hydroxycarbamide for less than 3 years and no cytoreductive treatment at all. In total, 257 patients received this treatment. The patients were divided into two groups: those receiving ropeginterferon or the other being given hydroxycarbamide.
During the PROUD-study, drug doses were increased until the hematocrit was achieved below 45% without the use of phlebotomies, and the normalization of the number of leukocytes and platelets was reached.
The PROUD-PV study lasted 12 months. After this time, the patients continued the treatment under the CONTINUATION-PV study for further 36 months. After the final analysis performed in the 12th month at the end of PROUD study, it was found that the hematological response rates did not differ between the ropeginterferon and hydroxycarbamide treatment groups. These were consecutively 43% in the ropeginterferon arm and 46% in the control arm.
However, after analyzing the CONTINUATION- PV study, it turned out that after 36 months of treatment, the rates of hematological responses begin to prevail in the group of patients receiving ropeginterferon, 53% versus 38% in the control group. Thus, from the above data, it can be seen that the response rate to ropeginterferon increases with the duration of treatment [23].
Another analysis of patients participating in the PROUD and CONTINUATION studies was based on the assessment of treatment results after 24 months, dividing patients into two groups according to age (under and over 60 years).
The initial comparison of both groups of patients showed that older patients had a more aggressive course of the disease. Patients over 60 years of age had a higher percentage of cells with a mutant JAK2 allele. They experienced both general symptoms and some complications, such as thrombosis, more frequently. Both patients under 60 years of age and over 60 years of age in the ropeginterferon arm had a higher rate of molecular response, namely 77.1 and 58.7% compared with the HU remission: 33.3 and 36.1%, respectively. Significantly higher reductions in the JAK2 allele were observed in both groups of patients after ropeginterferon treatment: it was 54.8% for younger patients and 35.1% for elderly patients. For comparison, this difference in the group of patients treated with HU was 4.5 and 18.4%, respectively.
What is more, the age did not affect the frequency of ropeginterferon side effects. In addition, the incidence of adverse ropeginterferon disorders was similar to that observed in the hydroxycarbamide group [24].
Essential thrombocythemia is a clonal growth of multipotential stem cells in the bone marrow. The consequence of this is increased proliferation of megakaryocytes in the bone marrow and an increase in the number of platelets in the peripheral blood. The level of platelets above 450,000/μl is considered a diagnostic criterion.
Essential thrombocythemia may progress over time to a more aggressive form of myeloproliferation, i.e., myelofibrosis. The disease can also evolve into acute myeloid leukemia or myelodysplastic syndrome, both with very poor prognosis. Thromboembolic complications are serious, and they concern over 20% of patients. Thrombosis occurs in the artery and venous area. Moreover, in patients with a very high platelet count, above 1,000,000/μl, bleeding may occur as a result of secondary von Willebrand syndrome [1, 2].
The treatment of ET is primarily aimed to prevent thrombotic complications.
In low-risk patients, only acetylsalicylic acid is used. In cases of high-risk patients, hydroxycarbamide is the first-line drug for most patients. Anagrelide and interferon are commonly used as second-line drugs.
Due to the possible effects of hydroxycarbamide of cytogenetic changes in the bone marrow cells after long-lasting usage, some experts recommend the use of interferon in younger patients in the first line. Interferon is also used as the drug of choice in patients planning a pregnancy [25].
The efficacy of pegylated interferon alpha-2a was assessed on the basis of the group of 39 patients with essential thrombocythemia and 40 patients with polycythemia vera.
Of the overall group, 81% of patients were previously treated prior to the study entry. The patients received pegylated interferon alpha-2a in a dose of 90 μg once a week. The dose of 450 μg was associated with a high percentage of intolerance.
In patients with essential thrombocythemia, the complete remission was achieved in 76%, while the overall hematological response rate brought 81%. Moreover, the molecular remission was achieved in 38%, in 14% of cases, JAK2 transcript became not detectable.
Patients diagnosed with polycythemia vera achieved 70% complete hematological remission and 80% general hematological response to treatment. JAK2 transcript was undetectable in 6% of patients. Molecular remission was achieved in 54% of cases.
Pegylated interferon alpha-2a at the dose of 90 μg per week was very well tolerated. In total, 20% of patients experienced a grade of 3 or 4 of adverse reaction, which was neutropenia. In addition, an increase in liver function tests was observed. Grade 4 of AE was not observed among patients who started the treatment with 90 μg/week while grade 3 neutropenia was an adverse event in only 7% of cases [26].
The effect of interferon alpha-2b treatment in patients with ET and PV was investigated. The study was prospective. Some of the results concerning the group of patients with polycythemia vera are presented in the subsection on polycythemia vera. In total, 123 patients with diagnosed essential thrombocythemia participated in the study. All of them received interferon alpha-2b. The patients were divided into two groups depending on the presence of the JAK2 V617F mutation. The enrolled patients were between 18 and 65 years of age. The treatment they received was, sequentially, interferon alpha-2b in the dose of 3 million units three times a week for the first 2 years, after which time the dose was changed into a maintenance dose, which amounted to 5 million units two times a week.
The analysis showed that the patients with the JAK2 V617F mutation present in a higher percentage achieved an overall hematological response as well as a complete hematological response. The overall hematological response was achieved in 83% of patients with JAK2 mutation, and the complete hematological remission was achieved in 23 cases. In the group of ET patients without the JAK2 V617F mutation, overall hematological response was achieved in 61.4%, while the complete hematological remission was achieved in 12 patients. The 5-year progression-free survival was obtained in 75.9% in the JAKV617F group and only in 47.6% without the mutation.
A significant proportion of patients experienced mild side effects. Grade 3 and 4 of adverse events were severe, most of them being a fever. The isolated cases of elevated liver tests and nausea have also been reported [19].
Pegylated interferon alpha-2b in patients with essential thrombocythemia who were previously treated with hydroxycarbamide, anagrelide, and other forms of interferon alpha, however, due to the lack of efficacy or toxicity, the patients required a change of treatment, was assessed. Pegylated interferon alpha-2b turned out to be effective in these cases. It led to the complete hematological remission in 91% of patients after 2 months of therapy, and in 100% of patients after 4 months. However, merely 11 patients participated in the study. Also only two patients required treatment discontinuation due to the side effects such as depression and general fatigue grade 3 [27].
In case of pregnant patients, interferon is currently considered the only safe cytoreductive drug. Over the years, several analyses of the results of interferon treatment during pregnancy have been carried out.
The assessment of 34 pregnancies in 23 women diagnosed with ET was performed retrospectively. All the pregnancies included in the analysis were of high risk. This high risk was associated with a high platelet count above 1,500,000/μl, a history of thrombotic episode, severe microcirculation disorders, or a history of major hemorrhage.
It turned out that the use of interferon allowed the birth of an alive child in 73.5% of cases. There was no difference in efficacy between the basic and pegylated forms of interferon alpha. In pregnancies without interferon treatment, the percentage of live births was only 60%. Moreover, it was not found if the presence of the JAK2 V617F mutation had any influence on the course of pregnancy [28].
An analysis of the course of pregnancy in patients with ET was assessed in Italy. Data from 17 centers were taken into account. Data from 122 pregnancies were collected from 92 women. In patients diagnosed with essential thrombocythemia, the risk of the spontaneous loss of pregnancy is about 2.5 times higher than among the general population. In the contrary to the study quoted above, it was found that the presence of the JAK2 mutation increases the risk of pregnancy loss. The proportion of live births in patients exposed to interferon during pregnancy was 95%, compared with 71.6% in the group of patients not treated with interferon.
The multivariate analysis also showed that the use of acetylsalicylic acid during pregnancy had no effect on the live birth rate of patients with ET [29].
Whatever its form, interferon is the drug of first choice in pregnancy. Hydroxycarbamide and anagrelide should be withdrawn for about 6 months, and at least for 3 months, before the planned conception. Experts recommend the use of interferon in high-risk pregnancies [30]. A Japanese analysis of 10 consecutive pregnancies in ET patients showed 100% live births in patients who received interferon [31].
In myelofibrosis (MF), monoclonal megakaryocytes produce cytokines that stimulate the proliferation of normal, non-neoplastic fibroblasts and stimulate angiogenesis. The consequence of this is the gradual fibrosis of the bone marrow, impaired hematopoiesis in the bone marrow, and the formation of extramedullary location mainly in the sites of fetal hematopoiesis, i.e., in the spleen and the liver.
The production of various cytokines by neoplastic megakaryocytes leads to the proliferation of normal, noncancerous fibroblasts as well as to increased angiogenesis.
Progressive bone marrow fibrosis leads to worsening anemia and thrombocytopenia. On the other hand, the production of proinflammatory cytokines by megakaryoblasts leads to the general symptoms such as weight loss, fever, joint pain, night sweats, and consequently, progressive worsening of general condition.
The prognosis for myelofibrosis is poor. In about 20% of patients, myelofibrosis evolves into acute myeloid leukemia with poor prognosis.
Currently, the only effective method of treatment that gives a chance to prolong the life is allogeneic bone marrow transplantation. However, this method is only available to younger patients.
The goal of treatment of patients who have not been qualified for allotranspalntation is to reduce the symptoms and to improve the patient’s quality of life. In case of leukocytosis cytoreducing drugs, such as hydroxycarbamide, melphalan, or cladribine can be used. They cause a reduction in the number of leukocytes and may, to some extent, inhibit splenomegaly. Interferon alpha has been used successfully for the treatment of myelofibrosis for many years. The results of its effectiveness will be presented below [2].
Currently, the JAK2 inhibitor ruxolitinib is approved for the treatment of myelofibrosis with enlarged spleen in intermediate and high-risk patients. Ruxolitinib reduces the size of the spleen, reduces general symptoms, and improves the quality of life; however, it does not prolong the overall survival of patients [32].
In 2015, the results of a retrospective study were published to compare the histological parameters of the bone marrow before and after interferon treatment. Twelve patients diagnosed with primary myelofibrosis as well as post-PV MF and post-ET MF were enrolled in the study. Patients were treated with pegylated recombinant interferon alpha-2a or recombinant interferon alpha-2b in standard doses. The time of treatment was from 1 to 10 years. Some patients had previously been treated with hydroxycarbamide or anagrelide. In all cases, karyotype was normal. The prognostic factor of Dynamic International Prognostic Scoring System (DIPSS) was assessed at the beginning as well as during the treatment.
Bone marrow cellularity decreased in cases with increased bone marrow cellularity before the treatment. After the interferon treatment, a reduction in the degree of bone marrow fibrosis was found. The parameters, such as the density of naked nuclei and the density of megakaryocytes in the bone marrow, also improved.
It proves that if the JAK2 V617F mutation had been present, DIPSS was decreased after interferon treatment. This relationship was not observed in patients without the JAK2 V617F mutation. The improvement in peripheral blood morphological parameters and the overall clinical improvement correlated with the improvement in the assessed histological parameters of the bone marrow.
Before the initiation of interferon, seven patients had splenomegaly. During the treatment with interferon, the complete resolution of splenomegaly was achieved in 17% of patients (two cases), and its size decreased in 25% (three cases). A good clinical response was achieved in 83% during interferon therapy. There was no significant difference in response between the two types of interferon used [33].
A prospective study was also conducted in patients with low and intermediate-1 risk group myelofibrosis. Seventeen patients were enrolled. Patients received interferon alpha-2b (0.5–3 milion units/three times a week) or pegylated interferon alpha-2a (45–90 μg/week). The duration of therapy was on average 3.3 years.
Most of the patients responded to the treatment. Partial remission was found in seven patients and complete remission in two patients. Moreover, in four cases, the disease was stabilized and in one case the clinical improvement was achieved. Three patients did not respond to treatment at all and progressed to myelofibrosis. Additionally, the assessment in reducing spleen size was performed. At baseline, 15 patients have splenomegaly, nine of them achieved the compete regression of spleen size [34].
However, the efficacy of interferon in the treatment of myelofibrosis appears to be limited only to a less advanced form, when the bone marrow still has an adequate percentage of normal hemopoiesis and the marrow stroma is not significantly fibrotic. In more advanced stages, interferon was not shown to have any significant effect on the regression of the fibrosis process [35].
In 2020, the results of the COMBI study were published. That was a two-phase, multicenter, single-arm study that investigated the efficacy and safety of the combination of ruxolitinib and pegylated interferon alpha. Thirty-two patients with PV and 18 patients with primary and secondary myelofibrosis participated in the study. The patients were at age 18 and older. Remission was achieved in 44% of myelofibrosis cases, including 28% (5 patients) of complete remission. In patients with PV, the results were slightly worse: 31% of remissions, including 9% of complete remissions. Patients received pegylated interferon alpha-2a (45 μg/week) or pegylated interferon alpha-2b (35 μg/week) in low doses and ruxolitinib in doses of 5–20 mg twice a day.
For the entire group of patients (with PV and MF), the initial JAK2 allele burden was 47% at baseline, and after 2 years of treatment with interferon and ruxolitinib, it decreased to 12%.
The treatment toxicity was low. The highest incidence of side effects occurred at initiation of therapy. It was mostly anemia and thrombocytopenia.
The observations from the COMBI study show that, for the combination of interferon in lower doses with ruxolitinib, it may be effective and well tolerated even in the group of patients who had intolerance to interferon used as the only drug in higher doses. The combined treatment improved the bone marrow in terms of fibrosis and its cellularity. It also allowed to improve the value of peripheral blood counts [36].
It is currently known that some of the additional mutations are associated with a worse prognosis in patients with myelorpoliferation, including patients with myelofibrosis. Some of these mutations have been identified as high-risk molecular mutations. These are ASXL1, EZH2, IDH1/2, or SRSF2. Earlier studies have shown their association with a more aggressive course of the disease, worse prognosis, and shorter survival of patients, as well as a poorer response to treatment. Due to their importance, they have been included in the diagnostic criteria of myelofibrosis [37].
It is also known that the presence of driver mutations, i.e., JAK2, CALR, and MPL or triple negativity, may affect the course of myeloproliferation, including the incidence of thromboembolic complications.
The assessment of the influence of driver mutations and a panel of selected additional mutations on the effectiveness of interferon treatment in patients with myelofibrosis was performed on a group of 30 patients. Only the patients with low- and intermediate-1-risk were enrolled in the study. The treatment with pegylated interferon alpha-2a or interferon alpha-2b resulted in a complete remission in two patients and partial remission in nine patients. The disease progressed in three cases. One patient relapsed and four died. The remaining patients achieved a clinical improvement or disease stabilization. In the studied group, it was not found if the effectiveness of interferon treatment was influenced by the lack of driver mutations. Among the group of four patients with additional mutations, two died and one had disease progression. It was a mutation of ASXL1 and SRSF2. The treatment with interferon in patients without additional molecular mutations in the early stages of the disease may prevent further progression of the disease [38].
The side effects of interferon in the group of patients with myelofibrosis are similar to those occurring after the treatment of other chronic myeloproliferative diseases. The most frequently described are hematological toxicity- anemia and thrombocytopenia, less often is the appearance of leukopenia. Hematological toxicity usually resolves with dose reduction or extension of the dose interval. The most frequently nonhematological toxicity was fatigue, muscle pain, weakness, and depression symptoms. All symptoms are usually mild and do not exceed grade 2 [38].
However, the use of interferon in the treatment of myelofibrosis has not been recommended as a standard therapy. Interferon is still being evaluated in clinical trials, or it is used in selected patients as a nonstandard therapy in this diagnosis.
Mastocytosis is characterized by an excessive proliferation of abnormal mast cells and their accumulation in various organs.
The basis for the development of mastocytosis is ligand-independent activation of the KIT receptor, resulting from mutations in the KIT proto-oncogene. The KIT receptor is a trans membrane receptor with tyrosine kinase’s activity. Its activation stimulates the proliferation of mast cells. That excessive numbers of mast cells infiltrate tissues and organs and release mediators such as histamine, interleukine-6, tryptase, heparin, and others, which are responsible for the appearance of symptoms typical of mastocytosis. In addition, the infiltration of tissues for mast cells itself causes damage to the affected organs.
The prognosis of mastocytosis depends on the type of the disease. In the case of cutaneous mastocytosis (CM), in the majority of cases prognosis is good and the disease does not shorten the patient’s life, but in aggressive systemic mastocytosis (ASM), the average follow-up is about 40 months. Mast cell leukemia has a poor prognosis with a median follow-up of approximately 1 year.
Systemic mastocytosis usually requires the implementation of cytoreductive therapy. The first line of therapy is interferon alone or its combination with corticosteroids. In aggressive systemic mastocytosis, the first line in addition to interferon 2-CdA can be used. An effective drug turned out to be midostaurin in the case of the present KIT mutation. In patients without the KIT D816V mutation, treatment with imatinib may be effective. In the case of mast cell leukemia, multidrug chemotherapy is most often required, as in acute leukemias, followed by bone marrow transplantation [39].
Systemic mastocytosis requiring treatment is a rare disease, this is why the studies available in the literature evaluating various therapies concern mostly small groups of patients.
In 2002, the French authors presented their experiences on the use of interferon in patients with systemic mastocytosis. They included 20 patients. The patients received interferon alpha-2b in gradually increased doses.
The patients were assessed after 6 months. In cases in which bone marrow was infiltrated for mast cells at baseline, it still remained infiltrated after 6 months of treatment.
However, the responses were obtained in terms of symptoms related to mast cell degranulation. Partial remission was achieved in 35% of patients and minor remission in 30%. It concerns mainly skin lesions and vascular congestion. Moreover, the assessment of the histamine level in the plasma revealed a decrease of it in patients who previously presented symptoms related to the degranulation of mast cells, such as gastrointestinal disorders and flushing.
A high percentage of side effects were found during treatment. They concerned 35% of patients. Depression and cytopenia were most frequent ones [40].
Another analysis was a report of five patients with systemic mastocytosis treated with interferon and prednisolone. All patients received interferon alpha-2b in a dose of 3 million units three times a week and four patients additionally received prednisolone. Four patients responded to interferon treatment at varying degrees. One patient, who at baseline had bone marrow involvement by mast cells in above 10%, progressed to mast cell leukemia. In two patients, the symptoms C resolved completely and in one of them they partially disappeared. In one case, stabilizing disease was achieved [41].
In 2009, a retrospective analysis of patients treated with cytoreductive therapy due to mastocytosis was published. The authors collected data from 108 patients treated at the Mayo Clinic. This analysis allowed for the comparison of the efficacy of four drugs used in systemic mastocytosis. There were interferon alpha alone or in the combination with prednisone—among 40 patients, hydroxycarbamide—among 26 ones, imatinib—among 22 persons, and 2-chlorodeoxyadenosine (2-CdA)—among 22 patients.
After dividing the patients into three additional groups on the basis of the type of mastocytosis—indolent systemic mastocytosis, aggressive systemic mastocytosis, and systemic mastocytosis associated with another clonal hematological nonmast cell lineage disease (SM-AHNMD)—the effectiveness of each of type of therapy was assessed.
The highest response rates in indolent and aggressive mastocytosis were achieved with interferon treatment. They were 60% of the responses in both groups, and in the SM-AHNMD group of patients, the percentage was also one of the highest and amounted to 45%. The second most effective drug was 2-CdA. The response rates were 56% for indolent MS, 50% for aggressive MS, and 55% for SM-AHNMD. The patients treated with imatinib achieved response in 14, 50, and 9% by following groups, respectively. In contrast, patients with indolent and aggressive systemic mastocytosis did not respond to hydroxycarbamide treatment at all. The response rate in both groups was 0%. However, patients with MS associated with another clonal hematological nonmast cell lineage disease achieved 21% response to hydroxycarbamide. Additionally, it was found that only interferon relieved symptoms caused by the release of inflammatory mediators by mast cells.
The additional analysis showed no influence of the TET 2 mutation on the response to treatment [42].
In the literature, there are also single cases of mastocytosis presenting trials of nonstandard treatment. That is description of a patient with systemic mastocytosis with mast cell bone marrow involvement. Mutation of c-kit Asp816Val was present. Patient progressed despite treatment with dasatinib and 2-chlorodeoxyadenosine. The patient developed symptoms related to the degranulation of mast cells and increased ascites.
The patient was treated with pranlukast, which is an anti-leukotriene receptor antagonist due to an asthma episode. The rate of ascites growth decreased significantly after one administration. The patient required paracentesis every 10 days and not every 3 days, as before starting to take the drug. After 15 days of treatment with pranlukast, the patient received interferon alpha, which resulted in complete regression of ascites, resolution of pancytopenia, and complete disappearance of the c-kit mutation clone. The infiltration of mast cells in the bone marrow significantly decreased [43].
Interferon alpha was also effective in a patient with systemic mastocytosis associated with myelodysplastic syndrome with the c-kit D816V mutation, which was refractory to imatinib treatment [44].
Interferon alpha also proved to be effective in the treatment of osteoporotic lesions appearing in the course of mastocytosis.
The series of 10 cases with resolved mastocytosis and osteoporosis-related fractures was presented in 2011. The patients received interferon alpha in a dose of 1.5 million units three times a week as well as pamindronic acid. The patients were treated for an average of 60 months. For the first 2 years, pamindronate was given at a dose of 1 mg/kg every month, and then every 3 months.
During the course of the study, no patient had a new-bone fracture. The level of alkaline phosphatase decreased by 25% in relation to the value before treatment and tryptase by 34%. Bone density increased during treated with interferon and pamindronate. The increase was on average 12% in the spine bones and 1.9% in the hip bones. At the same time, there was no increase in the density of the hip bone and a minimal increase in the density of the spine in patients treated with pamindronate alone.
The results of this observation suggest that it is beneficial to add low doses of interferon alpha to pamindronate treatment in terms of bone density increase [45].
That experiences show that interferon used in systemic mastocytosis significantly improves the quality of life of patients by inhibiting the symptoms caused by degranulation of mast cells. They prevent bone fractures and, in some patients, they cause remission of bone marrow infiltration by mast cells.
Chronic neutrophilic leukemia (CNL) is a very rare disease. It is characterized by the clonal proliferation of mature neutrophils.
The diagnostic criteria proposed by the World Health Organization (WHO) comprise leukocyte counts above 25,000/μl (including more than 80% of rod and segmented
Physical examination often shows enlargement of the liver and spleen, moreover, patients complain on weight loss and weakness [1].
The prognosis varies. The average survival time for patients with CNL is less than 2 years.
Only few descriptions of chronic neutrophilic leukemia are available in the literature, and these are mostly single case reports.
Because it is an extremely rare disease, there are no established and generally accepted treatment standards. In most cases, patients are given hydroxycarbamide or interferon. Patients who are eligible for a bone marrow transplant may benefit from this treatment. Bone marrow allotransplantation remains the only method that gives a chance for a significant extension of life.
The German authors presented a series of 14 cases of chronic neutrophilic leukemia. The group of patients consisted of eight women and six men. The average age was 64.7 years. From the entire group of patients, longer survival was achieved only in three cases. One of these patients was treated with interferon alpha and achieved hematological remission, the other underwent bone marrow allotransplantation from a family donor, and the third one was treated with hydroxycarbamide and transfusions as needed. The follow-up period of the patient after allogeneic matched related donor transplantation (allo-MRD) was 73 months, and for the patient after interferon treatment it was 41 months.
The remaining patients died within 2 years of diagnosis. Six patients, the largest group, died due to intracranial bleeding, three patients died because of leukemia cell tissue infiltration, one patient because of the disease transformation into leukemia, and one patient because of pneumonia [46].
It can be seen from these experiences that treatment with interferon alpha can significantly extend the survival time of patients.
The case of a 40-year-old woman diagnosed with chronic neutrophilic leukemia is presented by Yassin and coauthors. Initially, the patient had almost 41,000 leukocytes in the peripheral blood. In a physical examination, splenomegaly and hepatomegaly were not present. Patient received pegylated interferon alpha-2a. The initially dose was 50 μg once a week for the first 2 weeks, then the dose was increased to 135 μg weekly for 6 weeks, and then the dose interval was extended to another 2 weeks. As a result of the treatment, the general condition of the patient improved and the parameters of peripheral blood counts were normalized [47].
Another case report presented in the literature describes a 41-year-old woman diagnosed with CNL accompanied by focal segmental glomerulosclerosis (FSGS). The patient had increasing leukocytosis for several months. On the admission to the hospital, leukocytosis was 94,000/μl. Moreover, the number of platelets in the morphology exceeded 1,000,000/μl. More than a year earlier, the patient had splenectomy due to splenomegaly and spleen infraction.
Additionally, JAK2 V617F mutation was found. Some authors suggest that the presence of JAK2 mutation may be associated with longer survival in CNL.
The patient received hydroxycarbamide for 3 months and reduction in the number of leukocytes was achieved. After this time, interferon alpha-2b was added to hydroxycarbamide. As a result, focal segmental glomerulosclerosis disappeared and the renal tests improved [48].
Another case of chronic neutrophilic leukemia with a JAK2 gene mutation concerns a 53-year-old man. The patient’s baseline leukocytosis was 33,500/μl, including the neutrophil count of 29,700/μl. The patient also had splenomegaly.
The treatment with interferon alpha-2b at a dose of 3 million units every other day was started. After a month of treatment, the number of leukocytes was reduced to less than 10,000/μl. Then the patient was treated chronically with interferon alpha-2b in doses of 3 million units every 2 weeks. As a result of the therapy, the number of leukocytes remains between 8 and 10,000/μl. The patient remains in general good condition [49].
A series of two CNL cases are also shown. The first patient was a 70-year-old woman with stable leukocytosis of about 35,000/μl and the remaining morphology parameters in normal range. The patient was only observed for 5 years until hepasplenomegaly progressed rapidly. Then, interferon alpha-2b was included. Due to the treatment, the rapid regression of hepatosplenomegaly was achieved.
The second case is a 68-year-old woman with baseline leukocytosis of almost 14,000/μl. In this case, the treatment with hydroxycarbamide was started immediately. However, no improvement was achieved. After 6 weeks of HU treatment, interferon alpha-2b 3 million units 3 times a week was implemented and leukocytosis decreased. Due to the interferon treatment, the disease stabilized for a long time. Because the patient experienced an adverse reaction, a severe flu-like syndrome, interferon was discontinued. After interferon withdrawal, the disease progressed gradually and the treatment attempts by busulfan and 6-mercaptopurine were unsuccessful. Therefore, interferon was readministered and the disease went into remission. Interferon treatment was continued at a reduced dose. The disease regression was achieved again.
Additionally, the patient showed an improvement in the function of granulocytes in terms of phagocytosis and an improvement in neutral killer (NK) cell function after treatment with interferon [50].
The above examples show that interferon alpha is effective in the treatment of chronic neutrophilic leukemia. The side effects are rare and can be managed with dose reductions. Moreover, in these cases, interferon is also effective in a reduced dose. Disease remission or regression can be achieved without typical of CNL complications, such as intracranial bleeding.
Interferon has been used in the past to treat chronic myeloid leukemia. The treatment with tyrosine kinase inhibitors is now a standard practice. However, in a small number of patients, they are ineffective or exhibit unmanageable toxicity. Therefore, the attempts are underway to use interferon in combination with TKI in lower doses, which is to ensure the enhancement of the antiproliferative effect while reducing the toxicity.
There are ongoing attempts to use ropeginterferon in patients diagnosed with chronic myeloid leukemia, in whom treatment with imatinib alone has not led to deep molecular response (DMR). The first phase study was conducted in a small group of patients with chronic myeloid leukemia. The patients in first chronic phase treated with imatinib who did not achieve DMR, but in complete hematologic remission and complete cytogenetic remission, were included in the study. Patients have been treated with imatinib for at least 18 months. Twelve patients were enrolled in the study, and they completed the study according to the protocol. These patients received additional ropeginterferon to imatinib and four achieved DMR. Low toxicity was observed during the treatment. Among the hematological toxicities, neutropenia was the most common. There was no nonhematological toxicity with a degree higher than 1/2 during the treatment. Moreover, it has been found that better effects and fewer side effects are obtained when ropeginterferon is administered for a longer time, but in lower doses. The comparison of the effectiveness of interferon in chronic myeloproliferative disorders based on selected articles is presented in Table 1 [51].
Source | Type of trial | Interferon | Diagnosis | No. | Prior treatment status | Response rate |
---|---|---|---|---|---|---|
Yacoubet al. [15] | Phase II, multicenter | Pegylated IFN alfa-2a | PV | 50 | Resistance to HU or HU intolerance | CR:22% PR:38% |
ET | 65 | CR:43% PR:26% | ||||
Masarova et al. [16] | Phase II, single-center | Pegylated IFN alfa-2a | PV | 43 | Untreated or previously treated with cytoreductive therapy | CR:77% PR:7% |
ET | 40 | CR:73% PR:3% | ||||
Samuelsson et al. [18] | Phase II | Pegylated IFN alfa-2b | PV | 21 | Untreated or previously treated with cytoreductive therapy | CR: 69% for the entire group |
ET | 21 | |||||
Huang BT et al. [19] | Open label, multicenter | IFN alfa-2b | PV | 136 | Untreated or previously treated with cytoreductive therapy | OHR:70% Molecular response:54.7% |
ET | 123 | OHR (JAK2+ patients):83% CHR:23 cases OHR (JAK2-patients): 61.4% CHR:12 cases | ||||
Gisslinger et al. [23] | phase III, multicenter | Ropeginterferon | PV | 257 | Previously treated | OHR:53% |
Quintás-Cardama et al. [26] | phase II | Pegylated IFN alfa-2a | PV | 40 | Untreated or previously treated with cytoreductive therapy | OHR:80% CR:70% Molecular remission:54% |
ET | 39 | OHR:81% CR:76% Molecular remission:38% | ||||
Sørensen et al. [36] | Phase III, multicenter, COMBI | Pegylated IFN alfa-2a with ruxolitinib or Pegylated IFN alfa-2b with ruxolitinib | PV | 32 | Untreated or previously treated with cytoreductive therapy | OHR:44% CR:28% |
MF | 18 | OHR:31% CR:9% | ||||
Casassus et al. [40] | Open label, multicenter | IFN alpha-2b | Mastocytosis | 20 | Untreated and previously treated | PR:35% Minor remission: 30% |
Comparison of the effectiveness of interferon in chronic myeloproliferative disorders.
PV: polycythemia vera; ET: essential thrombocythemia; MF: myelofibrosis; HU: hydroxycarbamide/hydroxyurea; CR: complete remission; PR: partial remission; and OHR: overall hematological response.
Interferon alpha appears to be an effective and safe drug in the most type of chronic myeloproliferative disorders. Nowadays, all forms of its using have similar effectiveness. Interferon alpha can be effective even in cases of resistance for first-line treatment. Trial research is currently underway to combine it with some new drugs, such as ruxolitinib, and to add it to the already well-established therapy, it is a promising option for patients with refractory disease.
From time to time, new forms of interferon, such as ropeginterferon, are introduced, which gives hope for better effectiveness, better safety profile, and greater comfort in its use for patients who have to be treated for many years. In the case of the use of interferons alpha in the treatment of chronic myeloproliferative diseases, there are still opportunities to extend its use and to study its combination with newly introduced drugs.
"Open access contributes to scientific excellence and integrity. It opens up research results to wider analysis. It allows research results to be reused for new discoveries. And it enables the multi-disciplinary research that is needed to solve global 21st century problems. Open access connects science with society. It allows the public to engage with research. To go behind the headlines. And look at the scientific evidence. And it enables policy makers to draw on innovative solutions to societal challenges".
\n\nCarlos Moedas, the European Commissioner for Research Science and Innovation at the STM Annual Frankfurt Conference, October 2016.
",metaTitle:"About Open Access",metaDescription:"Open access contributes to scientific excellence and integrity. It opens up research results to wider analysis. It allows research results to be reused for new discoveries. And it enables the multi-disciplinary research that is needed to solve global 21st century problems. Open access connects science with society. It allows the public to engage with research. To go behind the headlines. And look at the scientific evidence. And it enables policy makers to draw on innovative solutions to societal challenges.\n\nCarlos Moedas, the European Commissioner for Research Science and Innovation at the STM Annual Frankfurt Conference, October 2016.",metaKeywords:null,canonicalURL:"about-open-access",contentRaw:'[{"type":"htmlEditorComponent","content":"The Open Access publishing movement started in the early 2000s when academic leaders from around the world participated in the formation of the Budapest Initiative. They developed recommendations for an Open Access publishing process, “which has worked for the past decade to provide the public with unrestricted, free access to scholarly research—much of which is publicly funded. Making the research publicly available to everyone—free of charge and without most copyright and licensing restrictions—will accelerate scientific research efforts and allow authors to reach a larger number of readers” (reference: http://www.budapestopenaccessinitiative.org)
\\n\\nIntechOpen’s co-founders, both scientists themselves, created the company while undertaking research in robotics at Vienna University. Their goal was to spread research freely “for scientists, by scientists’ to the rest of the world via the Open Access publishing model. The company soon became a signatory of the Budapest Initiative, which currently has more than 1000 supporting organizations worldwide, ranging from universities to funders.
\\n\\nAt IntechOpen today, we are still as committed to working with organizations and people who care about scientific discovery, to putting the academic needs of the scientific community first, and to providing an Open Access environment where scientists can maximize their contribution to scientific advancement. By opening up access to the world’s scientific research articles and book chapters, we aim to facilitate greater opportunity for collaboration, scientific discovery and progress. We subscribe wholeheartedly to the Open Access definition:
\\n\\n“By “open access” to [peer-reviewed research literature], we mean its free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself. The only constraint on reproduction and distribution, and the only role for copyright in this domain, should be to give authors control over the integrity of their work and the right to be properly acknowledged and cited” (reference: http://www.budapestopenaccessinitiative.org)
\\n\\nOAI-PMH
\\n\\nAs a firm believer in the wider dissemination of knowledge, IntechOpen supports the Open Access Initiative Protocol for Metadata Harvesting (OAI-PMH Version 2.0). Read more
\\n\\nLicense
\\n\\nBook chapters published in edited volumes are distributed under the Creative Commons Attribution 3.0 Unported License (CC BY 3.0). IntechOpen upholds a very flexible Copyright Policy. There is no copyright transfer to the publisher and Authors retain exclusive copyright to their work. All Monographs/Compacts are distributed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Read more
\\n\\nPeer Review Policies
\\n\\nAll scientific works are Peer Reviewed prior to publishing. Read more
\\n\\nOA Publishing Fees
\\n\\nThe Open Access publishing model employed by IntechOpen eliminates subscription charges and pay-per-view fees, enabling readers to access research at no cost. In order to sustain operations and keep our publications freely accessible we levy an Open Access Publishing Fee for manuscripts, which helps us cover the costs of editorial work and the production of books. Read more
\\n\\nDigital Archiving Policy
\\n\\nIntechOpen is committed to ensuring the long-term preservation and the availability of all scholarly research we publish. We employ a variety of means to enable us to deliver on our commitments to the scientific community. Apart from preservation by the Croatian National Library (for publications prior to April 18, 2018) and the British Library (for publications after April 18, 2018), our entire catalogue is preserved in the CLOCKSS archive.
\\n\\nOpen Science is transparent and accessible knowledge that is shared and developed through collaborative networks.
\\n\\nOpen Science is about increased rigour, accountability, and reproducibility for research. It is based on the principles of inclusion, fairness, equity, and sharing, and ultimately seeks to change the way research is done, who is involved and how it is valued. It aims to make research more open to participation, review/refutation, improvement and (re)use for the world to benefit.
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The Open Access publishing movement started in the early 2000s when academic leaders from around the world participated in the formation of the Budapest Initiative. They developed recommendations for an Open Access publishing process, “which has worked for the past decade to provide the public with unrestricted, free access to scholarly research—much of which is publicly funded. Making the research publicly available to everyone—free of charge and without most copyright and licensing restrictions—will accelerate scientific research efforts and allow authors to reach a larger number of readers” (reference: http://www.budapestopenaccessinitiative.org)
\n\nIntechOpen’s co-founders, both scientists themselves, created the company while undertaking research in robotics at Vienna University. Their goal was to spread research freely “for scientists, by scientists’ to the rest of the world via the Open Access publishing model. The company soon became a signatory of the Budapest Initiative, which currently has more than 1000 supporting organizations worldwide, ranging from universities to funders.
\n\nAt IntechOpen today, we are still as committed to working with organizations and people who care about scientific discovery, to putting the academic needs of the scientific community first, and to providing an Open Access environment where scientists can maximize their contribution to scientific advancement. By opening up access to the world’s scientific research articles and book chapters, we aim to facilitate greater opportunity for collaboration, scientific discovery and progress. We subscribe wholeheartedly to the Open Access definition:
\n\n“By “open access” to [peer-reviewed research literature], we mean its free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself. The only constraint on reproduction and distribution, and the only role for copyright in this domain, should be to give authors control over the integrity of their work and the right to be properly acknowledged and cited” (reference: http://www.budapestopenaccessinitiative.org)
\n\nOAI-PMH
\n\nAs a firm believer in the wider dissemination of knowledge, IntechOpen supports the Open Access Initiative Protocol for Metadata Harvesting (OAI-PMH Version 2.0). Read more
\n\nLicense
\n\nBook chapters published in edited volumes are distributed under the Creative Commons Attribution 3.0 Unported License (CC BY 3.0). IntechOpen upholds a very flexible Copyright Policy. There is no copyright transfer to the publisher and Authors retain exclusive copyright to their work. All Monographs/Compacts are distributed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Read more
\n\nPeer Review Policies
\n\nAll scientific works are Peer Reviewed prior to publishing. Read more
\n\nOA Publishing Fees
\n\nThe Open Access publishing model employed by IntechOpen eliminates subscription charges and pay-per-view fees, enabling readers to access research at no cost. In order to sustain operations and keep our publications freely accessible we levy an Open Access Publishing Fee for manuscripts, which helps us cover the costs of editorial work and the production of books. Read more
\n\nDigital Archiving Policy
\n\nIntechOpen is committed to ensuring the long-term preservation and the availability of all scholarly research we publish. We employ a variety of means to enable us to deliver on our commitments to the scientific community. Apart from preservation by the Croatian National Library (for publications prior to April 18, 2018) and the British Library (for publications after April 18, 2018), our entire catalogue is preserved in the CLOCKSS archive.
\n\nOpen Science is transparent and accessible knowledge that is shared and developed through collaborative networks.
\n\nOpen Science is about increased rigour, accountability, and reproducibility for research. It is based on the principles of inclusion, fairness, equity, and sharing, and ultimately seeks to change the way research is done, who is involved and how it is valued. It aims to make research more open to participation, review/refutation, improvement and (re)use for the world to benefit.
\n\nOpen Science refers to doing traditional science with more transparency involved at various stages, for example by openly sharing code and data. It implies a growing set of practices - within different disciplines - aiming at:
\n\nWe aim at improving the quality and availability of scholarly communication by promoting and practicing:
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Jamil Maah and Ismail Yusoff",authors:[{id:"25185",title:"Dr.",name:"Muhammad Aqeel",middleName:null,surname:"Ashraf",slug:"muhammad-aqeel-ashraf",fullName:"Muhammad Aqeel Ashraf"},{id:"101988",title:"Dr.",name:"Ismail",middleName:null,surname:"Yusoff",slug:"ismail-yusoff",fullName:"Ismail Yusoff"},{id:"169931",title:"Prof.",name:"Mohd Jamil",middleName:null,surname:"Maah",slug:"mohd-jamil-maah",fullName:"Mohd Jamil Maah"},{id:"169932",title:"Dr.",name:"Ng Tham",middleName:null,surname:"Fatt",slug:"ng-tham-fatt",fullName:"Ng Tham Fatt"}]},{id:"71931",title:"Open Pit Mining",slug:"open-pit-mining",totalDownloads:1744,totalCrossrefCites:1,totalDimensionsCites:1,abstract:"Open pit mining method is one of the surface mining methods that has a traditional cone-shaped excavation and is usually employed to exploit a near-surface, nonselective and low-grade zones deposits. It often results in high productivity and requires large capital investments, low operating costs, and good safety conditions. The main topics that will be discussed in this chapter will include an introduction into the general features of open pit mining, ore body characteristics and configurations, stripping ratios and stripping overburden methods, mine elements and parameters, open pit operation cycle, pit slope angle, stability of mine slopes, types of highwall failures, mine closure and reclamation, and different variants of surface mining methods including opencast mining, mountainous mining, and artisan mining.",book:{id:"8620",slug:"mining-techniques-past-present-and-future",title:"Mining Techniques",fullTitle:"Mining Techniques - Past, Present and Future"},signatures:"Awwad H. Altiti, Rami O. Alrawashdeh and Hani M. Alnawafleh",authors:[{id:"313182",title:"Prof.",name:"Rami",middleName:null,surname:"Alrawashdeh",slug:"rami-alrawashdeh",fullName:"Rami Alrawashdeh"},{id:"313522",title:"Dr.",name:"Awwad",middleName:null,surname:"Altiti",slug:"awwad-altiti",fullName:"Awwad Altiti"},{id:"313523",title:"Prof.",name:"Hani",middleName:null,surname:"Alnawafleh",slug:"hani-alnawafleh",fullName:"Hani Alnawafleh"}]},{id:"64027",title:"Stages of a Integrated Geothermal Project",slug:"stages-of-a-integrated-geothermal-project",totalDownloads:4497,totalCrossrefCites:3,totalDimensionsCites:4,abstract:"A geothermal project constitutes two big stages: the exploration and the exploitation. Each one has a single task whose results allow defining the feasibility of a geothermal project, until achieving the construction and operation stage of the power generation plant. The first stage contains the area recognition, its limitation to the target, and elimination of external factors until defining a geothermal zone with characteristics to be commercially exploited. The main studies and analysis that can be applied during the exploration stage are listed, and the major indicator to continue with the project or suspend is the prefeasibility report. The major risks in the exploration stage are due to studies that are carried out on the surface; at this stage, the costs can be considered low. The main results of the exploration are the selection of sites to drill three or four initial wells. Each well provides a direct overview of the reservoir: depth, production thicknesses, thermodynamic parameters, and production characteristics. The drilling of three to four exploratory wells is recommended, as far as there is certainty of the feasibility of the project, and the development of the field begins with drilling of sufficient wells to feed the plant. In this stage, the cost increases, but the risks decrease.",book:{id:"7504",slug:"renewable-geothermal-energy-explorations",title:"Renewable Geothermal Energy Explorations",fullTitle:"Renewable Geothermal Energy Explorations"},signatures:"Alfonso Aragón-Aguilar, Georgina Izquierdo-Montalvo,\nDaniel Octavio Aragón-Gaspar and Denise N. Barreto-Rivera",authors:[{id:"258358",title:"Dr.",name:"Alfonso",middleName:null,surname:"Aragón-Aguilar",slug:"alfonso-aragon-aguilar",fullName:"Alfonso Aragón-Aguilar"}]},{id:"65070",title:"Biochar: A Sustainable Approach for Improving Plant Growth and Soil Properties",slug:"biochar-a-sustainable-approach-for-improving-plant-growth-and-soil-properties",totalDownloads:6959,totalCrossrefCites:60,totalDimensionsCites:99,abstract:"Soil is the most important source and an abode for many nutrients and microflora. Due to rapid depletion of agricultural areas and soil quality by means of ever-increasing population and an excessive addition of chemical fertilizers, a rehabilitated attention is a need of the hour to maintain sustainable approaches in agricultural crop production. Biochar is the solid, carbon-rich material obtained by pyrolysis using different biomasses. It has been widely documented in previous studies that, the crop growth and yield can be increased by using biochar. This chapter exclusively summarizes the properties of biochar, its interaction with soil microflora, and its role in plant growth promotion when added to the soil.",book:{id:"7305",slug:"biochar-an-imperative-amendment-for-soil-and-the-environment",title:"Biochar",fullTitle:"Biochar - An Imperative Amendment for Soil and the Environment"},signatures:"Jyoti Rawat, Jyoti Saxena and Pankaj Sanwal",authors:null},{id:"39170",title:"Study of Impacts of Global Warming on Climate Change: Rise in Sea Level and Disaster Frequency",slug:"study-of-impacts-of-global-warming-on-climate-change-rise-in-sea-level-and-disaster-frequency",totalDownloads:6702,totalCrossrefCites:14,totalDimensionsCites:32,abstract:null,book:{id:"2206",slug:"global-warming-impacts-and-future-perspective",title:"Global Warming",fullTitle:"Global Warming - Impacts and Future Perspective"},signatures:"Bharat Raj Singh and Onkar Singh",authors:[{id:"26093",title:"Dr.",name:"Bharat Raj",middleName:null,surname:"Singh",slug:"bharat-raj-singh",fullName:"Bharat Raj Singh"},{id:"118426",title:"Prof.",name:"Onkar",middleName:null,surname:"Singh",slug:"onkar-singh",fullName:"Onkar Singh"}]}],onlineFirstChaptersFilter:{topicId:"10",limit:6,offset:0},onlineFirstChaptersCollection:[{id:"82823",title:"The Metropolitan Transformation of Ioannina City from 1940 to 2015",slug:"the-metropolitan-transformation-of-ioannina-city-from-1940-to-2015",totalDownloads:5,totalDimensionsCites:0,doi:"10.5772/intechopen.105884",abstract:"The chapter presents the urban and regional changes in the city of Ioannina, Greece. This city is located in the periphery of Epirus, which is in the western Balkans, Eastern Europe. The chapter examines, with the tools of aerial photos and QGIS software, the spatial transformation of Ioannina city from 1940 to 2015. Map science is a field through which the users could observe and compare maps from past to future. The plans and the planning were formed under the values, standards, and fundamentals of the mosaic of politics, good practices, urban rules, and citizen level. The urban space has already changed until nowadays. The chapter examines the reasons for urban politics and social–economic moments that became the epitome of these urban and regional changes. The results show the comparative spatial study from each historical period.",book:{id:"11488",title:"GIS and Spatial Analysis",coverURL:"https://cdn.intechopen.com/books/images_new/11488.jpg"},signatures:"Efthymios-Spyridon Georgiou"},{id:"83032",title:"Introductory Chapter: Solar Photovoltaic Energy",slug:"introductory-chapter-solar-photovoltaic-energy",totalDownloads:4,totalDimensionsCites:0,doi:"10.5772/intechopen.106259",abstract:null,book:{id:"9862",title:"Solar Radiation - Measurements, Modeling and Forecasting for Photovoltaic Solar Energy Applications",coverURL:"https://cdn.intechopen.com/books/images_new/9862.jpg"},signatures:"Mohammadreza Aghaei, Amir Nedaei, Aref Eskandari and Jafar Milimonfared"},{id:"82963",title:"Evolution of Radio Source Components and the Quasar/Galaxy Unification Scheme",slug:"evolution-of-radio-source-components-and-the-quasar-galaxy-unification-scheme",totalDownloads:4,totalDimensionsCites:0,doi:"10.5772/intechopen.106244",abstract:"In this work, a theoretical model is developed for explanation of temporal evolution of extragalactic radio sources via beaming, orientation effects and asymmetries. Equation of the form D≈P±q1+z−m is used to account for the D ∼ P/z relation. Also, D≈D01+z−1+z1+z2 accounted properly for Ω0=1 cosmology than the Ω0=0 counterpart in linear size versus redshift of radio sources. Similarly, D=Dc1∓lnPPc1/2 model explained redshift-luminosity relationship of extragalactic radio sources. The results from the regression analyses are q = +0.003 (r = 0.04) for sources with z < 1 and q = −1.59 (r = −0.6) for all z≥1 sources. A critical linear size, Dc of 316kpc which matches the maximum theoretical linear size, Dmax of 0.15D0 at a critical redshift zc∼1 and a critical luminosity Pc=26.33WHz−1 are obtained. The indication of all these results is that the linear size of radio sources evolves up to a certain limit in D–P plane and thereafter decreases with increasing luminosity as predicted in this work.",book:{id:"11737",title:"Astronomy",coverURL:"https://cdn.intechopen.com/books/images_new/11737.jpg"},signatures:"Costecia Ifeoma Onah, Augustine A. Ubachukwu and Finbarr C. Odo"},{id:"82981",title:"Wood Quality and Pulping Process Efficiency of Elite Eucalyptus spp. Clones Field-Grown under Seasonal Drought Stress",slug:"wood-quality-and-pulping-process-efficiency-of-elite-eucalyptus-spp-clones-field-grown-under-seasona",totalDownloads:8,totalDimensionsCites:0,doi:"10.5772/intechopen.106341",abstract:"The objective of the present study is to evaluate the wood quality of five elite Eucalyptus spp. clones at 4 years of age from a clonal test installed in a region of seasonal drought stress in central-western Brazil focusing on pulp production. A total of 25 trees were systematically felled and disks and logs were obtained along the trunk. Wooden disks were used for density and fiber analyses and the logs were converted into chips for application in the pulping process. For the denser genotype, clone D (E. grandis x E. urophylla x Eucalyptus tereticornis), a thicker cell wall associated to thinner fibers results in a negative effect on the fiber quality. In contrast, clone B (Eucalyptus pellita x E. grandis), which has relatively inferior pulping performance, displayed the lowest wood density associated to wider lumen and fibers. The best growth performances in response to acclimatization and adaptation to the site strongly influences the pulp productivity, which is identified as the parameter of greatest variance between genotypes, and highlighting clone E (E. grandis x E. urophylla).",book:{id:"11840",title:"Arid Environment - Perspectives, Challenges and Management",coverURL:"https://cdn.intechopen.com/books/images_new/11840.jpg"},signatures:"Deborah Rodrigues de Souza Santos, Camila Sarto, Rafael Fernandes dos Santos, Júlia Lôbo Ribeiro Anciotti Gil, Carlos de Melo e Silva-Neto, Regina Maria Gomes, Evandro Novaes, Carlos Roberto Sette-Junior, Mario Tomazello-Filho, Rafael Tassinari Resende and Matheus Peres Chagas"},{id:"82957",title:"The Socio-Economic Factors of the Covid-19 Pandemic in Turkey: A Spatial Perspective",slug:"the-socio-economic-factors-of-the-covid-19-pandemic-in-turkey-a-spatial-perspective",totalDownloads:9,totalDimensionsCites:0,doi:"10.5772/intechopen.106048",abstract:"This study investigates the role of various socioeconomic determinants and vaccination rates in the spread of Covid-19 in a spatial setting in Turkey. For this aim, we employ the 41 sub-indicators of Life Index in Provinces data provided by the Turkish Statistical Institute which is obtained based on the Organization for Economic Cooperation and Development (OECD) Better Life Index approach. Our results indicate no global interactions in the transmission process of the disease among Turkish provinces. This means that the infection burden in the neighboring province does not significantly affect the infection burden of a given state. Yet, we show that vaccination rates and the median age of a neighboring province significantly affect the number of total cases in a given province. We find that as the vaccination rates of a neighboring province rise, the number of total cases in a given province also increases. This finding can be attributed to the “neighbor–reliant immunity” concept. It seems that people with vaccine hesitancy toward Covid-19 feel safer without a vaccine when their neighbors are mostly vaccinated. Last, people with a higher satisfaction rate with their health status are more likely to catch the disease due to underestimation of negative consequences.",book:{id:"11488",title:"GIS and Spatial Analysis",coverURL:"https://cdn.intechopen.com/books/images_new/11488.jpg"},signatures:"Sevgi Eda Tuzcu and Esra Satıcı"},{id:"82652",title:"Intra-Plate Dynamics and Active Tectonic Zones of the Indian Plate",slug:"intra-plate-dynamics-and-active-tectonic-zones-of-the-indian-plate",totalDownloads:7,totalDimensionsCites:0,doi:"10.5772/intechopen.105647",abstract:"The tectonic framework of the Indian Plate started to evolve since the break-up of Gondwanaland in the Late Triassic. It evolved mainly during the time between its separation from the African plate in the Early-Cretaceous and its collision with the Eurasian plate on the north in Late-Middle Eocene and with the Burmese plate in the northeast in Late-Oligocene. Present active tectonic zones, responsible for earthquake generation, were created by the collision pattern and subsequent plate motion. Continued subduction and plate motion due to ridge push and slab pull are responsible for the activation of primordial faults in the inherent structural fabric of the craton depending on the related stress field. Major tectonic zones of the Indian continental plate are related to the collision fronts and the reactivated intra-cratonic faults along the resurgent paleo-sutures between the proto-cratons. Major Tectonic Zones (TZ) are Himalayan TZ, Assam-Arakan TZ, Baluchistan- Karakoram TZ, Andaman-Nicobar TZ, and Stable Continental Region (SCR) earthquake zone. The structure of the continental margins developed during the break-up of Gondwana continental fragments. Western margin evolved during the sequential separation of Africa, Madagascar, and Seychelles since the Late-Triassic to Late Cretaceous time. The Eastern margin structure evolved during the separation of Antarctica in Mid Cretaceous. The orogenic belt circumscribing the northern margin of Indian plate is highly tectonised as the subduction of the plate continues due to northerly push from the Carlsberg Ridge in the SW and slab-pull towards northeast and east along the orogenic and island arc fronts in the NE. This stress pattern induced an anticlockwise rotatory plate motion. The back thrust from the collision front in the direction opposite to the ridge push put the plate under an overall compressive stress. This stress pattern and the plate motion are responsible for the reactivation of the major intra-cratonic faults. While the tectonised orogenic belts are the zones for earthquake nucleation, the reactivated faults are also the strained mega shear zones across the plate for earthquake generation in SCR. These faults trending WNW-ESE are apparently the transform faults that extend across the continent from Carlsberg ridge in the west to the collision zones in the northeast. As such, they are described here as the ‘trans-continental transform faults’. Three such major fault zones from north to south are (i) North Kathiawar fault - Great Boundary fault (along the Aravalli belt) zone, (ii) South Saurashtra fault (extension of Narmada fault) – SONATA-Dauki-Naga fault zone, and (iii) Tellichery-Cauvery-Eastern Ghat-T3-Hail Hakalula-Naga thrust zone. All these trans-continental faults, which are mega-shear zones, are traceable from western offshore to the northeastern orogenic belts along mega tectonic lineaments across the continent. The neotectonic movements along these faults, their relative motion, and displacement are the architect of the present geomorphic pattern and shape of the Indian craton. The overall compressive stress is responsible for strain build-up within these fault zones and consequent earthquake nucleation. The mid-continental Sonata-Dauki shear zone follows the Central Indian Suture Zone between Bundelkhand Proto Continent (BPC) and Deccan Proto Continent (DPC). With the reactivation of this shear zone, the two proto-cratonic blocks are subjected to relative movement as the plate rotates anticlockwise. The kinematics of these movements and their implications are discussed here with a special reference to the recent 2001 Bhuj earthquake.",book:{id:"11490",title:"Advances in Plate Tectonics",coverURL:"https://cdn.intechopen.com/books/images_new/11490.jpg"},signatures:"Sanjib K. Biswas and Gaurav D. 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The whole process of submitting an article and editing of the submitted article goes extremely smooth and fast, the number of reads and downloads of chapters is high, and the contributions are also frequently cited.",author:{id:"55578",name:"Antonio",surname:"Jurado-Navas",institutionString:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002bRisIQAS/Profile_Picture_1626166543950",slug:"antonio-jurado-navas",institution:{id:"720",name:"University of Malaga",country:{id:null,name:"Spain"}}}},{id:"6",text:"It is great to work with the IntechOpen to produce a worthwhile collection of research that also becomes a great educational resource and guide for future research endeavors.",author:{id:"259298",name:"Edward",surname:"Narayan",institutionString:null,profilePictureURL:"https://mts.intechopen.com/storage/users/259298/images/system/259298.jpeg",slug:"edward-narayan",institution:{id:"3",name:"University of Queensland",country:{id:null,name:"Australia"}}}}]},series:{item:{id:"11",title:"Biochemistry",doi:"10.5772/intechopen.72877",issn:"2632-0983",scope:"Biochemistry, the study of chemical transformations occurring within living organisms, impacts all areas of life sciences, from molecular crystallography and genetics to ecology, medicine, and population biology. Biochemistry examines macromolecules - proteins, nucleic acids, carbohydrates, and lipids – and their building blocks, structures, functions, and interactions. Much of biochemistry is devoted to enzymes, proteins that catalyze chemical reactions, enzyme structures, mechanisms of action and their roles within cells. Biochemistry also studies small signaling molecules, coenzymes, inhibitors, vitamins, and hormones, which play roles in life processes. Biochemical experimentation, besides coopting classical chemistry methods, e.g., chromatography, adopted new techniques, e.g., X-ray diffraction, electron microscopy, NMR, radioisotopes, and developed sophisticated microbial genetic tools, e.g., auxotroph mutants and their revertants, fermentation, etc. More recently, biochemistry embraced the ‘big data’ omics systems. Initial biochemical studies have been exclusively analytic: dissecting, purifying, and examining individual components of a biological system; in the apt words of Efraim Racker (1913 –1991), “Don’t waste clean thinking on dirty enzymes.” Today, however, biochemistry is becoming more agglomerative and comprehensive, setting out to integrate and describe entirely particular biological systems. The ‘big data’ metabolomics can define the complement of small molecules, e.g., in a soil or biofilm sample; proteomics can distinguish all the comprising proteins, e.g., serum; metagenomics can identify all the genes in a complex environment, e.g., the bovine rumen. This Biochemistry Series will address the current research on biomolecules and the emerging trends with great promise.",coverUrl:"https://cdn.intechopen.com/series/covers/11.jpg",latestPublicationDate:"August 2nd, 2022",hasOnlineFirst:!0,numberOfPublishedBooks:33,editor:{id:"31610",title:"Dr.",name:"Miroslav",middleName:null,surname:"Blumenberg",slug:"miroslav-blumenberg",fullName:"Miroslav Blumenberg",profilePictureURL:"https://mts.intechopen.com/storage/users/31610/images/system/31610.jpg",biography:"Miroslav Blumenberg, Ph.D., was born in Subotica and received his BSc in Belgrade, Yugoslavia. He completed his Ph.D. at MIT in Organic Chemistry; he followed up his Ph.D. with two postdoctoral study periods at Stanford University. Since 1983, he has been a faculty member of the RO Perelman Department of Dermatology, NYU School of Medicine, where he is codirector of a training grant in cutaneous biology. Dr. Blumenberg’s research is focused on the epidermis, expression of keratin genes, transcription profiling, keratinocyte differentiation, inflammatory diseases and cancers, and most recently the effects of the microbiome on the skin. He has published more than 100 peer-reviewed research articles and graduated numerous Ph.D. and postdoctoral students.",institutionString:null,institution:{name:"New York University Langone Medical Center",institutionURL:null,country:{name:"United States of America"}}},editorTwo:null,editorThree:null},subseries:{paginationCount:4,paginationItems:[{id:"14",title:"Cell and Molecular Biology",coverUrl:"https://cdn.intechopen.com/series_topics/covers/14.jpg",isOpenForSubmission:!0,editor:{id:"165627",title:"Dr.",name:"Rosa María",middleName:null,surname:"Martínez-Espinosa",slug:"rosa-maria-martinez-espinosa",fullName:"Rosa María Martínez-Espinosa",profilePictureURL:"https://mts.intechopen.com/storage/users/165627/images/system/165627.jpeg",biography:"Dr. Rosa María Martínez-Espinosa has been a Spanish Full Professor since 2020 (Biochemistry and Molecular Biology) and is currently Vice-President of International Relations and Cooperation development and leader of the research group 'Applied Biochemistry” (University of Alicante, Spain). Other positions she has held at the university include Vice-Dean of Master Programs, Vice-Dean of the Degree in Biology and Vice-Dean for Mobility and Enterprise and Engagement at the Faculty of Science (University of Alicante). She received her Bachelor in Biology in 1998 (University of Alicante) and her PhD in 2003 (Biochemistry, University of Alicante). She undertook post-doctoral research at the University of East Anglia (Norwich, U.K. 2004-2005; 2007-2008).\nHer multidisciplinary research focuses on investigating archaea and their potential applications in biotechnology. She has an H-index of 21. She has authored one patent and has published more than 70 indexed papers and around 60 book chapters.\nShe has contributed to more than 150 national and international meetings during the last 15 years. Her research interests include archaea metabolism, enzymes purification and characterization, gene regulation, carotenoids and bioplastics production, antioxidant\ncompounds, waste water treatments, and brines bioremediation.\nRosa María’s other roles include editorial board member for several journals related\nto biochemistry, reviewer for more than 60 journals (biochemistry, molecular biology, biotechnology, chemistry and microbiology) and president of several organizing committees in international meetings related to the N-cycle or respiratory processes.",institutionString:null,institution:{name:"University of Alicante",institutionURL:null,country:{name:"Spain"}}},editorTwo:null,editorThree:null},{id:"15",title:"Chemical Biology",coverUrl:"https://cdn.intechopen.com/series_topics/covers/15.jpg",isOpenForSubmission:!0,editor:{id:"441442",title:"Dr.",name:"Şükrü",middleName:null,surname:"Beydemir",slug:"sukru-beydemir",fullName:"Şükrü Beydemir",profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0033Y00003GsUoIQAV/Profile_Picture_1634557147521",biography:"Dr. Şükrü Beydemir obtained a BSc in Chemistry in 1995 from Yüzüncü Yıl University, MSc in Biochemistry in 1998, and PhD in Biochemistry in 2002 from Atatürk University, Turkey. He performed post-doctoral studies at Max-Planck Institute, Germany, and University of Florence, Italy in addition to making several scientific visits abroad. He currently works as a Full Professor of Biochemistry in the Faculty of Pharmacy, Anadolu University, Turkey. Dr. Beydemir has published over a hundred scientific papers spanning protein biochemistry, enzymology and medicinal chemistry, reviews, book chapters and presented several conferences to scientists worldwide. He has received numerous publication awards from various international scientific councils. He serves in the Editorial Board of several international journals. Dr. Beydemir is also Rector of Bilecik Şeyh Edebali University, Turkey.",institutionString:null,institution:{name:"Anadolu University",institutionURL:null,country:{name:"Turkey"}}},editorTwo:{id:"13652",title:"Prof.",name:"Deniz",middleName:null,surname:"Ekinci",slug:"deniz-ekinci",fullName:"Deniz Ekinci",profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002aYLT1QAO/Profile_Picture_1634557223079",biography:"Dr. Deniz Ekinci obtained a BSc in Chemistry in 2004, MSc in Biochemistry in 2006, and PhD in Biochemistry in 2009 from Atatürk University, Turkey. He studied at Stetson University, USA, in 2007-2008 and at the Max Planck Institute of Molecular Cell Biology and Genetics, Germany, in 2009-2010. Dr. Ekinci currently works as a Full Professor of Biochemistry in the Faculty of Agriculture and is the Head of the Enzyme and Microbial Biotechnology Division, Ondokuz Mayıs University, Turkey. He is a member of the Turkish Biochemical Society, American Chemical Society, and German Genetics society. Dr. Ekinci published around ninety scientific papers, reviews and book chapters, and presented several conferences to scientists. He has received numerous publication awards from several scientific councils. 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He worked on the structure-function relationships of glycoconjugates and his main project was the investigations on the biological roles of the de-N-glycosylation enzymes (Endo-N-acetyl-β-D-glucosaminidase and peptide-N4-(N-acetyl-β-glucosaminyl) asparagine amidase). From 2002 he contributes to the understanding of the Blood-brain barrier functioning using proteomics approaches. He has published more than 70 papers. 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Since then, he has been working as an Adjunct Professor in the same Department at the University of Pavia. His research activity during the first years was primarily focused on the purification and structural characterization of enzymes from animal and plant sources. During this period, Prof. Iadarola familiarized himself with the conventional techniques used in column chromatography, spectrophotometry, manual Edman degradation, and electrophoresis). Since 1995, he has been working on: i) the determination in biological fluids (serum, urine, bronchoalveolar lavage, sputum) of proteolytic activities involved in the degradation processes of connective tissue matrix, and ii) on the identification of biological markers of lung diseases. In this context, he has developed and validated new methodologies (e.g., Capillary Electrophoresis coupled to Laser-Induced Fluorescence, CE-LIF) whose application enabled him to determine both the amounts of biochemical markers (Desmosines) in urine/serum of patients affected by Chronic Obstructive Pulmonary Disease (COPD) and the activity of proteolytic enzymes (Human Neutrophil Elastase, Cathepsin G, Pseudomonas aeruginosa elastase) in sputa of these patients. More recently, Prof. Iadarola was involved in developing techniques such as two-dimensional electrophoresis coupled to liquid chromatography/mass spectrometry (2DE-LC/MS) for the proteomic analysis of biological fluids aimed at the identification of potential biomarkers of different lung diseases. He is the author of about 150 publications (According to Scopus: H-Index: 23; Total citations: 1568- According to WOS: H-Index: 20; Total Citations: 1296) of peer-reviewed international journals. 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She gained considerable experience in developing and validating new methodologies whose applications allowed her to determine both the amount of biomarkers (Desmosine and Isodesmosine) in the urine of patients affected by COPD, and the activity of proteolytic enzymes (HNE, Cathepsin G, Pseudomonas aeruginosa elastase) in the sputa of these patients. Simona Viglio was also involved in research dealing with the supplementation of amino acids in patients with brain injury and chronic heart failure. She is presently engaged in the development of 2-DE and LC-MS techniques for the study of proteomics in biological fluids. The aim of this research is the identification of potential biomarkers of lung diseases. 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She is also the Global Harmonization Initiative (GHI)",institutionString:"Australian College of Business & Technology",institution:{name:"Kobe College",institutionURL:null,country:{name:"Japan"}}}]},{type:"book",id:"6820",title:"Keratin",subtitle:null,coverURL:"https://cdn.intechopen.com/books/images_new/6820.jpg",slug:"keratin",publishedDate:"December 19th 2018",editedByType:"Edited by",bookSignature:"Miroslav Blumenberg",hash:"6def75cd4b6b5324a02b6dc0359896d0",volumeInSeries:2,fullTitle:"Keratin",editors:[{id:"31610",title:"Dr.",name:"Miroslav",middleName:null,surname:"Blumenberg",slug:"miroslav-blumenberg",fullName:"Miroslav Blumenberg",profilePictureURL:"https://mts.intechopen.com/storage/users/31610/images/system/31610.jpg",biography:"Miroslav Blumenberg, Ph.D., was born in Subotica and received his BSc in Belgrade, Yugoslavia. He completed his Ph.D. at MIT in Organic Chemistry; he followed up his Ph.D. with two postdoctoral study periods at Stanford University. 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He previously worked as a post-doctoral fellow at the Ben-Gurion University of Negev, Israel; University of the Free State, South Africa; and Central University of Technology Bloemfontein, South Africa. He obtained his Ph.D. in Organic Chemistry from Nagaoka University of Technology, Japan. He has published more than seventy-four journal articles and attended several national and international conferences as speaker and chair. Dr. Kendrekar has received many international awards. He has several funded projects, namely, anti-malaria drug development, MRSA, and SARS-CoV-2 activity of curcumin and its formulations. He has filed four patents in collaboration with the University of Central Lancashire and Mayo Clinic Infectious Diseases. His present research includes organic synthesis, drug discovery and development, biochemistry, nanoscience, and nanotechnology.",institutionString:"Visiting Scientist at Lipid Nanostructures Laboratory, Centre for Smart Materials, School of Natural Sciences, University of Central Lancashire",institution:null},{id:"428125",title:"Dr.",name:"Vinayak",middleName:null,surname:"Adimule",slug:"vinayak-adimule",fullName:"Vinayak Adimule",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/428125/images/system/428125.jpg",biography:"Dr. Vinayak Adimule, MSc, Ph.D., is a professor and dean of R&D, Angadi Institute of Technology and Management, India. He has 15 years of research experience as a senior research scientist and associate research scientist in R&D organizations. He has published more than fifty research articles as well as several book chapters. He has two Indian patents and two international patents to his credit. Dr. Adimule has attended, chaired, and presented papers at national and international conferences. He is a guest editor for Topics in Catalysis and other journals. He is also an editorial board member, life member, and associate member for many international societies and research institutions. His research interests include nanoelectronics, material chemistry, artificial intelligence, sensors and actuators, bio-nanomaterials, and medicinal chemistry.",institutionString:"Angadi Institute of Technology and Management",institution:null},{id:"284317",title:"Prof.",name:"Kantharaju",middleName:null,surname:"Kamanna",slug:"kantharaju-kamanna",fullName:"Kantharaju Kamanna",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/284317/images/21050_n.jpg",biography:"Prof. K. Kantharaju has received Bachelor of science (PCM), master of science (Organic Chemistry) and Doctor of Philosophy in Chemistry from Bangalore University. He worked as a Executive Research & Development @ Cadila Pharmaceuticals Ltd, Ahmedabad. He received DBT-postdoc fellow @ Molecular Biophysics Unit, Indian Institute of Science, Bangalore under the supervision of Prof. P. Balaram, later he moved to NIH-postdoc researcher at Drexel University College of Medicine, Philadelphia, USA, after his return from postdoc joined NITK-Surthakal as a Adhoc faculty at department of chemistry. Since from August 2013 working as a Associate Professor, and in 2016 promoted to Profeesor in the School of Basic Sciences: Department of Chemistry and having 20 years of teaching and research experiences.",institutionString:null,institution:{name:"Rani Channamma University, Belagavi",country:{name:"India"}}},{id:"158492",title:"Prof.",name:"Yusuf",middleName:null,surname:"Tutar",slug:"yusuf-tutar",fullName:"Yusuf Tutar",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/158492/images/system/158492.jpeg",biography:"Prof. Dr. Yusuf Tutar conducts his research at the Hamidiye Faculty of Pharmacy, Department of Basic Pharmaceutical Sciences, Division of Biochemistry, University of Health Sciences, Turkey. He is also a faculty member in the Molecular Oncology Program. He obtained his MSc and Ph.D. at Oregon State University and Texas Tech University, respectively. He pursued his postdoctoral studies at Rutgers University Medical School and the National Institutes of Health (NIH/NIDDK), USA. His research focuses on biochemistry, biophysics, genetics, molecular biology, and molecular medicine with specialization in the fields of drug design, protein structure-function, protein folding, prions, microRNA, pseudogenes, molecular cancer, epigenetics, metabolites, proteomics, genomics, protein expression, and characterization by spectroscopic and calorimetric methods.",institutionString:"University of Health Sciences",institution:null},{id:"180528",title:"Dr.",name:"Hiroyuki",middleName:null,surname:"Kagechika",slug:"hiroyuki-kagechika",fullName:"Hiroyuki Kagechika",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/180528/images/system/180528.jpg",biography:"Hiroyuki Kagechika received his bachelor’s degree and Ph.D. in Pharmaceutical Sciences from the University of Tokyo, Japan, where he served as an associate professor until 2004. He is currently a professor at the Institute of Biomaterials and Bioengineering (IBB), Tokyo Medical and Dental University (TMDU). From 2010 to 2012, he was the dean of the Graduate School of Biomedical Science. Since 2012, he has served as the vice dean of the Graduate School of Medical and Dental Sciences. He has been the director of the IBB since 2020. Dr. Kagechika’s major research interests are the medicinal chemistry of retinoids, vitamins D/K, and nuclear receptors. He has developed various compounds including a drug for acute promyelocytic leukemia.",institutionString:"Tokyo Medical and Dental University",institution:{name:"Tokyo Medical and Dental University",country:{name:"Japan"}}},{id:"94311",title:"Prof.",name:"Martins",middleName:"Ochubiojo",surname:"Ochubiojo Emeje",slug:"martins-ochubiojo-emeje",fullName:"Martins Ochubiojo Emeje",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/94311/images/system/94311.jpeg",biography:"Martins Emeje obtained a BPharm with distinction from Ahmadu Bello University, Nigeria, and an MPharm and Ph.D. from the University of Nigeria (UNN), where he received the best Ph.D. award and was enlisted as UNN’s “Face of Research.” He established the first nanomedicine center in Nigeria and was the pioneer head of the intellectual property and technology transfer as well as the technology innovation and support center. Prof. Emeje’s several international fellowships include the prestigious Raman fellowship. He has published more than 150 articles and patents. He is also the head of R&D at NIPRD and holds a visiting professor position at Nnamdi Azikiwe University, Nigeria. He has a postgraduate certificate in Project Management from Walden University, Minnesota, as well as a professional teaching certificate and a World Bank certification in Public Procurement. Prof. Emeje was a national chairman of academic pharmacists in Nigeria and the 2021 winner of the May & Baker Nigeria Plc–sponsored prize for professional service in research and innovation.",institutionString:"National Institute for Pharmaceutical Research and Development",institution:{name:"National Institute for Pharmaceutical Research and Development",country:{name:"Nigeria"}}},{id:"436430",title:"Associate Prof.",name:"Mesut",middleName:null,surname:"Işık",slug:"mesut-isik",fullName:"Mesut Işık",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/436430/images/19686_n.jpg",biography:null,institutionString:null,institution:{name:"Bilecik University",country:{name:"Turkey"}}},{id:"268659",title:"Ms.",name:"Xianquan",middleName:null,surname:"Zhan",slug:"xianquan-zhan",fullName:"Xianquan Zhan",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/268659/images/8143_n.jpg",biography:"Dr. Zhan received his undergraduate and graduate training in the fields of preventive medicine and epidemiology and statistics at the West China University of Medical Sciences in China during 1989 to 1999. He received his post-doctoral training in oncology and cancer proteomics for two years at the Cancer Research Institute of Human Medical University in China. In 2001, he went to the University of Tennessee Health Science Center (UTHSC) in USA, where he was a post-doctoral researcher and focused on mass spectrometry and cancer proteomics. Then, he was appointed as an Assistant Professor of Neurology, UTHSC in 2005. He moved to the Cleveland Clinic in USA as a Project Scientist/Staff in 2006 where he focused on the studies of eye disease proteomics and biomarkers. He returned to UTHSC as an Assistant Professor of Neurology in the end of 2007, engaging in proteomics and biomarker studies of lung diseases and brain tumors, and initiating the studies of predictive, preventive, and personalized medicine (PPPM) in cancer. In 2010, he was promoted to Associate Professor of Neurology, UTHSC. Currently, he is a Professor at Xiangya Hospital of Central South University in China, Fellow of Royal Society of Medicine (FRSM), the European EPMA National Representative in China, Regular Member of American Association for the Advancement of Science (AAAS), European Cooperation of Science and Technology (e-COST) grant evaluator, Associate Editors of BMC Genomics, BMC Medical Genomics, EPMA Journal, and Frontiers in Endocrinology, Executive Editor-in-Chief of Med One. He has\npublished 116 peer-reviewed research articles, 16 book chapters, 2 books, and 2 US patents. His current main research interest focuses on the studies of cancer proteomics and biomarkers, and the use of modern omics techniques and systems biology for PPPM in cancer, and on the development and use of 2DE-LC/MS for the large-scale study of human proteoforms.",institutionString:null,institution:{name:"Xiangya Hospital Central South University",country:{name:"China"}}},{id:"40482",title:null,name:"Rizwan",middleName:null,surname:"Ahmad",slug:"rizwan-ahmad",fullName:"Rizwan Ahmad",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/40482/images/system/40482.jpeg",biography:"Dr. Rizwan Ahmad is a University Professor and Coordinator, Quality and Development, College of Medicine, Imam Abdulrahman bin Faisal University, Saudi Arabia. Previously, he was Associate Professor of Human Function, Oman Medical College, Oman, and SBS University, Dehradun. Dr. Ahmad completed his education at Aligarh Muslim University, Aligarh. He has published several articles in peer-reviewed journals, chapters, and edited books. His area of specialization is free radical biochemistry and autoimmune diseases.",institutionString:"Imam Abdulrahman Bin Faisal University",institution:{name:"Imam Abdulrahman Bin Faisal University",country:{name:"Saudi Arabia"}}},{id:"41865",title:"Prof.",name:"Farid A.",middleName:null,surname:"Badria",slug:"farid-a.-badria",fullName:"Farid A. Badria",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/41865/images/system/41865.jpg",biography:"Farid A. Badria, Ph.D., is the recipient of several awards, including The World Academy of Sciences (TWAS) Prize for Public Understanding of Science; the World Intellectual Property Organization (WIPO) Gold Medal for best invention; Outstanding Arab Scholar, Kuwait; and the Khwarizmi International Award, Iran. He has 250 publications, 12 books, 20 patents, and several marketed pharmaceutical products to his credit. He continues to lead research projects on developing new therapies for liver, skin disorders, and cancer. Dr. Badria was listed among the world’s top 2% of scientists in medicinal and biomolecular chemistry in 2019 and 2020. He is a member of the Arab Development Fund, Kuwait; International Cell Research Organization–United Nations Educational, Scientific and Cultural Organization (ICRO–UNESCO), Chile; and UNESCO Biotechnology France",institutionString:"Mansoura University",institution:{name:"Mansoura University",country:{name:"Egypt"}}},{id:"329385",title:"Dr.",name:"Rajesh K.",middleName:"Kumar",surname:"Singh",slug:"rajesh-k.-singh",fullName:"Rajesh K. Singh",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/329385/images/system/329385.png",biography:"Dr. Singh received a BPharm (2003) and MPharm (2005) from Panjab University, Chandigarh, India, and a Ph.D. (2013) from Punjab Technical University (PTU), Jalandhar, India. He has more than sixteen years of teaching experience and has supervised numerous postgraduate and Ph.D. students. He has to his credit more than seventy papers in SCI- and SCOPUS-indexed journals, fifty-five conference proceedings, four books, six Best Paper Awards, and five projects from different government agencies. He is currently an editorial board member of eight international journals and a reviewer for more than fifty scientific journals. He received Top Reviewer and Excellent Peer Reviewer Awards from Publons in 2016 and 2017, respectively. He is also on the panel of The International Reviewer for reviewing research proposals for grants from the Royal Society. He also serves as a Publons Academy mentor and Bentham brand ambassador.",institutionString:"Punjab Technical University",institution:{name:"Punjab Technical University",country:{name:"India"}}},{id:"142388",title:"Dr.",name:"Thiago",middleName:"Gomes",surname:"Gomes Heck",slug:"thiago-gomes-heck",fullName:"Thiago Gomes Heck",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/142388/images/7259_n.jpg",biography:null,institutionString:null,institution:{name:"Universidade Regional do Noroeste do Estado do Rio Grande do Sul",country:{name:"Brazil"}}},{id:"336273",title:"Assistant Prof.",name:"Janja",middleName:null,surname:"Zupan",slug:"janja-zupan",fullName:"Janja Zupan",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/336273/images/14853_n.jpeg",biography:"Janja Zupan graduated in 2005 at the Department of Clinical Biochemistry (superviser prof. dr. Janja Marc) in the field of genetics of osteoporosis. Since November 2009 she is working as a Teaching Assistant at the Faculty of Pharmacy, Department of Clinical Biochemistry. In 2011 she completed part of her research and PhD work at Institute of Genetics and Molecular Medicine, University of Edinburgh. She finished her PhD entitled The influence of the proinflammatory cytokines on the RANK/RANKL/OPG in bone tissue of osteoporotic and osteoarthritic patients in 2012. From 2014-2016 she worked at the Institute of Biomedical Sciences, University of Aberdeen as a postdoctoral research fellow on UK Arthritis research project where she gained knowledge in mesenchymal stem cells and regenerative medicine. She returned back to University of Ljubljana, Faculty of Pharmacy in 2016. She is currently leading project entitled Mesenchymal stem cells-the keepers of tissue endogenous regenerative capacity facing up to aging of the musculoskeletal system funded by Slovenian Research Agency.",institutionString:null,institution:{name:"University of Ljubljana",country:{name:"Slovenia"}}},{id:"357453",title:"Dr.",name:"Radheshyam",middleName:null,surname:"Maurya",slug:"radheshyam-maurya",fullName:"Radheshyam Maurya",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/357453/images/16535_n.jpg",biography:null,institutionString:null,institution:{name:"University of Hyderabad",country:{name:"India"}}},{id:"418340",title:"Dr.",name:"Jyotirmoi",middleName:null,surname:"Aich",slug:"jyotirmoi-aich",fullName:"Jyotirmoi Aich",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0033Y000038Ugi5QAC/Profile_Picture_2022-04-15T07:48:28.png",biography:"Biotechnologist with 15 years of research including 6 years of teaching experience. Demonstrated record of scientific achievements through consistent publication record (H index = 13, with 874 citations) in high impact journals such as Nature Communications, Oncotarget, Annals of Oncology, PNAS, and AJRCCM, etc. Strong research professional with a post-doctorate from ACTREC where I gained experimental oncology experience in clinical settings and a doctorate from IGIB where I gained expertise in asthma pathophysiology. A well-trained biotechnologist with diverse experience on the bench across different research themes ranging from asthma to cancer and other infectious diseases. An individual with a strong commitment and innovative mindset. Have the ability to work on diverse projects such as regenerative and molecular medicine with an overall mindset of improving healthcare.",institutionString:"DY Patil Deemed to Be University",institution:null},{id:"349288",title:"Prof.",name:"Soumya",middleName:null,surname:"Basu",slug:"soumya-basu",fullName:"Soumya Basu",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0033Y000035QxIDQA0/Profile_Picture_2022-04-15T07:47:01.jpg",biography:"Soumya Basu, Ph.D., is currently working as an Associate Professor at Dr. D. Y. Patil Biotechnology and Bioinformatics Institute, Dr. D. Y. Patil Vidyapeeth, Pune, Maharashtra, India. With 16+ years of trans-disciplinary research experience in Drug Design, development, and pre-clinical validation; 20+ research article publications in journals of repute, 9+ years of teaching experience, trained with cross-disciplinary education, Dr. Basu is a life-long learner and always thrives for new challenges.\r\nHer research area is the design and synthesis of small molecule partial agonists of PPAR-γ in lung cancer. She is also using artificial intelligence and deep learning methods to understand the exosomal miRNA’s role in cancer metastasis. Dr. Basu is the recipient of many awards including the Early Career Research Award from the Department of Science and Technology, Govt. of India. She is a reviewer of many journals like Molecular Biology Reports, Frontiers in Oncology, RSC Advances, PLOS ONE, Journal of Biomolecular Structure & Dynamics, Journal of Molecular Graphics and Modelling, etc. She has edited and authored/co-authored 21 journal papers, 3 book chapters, and 15 abstracts. She is a Board of Studies member at her university. She is a life member of 'The Cytometry Society”-in India and 'All India Cell Biology Society”- in India.",institutionString:"Dr. D.Y. Patil Vidyapeeth, Pune",institution:{name:"Dr. D.Y. Patil Vidyapeeth, Pune",country:{name:"India"}}},{id:"354817",title:"Dr.",name:"Anubhab",middleName:null,surname:"Mukherjee",slug:"anubhab-mukherjee",fullName:"Anubhab Mukherjee",position:null,profilePictureURL:"https://intech-files.s3.amazonaws.com/0033Y0000365PbRQAU/ProfilePicture%202022-04-15%2005%3A11%3A18.480",biography:"A former member of Laboratory of Nanomedicine, Brigham and Women’s Hospital, Harvard University, Boston, USA, Dr. Anubhab Mukherjee is an ardent votary of science who strives to make an impact in the lives of those afflicted with cancer and other chronic/acute ailments. He completed his Ph.D. from CSIR-Indian Institute of Chemical Technology, Hyderabad, India, having been skilled with RNAi, liposomal drug delivery, preclinical cell and animal studies. He pursued post-doctoral research at College of Pharmacy, Health Science Center, Texas A & M University and was involved in another postdoctoral research at Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Santa Monica, California. In 2015, he worked in Harvard-MIT Health Sciences & Technology as a visiting scientist. He has substantial experience in nanotechnology-based formulation development and successfully served various Indian organizations to develop pharmaceuticals and nutraceutical products. He is an inventor in many US patents and an author in many peer-reviewed articles, book chapters and books published in various media of international repute. Dr. Mukherjee is currently serving as Principal Scientist, R&D at Esperer Onco Nutrition (EON) Pvt. 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