A SUMMER TRAINING REPORT ON “THE POSITION OF ORAL SOLID FERROUS ASCORBATE IN PREGNANCY”
FOR THE PARTIAL FULLFILLMENT FULLFILLMENT OF PGDM FULL TIME PROGRAM (2008-2010)
COMPANY GUIDE: MR.C.GANESHAN MR.C.GANESHA N MARKETING MANAGER MICRO LABS
FACULTY GUIDE: MR.SOMIL MISHRA FACULTY MEMBER GHSIMR SUBMITTED BY: YASHI VAJPEYI
DR. GAUR HARI SINGHANIA INSTITUTE INSTITUTE OF MANAGEMENT AND RESEARCH
ACKNOWLEDGEMENT
It is a pleasure to record my thanks and gratitude to persons whose generous help and support enabled me to complete this project within the stipulated time period. I feel indebted and place my special thanks to Mr. C. Ganeshan, Marketing Manager of Micro Labs, Bangalore for his active guidance and support from time to time during the training and project. I would also like to place my sincere thanks to Mr. D.V Dixit and Mrs. Monica for providing me the required inputs for the completion of the project and always being there whenever required. I would also like to thank other staff members of the organization for their generous help. I am also thankful to my faculty mentor Mr. Somil Mishra, for guiding me throughout the summer internship project. I am also thankful to the Library and Computer lab staff of the Institute, who provided great help. My family and friends also deserve the praise for all their help, support, interest and valuable suggestions. Lastly I cannot forget the generous people of Bangalore without whom the project would not have been a success.
Yashi Vajpeyi
CONTENTS
1. Preface 2. Introdu Introductio ction n – Indian Pharmac Pharmaceuti eutical cal Industr Industry y 3. Micr Micro o Labs Labs Pro Profi file le 4. Under Understa stand nding ing Blood Blood 5. What What is anae anaemi mia? a? 6. Signific Significanc ancee of of the the Researc Research h 7. Rese Researc arch h Objec Objectiv tivee 8. Rese Researc arch h Meth Method odolo ology gy 9. Analy Analysis sis and and Fin Findin dings gs 10.Suggestions 11.Limitations
INDIAN PHARMACEUTICAL INDUSTRY “The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.” Richard Gerster
The Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously. Playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers and many units approved by regulatory authorities in USA and UK. International companies associated with this sector have stimulated, assisted and spearheaded this dynamic development in the past 53 years and helped to put India on the pharmaceutical map of the world. The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical companies control 70% of the market with market leader holding nearly 7% of the market share. It is an extremely fragmented market with severe price competition and government price control. The pharmaceutical The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectibles. There are about 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). These units produce the complete range of pharmaceutical formulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and used for production of pharmaceutical formulations. Following the de-licensing of the pharmaceutical industry, industrial licensing for most of the drugs and pharmaceutical products has been done away with. Manufacturers are free to produce any drug duly approved by the Drug Control Authority. Technologically strong and totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. The Pharmaceutical Industry, with its rich scientific talents and
research capabilities, supported by Intellectual Property Protection regime is well set to take on the international market. The pharmaceutical market intelligence company, ORG IMS, says that the Indian pharmaceutical industry is expected to see high growth this year, as it is the world’s second largest pharmaceutical market by volume and consumption, as reported by Pharmaceutical online. Further, the Indian pharmaceutical market surged 13% last year while it grew 14.80% in the fiscal 2008, with the domestic market reached Rs 32,095 Crore. Tier II cities with total population below 100,000 along with rural areas represent 40% of the market, and are anticipated to see faster growth than the rest of the country. The Indian pharmaceutical industry is expected to grow on account of rising volume of the industry and launch of new products. Moreover, both domestic and export segments of the industry are rapidly expanding owing to the strong domestic pharmaceutical market which is supported by large population base of more than one billion and booming Indian economy. Further, India is a preferred destination for contract services in the field of research and manufacturing as it has skilled manpower and efficient manufacturing capability, low operation costs and a large number of USFDA approved plants. In addition, the pharmaceutical industry is getting strong support from various facilities provided by domestic service providers, such as Active Pharmaceutical Ingredient (API) manufacturing, basic research and clinical research. Moreover, the value of prevalent diseases is likely to scale up with rising population and urbanization in coming years. The Indian pharma industry has a critical role in the growth of global pharmaceutical industry as both domestic and MNCs are greatly benefited. The Indian pharmaceutical companies are performing quite well overseas, partly on account of depreciation in the Indian rupee. Despite this, the return from pharma industry depends on the market growth. In face of weak rupee and high inflation and interest rates, the overall industry is anticipated to be range-bound for a short period of time. According to a Research Analyst at RNCOS, “Investors in the Indian pharmaceutical industry are under intense pressure though exports are increasing and domestic market is expected to grow well. If decline in rupee continues, it will boost the earning of the industry players. Under such conditions, the pharma sector, a defensive and under-owned sector, is expected to outperform the broad market.”
ADVANTAGE INDIA Competent workforce: India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force and English is commonly used. Professional services are easily available. Cost-effective Cost-effective chemical synthesis: Its track record of development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs.
Legal & Financial Framework : India has a 60 year old democracy and hence has a solid legal framework and strong financial markets. There is already an established international industry and business community. Globalization: The country is committed to a free market economy and globalization. Above all, it has a 70 million middle class market, which is continuously growing. Consolidation: For the first time in many years, the international pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has started taking place in India. Pharma MNCs turn to India for cost management. If you can’t beat them, collaborate with them. That seems to be the latest buzz in the global pharmaceutical industry. It is the larger Indian companies that first set the trend in the last decade, with Ranbaxy-Eli Lilly and Lupin-Cynamid signing among the first major contract manufacturing deals in the country. Now, as the pie is getting bigger, other, smaller companies are getting into the fray. Some of the MNC activity in India are : Novartis AG seeking tie ups with Indian companies. • Bristol Mayers to enter India again • Pfizer India doubles research investment in India •
SWOT Analysis It is often said that the pharma sector has no cyclical factor attached to it. Irrespective of whether the economy is in a downturn or in an upturn, the general belief is that demand for drugs is likely to grow steadily over the long-term. Strengths:
1. India with with a population population of over a billion billion is a largely untapped market. market. To To put things things in perspective, per capita expenditure on health care in India is US$ 93 while the same for countries like Brazil is US$ 453 and Malaysia US$189. 2. The growth growth of middle class class in the country country has resulted in fast changing lifesty lifestyles les in urban and to some extent rural centers. This opens a huge market for lifestyle drugs, which has a very low contribution in the Indian markets. 3. Indian manufactu manufacturers rers are one of the the lowest lowest cost producers of drugs in the world. With a scalable labor force, Indian manufactures can produce drugs at 40% to 50% of the cost to the rest of the world. 4. Indian pharmaceutical pharmaceutical industry possesses excellent excellent chemistry chemistry and process process reengineering skills. This adds to the competitive advantage of the Indian companies. The strength in chemistry skill helps Indian companies to develop processes, which are cost effective. Weaknesses: 1.
The Indian pharma companies are marred by the price regulation. The National Pharma Pricing Authority, which is the authority to decide the various pricing parameters, sets prices of different drugs, which leads to lower profitability for the
companies. The companies, which are lowest cost producers, are at advantage while those who cannot produce have either to stop production or bear losses. 2. Indian pharma pharma sector sector has been marred marred by lack of product patent, patent, which prevents prevents global pharma companies to introduce new drugs in the country and discourages innovation and drug discovery. 3. Due to very very low barriers barriers to entry, entry, Indian Indian pharma pharma industry is highly fragmented. fragmented. This This makes Indian pharma market increasingly competitive. The industry witnesses price competition, which reduces the growth of the industry in value term. Opportunities:
1. The migration migration into a product product patent patent based based regime regime is likely likely to transform transform industry industry fortunes in the long term. The new product patent regime will bring with it new innovative drugs. 2. Large number number of drugs going going off-patent off-patent in Europe and in the US during 2005 2005 - 2009 offers a big opportunity for the Indian companies to capture this market. Since generic drugs are commodities by nature, Indian producers have the competitive advantage, as they are the lowest cost producers of drugs in the world. 3. Being the lowest lowest cost cost producer producer combined combined with FDA FDA approved approved plants; plants; Indian companies can become a global outsourcing hub for pharmaceutical products. Threats:
1. Threats Threats from other other low cost countries countries like like China China and Israel Israel exist. exist. However, However, on on the quality front, India is better placed relative to China. 2. The short-term short-term threat for for the pharma pharma industry industry is the implementation implementation of VAT. VAT. Though Though this is likely to have a negative impact in the short-term, the implications over the long-term are positive for the industry.
The deciding factors for profitable growth and survival of this industry will be
• • • •
Efficient use of Knowledge engineering techniques Structured management of innovation Setting up systems to enforce the acquired rights and At the same time evolving creative process of cooperative working and sharing of benefits
MICRO LABS PROFILE Establishment-Micro Labs was established in the year 1973, with an objective of providing quality healthcare products at an affordable cost by Mr G. C. Surana, Chairman Micro Labs. Headquarters - Bengaluru Key People- Mr. Dilip Surana (Managing Director) and Mr. Anand Surana (Director)
Industry -Pharmaceuticals Employee-Marketing and Sales force of over 2000 executives, Distribution networking of 5,00,000 pharmacies, Over Over 2000 wholesalers History:
Micro Labs is one of the leading pharmaceutical companies in India, rated the 1 5 t h largest in India as p er ORG-IMS study as on March 2006. The company was started in 1973 by Mr. G. C. Surana a visionary entrepreneur.
Micro Labs began to expand in the early eighties when increased thrust was given to the branded prescription market. Greatly encouraged by the wide acceptance and positive market response, the company expanded its products range to various other more vital segments like cardiovascular, psychotropic, neurological, anti diabetic, gynecological, gastro-enterological, dermatological, ophthalmologic and veterinary products.
The company later became a multi-divisional group to suit changing market trends and customer profiles. In 2002 Micro Labs acquired EROS Pharma a Bangalore-based formulations company. Micro Labs has 10 overseas offices, 12 formulation manufacturing plants, a strong distribution network and about 5000 plus dedicated employees.
About the Company:
Micro Labs Ltd with its associate companies is a multi-faceted drug manufacturing organization with 9 oral formulation plants, an injectable unit, a bulk drug facility, 4 overseas offices, a strong distribution network and over 5200 dedicated employees. In addition to the above, Micro Labs also has the state-of-the-art facilities and R&D centers’ with international standards, in the suburbs of a beautiful metropolitan city in South India - Bangalore popularly known as the ‘Silicon Valley’ or the ‘Garden City of India’ It is a diversified pharmaceuticals manufacturing company with products ranging from oral solids, oral liquids, topicals to injectables. With dedicated plants for penicillin and non penicillin categories, Micro Labs has been ranked in top 25 of top 300 pharmaceutical companies by AC Nielsen ORG. The company is aiming to be in top 10 by 2010. With a constant aim to excel, the vision of the company is to exceed expectations globally, placing quality and efficiency at the top end of company values. The Micro Group has been contributing significantly to the healthcare needs of the domestic market for over 3 decades. Growing at a phenomenal annual compounded growth rate of 25% in the last few years. It is well poised to achieve unparalleled status in the global pharmaceutical industry, through business expansion plans. The company is also at the forefront in social contribution. The company has been striving to be a model corporate citizen in terms of Environmental Protection & Social Initiatives with significant contributions in the areas of education and health. Micro Labs Ltd has set-up an educational institution to provide quality education to the deserving and needy. The Surana College offers courses in arts, science, commerce, Jainology and computer applications besides a PG Center for Management Studies.
Vision & Values:
Being one of the leading Indian healthcare providers in India, we aim to be a prominent pharmaceutical player in regulated and non-regulated markets across the globe. Our vision is to be among the top 10 pharmaceutical companies in India by 2010.
Business Objectives: • • • • • •
Adapting latest international technology to match global health care requirements Accelerate growth through brand building Continuous research and product development Constant manufacturing facilities expansion US-FDA standard facilities to cater to regulated market Overseas joint venture
Quality Objectives:
In addition to this it has a well-documented quality management system in force, which ensures compliance with the quality standards of ISO 9001. Micro Labs believe that quality is the key to success. Every product manufactured by Micro Labs goes through a highly sophisticated quality control procedure. The quality objectives will ensure that the products will be safe, effective and of high quality. The driving factors at the MICRO group are their core values: • • • • •
Strategic Partnerships Quality and Service Transparency in conduct at all times Innovation to provide added value to customers Committed employees to make a difference Their core values are based on respect for people, integrity, networking, diversity, creativity, empowerment and customer care.
Group Foray:
The Micro Group’s success in India has opened up new vistas and given them new wings. While providing quality healthcare solutions to Asia and most other Eastern countries, the company is forging ahead in areas like Latin America and Eastern Europe. The group is currently operational in the Asian, European, Latin American and African continents.
Highlights: • • •
Presence in 50 countries Exporting all major dosage forms in every therapeutic segment Corporate offices in ten countries including UK, Thailand, Russia, Vietnam &
• • • • •
Ukraine Independent marketing operations with fullfledged sales teams Focus on ethical promotion (brand building) - sale of branded Generic drugs Strategic marketing alliances with local transnational marketing companies Site/plant approvals from Health Canada (PICS countries) Approved by the MCC South Africa, Health Canada and UK MHRA
Major Brands of Micro Labs:
Micro Labs manufactures and markets a wide range of prod ucts for a wide range of therapies and age groups. With over 300 widely accepted brands under its label and many more in the pipeline, Micro Labs is clearly set to lead the pharma revolution in the years to come. Therapy Areas:
• • • • • • • • • • • •
Cardio vascular Gynaecology Gastroenterology Dermatology Ophthalmology Neuro psychiatry Anti diabetic Antimicrobials Antiseptics Nutraceticals Analgesics/Antipyretics Anti malarials and more
Competitors of Micro Labs in India 1. 2. 3. 4. 5. 6. 7.
Ranbaxy Torrent Lupin Nicholus Piramal GSK Unichem Alkem
8. Sun Pharmaceuticals 9. Dr. Reddy 10. Zodius Cadila
Understanding blood Blood is a fluid connective tissue •
•
In an average healthy adult, the volume of blood is one-eleventh of the body weight, or between 4.5 and 6 liters. Blood is about 55% plasma and 45% cells
Red blood cells •
•
•
•
•
•
•
Also called as erythrocytes Small, circular biconcave discs, non-nucleated (in human beings) ○ ○ An outer envelope (stroma) encloses a mass of haemoglobin ( Haemoglobin binds to oxygen and takes oxygen from the lungs to all parts of the body.) Single cells are pale buff colored but masses appear red. Red blood cells are made in the bone marrow, and millions are released into the bloodstream each day. A constant new supply of red blood cells is needed to replace old cells that break down. To constantly make red blood cells and haemoglobin you need a healthy bone marrow and nutrients such as iron and certain vitamins which we get from food. The normal RBC count in human beings: 5 million/cubic mm of blood. ○ Average life: 120 days. ○ After this period, they are disintegrated in spleen and destroyed in liver. RBC’s take up oxygen from the lungs and transport it to rest of the body and release carbon dioxide back to the lungs.
Haemoglobin •
•
•
A complex iron rich protein with an affinity for O2 forming oxyhaemoglobin. Normal Hb values[also called 100%]: 13-14 g / 100 ml for males and ○ 11-12 g / 100 ml for females ○ Consists of 2 parts: globin-a simple protein 96% and ○ haem-an iron containing pigment 4% ○
White blood cells •
Part of the immune system and defend the body from infection.
Platelets •
Help the blood to clot if we cut ourselves.
What is Anaemia?
Anaemia means reduction in oxygen carrying capacity of the blood. This can be due to Increased blood loss due to accident, menstruation etc Infections like malaria Decreased iron intake • • •
• • • • •
Decreased iron absorption Decreased Vitamin B12, Folic acid & Protein Increased demand of RBC as in pregnancy You have fewer red blood cells than normal You have less haemoglobin than normal in each red blood cell
In all cases, a reduced amount of oxygen is carried around in the bloodstream. The most common cause of anaemia is a lack of iron. Anaemia caused by a lack of iron is called iron deficiency anaemia. The bone marrow (in the center of the bone) needs iron to make
haemoglobin. Without adequate iron, the body cannot produce enough haemoglobin for red blood cells. Iron deficiency Anaemia usually develops gradually, in stages. Symptoms develop in the later stages. And, there are basically 5 stages: Stage 1: • •
Iron loss exceeds intake, depleting iron reserves, primarily in bone marrow. Blood levels of ferritin (a protein that stores iron) progressively decrease.
Stage 2: • Because depleted iron reserves can't meet the needs of developing red blood cells, fewer red blood cells are produced. Stage 3: • Anaemia Anaemia begin beginss to develop develop.. Early Early in this this stage, stage, the the red blood blood cells cells appear appear norm normal, al, but but there are fewer of them. • Hemo Hemogl glob obin in leve levels ls are are red reduc uced ed Stage 4: • The bone bone marrow marrow tries tries to to compens compensate ate for for the lack lack of iron iron by speedi speeding ng up cell cell divisi division on and producing very small (microcytic) red blood cells, which are typical of iron deficiency Anaemia . Stage 5: • As iron iron deficien deficiency cy and Anaem Anaemia ia progres progress, s, the symp symptom tomss of iron iron deficien deficiency cy may may develop and symptoms of Anaemia worsen.
What are the causes of iron deficiency anaemia?
A normal balanced diet will usually contain enough iron for the body's needs. A low level of body iron leading to anaemia can result from various causes. Some are more serious than others, and include the following:
Heavy menstrual periods Anaemia is common in women of all ages who have heavy periods. About 1 in 10 women will become anaemic at some stage due to heavy periods. The amount of iron that you eat may not be enough to replace the iron that you lose with the blood each period. Having heavy periods does not always lead to anaemia. Anaemia is more likely to develop if you have heavy periods and eat a diet that contains little iron. Pregnancy A growing baby needs iron and will take it from the mother. Anaemia is common in pregnant women. It is more likely to develop during pregnancy if you eat a diet that has little iron. Poor absorption of iron Some conditions of the gut (intestine) lead to poor absorption of various foods, including iron. Coeliac disease is an example. Bleeding from the gut (intestine) Several conditions of the gut can lead to 'internal bleeding'. Sometimes this is sudden, for example, after a burst duodenal ulcer. Vomiting or passing blood is then obvious.
However, often the bleeding is not obvious. A constant trickle of blood into the gut can be passed unnoticed in the stools (faeces). The iron that you may lose with the bleeding may be more than you eat. Conditions causing this include: stomach or duodenal ulcers, colitis (inflammation of the large intestine), inflammation of the oesophagus (gullet), piles (haemorrhoids), cancers of the bowel, and other rare bowel disorders. If you have one of these problems, you may have other gut symptoms such as stomach pains, constipation, or diarrhoea. However, in the early stages of these conditions, you may not have any symptoms, and anaemia may be the first thing that is noticed. For example, iron deficiency anaemia in an older person is a common first indication that bowel cancer has developed.
Medication Some medicines which you may take for other conditions can sometimes cause bleeding into the gut without causing symptoms. The most common example is aspirin. Other antiinflammatory painkillers such as ibuprofen, naproxen, diclofenac, etc, also have this sideeffect in some people. (The reason anti-inflammatories may cause bleeding is because they sometimes irritate the stomach lining which can lead to bleeding.) Bleeding from the kidney A small but regular trickle of blood from diseases of the kidney or bladder may not be noticed in the urine. However, enough may be lost to cause anaemia. Dietary factors Not eating foods with enough iron is sometimes the cause of iron deficiency anaemia. This is uncommon in non vegetarians as iron is in meat, liver, green vegetables, flour, eggs, and other foods. However, some people who may have a poor diet with 'just enough' iron to get by normally may slip into anaemia if other factors develop. For example, a barely adequate
diet combined with a growth spurt in children, with pregnancy, or with heavy periods may lead to anaemia. A restricted diet such as a vegan or a limited vegetarian diet sometimes does not contain enough iron. Traditional diets in some parts of the world contain a high level of chemicals such as phytates and polyphenols. For example, certain types of unleavened breads (such as chapatis) may contain a high level or phytates, and tea can contain a high level of polyphenols. These chemicals interfere with the way iron is absorbed from the gut. So, if you eat a lot of these foods, it can lead to iron deficiency. For example, in parts of India where chapatis are a staple food, iron deficiency anaemia is common. Hookworm infection This gut infection is the most common cause of iron deficiency anaemia world-wide. It affects people living in, and visiting, certain tropical countries. The worm feeds off blood inside the gut. What are the symptoms of iron deficiency anaemia? •
•
• •
•
Common symptoms are due to the reduced amount of oxygen in the body. These include: tiredness, lethargy, feeling faint, becoming easily breathless. Less common symptoms include: headaches, palpitations, altered taste, sore mouth, and ringing in the ears (tinnitus). You may look pale. IDA may produce its own symptoms, such as ○ pica (craving for non foods such as ice,dirt or pure starch), tongue irritation (glossitis), and ○ cracks at the sides of the mouth (cheilosis) and ○ spoonlike deformity in the fingernails. ○ Various other symptoms may develop, depending on the underlying cause of the anaemia (see below).
Possible complications: Complications may develop if the anaemia becomes severe and is not treated. For example, you can develop: fragile and broken nails, heart failure, and hair loss. You may also be more prone to develop infections as a lack of iron can affect the immune system.
Anaemia in pregnancy increases the risk of complications in both mother and baby. For example, there is an increased risk of: having a low birthweight baby, preterm (premature) delivery, postnatal depression, and low iron reserves in the baby which may possibly lead to anaemia in the newborn baby. How is iron deficiency anaemia diagnosed?
A blood test can confirm that you are anaemic. A test called the full blood count (FBC) is the main test. For this test the blood sample is put into a machine which automatically: Counts the number of red cells, white cells, and platelets per ml of blood. •
Measures the size of the red blood cells and calculates their average (mean) size. Calculates the proportion of blood made up from red blood cells (the haematocrit). Measures the amount of haemoglobin in the red blood cells. This test can determine if you are anaemic, and often give a good idea as to the cause of anaemia. But, as there are many different causes of anaemia, there may be some doubt as to the cause of the anaemia. • • •
Therefore, you may need another blood test to confirm that the cause of the anaemia is due to lack of iron. A blood test that measures a protein called ferritin may be done. The level of this protein usually reflects the total body iron stores. A low level usually indicates that you have a lack of iron. (However, the test is sometimes difficult to interpret if infection or inflammation is present, as levels of ferritin can be high even in the presence of iron deficiency.) It is important to find the cause of the iron deficiency. The cause may be obvious in some people. For example, anaemia is common in pregnancy, and in women with heavy periods. In these situations, if you are otherwise well and have no other symptoms, then no further tests may be needed. However, further tests may be advised if the cause is not clear. Every case is different and your doctor will assess if you should have further tests. Tests that may be advised include one or more of the following: Tests to look into the gut to see if there is any internal bleeding. These may be advised even if you do not have gut symptoms, especially in older people. The tests may include looking into the stomach with a special telescope (endoscopy). Checking the rectum and bowel may also be advised. This is commonly done by using a special telescope (sigmoidoscopy or colonoscopy). It is sometimes done with a special X-ray examination (barium enema). A biopsy (small sample) of the lining of the gut may be taken if coeliac disease is suspected as the cause. If you have recently been to the tropics, a stool sample (sample of faeces) may be checked to rule out hookworm. Other tests may be advised if the cause is still unclear. •
•
•
•
What is the treatment for iron deficiency anaemia?
Iron tablets are usually prescribed to correct the anaemia. Other treatments may also be advised, depending on the underlying cause. Iron tablets Various iron tablets and liquid medicines are available. A doctor will advise on one. The length of course will vary depending on how bad the anaemia is. A blood test after a few weeks will show if the treatment is working. Once the blood level is back to normal, you should continue to take iron for at least three further months. This will ensure that reserves of iron are built up in your body.
Side-effects from taking iron occur in some people. These include: feeling sick (nausea), an upset stomach, constipation, or diarrhoea. Tell a doctor if side-effects are a problem. Don't
stop the iron, as the anaemia will not get better. Possible ways that a doctor may suggest to reduce the problem with side-effects are: Take the iron tablets with meals. Food reduces the absorption of the iron and so you may need to take a longer course to correct the anaemia. Take a lower dose, but again a longer course will be needed to correct the anaemia. Drink plenty of fluids if constipation develops. Iron tablets may make your stools (faeces) black. This is normal and nothing to worry about. However, it is sometimes confused with blood in the stools from internal bleeding which can also make your stools black. •
• •
Anaemia in Pregnancy
As already told the normal haemoglobin (Hb) concentration in the body is between 12-14 grams percent. WHO has accepted up to 11gm percent as the normal haemoglobin level in pregnancy. Therefore any haemoglobin level below 11gm in pregnancy should be considered as anaemia. However in India and most of the other developing countries the lower limit is often accepted as 10 grams percent. Degree of Anaemia : Anaemia is often classified as: • Mild degree (9-11 gm %), • Moderate (7-9 gm %), • Severe (4-7 gm %) and • Very severe (<4gm %). Incidence: Anaemia in pregnancy is present in very high percentage of pregnant women in India. Any patient with a haemoglobin of less than 11 gm/dl to 11.5 gm/dl at the start of pregnancy will be treated as anaemic. The reason is that as the pregnancy progresses, the blood is diluted and the woman will become anaemic. The dilution of blood in pregnancy is a natural process and starts at approximately the eighth week of pregnancy and progresses until the 32nd to 34th week of pregnancy.
However according to WHO, the prevalence of Anaemia in pregnancy in south East Asia is around 56%. In India incidence of anaemia pregnancy has been noted as high as 40-80%. As there is reduction in Haemoglobin of blood • • • •
30 to to 40 mg dieta dietary ry iron iron giv gives es 4 to 6 mg of elem element ental al iron iron Need Need is 3 tim times es the the amo amoun untt Deficie Deficiency ncy of Vita Vitamin min C leads leads to decre decrease ase in in iron iron absor absorptio ption n nd rd In 2 & 3 trimester, more iron is required for the growing foetus
Magnitude of the problem: According to the National Family Health Survey, India has among the highest number of cases of anaemia in the world. As many as 79.1% of India’s children between the ages of three and six, and 56.2% of married women in the age-group 15-49 were found to be anaemic in 2006. Almost 20 per cent of maternal deaths are caused directly because of iron deficiency anaemia and it is a contributory factor in 20 per cent more deaths. Apart from this, there is the huge Productivity Loss: Anemia and iron deficiency cause weakness, fatigue, and reduced physical ability to work. Pregnancy anaemia is one of the important public health problems not only in India but also in most of the south East
Asian countries. About 4-16% of maternal death is due to anaemia. It also increases the maternal morbidity, foetal and neonatal mortality and morbidity significantly. Anaemia in pregnancy is a condition with effects that may be deleterious to mothers and foetuses. Indeed, it is a known risk factor for many maternal and foetal complications. Maternal risk during Antenatal period : poor weight gain. Pre term labours, PIH, placenta previa, accidental Hg, eclampsia, premature rupture of membrane (PROM) etc.
Cause of preeclampsia remains unknown. Hypothesis is that preeclampsia is caused by reduced NO levels as majority of preeclampsia patients had low levels of NO in their blood. During pregnancy, nitric oxide levels maintain a healthy flow of blood to the baby. When NO levels in the placenta are reduced or the NO is blocked from doing its work the risks of pre-eclampsia can occur with first manifestation being increase in BP. NO is one of the few gaseous signalling molecules known and plays an important role in blood pressure control. It is a vasodilator i.e. opens up blood vessels Severe forms of pre-eclampsia appear before the 34th week of gestation. Foetus suffers from • incre increasi asing ng nutri nutriti tiona onall and respi respira rator tory y proble problems ms,, • asphyxia and, • Ultimately, might die.
Maternal risk during intranatal period : Dysfunctional labour, intranatal hemorrhage, shock, anaesthesia risk, cardiac failure Maternal risk during postnatal period : Postnatal sepsis, sub involution, embolism Foetal and Neonatal risk : Complications include prematurity, low birth weight, poor Apgar score, foetal distress, neonatal distress requiring prolonged resuscitation, and neonatal anaemia due to poor reserve. Infants with anaemia have higher prevalence of failure to thrive, poorer intellectual developmental milestones, and higher rates of morbidities and neonatal mortalities than infants without anaemia. Moreover, babies whose mothers had AIP during their first trimester in utero experienced higher rates of cardiovascular morbidities and mortalities in their adult lives than babies whose mothers did not have AIP. Causes: 1) Physiological Pregnancy causes a state of hydraemic plethora. There is disproportionate increase of plasma volume during pregnancy leading to apparent reduction of RBC, haemoglobin and haematocrit value. Hb is consequently reduced to a varying extent occasionally as low as 80%. The dilution picture is normochromic and normocytic. This is so called physiological anaemia. 2) Acquired- Nutritional a) Iron deficiency anaemia (60%), b) Macrocytic anaemia (10%) due to deficiency of folic acid and/or vitaminB12
c) Dimorphic and protein deficiency anaemia (30%) both due to deficiency of iron and folic acid and /or vitaminB12 d) Protein deficiency due to protein deficiency in extreme malnutrition. Haemolytic or Haemorrhagic (due to acute blood loss) ; chronic (hook worm, bleeding piles) Iron and folate deficiency is by far the most important aetiological factor. Haemolytic anaemia may be caused by haemoglobinopathies, drug reaction or infestation with malaria parasites. Risk factors Socio demographic factors (age, level of formal education, marital status, areas and cities of residence) Obstetrical factors (gravidity, parity, history of previous preterm or Small-forgestational- age deliveries, plurality of pregnancy multiple Or singleton) Behavioural factors (smoking or tobacco usage, alcohol usage, utilization of prenatal care services) Medical conditions (diabetes, renal or cardio-respiratory diseases, chronic hypertension AIP anaemia in pregnancy Clinical presentation: presentation: To start with the pregnant women with anaemia may not have any symptom as the body system get adjusted to reduce haemoglobin mass. However she may represent with vague complain of ill health, fatigue, loss of appetite, digestive upset, dyspnoea, palpitation etc. Clinical examination may reveal pallor, pale nails, koilonychias, pale tongue etc. In severe cases there may be oedema also. Management: A pregnant woman requires about 2 to 4.8 mg iron every day. To have it from the dietary sources she must consume 20-48 mg of dietary iron. This is practically impossible in India because of average vegetarian diet does not contain more than 10-15 mg of iron and the phytate content in it further reduces iron absorption. Moreover majority of Indian women enter pregnancy already with iron depleted condition. The iron store is markedly diminished when there is fall in Hb values. Therefore in India there is a need for routine iron supplementation to all pregnant women Prophylaxis: It is advisable to build up iron store before a woman marries and becomes pregnant. This can be achieved by 1) Routine screening for anaemia for adolescent girls form school days 2) Encouraging iron reach foods 3) Fortification of widely consumed food with iron 4) Providing iron supplementation from school days 5) Annual screening for those with risk factors Iron rich foods: Pulses, cereals, jaggery, Beet root, Green leafy vegetables, meat, liver, egg, fish, legumes, dry beans, and iron reached white breads etc. Haematinic: Haematinics are agents which improve the quality of the blood, increasing the haemoglobin level and the number of erythrocytes. They are used in the treatment of anaemia. A doctor expects a set of features and benefits from a haematinic: • Good ab absorption
• • • • •
Signi Signifi fica cant nt incr increas easee in haemo haemoglo globi bin n level levelss Rapi Rapid d ris risee in RBC RBC coun counts ts No rel relea ease se of of free free rad radic ical al gen gener erat atio ion n Increase Increase patient patient complia compliance nce with with less less GI disturba disturbances nces Effe Effect ctiv ivee and and well well tol toler erat ated ed reg regim imen en
Oral Iron therapy: Oral Iron is safe, inexpensive & effective way to administer iron. Oral route should be the route of choice in routine cases. Parenteral route of iron therapy should only be considered when oral route is not possible due to any reason. If all pregnant women receive routine iron and folic acid, it is possible to prevent nutritional anaemia in pregnant women. National nutritional anaemia prophylaxis program advices 60 milligrams elemental iron and 500 micrograms of folic acid daily for 100 days to all pregnant women. However it is suggested that 120 milligram of elemental iron and 1 milligram folic acid are the optimum daily doses needed to prevent pregnancy anaemia.The higher dose in Indian women is required as they start pregnancy with low or absent iron stores due to poor nutrition and frequent infection like hook worm and malaria. Some of the oral iron formulations are: • Ferrous sulphate • Carbonyl iron • Ferr Ferrou ouss asco ascorb rbat atee with with zinc zinc • Ferr Ferrou ouss asc ascor orba bate te with withou outt zin zincc Ferrous Ascorbate Ferrous Ascorbate is a synthetic molecule of ascorbic acid and iron. Ascorbic acid enhances absorption of iron. Major brands of Ferrous Ascorbate in the market are:
• • • • • • • • • • •
Brand Orofer XT Dexorange Autrin Raricap Ferium XT Fesovit C-Pink Livogen Z Fefol Feronia XT Biofer XT
Company Emcure FI Wayeth J&J Emcure GSK Warnberry GSK GSK Zuv Micro Labs
How to select the iron salt: There are many iron preparations available in the market and a clinician is often confused as to which iron preparation should be advised to the patient. Ferrous sulphate is least expensive and best absorbed form of iron. It also allows more elemental iron absorbed per gram administered. If for some reasons this is not tolerated, then ferrous gluconate, fumarate are the next choice for iron therapy. However the iron salt should be selected based on compliance of the patient, tolerance, side effects, and clinical situation of the patient and availability of a particular salt. Oral iron must be continued for 3-6 months after haemoglobin has come to normal levels. This helps in building iron stores.
Timing of oral iron intake in relation to food: It is true that if iron is taken with food there is some reduction in side effect related to GI Tract. However staple Indian diet consists of cereals and cereals contain phytic acid. Phytate reduce iron absorption. Addition of vitamin C in medicine or in the diet enhances iron absorption. If the predictable rise in haemoglobin does not occur after oral iron therapy, one must find out the possible reasons. Some of the reasons area as follows 1. Incorrect diagnosis. 2. Mal-absorption syndrome 3. Presence of chronic infection 4. Loss of iron from the body 5. Lack of patients compliance 6. Ineffective release of iron from a particular preparation Parenteral Parenteral Iron: The indications for parenteral iron therapy are as follows 1. Cannot tolerate side effects of oral iron 2. Suffers from inflammatory bowel disease 3. Patient does not comply 4. Patient near term The defaulting rate with oral iron therapy in pregnant women is fairly high because of gastrointestinal side effects like nausea, vomiting, diarrhoea and abdominal pain. Sometimes pregnant women present with severe anaemia after 30-32 weeks of pregnancy and in those cases time is an important factor to improve haemoglobin status. In such situations parenteral iron therapy is indicated. Parenteral iron can be given by intramuscular or intravenous route. Iron- sorbitol -citric acid complex (jectofer (1.5ml) 75mg is used for intramuscular route only. On the other hand iron-dextran can be used both by intramuscular and intravenous route. The main drawback of intramuscular iron is the pain and staining of the skin at injection site, myalgia, arthralgia and injection abscess. Intravenous route should be reserved for those who do not wish to have frequent intramuscular injections. Iron can be given intravenously at one shot as total dose infusion (TDI). Utmost caution is needed for total dose iron therapy via intravenous route because of severe anaphylactic reaction that may occur. TDI reaction: Immediate vascular collapse, tachycardia, dyspnoea, cyanosis vomiting, pyrexia etc. Therefore total dose of iron therapy by intravenous route should only be given in a hospital setting where facilities are available to manage severe reaction after iron dextran. How to calculate TDI: total dose of infusion of iron is calculated as: (15- patient s Hb%) x body weight in Kg x3 =Mg. Contraindication Contraindication of parenteral iron therapy: Nephritis, cardio respiratory disease, allergy
Significance of the Research: Customer satisfaction is the curse of the success of any company. To achieve success the foremost thing is to be in pace with the customer needs, consistent and systematic improvement are necessary to demonstrate is the strategic business objective. But in case of pharmaceutical company it is a little bit different as not only customer but doctors’ satisfaction is much more important. If doctor won’t be satisfied with the drug he wouldn’t prescribe it to the patients. So the sale depends on doctors’ prescription. Continuous improvement for a pharma company implies that business philosophies must change to meet the increasing expectations of not only the customer but also the doctors. Hence a research should be a step towards the awareness of the expanding and ever changing needs of the customer and thereby to meet them. Just as many dissatisfied customers do not register formal complaints, satisfied customers may not provide the feedback necessary to understand what made them satisfied. Hence a detailed research is required to know what is lacking in the products and how can they be improved. A recent study has clearly established the fact that only those corporations survive which give their customer maximum value for their money. Only such of these companies that have gone beyond the stages of satisfying the customer into delighting them by exceeding their expectations have really grown beyond one’s wildest dreams.
Research Objective: Keeping the above things in mind, the survey was done to find the perception of solid ferrous ascorbate in pregnancy. Ferrous ascorbate is a new formulation and is a improved haematinic launched in the market. So it was essential to know how the formulation has been accepted by the doctors and what their perception is. The objective of the research is to find out the “Position of oral solid ferrous ascorbate in Pregnancy.”
Researc Res earch h Methodol Meth odology ogy :
This section of the report emphasizes on the procedure used to accomplish the project. To accomplish the project some data have been collected. The data collected is basically of two types: • •
Primary data Secondary data
Primary Data:
Primary data generally means those raw data or data structures that are collected “first hand” and have not had any previous meaningful interpretation. For my summer internship project report, I have collected such primary data through observation method and through personal interviews with gynaecologists. •
Type of Research : Exploratory (Qualitative)
1.
Research Design: For this I had conducted structured interview . The aim of this approach is to ensure that each interviewee is presented with exactly the same questions in the same order. This ensures that answers can be reliably aggregated and that comparisons can be made with confidence between sample subgroups or between different survey periods.
2.
Sampling Characteristics: Characteristics:
1. Targ Target et Pop Popul ulat atio ion n The target population for the research is defined as follows: ELEMENTS- All the gynaecologists and P.G students of the gynaecology department of the Bangalore city. SAMPLING UNITS- Sampling units are the hospitals and private clinics where we can meet the doctors. TIME- 2009 • •
•
1.
1.
Sampling Techniques: The sampling technique applied here is sampling without replacement. replacement. Sampling Technique used here is simple random sampling. I had visited different hospitals and private clinics of Bangalore city to meet the doctors. The instrument which was used to gather the required information was a questionnaire. The questions were generally closed ended, and were framed in a way to be filled in minimum time. Factors taken into account while framing the questions were to acquire maximum possible information from the doctors about the formulation. Sample Size: The total sample size was 100 and included the gynaecologists and some P.G students. While taking the sample I have mainly taken a point into consideration i.e., to design and obtain a sample in such a way that it will be representative of the entire population.
2.
Sample Area: The interviews were conducted in different hospitals and private clinics of Bangalore.
Secondary Data:
Any data which have been gathered earlier for some other purposes are secondary data for the current purpose. For my report, I have collected such data from various internet websites and different reference books containing related topics. List of Gynaecologists interviewed for the study:
1. Dr. Dr. Sath Sathya yana nare reya yane ne 3. Dr. Jagann gannaath 5. Dr. Aparna rna 7. Dr. Dr. Veen Veenaa K. 9. Dr. Dr. Deep Deepika ika 11. Dr. Soumya Soumyagowd gowdaa 13. Dr. Mahesh Mahesh 15. Dr. Shaheen Shaheen 17. Dr. Vinutha Vinutha 19. Dr. Mamatha Mamatha 21. Dr. Varsha Varsha R. 23. Dr. Nandini Nandini 25. Dr. Rajini Rajini Uday Uday 27. Dr. N.V. N.V. Manjula Manjula 29. Dr. Sahera Sahera 31. Dr. Rajalaxmi Rajalaxmi V. Rao 33. Dr. Padmavathi Padmavathi Gorijala Gorijala 35. Dr. N. Vimala Vimala 37. Dr. Kanaklaxmi Kanaklaxmi Gopal 39. Dr. Devi Devi Devraj Devraj 41. Dr. Maithili Maithili Kumar 43. Dr. Anuradha Parmeshwar Parmeshwar 45. Dr. Neetu Neetu K. 47. Dr. Beena Ravi 49. Dr. Veena Surendra 51. Dr. Anuradh Anuradhaa 53. Dr. Sharada Menon 55. Dr. Vidya Jagirdhar 57. Dr. Taniya Taniya Khanum Khanum 59. Dr. Rajkuma Rajkumarr 61. Dr. Vidya Hebbale 63. Dr. Suchitr Suchitraa 65. Dr. Jyotsana Reddy 67. Dr. Sreela Sreelatha tha 69. Dr. Roopshr Roopshree ee 71. Dr. Homeir Homeiraa Nishat Nishat 73. Dr. Asha 75. Dr. Lalitha Lalitha 77. Dr. Shakunt Shakuntala ala 79. Dr. S.K. Sharma 81. Dr. Poornim Poornimaa 83. Dr. Gowri Gowri 85. Dr. Susheel Susheelaa 87. Dr. Soumya Soumya D.S 89. Dr. Yogitha Sanjay 91. Dr. Divya Divya 93. Dr. Soumya Soumya K. 95. Dr. Jayanth Jayanthy y T. 97. Dr. Nirmala Nirmala Shivalingan Shivalingan 99. Dr. Savithri Savithri D.R
2. Dr. Dr. Shas Shashi hi Agar Agarwa wall 4. Dr. Kavitha 6. Dr. Payal Roy 8. Dr. Dr. Pari Parima mall En Endu du Sark Sarkar ar 10. Dr. Dr. Susan Susan Abra Abraham ham 12. Dr. Y. Sujath Sujathaa 14. Dr. Ramani Ramani Pooranes Pooraneson on 16. Dr. Sheela Sheela 18. Dr. Shashik Shashikala ala 20. Dr. Divya Divya 22. Dr. Gayatri Gayatri 24. Dr. Vishnu Vishnu Priya Priya 26. Dr. Shilpa Shilpa 28. Dr. Manjula Manjula 30. Dr. Rita Rita Maskar Maskar 32. Dr. Anuradha 34. Dr. Solly 36. Dr. Jayashr Jayashree ee 38. Dr. Shashikala Shashikala 40. Dr. Nidhi Nidhi Nigam Nigam 42. Dr. Sweety Sweety Sehgal 44. Dr. Akansha Lumba 46. Dr. Sushma Sushma Singh Singh 48. Dr. Rashmi Awasthi Awasthi 50. Dr. Shobha Agarwal 52. Dr. Nidhi Nidhi Singhvi Singhvi 54. Dr. Neerja Katiyar Katiyar 56. Dr. Manjulika Manjulika Bajpai 58. Dr. Rashmi Rashmi Sahni Sahni 60. Dr. Nidhi Nidhi Katiyar Katiyar 62. Dr. Sumita Singh 64. Dr. Jyotsan Jyotsanaa Mohan Mohan 66. Dr. Sangeeta Sangeeta Sarasvat 68. Dr. Reshma Reshma Nigam Nigam 70. Dr. Sumita Sumita Bhatia Bhatia 72. Dr. Pushpla Pushplata ta 74. Dr. Shruti Shruti Gupta Gupta 76. Dr. Aparna Aparna Saxena Saxena 78. Dr. Rashmi Rashmi Suri Suri 80. Dr. Rekha Gupta 82. Dr. Gunjan Gunjan 84. Dr. Meeta Meeta Chaudhr Chaudhry y 86. Dr. Preeti Preeti Nigam Nigam 88. Dr. Pratibha Pratibha Agarwal Agarwal 90. Dr. Richa Agarwal Agarwal 92. Dr. Kiran Kiran Agarwal Agarwal 94. Dr. Kalpana Kalpana Singh Singh 96. Dr. Rekha Rekha Shukla Shukla 98. Dr. Urmila Kushwaha 100.Dr. Manisha
Analysis of research Problem Definition-
From this research I had to find the perception of oral solid ferrous ascorbate in pregnancy. By this data we can easily find out the perception of the new formulation in the doctors mind, how is it progressing in the market and how it can be improved.
No. of pregnancies per week
Frequency Valid
0 -2 2 -4 4 -8 >8 Total
4 19 35 46 1 04
Percent 3.8 18.3 33.7 44.2 100.0
Valid Percent 3.8 18.3 33.7 44.2 100.0
Cumulative Percent
No. of pregnancies per week (gov.)
Valid
2 -4 4 -8 >8
Frequency 4 14 27
Percent 8.9 31.1 60.0
Valid Percent 8.9 31.1 60.0
Cumulative Percent 8.9 40.0 100.0
3 .8 2 2 .1 5 5 .8 1 00 . 0
Total
Valid
0-2 2-4 4-8 >8 Total
45 100.0 100.0 No. of pregnancies per week(pvt.) Frequency 4 15 21 19 59
Percent Valid Percent 6.8 6 .8 25.4 25 .4 35.6 35 .6 32.2 3 2 .2 100.0 1 0 0 .0
Cumulative Percent 6.8 32.2 67.8 100.0
Findings: •
•
•
•
As we can see that around 45 percent of the total doctors see more than 8 patients per week. Among the government doctors out of 45 doctors 27 see more than 8 patients ie around 60 percent doctors. While in the private hospitals and clinics 19 out of 59 doctors see more than 8 patients ie 32.2 percent doctors. By looking at the data, we can say that government hospitals have a greater potential for ferrous ascorbate.
Out of these how many are anaemic?
Valid
0-20% 20-40% 40-80% Total
Frequency 30 50 24 1 04
Percent Valid Percent 28.8 2 8 .8 48.1 4 8 .1 23.1 2 3 .1 100.0 1 0 0 .0
Cumulative Percent 28.8 76.9 100.0
Out of these how many are anaemic? (gov.)
Valid
0-20% 20-40% 40-80% Total
Frequency 15 18 12 45
Percent 33.3 40.0 26.7 100.0
Valid Percent 33.3 40.0 26.7 100.0
Cumulative Percent 33.3 73.3 100.0
Out of these how many are anaemic? (pvt.)
Valid
0-20% 20-40% 40-80% Total
Frequency 15 32 12 59
Percent 25 . 4 5 4 .2 2 0 .3 1 00 .0
Valid Percent 2 5 .4 5 4 .2 2 0 .3 1 00 . 0
Cumulative Percent 25.4 79.7 100.0
Findings:
While looking at the data here its seen that 50 out of 104 doctors said that 20-40 percent of their patients are anaemic. • When When looking looking at the the governm government ent practi practitio tioners ners 40 perce percent nt said said that 20-40 20-40 perc percent ent of their patients are anaemic while this number was 54.2 in private practitioners. • But 27 perc percent ent of the the governm government ent doctors doctors said said that that their their patient patientss are 40-80 40-80 percen percentt anaemic while this number was only 20 percent in the private clinics. • This This indicat indicates es that that number number of anaem anaemic ic patient patientss are more more in govern governmen mentt clinics clinics than than in private clinics. •
Stage of anaemia
Valid
Mild moderate severe very severe mild to moderate All Total
Frequency 55 37 2 2
Percent 52.9 35.6 1.9 1.9
Valid Percent 52.9 35.6 1.9 1.9
Cumulative Percent 52.9 88.5 90.4 92.3
7
6.7
6.7
99.0
1 10 4
1.0 100.0
1.0 100.0
100.0
Stage of anaemia(gov.)
Valid
mild moderate severe very severe mild to moderate all
Frequency 24 13 1 1 5 1
Percent Valid Percent 5 3 .3 53.3 2 8 .9 28.9 2 .2 2.2 2 .2 2.2 1 1 .1 11.1 2 .2 2.2
Cumulative Percent 53.3 82.2 84.4 86.7 97.8 100.0
Total
45
1 0 0 .0
100.0
Stage of anaemia(pvt.)
Valid
Frequency mild 31 moderate 24 severe 1 very severe 1 mild to moderate 2 Total 59
Percent 52 .5 40 . 7 1 .7 1 .7 3 .4 1 00 . 0
Valid Percent 52.5 40.7 1.7 1.7 3.4 100.0
Cumulative Percent 5 2 .5 9 3 .2 9 4 .9 9 6 .6 1 0 0 .0
Findings: •
•
When we see the stage of anaemia, generally all the doctors whether it be government or private say that their patients have mild anaemia. The reason for this is increased concern and awareness of the patients in metropolitan cities. One thing to notice here was that I met a doctor of the rural district hospital. She was the only doctor who said that her patients are severely anaemic. This indicates that great amount of improvement is still needed in the rural areas.
Prescription
Valid
Ferrous Sulphate carbonyl iron Ferrous ascorbate with zinc Ferrous ascorbate without zinc any other 1,4 1,2 2,4 Total Missing System Total
Frequency 26 8
Percent 25.0 7.7
Valid Percent 25 . 5 7 .8
Cumulative Percent 25.5 33.3
42
40.4
4 1 .2
74.5
2
1.9
2 .0
76.5
3 8 5 8 1 02 2 1 04
2.9 7.7 4.8 7.7 98.1 1.9 100.0
2 .9 7 .8 4 .9 7 .8 1 0 0 .0
79.4 87.3 92.2 100.0
Prescription(gov.)
Valid
Ferrous Sulphate carbonyl iron Ferrous ascorbate with zinc Ferrous ascorbate without zinc any other 1,4 1,2 2,4 Total Missing System Total
Frequency 20 5
Percent 44.4 11.1
Valid Percent 4 5 .5 11 .4
Cumulative Percent 45.5 56.8
8
17.8
1 8 .2
75.0
1
2.2
2 .3
77.3
1 2 4 3 44 1 45
2.2 4.4 8.9 6.7 97.8 2.2 100.0
2 .3 4 .5 9 .1 6 .8 1 0 0 .0
79.5 84.1 93.2 100.0
Prescription(pvt.)
Valid
Missing Total
Ferrous Sulphate carbonyl iron Ferrous ascorbate with zinc Ferrous ascorbate without zinc any other 1,4 1,2 2,4 Total System
Frequency 6 3
Percent Valid Pe Percent 10.2 1 0 .3 5.1 5 .2
Cumulative Percent 10.3 15.5
34
57.6
5 8 .6
74.1
1
1.7
1 .7
75.9
2 6 1 5 58 1 59
3.4 10.2 1.7 8.5 98.3 1.7 100.0
3 .4 1 0 .3 1 .7 8 .6 1 0 0 .0
79.3 89.7 91.4 100.0
Findings:
•
The basic basic differe difference nce which which was was seen seen betwee between n the priva private te and and governme government nt doctor doctorss were the prescription to the patients.
• •
•
•
•
•
20 out of 45 doctors i.e., around 45 percent prescribe ferrous sulphate in government hospitals while this number is only 10 percent in private clinics. While in private clinics 34 out of 59 doctors i.e., 58 percent of the doctors prescribe ferrous ascorbate with zinc. This number was only 18 percent in government hospitals. The basic basic reason reason behind behind this as told told by the the doctors doctors was was that that ferrou ferrouss sulphate sulphate is is the cheapest haematinic present in the market. So it is affordable by most of the patients. Even patients from middle income don’t lie to spend much on iron tablets. With this not only theoretically but practically also, it gives good results. With this 12 percent of the government doctors prescribe carbonyl iron; this number is less among the doctors of private clinics. Some Some of the doct doctors ors said said that they they avoid avoid presc prescrib ribing ing oral oral iron iron tablets tablets as they they are are less less tolerant. In place of that they prescribe diet regulation i.e., addition of spinach, apple etc in case of mild to moderate anaemia or they use parenteral iron in severe anaemia. With With this the prescri prescripti ption on also depends depends on individu individualit ality, y, tolerabi tolerability lity and and affordabil affordability ity..
Perception of FA
Frequency Valid
Offe ffers be better absorption absorption and lesser side effect Offers good rise in haemoglobin and RBC levels Both of the above don't know Total
Percent
Valid Percent
Cumulative Percent
19
18.3
1 8 .3
18.3
9
8.7
8 .7
26.9
72 4 10 4
69.2 3.8 100.0
6 9 .2 3 .8 1 0 0 .0
96.2 100.0
Perception of FA(gov.)
Frequency Vali alid
Offer fers be better absorption and lesser side effect Offers good rise in haemoglobin and RBC levels Both of the above don't know Total
Percent
Valid Percent
Cumulative Percent
13
28.9
28.9
2 8 .9
3
6.7
6.7
3 5 .6
27 2 45
60.0 4.4 100.0
60.0 4.4 100.0
9 5 .6 1 00 .0
Perception of FA(pvt.)
Frequency Vali Valid d
Offe Offers rs bett better er abso absorp rpti tion on and lesser side effect Offers good rise in haemoglobin and RBC levels Both of the above don't know Total
Percent
Valid Percent
Cumulative Percent
6
10.2
10.2
10.2
6
10.2
10.2
20.3
45 2 59
76.3 3.4 100.0
76.3 3.4 100.0
96.6 100.0
Findings: When asked about the perception of ferrous ascorbate, the doctors of both government and private hospitals said that not only they believe that ferrous ascorbate offers better absorption and lesser side effect but it also offers good rise in haemoglobin and RBC levels. The percentage here was 60 percent in government and around 77 percent in private clinics. •
•
Have you received any comm. from pharma comp. which propelled you to prescribe FA?
Valid
Yes No Total
Frequency 69 35 1 04
Percent 66.3 33.7 100.0
Valid Percent 66.3 33.7 100.0
Cumulative Percent 66.3 100.0
Have you received any comm. from pharma comp. which propelled you to prescribe FA?(gov.)
Valid
Yes No Total
Frequency 24 21 45
Percent 53.3 46.7 100.0
Valid Percent 53.3 46.7 100.0
Cumulative Percent 53.3 100.0
Have you received any comm. from pharma comp. which propelled you to prescribe FA? (pvt.)
Valid
Yes No Total
Frequency 45 14 59
Percent 7 6 .3 2 3 .7 1 0 0 .0
Valid Percent 76.3 23.7 100.0
Cumulative Percent 76.3 100.0
Findings: When asked the question were the doctors propelled to prescribe ferrous ascorbate by • any communication given by any pharmaceutical company around 67 percent of the doctors said, yes. When we look at government and private hospitals individually then the number was • 54 percent in the government doctors and 77 percent in private clinics. This shows that the number is less in government hospitals, hence pharmaceutical • companies should focus more there. Patients going into preeclampsia
Valid
0-10% 10-20% 20-40% >40% Total
Frequency 49 48 5 2 10 4
Percent Valid Percent 47.1 4 7 .1 46.2 46 .2 4.8 4 .8 1.9 1 .9 100.0 1 0 0 .0
Cumulative Percent 47.1 93.3 98.1 100.0
Patients going into preeclampsia(gov.) preeclampsia(gov.)
Valid
0-10% 10-20% 20-40% > 40 % Total
Frequency 19 22 3 1 45
Percent 42.2 48.9 6.7 2.2 100.0
Valid Percent 42.2 48.9 6.7 2.2 100.0
Cumulative Percent 42.2 91.1 97.8 100.0
Patients going into preeclampsia(pvt.) preeclampsia(pvt.)
Valid
0 - 10 % 10-20% 20-40% > 40 % Total
Frequency 30 26 2 1 59
Percent 50.8 44.1 3.4 1.7 100.0
Valid Percent 50.8 44.1 3.4 1.7 100.0
Cumulative Percent 50.8 94.9 98.3 100.0
Findings: •
As told by the doctors, number of cases going into preeclampsia has greatly reduced over the years. As preeclampsia generally occur in severe or very severe anaemia.
•
And there are very rare cases of severe anaemia in metropolitan cities. This is due to more awareness of the people there. 47 percent of the doctors said that only 0-10 percent of the patients go into preeclampsia.
Can FA reduce risk of preeclampsia?
Valid
Frequency Yes 46 No 45 don't know 13 Total 1 04
Percent 44.2 43.3 12.5 100.0
Valid Percent 4 4 .2 4 3 .3 12 .5 1 00 .0
Cumulative Percent 44.2 87.5 100.0
Can FA reduce risk of preeclampsia?(gov.)
Valid
Yes No
Frequency 16 22
Percent 35.6 48.9
Valid Percent 35.6 48.9
Cumulative Percent 35.6 84.4
don't know Total
7
15.6
15.6
45
100.0
100.0
100.0
Can FA reduce risk of preeclampsia?(pvt.)
Valid
Yes No don't know Total
Frequency 30 23
Percent 50.8 39.0
Valid Percent 50.8 39.0
6
10.2
10.2
59
100.0
100.0
Cumulative Percent 50.8 89.8 100.0
Findings: •
• •
When asked to the doctors, can ferrous ascorbate reduce risk of preeclampsia around 44 percent of the doctors said yes and 42 percent of the doctors said no. There were 12 percent of the doctors who didn’t know about it. More of the government doctors i.e., 49 percent of them don’t think that ferrous ascorbate can reduce risk of preeclampsia.
Has any pharma company communicated to you the use of FA in preeclampsia?
Valid
Yes No Total
Frequency 31 73 1 04
Percent Valid Pe Percent 29.8 29.8 70.2 70.2 100.0 100.0
Cumulative Percent 29.8 100.0
Has any pharma company communicated to you the use of FA in preeclampsia?(gov.)
Valid
Yes No Total
Frequency 11 34 45
Percent Valid Percent 2 4 .4 2 4 .4 75 .6 7 5 .6 1 0 0 .0 1 0 0 .0
Cumulative Percent 24.4 100.0
Has any pharma company communicated to you the use of FA in preeclampsia?(pvt.)
Valid
Yes No Total
Frequency 20 39 59
Percent Valid Pe Percent 33.9 33.9 66.1 66.1 100.0 100.0
Cumulative Percent 33.9 100.0
Findings: •
•
When asked has any pharmaceutical company communicated to you the use of ferrous ascorbate in preeclampsia, 71 percent of the doctors said, no. 76 percent of the government doctors said that they didn’t received any communication from any pharmaceutical company regarding use of ferrous ascorbate in preeclampsia.
•
•
While only 67 percent of the doctors of private clinics didn’t received any communication about ferrous ascorbate’s role in preeclampsia. This indicates that pharmaceutical companies have to work upon their communication strategy regarding role of ferrous ascorbate in preeclampsia.
Side Effects of FA on patients
Frequency Valid GI disturbances 26 Constipation 1 Black Stools 2 Vomiting 5 All of the Above 17 None of the Above 41 not used or not observed 12 Total 10 4
Percent 25.0 1.0 1.9 4.8 16.3 39.4 11.5 100.0
Valid Percent 2 5 .0 1 .0 1 .9 4 .8 1 6 .3 3 9 .4 1 1 .5 1 0 0 .0
Cumulative Percent 25.0 26.0 27.9 32.7 49.0 88.5 100.0
Side Effects of FA on patients(gov.)
Valid
GI disturbances Black Stools All of the Above None of the Above not used or not observed Total
Frequency 15 1 8 10
Percent 33.3 2.2 17.8 22.2
Valid Percent 33.3 2.2 17.8 22.2
11
24.4
24.4
45
100.0
100.0
Cumulative Percent 33.3 35.6 53.3 75.6 100.0
Side Effects of FA on patients(pvt.)
Valid
GI disturbances Constipation Black Stools Vomiting All of the Above None of the Above not used or not observed Total
Frequency 11 1 1 5 9 31
Percent 18.6 1.7 1.7 8.5 15.3 52.5
Valid Percent 18.6 1.7 1.7 8.5 15.3 52.5
1
1.7
1.7
59
100.0
100.0
Cumulative Percent 18 .6 20 .3 2 2 .0 3 0 .5 4 5 .8 98 . 3 1 0 0 .0
Findings: •
• •
•
When asked about side effects around 40 percent of the doctors said that there were no side effects noticed. The side effects generally seen was GI disturbance. Around 25 percent of the government doctors said that they have not used ferrous ascorbate or have not observed the side effects in patients. So one of the improvement needed to be done in the formulation is to reduce the side effect observed.
Is FA cost effective?
Valid
Yes No don't know Total
Frequency 56 39
Percent 5 3 .8 3 7 .5
Valid Percent 53.8 37.5
9
8 .7
8.7
10 4
1 0 0 .0
100.0
Cumulative Percent 53.8 91.3 100.0
Is FA cost effective?(gov.)
Valid
Yes No don't know Total
Frequency 21 17 7 45
Percent Valid Pe Percent 46.7 46.7 37.8 37.8 15.6 15.6 100.0 100.0
Cumulative Percent 4 6 .7 84 . 4 1 00 .0
Is FA cost effective?(pvt.)
Valid
Yes No don't know Total
Frequency 35 22 2 59
Percent Valid Percent 59.3 59.3 37.3 37.3 3.4 3.4 100.0 100.0
Cumulative Percent 5 9 .3 9 6 .6 1 00 . 0
Findings: •
•
•
•
54 percent of the doctors said that ferrous ascorbate is cost effective. 47 percent of the government doctors and 59 percent doctors of private clinic said that ferrous ascorbate is cost effective. Around 16 percent of the government doctors said that they don’t know the cost of the formulation as they have not prescribed it. But in the suggestions column, around 80 percent of the doctors suggested to decrease the cost of the formulation, so that it is affordable by all.
SUGGESTIONS •
•
•
•
•
•
•
Cost of the formulation should be reduced. As many of the doctors who said that ferrous ascorbate is cost effective also gave the suggestion to reduce its cost so that it can be affordable by all. Some of the doctors also suggested to reduce the size of the tablet as patients didn’t like to have big size iron medicines. The major reason given by most of the government doctors for not prescribing ferrous ascorbate was unavailability in the pharmacy. So if the market share of ferrous ascorbate has to be increased then it should be made available in the government pharmacy. As it is seen by figures that most of the government doctors see more than 8 patients, hence there is a huge market potential of ferrous ascorbate in government hospitals. Other suggestion would be to reduce the side effects. Many doctors told that problem of GI disturbances are noticed in the patients having ferrous ascorbate. Some of the doctors also complained about the intolerability effect of oral iron, so this should also be taken into consideration. Better communication strategy should be adopted by the pharmaceutical companies. As many of the doctors were unaware of ferrous ascorbate’s role in preeclampsia. Some of the doctors also demanded evidences of clinical haemoglobin rise by ferrous ascorbate through the pharmaceutical companies. This would increase their confidence in the medicine and they would easily prescribe it. Lastly better compliance is needed.
Limitations: •
• •
•
•
There were time constraints. Generally researches are not done in such a short span of time. A lot of time is taken by the researchers for conducting a research. There may be error due to lack of response as the doctors were really busy. Lack of awareness among the doctors regarding the newly launched formulation may also lead to an error. Sample size is of 100 gynaecologists which may not represent the entire population. So we cannot say it is a mass opinion. Money is another constraint in research.
BIBLIOGRAPHY AND WEBLIOGRAPHY
• • • • • • •
MARKETING RESEARCH – NARESH K. MALHOTRA MARKETING MANAGEMENT- PHILIP KOTLER BUSINESS STATISTICS-KEN BLACK SUMMER INTERNSHIP SIMPLIFIED-ANIL MISHRA microlabs.com google.com wikipedia
