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GARDASIL® is First Cervical Cancer Vaccine to Receive WHO Pre-qualification

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Cervical cancer is the second most common cancer among women worldwide. Almost 80 percent of cervical cancer cases occur in developing countries.
Human papillomavirus (HPV) is estimated to cause about half a million new cervical cancer cases every year, with a majority affecting women in developing countries. For most women, HPV goes away on its own, however, for some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer.
HPV types 16 and 18 cause approximately 70 percent of cervical cancer cases. Not all vulvar and vaginal cancers are caused by HPV and the exact number of cases caused by HPV types 16 and 18 is unknown. However, it is estimated that HPV types 16 and 18 account for 40-50 percent of vulvar cancers and about 70 percent of vaginal cancer. Genital warts are abnormal skin growths caused by HPV, particularly types 6 and 11, which cause more than 90 percent of genital warts.

Now for some good news:

GARDASIL®
[Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], Merck Sharp & Dohme’s cervical cancer vaccine, has been awarded World Health Organization (WHO) pre-qualification. GARDASIL® is the first cervical cancer vaccine to receive WHO pre-qualification.

WHO pre-qualification means that GARDASIL® is now eligible for procurement by the United Nations Children’s Fund (UNICEF) and other United Nations (UN) agencies including the Pan American Health Organization (PAHO), for use in national immunization programs.

“We recognize the significant impact cervical cancer has on women and families, especially in the developing world, which is why Merck Sharp & Dohme is committed to improving access to innovative vaccines like GARDASIL®,” said Margaret G. McGlynn, president, Merck Sharp & Dohme Vaccines and Infectious Diseases. “WHO pre-qualification is an important step in helping to ensure greater global access to GARDASIL® and to help protect against cervical cancer and other HPV-related diseases caused by HPV types 6, 11, 16 and 18 in more countries throughout the world.”

WHO pre-qualification aims to ensure that vaccines meet WHO standards of quality, safety and efficacy, which in conjunction with other criteria, is used by the UN and other agencies to make purchasing decisions.

“Cervical cancer is a significant burden in developing countries. WHO pre-qualification of an HPV vaccine signifies a move to help protect young women and improve access to better health care, particularly in the poorest countries,” comments Graça Machel, Founder and President of the Foundation for Community Development (FDC), Mozambique and a passionate advocate for women’s health.

About GARDASIL®

GARDASIL® is currently indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical cancers, vulvar and vaginal pre-cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancer cases and HPV types 6 and 11 are responsible for approximately 90 percent of genital warts and about 10 percent of low-grade cervical changes/lesions/dysplasias.

GARDASIL® is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL®

About access to GARDASIL® in the developing world

WHO pre-qualification is a significant part of Merck Sharp & Dohme’s approach to accelerating access to GARDASIL® in the developing world through four key pillars:

  • Innovation
  • Partnerships
  • Pricing
  • Implementation

This development follows the recent WHO position paper on the use of HPV vaccines.

Merck Sharp & Dohme will offer GARDASIL® to the public sectors of GAVI-eligible countries at a price at which we do not profit. Additionally, Merck Sharp & Dohme is exploring several ways to further reduce product cost for the developing world, including manufacturing efficiencies and reduction of royalties paid out to licensors on GARDASIL® doses sold in the developing world.

In 2007, Merck Sharp & Dohme made a commitment to donate at least 3 million doses of GARDASIL® over five years to help address the problem of HPV infection in under-resourced communities through the GARDASIL® Access Program which is managed by Axios Healthcare Development. In February 2009, the first doses of the donated GARDASIL® were shipped.

Additionally, Merck Sharp & Dohme is partnering with PATH, an international non-profit organization, to conduct demonstration projects of GARDASIL® in the developing world by providing vaccine and technical support at no cost. These demonstration projects are designed to support the accelerated availability of cervical cancer vaccines in the world’s least-developed countries. The projects are complete in Peru and ongoing in Vietnam and India.

Merck Sharp & Dohme is also sharing clinical data on GARDASIL®, HPV epidemiology and cervical cancer rates from studies done in 41 countries and more than 38,000 patients with health authorities, governments, non-governmental organizations and physicians around the world.

Additional important information about GARDASIL®

  • The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening.
    Women who receive GARDASIL® should continue to undergo cervical cancer screening.
  • GARDASIL® is not recommended for use in pregnant women.
  • GARDASIL® is not intended to be used for treatment of active genital warts, cervical, vaginal and vulvar pre-cancers, cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).
  • GARDASIL® has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL® has not been shown to protect against diseases due to HPV types not contained in the vaccine.
  • Not all vulvar and vaginal cancers are caused by HPV and GARDASIL® protects only against those vulvar and vaginal pre-cancers caused by HPV 16 and 18. Vaccination with GARDASIL® may not result in protection in all vaccine recipients.
    In clinical studies for GARDASIL®, headache was the most commonly reported adverse reaction. Common adverse reactions that were observed at a frequency of at least 1 percent among recipients of GARDASIL® and also greater than those observed among recipients of control group, respectively, were pain, swelling, erythema, fever, nausea, pruritis, dizziness and bruising. In addition, syncope has been reported following vaccination with GARDASIL®, sometimes resulting in falling with injury: observation for 15 minutes after administration is recommended.

Dosage and administration for GARDASIL®

GARDASIL® is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL® should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

GARDASIL® is approved in 111 countries

GARDASIL® has been approved in 111 countries, 23 of which are GAVI-eligible, and additional applications are currently under review with regulatory agencies in more countries around the world.

DesignTech Systems to provide solutions to Nairobi’s Coptic Hospital

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DesignTech Systems bags ERP order from Kenya Hospital and two clinical units

 


DesignTech Systems Limited, leading Product Lifecycle Management, engineering design firm and healthcare solution provider, has bagged an international contract. After delivering its Enterprise Resource Planning (ERP) solution to over a dozen hospitals across India, DesignTech has now got a contract for its ERP installation in one of the largest private hospitals in Kenya’s capital Nairobi. This is DesignTech’s first international project which is to be installed in May.

Mr Vikas Khanvelkar managing director DesignTech Systems Limited said “We have received an order from Coptic Hospital in Nairobi to install the ERP solution developed by our healthcare team. Coptic Hospital is a 250-bed specialty hospital. “

The ERP will also be installed at the two small clinical units run by the group. Asclepius, the ERP developed by DesignTech is a comprehensive hospital management system that takes care of the entire operation within a hospital set-up. Right from patient’s registration to blood bank details and billing procedure, all processes are integrated in the 42-module software

“We could win over the competition because we were able to deliver state-of-the-art technology such as ‘n’ level distributed architecture through our products; thus not only were we able to deliver performance but make sure to protect customer’s cost of ownership for years to come” said Mr. Sachin Chougule, Director, DesignTech Systems.

Asclepius is a comprehensive range of solutions that not only manages and provides all the data but also configures and executes workflows. Asclepius is scalable to meet the needs of small, big and growing clinics and medicals hospitals. DesignTech Systems Limited is also in talks with leading hospitals in other African countries for the same project.

For more information visit:

http://www.dt-healthcare.com

www.designtechsys.com

 


Written by sreelakshmi

25 May, 2009 at 8:12 pm

iSOFT wins US$ 3.54m deal in England for a hospital information system

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iSOFT, an IBA Health Group Company, today announced that it has won a contract for a hospital information system with a National Health Service (NHS) trust in southern England worth £2.4 million (US$3.54m) over five years.

The contract with Heatherwood and Wexham Park Hospitals NHS Foundation Trust is for iSOFT’s i.Patient Manager (i.PM) PAS and a technical refresh of an existing iSOFT clinical solution, i.Clinical Manager (i.CM). i.PM is replacing an outdated third-party system.

The trust elected to contract directly with iSOFT for a replacement PAS instead of waiting for a solution under England’s National Programme for IT. This is one of the first major deals in the Southern Cluster, which was formerly serviced by Fujitsu.

Jonathan Pearce, the Trust’s Director of Infrastructure, said: “We are delighted to be working with iSOFT on this very important programme for Heatherwood and Wexham Park Hospitals NHS Foundation Trust. We already have a strong working relationship with iSOFT as we already use its clinical information system, i.CM. We very much value our partnership with iSOFT and look forward to strengthening this and working with the company to deliver the new PAS solution to the trust.”

Adrian Stevens, Managing Director of iSOFT UK and Ireland, said: “i.PM is a highly robust and proven solution from a company with an established pedigree in the NHS.”

“The seamless integration with i.CM provides a complete patient and clinical management solution to better manage appointments, improve efficiency and reduce waiting times. It also provides a foundation for a smooth transition to iSOFT’s next generation of healthcare solutions. This underlines our position as the leading provider of healthcare solutions to the NHS,” Stevens said.

The trust serves a population of more than 450,000 in six locations: Wexham Park Hospital near Slough, Heatherwood Hospital in Ascot, and hospitals and outpatient clinics in Bracknell, Maidenhead, the Chalfonts, and Windsor.

Piramal Healthcare honours the best interventional cardiologists in India

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Piramal Healthcare Limited, one of India’s largest pharmaceutical companies, awarded the ‘Piramal Knowledge Academy Best Intervention Award 2009‘ to four eminent interventional cardiologists at the National Intervention Council (NIC) on April 26, 2009 in Hyderabad. Around 500 interventional cardiologists attended the program. Dr. Sarat Chandra, Chairman, National Intervention Council was instrumental in integrating this award in NIC. He presided over the conference and headed the jury that chose the winners.

Piramal Knowledge Academy supports the cause of the Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry and is aimed at promoting unique Percutaneous Coronary Intervention (PCI) by interventional cardiologists. PTCA Registry is a mid-term scientific fiesta which is organised every year, where more than 100 pre-selected cases are shown and discussed for everyone’s benefit over the course of the three days of the Registry. Piramal Knowledge Academy will continue to honour and acknowledge the best angioplasty cases in the country every year.

Piramal Knowledge Academy conducts a host of Advisory Panel Programmes, Skill Upgradation Programmes and Collaborative Educational Programmes with the medical fraternity. Dr. Swati Piramal, Director Communications & Strategic Alliances, Piramal Healthcare Limited said, “Piramal Knowledge Academy was conceptualized with the belief that sharing of knowledge with the medical fraternity is an imperative to alleviate the lives of the end patients and thereby the status of healthcare in India. It is our humble attempt at recognizing and felicitating stellar achievements in interventional cardiology.”

The winners of the prestigious award this year are:

  • Dr. Navneet Singh from AIIMS, Delhi for his unusual case of CoArc dilatation,
  • Dr. Bhanu from J.J. Medical College, Mumbai for her case on ballooning and stenting in peripheral and pulmonary artery stenosis,
  • Dr. Pankaj Jariwalla from Nizam’s Institute of Medical Sciences, Hyderabad for his case on left systemic artery to pulmonary vein AV valve formation, closed by vascular plug & coil embolisation and
  • Dr. Harikrishna from Shri Chitra Institute of Medical Sciences, Trivandrum for Ductal stenting in a neonate. The winners were honoured with a monetary award of Rs. 20,000, a certificate and an annual print subscription to an international health journal of repute.

The medical fraternity unreservedly appreciated this initiative from Piramal Healthcare. “It is a great honour for me to receive this award,” said Dr. Harikrishnan.

Fortis Healthcare plans for Fortis Hospital Seshadripuram in Bengaluru

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Unveils new logo of the hospital

 

Fortis Healthcare, the second largest healthcare chain in India that recently acquired a majority stake in erstwhile Apollo RM Hospital today shared its plans for repositioning the hospital as a complete multi-specialty neighbourhood healthcare facility providing medical care at secondary level. The hospital has been rechristened as Fortis Hospital, Seshadripuram. Consequently, the range and quality of healthcare services at the hospital will be enhanced over a period of time.

Mr. Shivinder Mohan Singh, Managing Director, Fortis Healthcare also unveiled the hospital’s new logo. Speaking at the occasion, Mr. Singh said, “Karnataka is very important for us in deepening our presence in the south. We are delighted to be in the high tech city of Bangalore with our first project in the state. This takes us a step closer to becoming a national player and in realizing our vision of bringing the Fortis quality of healthcare to the people of India. We shall continue to expand our presence in south.”

Fortis is committed to use its experience and expertise to upgrade and expand the range and quality of services being provided at Fortis Hospital Seshadripuram and also expand the bed capacity to 200 over time. Fortis Hospital, Seshadripuram will meet every aspect of common man’s day to day healthcare needs. In line with its patient centric approach, Fortis plans to introduce Home Care services wherein basic medical services shall be provided right at the patient’s doorstep. Besides, the hospital shall tie up with prominent medical experts of the city in different specialties for rendering OPD and IPD services.

The hospital will also upgrade the existing medical program and introduce new specialties while continuing to provide high end advanced medical care in Renal Sciences. The range of multi specialty services available at the hospital includes General Surgery, Orthopedics and Trauma, Obstetrics and Gynecology, Psychiatry, General Medicine, Pediatrics amongst others. The hospital will also be equipped to offer high end Emergency Care to ensure that patients are attended to within the shortest possible time.

The hospital shall be fully equipped to provide comprehensive diagnostics services as per well established Fortis standards. It will also provide Executive Health Checks and pre-employment checks for Corporates and offer a screening process for Cardiac, Diabetes, Cancer and Renal problems.

Medium Healthcare – A healthcare consultancy firm in India

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Consulting for business strategy, performance enhancement, marketing impact and service quality for the healthcare industry in India and other emerging economies

With a vision to spur innovation in the healthcare industy, Medium Healthcare Consultancy has been launched in India. Medium Healthcare aims to provide consulting services in the areas of business strategy, performance enhancement, marketing impact and service quality to healthcare organizations in India and other emerging economies.

Medium Heathcare Consulting helps its clients identify niche, but with significant potential, opportunities in healthcare in line with their overall objectives. These opportunities – typically aimed at a single or mix of specialties and focused target audience from a particular income segment – offer scope to emerge as viable, sustainable and scalable business models. Medium Healthcare also offers services in marketing of healthcare services with focus on enhancing revenue and profitability and service quality with a motto to maximize word-of-mouth referrals.

There are a few general consulting firms, which also have healthcare vertical. Healthcare consulting firms in India focus primarily on the project-related areas. Medium Healthcare intends to focus on business strategy and the softer’ side – marketing and service quality and is perhaps the only firm with this focus. The company plans to engage with existing healthcare players with a greater focus on emerging markets including India. It is also keen to advise newer entrants about the right healthcare strategy

Announcing the launch, Mr. Ratan Jalan, Founder & Principal Consultant, Medium Healthcare Consulting, said, “Almost everyone wants to build large, multi-specialty world-class hospitals in metros. It is a very myopic view, since the industry offers significant scope for innovation in alternative business models that are even more profitable and scalable.” He added, “In comparison to other service industries such as hospitality, banking or aviation, critical areas such as marketing and service quality continue to be handled in a fairly primitive manner in most healthcare organizations”.

“Within a few weeks, we have had very encouraging response from diverse players ranging from large, multi-specialty hospitals and small rural community hospitals on one hand to diagnostic services providers and healthcare architectural firms on the other”, he added.

You can visit www.med-ium.com

iSOFT wins US $ 2.78 million deal with Healthscope

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iSOFT, an IBA Health Group company, yesterday announced an agreement with leading Australian private hospital provider Healthscope Limited valued at US $ 2.78 million over three years.

The agreement to implement its iSOFT’s software at 38 Healthscope hospitals is in addition to a US $ 9.27 million agreement in December 2007 for software licences and support services over seven years. The initial agreement included pilot implementations of iSOFT’s web-based patient administration solution at two hospitals. Following the success of these pilots, implementation will start shortly at Healthscope’s remaining hospitals, including Knox Private Hospital in Victoria, Allamanda Private Hospital in Queensland and Mount Hospital in Western Australia.

The implementation services covered under the latest agreement include:

  • project management
  • software installation
  • system configuration
  • training
  • migrating medical records and data from a range of legacy systems

`Dougall McBurnie, Healthscope’s Group Chief Information Officer said: “Given the marked improvements in feature and function from iSOFT’s web-based patient administration solution experienced at the two pilot installations, we have elected to roll-out the solution to all of our hospitals, thus standardising our data sets, configurations and business processes.” He further added, “The ease of implementation of a common group-wide solution and smooth transition to a modern solution with minimal disruption for staff is a huge bonus.

Healthscope, one of Australia’s largest private healthcare operators, owns or manages medical/surgical, rehabilitation and psychiatric hospitals. It also operates a leading pathology business with facilities in Australia, New Zealand, Singapore and Malaysia.

iSOFT, an IBA Health Group company, is one of the world’s largest providers of healthcare IT solutions. It designs, builds and delivers industry-leading software systems that serve the entire health sector. iSOFT’s capacity to embrace change and keep abreast of emerging new directions in healthcare allows its customers to explore the exciting potential of new technologies while securing their existing investments. Today, over 13,000 provider organizations in 35 countries across five continents use iSOFT solutions to manage patient information and drive improvements in core processes. Its solutions are a catalyst for change, increasing efficiencies and providing direct benefits to all stakeholders across the whole spectrum of care. iSOFT’s business is driven by the collective talent, experience and commitment of over 4,000 specialists around the globe. iSOFT Global Development Centres of Excellence in Chennai and Bangalore contribute strategically to this international footprint.

For further details, please contact:

Ramesh Karajgikar

iSOFT – An IBA Health Group Company

Mobile: +91 (0) 97910 35005

Email: ramesh.karagikar@isoftplc.com