Indmedica Home | About Indmedica | Medical Jobs | Advertise On Indmedica
Search Indmedica Web
Indmedica - India's premier medical portal

Journal of the Academy of Hospital Administration

Notes, News and Journal Scan

Author(s): S. Satpathy*

Vol. 17, No. 2 (2005-01 - 2005-12)

Key Messages

  • Global function envisaged for World Health Organisation during 2006-2007 budget discussion
  • Study in UK show that half of the patients in intensive care units receive sub-optimal care
  • Legal provisions bobler data protection & freedom of information in NHS
  • Stem cell therapy-hope or hype? Public debate
  • Four key international Pharma companies sign up an agreement to make clinical trials public
  • New standards for cardiopulmonary resuscitation
  • Patient safety alliance to tackle mandatory Worldwide swp WHO
  • Indian Council for Medical Research to start out technical test
  • Identity in barriers to global development swp world bank

1. GLOBAL FUNCTIONS AT THE WORLD HEALTH ORGANIZATION

J.P.Ruger and D.Yach state in a BMJ editorial that WHO must reassert its role in integrating, coordinating, and advancing the worldwide agenda on health. Delegates from the World Health Organization's 191 member state convened in Geneva in May to review WHO's proposed 2006-7 budget and to priorities the organisation's core functions. This is a good time, therefore, to consider the optimal balance that WHO could strike between its global role in advocacy, surveillance, standard setting, and research as compared with its more operational work in specific countries and regions.

Accelerating globalisation has changed dramatically the context in which WHO works, offering both opportunities and challenges for health and its distribution. The transfer of knowledge and technology and the sharing of best practices, treatments, and health strategies provide real benefits to previously unserved populations. But globalisation has also hastened the spread of infectious diseases. Moreover, aspects of global business have promoted unhealthy behaviours, such as eating unhealthy diets and using tobacco.

WHO's work and functions are defined by its constitution and can be categorised as global, national, and international. Worldwide, WHO can set standards, develop and run international initiatives, provide professional management, manage financial transfers, and build scientific research capacity. It can also promote public health goods for the benefit of all. These goods include leadership and advocacy for health, instruments to protect bio-ethics and human rights, methods for disease surveillance, and application of standards. Examples include WHO's leadership in developing the International Code of Marketing of Breastmilk Substitutes and the Framework Convention on Tobacco Control.

Pluralism in International health

The framework of international health is no longer dominated by a few organisations, and it now involves numerous players. A private and not for profit sector has become an important force in international health as new organisations such as the Global Fund for Aids, Malaria and TB ; the Bill and Melinda Gates Foundation ; and pharmaceutical companies play larger roles. More than 50 private-public partnerships, such as the Global Alliance for Vaccines and Immunizaiton, have been established to tackle specific challenges. International nongovernmental organisations, including among others Medicines Sans Frontieres, Oxfam, and CARE, now work together in health emergencies and disasters and take part in policy development, and in the past two decades the World Bank has had a greater role in health development.

WHO shifts to operational work

But now, despite a growing consensus calling for global solutions, current thinking at WHO reflects a different emphasis. To overcome the glacial pace of drug delivery to patients with AIDS and tuberculosis, WHO's director-general, Dr. Lee Jong-wook, is focusing on shifting staff to countries so that they can work to enhance the distribution of treatments and build up local offices. WHO's "3 by 5" initiative, an admirable effort to increase access to antiretroviral medicines for three million people with HIV in less developed countries by 2005, exemplifies this approach.

A mandate for leadership

A notable exception to these trends is the WHO Commission on Social Determinants of Health, which brings together academics and practitioners to review knowledge and to promote policies to reduce global health inequalities. The commission is fulfilling WHO's agenda-setting role by identifying this issue as a priority for international cooperation and national action.

Future success in implementing WHO's global mandate will depend on considerable investments in internal expertise related to, for example, the Codex Alimentarius Commission, in which WHO and the UN Food and Agriculture Organization will establish international food standards ; the crucial next steps in the Framework Convention on Tobacco Control ; the impacts on health of trade agreements ; and efforts to implement the Global Strategy on Diet and Physical Activity. These areas of work and others urgently need strengthening, and WHO must reassert its role in integrating, coordinating, and advancing the worldwide agenda on health. In the months ahead the executive board must discuss, openly and rigorously, WHO's core functions and mandate. The global health community will eagerly await its conclusions.

(Full text available at BMJ Vol. 330, 14 May 2005, 1099-1100)


2. HALF OF PATIENTS IN INTENSIVE CARE RECEIVE SUB-OPTIMAL CARE

Zosta Kmietowicz reports in BMJ that Consultants need to be more available to supervise emergency medical admissions to improve the care of acutely sick patients.

A study by the charity the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) shows that a quarter of patients who were admitted to intensive care units in England and Wales in one month in 2003 died. Nearly half of these patients received care that was judged to be less than good practice. And deficiencies in care in a third of the admitted patients may have contributed to their death, it says. The charity aims to maintain and improve medical and surgical care. Its report covered all 1677 patients who were admitted to intensive care units in hospitals in England and Wales in June 2003. Of these patients 560 died, and 439 of the deaths were investigated fully by the charity.

In general, senior house officers were left in charge of caring for severely ill patients, especially in the evening and at nightthe busiest time for new admissions to intensive care units, the study shows. In nearly 6 in 10 cases consultants had no knowledge or input into the referral, and one in four patients had to wait for more than 12 hours before being seen by a consultant.

"Patients should rarely be admitted to ICU (intensive care units) without the prior knowledge or involvement of a consultant intensivist," the report says.

Creating new acute physician posts may help in the long term to improve the care of patients who need intensive care, says the report. But in the short term consultants' job plans should reflect the pattern of demand for emergency admissions, especially at the busiest times in the evenings and at night, it recommends. "Provision should be made for planned consultant presence in the evenings (and perhaps at night in busier units)," it says.

The report also calls for better training for junior doctors in how to recognise critical illness and the role of fluid and oxygen treatment in managing emergency patients. It adds that consultants should supervise junior doctors more closely. (BMJ, Volume 330, 14 May, 2005 bmj.com)


3. DATA PROTECTION AND FREEDOM OF INFORMATION IN NHS

Barbara Meredith states in a BMJ editorial that the protection and use of confidential information about patients has had welcome priority in the government's thinking in recent years and becomes more important with the planned introduction of the new NHS care records service. The legal framework for the processing and use of personal information is set out in the Data Protection Act 1998, which makes provision for the protection of privacy and confidentiality of people's personal information. At the other end of the privacy spectrum, openness and accountability in the NHS have been given a boost with the implementation in January 2005 of the Freedom of Information Act 2000. Many members of the public and healthcare professionals are unclear about the details, perhaps even the existence, of both laws and what they mean in practice.

The Freedom of Information Acts (Scotland's was passed in 2002) give people a general right of access to information held by or on behalf of public bodies, which include NHS trusts, primary care trusts, strategic and special health authorities, and other-general practitioners, dentists, opticians, and pharmacists-providing services under parts II or 28C of the NHS Act 1977. The act creates an obligation on these bodies to have a publication scheme showing what information they publish and how it can be obtained. They have to reply to a request under the act for specific information, saying whether that information is held and making it available-subject to some exemptions.

For example, a patient's request to see his or her own health record is not covered by the Freedom of Information Act. Section 40 specifically exempts personal information of the person making the request within the meaning of the Data Protection Act 1998. Even if the request is received as a request under the Freedom of Information Act, public bodies are obliged to treat it as one made under the provisions of the Data Protection Act, which gives people the right to access to their own electronic and paper based health records, subject in most instances to a prescribed fee. Patients do not have an automatic right to see everything-data controllers (the holders of the record) should not reveal confidential information about a third party without that person's consent ; and they do not have to reveal information that they judge would be harmful to the patient.

But in addition to personal information, patients and members of the public have a legitimate right to know more about the activities of arranging and providing NHS services. They can now make a request under the Freedom of Information Act about how decisions were made, for instance on service allocation, overall prescribing patterns, or major capital expenditure. The act is fully retrospective, so people can request information about events at any time in the past.

In addition to personal data of the individual making the request, specific exemptions (subject to a judgement about public interest) include among others the likelihood of creating an actionable breach of confidence around information provided by a third party (section 41) and revealing of trade secrets, or prejudicing commercial interests of any person or body (section 43). A request under the Freedom of Information Act can also be refused if the cost of meeting it would exceed the sums laid down in regulations or would cause unjustifiable workload.

The acts are symbolic of the need in modern societies to protect the privacy and confidentiality of individuals and at the same time ensure appropriate accountability of publicly funded services. At their best the acts should promote improved communication and management of records. The more that is published and the more easily and frequently patients have routine access to information about their health care, the less likely they are to need recourse to the law to get the information they seek.

Many clinicians and health managers are unused to providing information about their performance, which is now open to scrutiny. Some may grudgingly seek to comply only with the letter of the law, and in doing so they may miss the wider potential of the acts to contribute to a patient centred NHS. Legislation on its own cannot bring about a major change in culture. But it can act as a catalyst for improved performance in many ways. At its best, freedom of information should be a marker for openness and accountability in public services. (Full text can be accessed at BMJ Vol.330, 5 March 2005, 490-1)


4. STEM CELL THERAPY: HOPE OR HYPE?

P.Braude, S.L Minger & R M Warwick in a BMJ editorial emphasise that safety and quality must be assured before this treatment can really benefit patients.

The use of human embryonic stem cells has been hailed as the next major step in the battle against serious degenerative disorders, such as diabetes and heart disease, and for some debilitating or lethal neurological diseases, such as Parkinson's and motor neurone disease. News reports and promotional material on websites often convey the impression that this therapy is safe and immediately or imminently available. Whether this is just hype, and how much hope patients should invest in this technology, are issues which were discussed at a public debate in London in May 2005.

Although the number of human embryonic stem cell lines has increased considerably in the past two years, few of these have been well characterised, and large hurdles still need to be overcome to ensure safety and efficacy. These will require substantial further investment and research. Stem cells have not yet been grown in the conditions that would be expected for any pharmaceutical product destined for use in vivo. Even the embryos from which human embryonic stem cells could be derived are still cultured in vitro in the presence of human or animal products. The premature use of cell therapy could put many patients at risk of viral or prion diseases unless systems are in place for the appropriate selection and screening of donors and for quality assurance.

Although those working with stem cells in the United Kingdom have non-statutory guidance in the form of a "Code of Practice" for tissue banks, by April 2006 it will become mandatory for them to comply with the EU directive on tissues and cells. Thus laboratories for in vitro fertilisation and laboratories for producing cell lines with therapeutic intent will have to conform to a new standard of quality even more stringent than the current requirements of the Human Fertilisation and Embryology Authority (HFEA).

The EU directive will cover selection of donors, testing and procurement of the starting material for cell lines, tracking cells from donor to recipient, use of a specified coding system, and reporting of adverse events. The source of all material will have to be traceable even if it is anonymised at the point of production. A policy collaborative group convened by the English Department of Health, working over two years, enabled key stakeholders from across the United Kingdom to develop guidance to support local implementation of the directive : this guidance will be issued this summer. Furthermore, the Medical Research Council has awarded grants to five units performing in vitro in the United Kingdom to help achieve rigorous standards for the production of therapeutic grade embryonic stem cells.

The drive to be the first to provide cell lines for therapy could compromise safety for recipients and could lead this technology into the realms of quackery. Such fears are already being realised in India and Russia, where intervention by the governments may be needed to limit or prevent the escalating numbers of clinics offering stem cell cures for all sorts of ills. Despite inadequate preliminary data on clinical safety or from animal experiments, trials using cells derived from autologous bone marrow samples are already being conducted on patients with heart disease, with urgency and therapeutic need being cited as the reasons for immediate implementation. However, urgency is not an excuse for bad science. Animal experiments should be conducted to understand further the host destination and integration of transplanted cells, and the risks of neoplasia arising in cells implanted into new environments. The ethics of transferring human stem cells into animal hosts in order to develop new therapies for debilitating disorders must be considered as part of the wider stem cell ethical debate.

Commercial companies are springing up around the world with all the fervour of a new "biological dotcom" era, but with selective memory loss for the fact the unrealistically high expectations burst that bubble. We can only hope that any corporate failure to make immediate financial success out of stem cell research does not drag down a promising technology. Stem cell therapy needs to be nurtured safely and methodically to provide real benefit to patients in the future. (Full editorial can be accessed at BMJ Vol. 330, 21 May 2005, 1159-60)


5. DRUG COMPANIES AGREE TO MAKE CLINICAL TRIAL RESULTS PUBLIC

Susan Mayor reports in BMJ that pharmaceutical companies around the world have agreed to make results from clinical trials of new prescription medicines publicly available. The voluntary agreement has been drawn up by the world's main pharmaceutical industry trade associations and agreed by key companies. It states that summary results of completed, industry sponsored clinical trials will be publicly accessible databases, regardless of outcome, for any medicine approved for marketing in at least one country.

The results will be published in a standard, non-promotional summary that will include a description of trial design and methods, results of primary and secondary outcome measures described in the protocol, and safety results. Each company can select the website where they publish trial results, but if they are published in a peer reviewed journal, the database will include a link to the relevant article. The agreement says that the pharmaceutical industry is "committed to increasing the transparency of the clinical trials our member companies sponsor."

Four key international pharmaceutical associations, including the European Federation of Pharmaceutical Industries and Associations, and the Pharmaceutical Research and Manufacturers of America, signed up to the agreement, which will be adopted later this year.

The agreement follows several serious problems with prescription medicines associated with lack of open access to clinical trial results - including the increased risk of cardiovascular deaths resulting in the recent withdrawal of rofecoxib (BMJ 2004;329:816).

Wendy Garlick, principal policy adviser in "Health to Which?", a UK consumer organisation and publisher of Drug and Therapeutics Bulletin, said, "We support the agreement but consider that it should be mandatory - enforced by legislation - and not voluntary."

(Full text can be accessed at BMJ Vol. 330, 15 Jan.2005, 109)


6. NEW STANDARDS FOR CARDIOPULMONARY RESUSCITATION

C D Deaken in a BMJ editorial states that a joint statement, "Cardiopulmonary Resuscitation - Standards for Clinical Practice and Training", has been issued by the Royal College of Anaesthetists, Royal College of Physicians of London, the Intensive Care Society, and the Resuscitation Council (UK). This was endorsed by a further nine healthcare organisations including the National Patient Safety Agency and defines minimum standards for the delivery of resuscitation related services in healthcare institutions. Perhaps the only major omissions from this list are the Royal College of General Practitioners and the Royal College of Obstetricians. This is surprising given that most cardiac arrests occur out of hospital and that cardiac arrest of mothers has a potentially catastrophic outcome. However, the endorsement of these guidelines by so many national professional organisations is a milestone, and their implementation marks an advance in resuscitation practice and patient safety.

The main recommendations of the document form the basis for integrated resuscitation related practice. A local resuscitation committee should be responsible for the delivery of an effective audited response to a cardiac arrest. The committee should determine the level of resuscitation training required by staff, which must be in accordance with national guidelines and standards. Although the document could be criticised for not specifying the individual staff members or specialities that should comprise a cardiac arrest team, it takes a more modern, competency based approach to this contentious area. Evidence that formal structured resuscitation teams improve survival to discharge is limited, but organised cardiac arrest teams improve the rates of return of spontaneous circulation at cardiac arrest and are regarded as best practice. Resuscitation committees need to consider best methods of delivering these resuscitation skills on the background of changes such as the European Working Time Directive and "Hospital at Night" projects, which will limit the availability of appropriate clinical staff.

Adequate funding, particularly of resuscitation officers, is vital to the effective implementation of these standards and is likely to require more investment, particularly in trusts, which already fail to meet current standards on resuscitation set by the Clinical Negligence Scheme for Trusts - a mutual financial pooling arrangement for NHS trusts. With the reduction in junior doctors' hours, the need for regular resuscitation training is likely to exacerbate the workload of trainers further.

The remit of this document extends beyond acute resuscitation procedures. Several retrospective studies have shown that cardiac arrests that occur in hospitals are rarely unheralded and are usually preceded by a physiological deterioration. The main causes of sub-optimal care are failure of organisation, lack of knowledge, failure to appreciate clinical urgency, lack of supervision, and failure to seek advice. These failings have been dealt with in some hospitals by the introduction of medical emergency teams or outreach teams that have been shown to reduce morbidity, mortality, and rates of unexpected cardiac arrest. Recommendations to develop outreach teams should not be viewed as a substitute for adequate clinical teaching and training of junior doctors and nurses who have direct responsibility for the care of patients.

Hopefully these guidelines will improve early identification of patients who may progress to cardiac arrest and the provision of care for patients in whom resuscitation is attempted.

(Full text of the editorial can be accessed at BMJ Vol. 330, 26 March 2005, 685-6)


7. PATIENT SAFETY ALLIANCE TO TACKLE HAND WASHING WORLDWIDE

Nellie Bristol reports in a Lancet report that "Errors in diagnosis, treatment, and medical care are the target of a new international movement to improve patient safety. One month ahead of the initiative's first "challenge" to health leaders, its proponents say patient safety must start with a revolution in hand washing.

Susan Sheridan a patient safety advocate chairs the patient arm of WHO's newly formed World Alliance for Patient Safety. Her goal is to ensure that the collective voice of medical consumers is infused in every strand of the Alliance's efforts. "It's really easy for medical errors to turn into simply bar graphs and statistics", Sheridan notes "But when you bring it down to the human level, from a mom's point of view, from a dad who died at 45, his point of view, I think it's more motivating for health care leaders to become engaged". Sheridan is one of several passionate, energetic forces behind the WHO Alliance, which by all accounts is making remarkable progress in raising the level of awareness on the issue of patient safety worldwide.

The Alliance was officially launched last year in Washington and is poised to issue its first patient safety "challenge" to the world's health leaders on October, 31, in Geneva. Focusing on the issue of infection reduction through a "clean care is safer care" programme, the ground will issue an advanced draft of the first ever evidence-based global guidelines for hand hygiene, developed by an international team of infection control experts led by Didier Pittet, director of the infection control programme for the University of Geneva Hospitals.

To participate in the challenge, health leaders will sign a pledge vowing to take specific steps to reduce health-care associated infections in their own countries. The Alliance hopes to issue a new challenge every 2 years, while still continuing to support projects already under way.

The hand hygiene guidelines will promote a "systems change" of using alcohol-based solutions rather than soap and water to clean hands, according to Pittet. He adds that WHO is developing an alcohol-based formulation for healthcare settings that countries will be able to manufacture themselves and that will include quality control mechanisms that can be applied worldwide.

The guidelines will be finalized only after they have been tested in various WHO regions and different health-care settings. The Alliance decided on infection control as its first challenge because the problem is universal and the solution is not expensive. "We wanted something that was of relevance to both developed countries and developing countries", Sir Lian Donaldson the Alliance Chairperson explains.

Several other error-prone areas were considered, including medication mistakes and equipment failures, but Donaldson says the Alliance "decided on health-care infection because we thought it was an even bigger problem and it has a very different character in different countries of the world". To the extent possible, the Alliance will strive to make the patient safety programme achievable everywhere, "ensuring patient safety is seen as a challenge for everybody and not just happened to have made the early running with research and interest in it", Donaldson notes. Alliance adviser and USA patient-safety expert Donald Berwick, President and CEO of the Institute for Healthcare improvement in Boston, says some changes may actually be easier to make in developing health-care systems, and could save them money.

Some improvements are as basic as overhauling record keeping systems and simplifying procedures, Berwick says. "I really do believe that improvements in quality of care generally and safety in particular are within reach in resource poor settings", he adds.

Kenya is one of 140 countries that have expressed interest in Alliance efforts so far. Recent events included the designation of the US-based Joint Commission on the Accreditation of Healthcare Organizations and Joint Commission International to facilitate identification and disseminating of patient safety solutions. The Alliance is also planning a "Patients for Patient Safety" workshop in late November in London.

Patients will be among teachers in the Alliance, even if they are sometimes only reluctantly included by health-care leaders. "Initially, we get a push back because it's a new area, it's a new thought... it's maybe a little threatening", Sheridan says. But she adds, after a few days she sees an evolution in acceptance, particularly when it's made clear that patients will be partners instead of adversaries in reform efforts and when providers start to see the value of patient experiences.

(The full article is available at Lancet Vol. 366, Sep. 17,2005 p973-974.)


8. INDIA PLANS TO AUDIT CLINICAL TRIALS

Ganapati Mudur reports in BMJ that The Indian government has announced a plan to set up a registry and to audit some clinical trials after being dogged for years by controversies over illegal and unethical trials. The Indian Council of Medical Research will establish a registry of clinical trials conducted in the country, and drug regulators will scrutinize trials to ensure compliance with ethical guidelines and good clinical practice, officials said last week.

The health ministry has begun training drug inspectors to audit trials, Ashwini Kumar, the Drugs Controller General of India, said. "But it won't be easy, because we don't have a culture of policing doctors," Mr. Kumar said after a two day, closed conference of government officials, industry representatives, and doctors that was called to consider India's capacity for clinical trials.

Nearly 100 trials are currently under way in India as part of international multicentre studies to evaluate drugs, Mr. Kumar said. Although India's large numbers of patients and doctors make it an attractive site for trials, experts at the conference warned that the country is largely unprepared for the expected expansion of trials.

A survey by the Indian Council of Medical Research earlier this year showed that one in two institutional ethical committees had a chairman or chairwoman from the parent institution, creating potential for a conflict of interest. Only 40 of 179 committees follow prescribed guidelines. The council had drafted ethical guidelines for medical research more than five years ago. "But legislation to enforce guidelines and introduce penalties for violation is pending," said Vasantha Muthuswamy, the council's deputy director general.

Over the past decade public sector and private doctors in India have conducted several clinical trials without regulatory approvals. Between 1998 and 2000 surgeons in a north Indian city injected vascular endothelial growth factor in patients with heart disease (BMJ 2001; 322:1142). Four years ago government doctors teamed up with a researcher at Johns Hopkins University, Baltimore, Maryland, in an illegal trial of a cancer drug BMJ 2001;323:299).

9. INEQUALITY IS BARRIER TO GLOBAL DEVELOPMENT, SAYS WORLD BANK

Owen Dyer reports in a BMJ report that Inequality is the primary barrier to global development, and only welfare systems providing health and education to the poorest can tackle the problem, the World Bank's annual World Development Report said this week. The report echoes the findings of the UN Human Development Report released earlier this month, in criticizing the "trickledown" model of international development (BMJ 2005;331:593, 17 Sep).

Inequalities within countries are almost as significant as inequalities between them, the report says, citing the example of infant mortality. "In the 45 developing countries for which a demographic health survey was available in 2000, 4.9 million infant deaths could be prevented by bringing their infant mortality levels to the [Organisation for Economic Cooperation and Development] average. But if one eliminated the infant mortality gap between the rich and the poor within each of the same countries by lowering the infant mortality rate for everyone to the level of the top decile, 3.1 million infant deaths could be prevented."

In the field of health, "Insurance markets for catastrophic health problems are beset with failures... what can work better is public provisioning or regulation that provides some insurance for all. Examples include risk pooling in Colombia, health cards in Indonesia and Vietnam, and Thailand's '30 baht' universal coverage scheme."

The authors also urge an end to unfair trade practices, including subsidies given to Western farmers. The TRIPS (trade related aspects of intellectual property rights) agreement, which gives 20 year patent protection to pharmaceutical companies, "is perceived by many to be grossly inequitable". The losses to Western pharmaceutical companies are negligible when their patents are infringed in developing countries, yet the local gains are considerable. The report criticises recent bilateral agreements between the United States and Chile, Jordan, Morocco, Singapore, Vietnam and others, which grant "patent extensions on pharmaceuticals... it is hard to argue that the parties to these various bilateral and multilateral agreements were on a level playing field".

Paul Wolfowitz, the World Bank president, echoed the call for fair trade in a speech that he gave at the United Nations' summit in New York last week, and expressed concern that the UN's millennium development goals would not be achieved.

The report is available at www.worldbank.org.


* Associate Professor, Department of Hospital Adiministration, AIIMS

Access free medical resources from Wiley-Blackwell now!

About Indmedica - Conditions of Usage - Advertise On Indmedica - Contact Us

Copyright © 2005 Indmedica