July 27, 2013

The story of one million lives lost

Source: Fri, 26 Jul 2013 08:15 AM

Author: Ding-Shinn Chen, CEVHAP

On Sunday advocates, patients, clinicians and a growing number of government representatives will come together in support of World Hepatitis Day, an annual event endorsed by the World Health Organization (WHO) that aims to raise awareness of viral hepatitis among at-risk groups.

The need for raising awareness of viral hepatitis is immense. Indeed, although the transmission of viruses that cause hepatitis is preventable, we now know that the number of people dying globally every year from these viruses has increased from approximately 986,000 in 1990 to more than 1.4 million people today. This is a similar number of people that die each year as a result of HIV/AIDS.

The situation is graver in the Asia Pacific region, where the data shows that 70 percent of all worldwide deaths related to viral hepatitis occur. That means that in Asia, one million people die needlessly every year and on average one person dies every 30 seconds. These figures - from the Global Burden of Disease Study (GBDS) by the University of Washington’s Institute for Health Metrics and Evaluation - were presented for the first time in Asia in June 2013, at the Liver Week conference of the Asian Pacific Association for the Study of the Liver (APASL).

An important part of a worldwide movement to halt this death toll, World Hepatitis Day aims to raise awareness of how hepatitis is transmitted and to prevent the many millions of new infections that occur each year. The event addresses the abysmally low awareness levels that surround these diseases, which mean that in the case of South East Asia around 65 percent of people living with chronic hepatitis B, and 75 percent with hepatitis C, are unaware they are infected.

The significant number of undiagnosed people explains why - despite the existence of an effective vaccine for hepatitis B and treatments for chronic hepatitis C that could save millions of lives - the number of people dying from viral hepatitis continues to rise. Fundamentally, a large proportion of people are diagnosed late - once they start to have symptoms and become ill. It is only then, when their infection has led to liver cirrhosis or liver cancer, that they discover the infection they have carried, usually for many years. Unfortunately, by the later stages of the disease, treatment options are more limited.

Viral hepatitis represents one of the world’s greatest threats to health, and yet these diseases remain low on the global and Asia health priority list, falling way behind other diseases such as HIV, tuberculosis (TB) and malaria. These new figures reveal the increasing threat posed by viral hepatitis to the Asia Pacific region and are symptomatic of the poor understanding and lack of political commitment that has typically surrounded these diseases in many countries.

In defence of government policymakers, however, there has been a distinct lack of categorical evidence needed to guide policy development and justify the required investments. We now have the evidence we need to prove that viral hepatitis is an urgent public health priority in Asia. On World Hepatitis Day, the Coalition to Eradicate Viral Hepatitis in Asia Pacific (CEVHAP) is urging governments to embrace the blueprint contained in the WHO’s new Global Framework for Action.

The WHO’s framework was first launched on World Hepatitis Day 2012 and, recognising that each country will face a different set of challenges, provides a guide for governments to develop their own nationally-coordinated action plans to tackle viral hepatitis. The WHO framework represents a comprehensive strategic policy approach, and over the last year, many of our members have held encouraging discussions with ministries of health across the region, a number of which have expressed interest in strengthening their country’s response to viral hepatitis.

The success in implementing the framework within countries requires, however, the realisation that many countries, particularly in the Asia Pacific region, are resource-constrained and that funding issues present a significant barrier to their ability to implement lasting measures to reduce the burden of disease. The recent formation of WHO’s Global Hepatitis Network provides governments with access to the expertise needed to translate this framework into national action plans and public policy, but its work will require funding, and many governments will need support to build capacity and mobilise resources.

In the past, we have seen what can be achieved when governments, the medical community, donor organisations and civil society come together in a collective response to spur change and secure funding through the global response provided by UNAIDS, the Stop TB Partnership and Rollback Malaria Partnership. Viral hepatitis lacks a major international funding structure to resource the change that is needed to implement the framework within individual countries. On World Hepatitis Day, our members will ask governments to embrace the WHO’s new global framework and CEVHAP will offer our support, but we need international commitment.

In Asia Pacific, World Hepatitis Day is a story of one million lives lost every year, but it simply does not need to be that way. We can save lives if all people who are touched by viral hepatitis work together, but our human resources alone are not enough. Development agencies, governments and donor bodies must also come to the table and designate viral hepatitis as a funding priority if we are to reverse the escalating impact of these silent but destructive diseases.

Ding-Shinn Chen is the chairman of the Coalition to Eradicate Viral Hepatitis in Asia Pacific (CEVHAP).

Any views expressed in this article are those of the author and not of Thomson Reuters Foundation.

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Don’t use used syringes

By Dr Arshad Altaf Published: July 28, 2013

According to the World Hepatitis Alliance, which is commemorating the World Hepatitis Day on July 28, there are 500 million people worldwide infected with hepatitis B or C, a number which is much higher than those suffering from HIV or any cancer. Pakistan is among those countries, which has one of the highest rates of hepatitis B and C infections. A national study in 2007 estimated that there are 12 million Pakistanis infected with these two life-threatening infections. The nationwide prevalence of hepatitis B is 2.5 per cent and that of hepatitis C is 4.9 per cent. Both these infections can be life-threatening and even if the treatment is provided free, it is a complicated and lengthy process with a varying success rate and has some very serious side-effects. While there are multiple causes of transmission of hepatitis B and C, ranging from unsafe blood transfusion, use of unsterilised surgical equipment, unsafe dental procedures, ear piercing or tattooing and shaving by barbers, the most established risk based on epidemiological research is unsafe injection practices by healthcare providers.

The World Health Organisation defines a safe injection as one that does not harm the recipient or the provider and does not result in waste that is dangerous to the community. Unfortunately in Pakistan, unsafe injection practices are very common and MBBS doctors, as well as untrained ones (quacks), prescribe unnecessary injections to patients. Another dangerous aspect is the reuse of single-use disposable syringe for economic reasons. Often the patient is so poor that she/he cannot afford to pay extra or the practitioner has a package deal in which some cheap medicines and an injection is part of the prescription. The reuse of disposable syringes still happens in Pakistan in this day and age, and is an intentional practice on part of the provider. The Safepoint Trust describes this practice in the following manner: “Syringe reuse is quite literally murder on a global scale.”

The Sindh government is sensitised on the issue and has been cognisant of this life-threatening practice. The Sindh cabinet approved the draft and the Sindh Assembly passed the Sindh Regulation and Control of Disposable Syringe Bill, 2010 on January 12, 2011. It has also become an Act of the Legislature of Sindh. The full Act is available at the official website of the Sindh Assembly. This action on part of the previous government must be appreciated as to the best of our knowledge, no other province has gone through this exercise.

The main clause of this Act under the heading of “Restriction” states that “no person shall manufacture, sell or use disposable syringes other that auto lock, auto destruct or auto break for injection, drawing of blood and other purposes.”  Under the heading of “Offence and Penalty”, it states that all directors, managers, secretaries or agents shall follow this Act, and those contravening will be punished with imprisonment for a term that may extend to two years or a fine which may extend to Rs500,000 or with both.

The key reason to pass this bill was to control the reuse of single-use disposable syringes, which as mentioned earlier, has been strongly associated with the spread of hepatitis B and C infections. Unfortunately, there are areas which still need improvement.

For the ease of readers, it should be clarified what an auto disable (AD) is. It is a type of syringe that was specifically developed to restrict the reuse on part of the providers. The syringe has a mechanism, which if used correctly, can make it difficult to reuse it after a single use. At the end of the procedure i.e., after administering an injection, a small force is applied on the plunger and there is a click sound, which practically locks the plunger, making the syringe hard to reuse. In many developed countries, the use of AD syringes is mandatory by law in healthcare settings.

Now coming to the gaps in the Act. The first major weakness is its lack of implementation. To the best of my knowledge, majority of public sector hospitals are still using and tendering conventional disposable syringes. It is safe to assume that medical superintendents or purchase departments are violating the law and can easily go to jail or be liable to huge fines. Most of these persons are probably not even aware of the Act.

The other problem in this Act pertains to the selling and manufacturing of AD syringes. Even though it states that no person shall manufacture or sell syringes other than AD, the Act has overlooked a very important condition, which is that the syringe has to conform to the standard set by the International Organisation for Standardisation Standard (ISO) 7886-4. Accordingly, the manufacturer of the syringe should also comply with the ISO Quality Systems Standards for Medical Devices Manufacturing ISO 13485. The language of this Act is such that at the moment, any supplier or manufacturer can provide any type of AD syringe and no one can legally question its quality or standard of manufacturing.

As an injection safety advocate and researcher, a major gap that I see in this Act is that it does not address the intentional reuse of syringes by healthcare providers. As mentioned earlier, this practice is still around and must be addressed in the form of a law. Prior to devolution, a team, of which I was a part, and other highly trained public health professionals, worked on several drafts of a similar kind of legislation. Even though it got stuck in the government’s bureaucratic system, it properly addressed this practice in detail. The poor and uneducated patient is often unaware of this kind of practice and rarely asks the provider if the syringe is new and opened from a sealed packet. No legislation is available in the province or at the national level, which addresses this issue.

In the end, to reiterate, it must be mentioned that this Act has some serious weaknesses in it. While it was being compiled, technical and public health experts should have been consulted. Making amendments in an existing legislation is a formidable task, knowing the political culture and wranglings that go around in the provincial legislature. Who will take the lead, who will revise it and who will improve it, remains a question for all concerned. One practical way is to form a provincial health promotion legislation committee, which should comprise relevant members of the provincial assembly, as well as public health professionals. They can work collectively to address weaknesses and gaps, and make improvement in this Act, which I am sure, was passed with all good intentions.

Published in The Express Tribune, July 28th, 2013

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Tropical Medicine & International Health

Early View (Online Version of Record published before inclusion in an issue)

Editorial

C. Gore1, J. V. Lazarus2,*, R. J. J. Peck1, I. Sperle2, K. Safreed-Harmon2

Article first published online: 23 JUL 2013

DOI: 10.1111/tmi.12151

© 2013 John Wiley & Sons Ltd

Keywords: hepatitis; injecting practices; public health; World Health Organization

In 2012, we sought responses from all 194 World Health Organization (WHO) Member States for the WHO/World Hepatitis Alliance Global Hepatitis Survey (World Health Organization 2013). While the full survey results will be released on 28 July 2013, World Hepatitis Day, we feel that it is imperative to draw attention to one finding with potentially far-reaching public health implications. Only 7 of 126 Member States that responded to the survey were able to provide data for the following question: ‘What are your government's official estimates of the number and percentage of unnecessary injections administered annually in healthcare settings?’ Another 6 respondents skipped the question, and 113 – almost 90% – answered ‘do not know’.

It is dismaying to learn that such a large number of countries do not appear to have these data available in light of what has been documented regarding injection overuse in developing countries. Much of the evidence is from the 1980s and 1990s, but more recent studies in China and Egypt found unnecessary health facility injection rates of 57% and 95%, respectively (Yan et al. 2006; Bodenschatz et al. 2009). A 2006 Pakistani study estimated that 94% of therapeutic injections nationally are unnecessary (Altaf et al. 2009). A 1999 review article summarising earlier evidence noted levels of unnecessary injections ranging from 70% to 99% in various patient populations in India, Indonesia, the Russian Federation and Tanzania (Simonsen et al. 2006).

The findings from the recent global hepatitis survey are a stark reminder of the persistence of this danger. In our survey, the three highest national estimates for the proportion of unnecessary injections were 68% (Mongolia), 50% (Cambodia) and 20% (Pakistan). These figures, coupled with the absence of data from many other countries, raise the question of whether progress is being made on reducing unnecessary injections, which WHO identifies as a key strategy for reducing injection-associated disease transmission (World Health Organization 2010).

Simonsen et al. (1999) define an unnecessary injection as ‘one where oral alternatives are available, where the injected substance is inappropriate or harmful or where the symptoms or diagnosis do not warrant treatment by injection’. The literature on this phenomenon indicates that a complex array of factors may influence the decision-making of both patients and healthcare providers. Providers may recommend injections and patients may welcome them because of widespread misconceptions about injected medications being stronger or more effective than other types of treatment (Safe Injection Global Network 1999). Even providers who know otherwise may feel pressured by patients to administer injections (Kotwal 2005; Safe Injection Global Network 2011) – and may be concerned that withholding injections will undermine their professional credibility (Kotwal 2005; Chowdhury et al. 2011). Furthermore, it has been suggested that some providers may be motivated to administer injections because of the profitability of this practice (Safe Injection Global Network 2011).

We contacted the five Member States with national estimates of unnecessary injection levels of 5% or higher to obtain more information about why unnecessary injections occur. Three of them – Cuba, Mongolia and Pakistan – responded to this request, while two – Cambodia and Guyana – did not. (The two other Member States that reported national estimates of unnecessary injection levels were Denmark and Tonga, both of which indicated that no unnecessary injections take place).

Respondents were given several possible reasons for the occurrence of unnecessary injections and were asked to choose ‘yes’, ‘no’ or ‘do not know’ for each one. All three countries indicated that healthcare workers believe injections to be more effective. Two indicated that patients prefer injections rather than oral medication. One indicated that oral equivalents are unavailable, although the other two indicated that this is not a reason for why unnecessary injections occur. Additionally, one country selected each of the following as a reason: healthcare workers believe that patients expect injections; healthcare workers are paid more for injections; and better adherence can be achieved through the use of injectable medicine as opposed to the oral equivalent. The survey also asked for examples of ‘a drug that is typically injected when a cheaper oral equivalent is also available’. Responses included antibiotics, diclofenac and vitamins.

It is our hope that the global hepatitis survey findings about unnecessary injection rates and follow-up survey findings will rekindle interest in a problem that may be causing widespread unnecessary suffering. In 2008, an estimated 14% of HIV infections were attributable to unsafe injections, as were 25% of hepatitis B infections, 8% of hepatitis C infections and 7% of infections with bacteraemia. These estimates collectively represented 28 million disability-adjusted life years (DALYs) (Safe Injection Global Network). Therefore, if even one tenth of unsafe injections globally in 2008 were cases in which the injection was not warranted, this would translate into a disease burden of 2.8 million DALYs attributable to unnecessary injections.

In actuality, it appears that estimating the global disease burden attributable to unnecessary injections would be a difficult task if at least 119 countries do not have national estimates for unnecessary injections. The lack of data gives rise to the first of four recommendations regarding how to reduce unnecessary injections. Tracking the incidence of unnecessary injections – understood as providing an injection when an oral equivalent is available – at the country level is essential for determining the magnitude of the problem and measuring progress on the response. Governments are urged to incorporate this metric into ongoing health system monitoring, including tracking it as a mode of transmission for all bloodborne viruses.

Our second recommendation calls for a more concerted global effort to reduce unnecessary injections. This issue is already on the agenda of the Safe Injection Global Network (SIGN), which since its inception in 1999 has provided leadership in the campaign to reduce unsafe injections. Given that SIGN and WHO now have a toolkit and other resources in place to help countries address the general problem of unsafe injections (Safe Injection Global Network), it is logical to focus more on increasing awareness of the contribution of unnecessary injections to disease transmission. Furthermore, the toolkit might be expanded with tools such as a global guidance document that informs decision-making around whether injections are warranted and identifies commonly injected medicines that should be replaced with oral equivalents. The latter might require WHO to carry out a review of the evidence regarding oral versus injectable drugs. Guidance is also needed on how to stage information, education and communication interventions to change perceptions among both health providers and the general public in regard to the role of injections in health care.

As for our two other recommendations, an informative body of evidence provides insight into the behavioural, economic and structural drivers of unnecessary injecting in healthcare settings, but the majority of these studies are more than a decade old. Health systems in many countries have undergone extensive changes in recent years, and research is needed to illuminate the dynamics behind current injecting practices. Finally, with the intensification of efforts to reduce unnecessary injections, research will also be needed to measure progress and to refine interventions, with particular attention given to how interventions should be adapted to address different drivers of the problem in different countries and cultures.

WHO research indicates that interventions to reduce unnecessary injections are cost-effective, as are interventions combining these activities with efforts to also reduce unsafe injections (World Health Organization 2003). WHO, SIGN and government authorities must work in collaboration with medical associations, nursing associations and civil society partners such as patient advocacy groups to take stock of this problem and develop country-specific strategies for its resolution. The WHO Director-General's upcoming injection safety initiative has the potential to serve as the backbone of this effort by increasing the global focus on unnecessary injections. Strong leadership on this issue is a moral imperative: it is simply unacceptable for the provision of medical treatment to be a pathway for large-scale disease transmission, suffering and death.

References

Altaf A, Janjua NZ & Hutin Y (2006) The cost of unsafe injections in Pakistan and challenges for prevention program. Journal of the College of Physicians and Surgeons Pakistan 16, 622–4.

Bodenschatz C, Talaat M, Kandeel A, Lohiniva AL, Radwan E & Mahoney F (2009) Injection prescribing patterns in public health care facilities in Egypt. East Mediterranean Health Journal 15, 1440–8.

Chowdhury AK, Roy T, Faroque AB et al. (2011) A comprehensive situation assessment of injection practices in primary health care hospitals in Bangladesh. BMC Public Health 11, 779. doi: 10.1186/1471-2458-11-779.

Kotwal A. (2005) Innovation, diffusion and safety of a medical technology: a review of the literature on injection practices. Social Science and Medicine 60, 1133–47.

Safe Injection Global Network (2011) Advocacy Booklet. http://www.who.int/injection_safety/sign/sign_advocacy_booklet.pdf.

Safe Injection Global Network. Report of the SIGN2010 meeting. http://www.who.int/injection_safety/toolbox/sign2010_meeting.pdf.

Simonsen L, Kane A, Lloyd J, Zaffran M & Kane M (1999) Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bulletin of the World Health Organization 77, 789–800.

World Health Organization (2003) Managing an injection safety policy. http://www.who.int/injection_safety/toolbox/en/ManagingInjectionSafety.pdf

World Health Organization (2010) WHO best practices for injections and related procedures toolkit. http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf

World Health Organization (2013) Global Policy Report on the Prevention and Control of Viral Hepatitis in WHO Member States Geneva.

Yan Y, Zhang G, Chen Y, Zhang A, Guan Y & Ao H (2006) Study on the injection practices of health facilities in Jingzhou district, Hubei, China. Indian Journal of Medical Sciences 60, 407–16.

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World Hepatitis Day: 28 July 2103

225px-WHD_Globe

26/07/2013

The European Medicines Agency supports World Hepatitis Day, which is taking place on Sunday 28 July 2013.

World Hepatitis Day is held every year on 28 July to provide international focus for patient groups and people living with hepatitis B and C. It aims to raise awareness and influence change in disease prevention and access to testing and treatment.

The World Hepatitis Alliance first launched World Hepatitis Day in 2008. The Alliance is a non-governmental organisation that represents hepatitis B and hepatitis C patient groups from around the world. The World Hepatitis Day is organised in partnership with the World Health Organisation (WHO).

Hepatitis B and C are caused by viruses that infect liver cells. Both diseases can lead to inflammation, scarring and cancer of the liver if left untreated. Viral hepatitis affects 500 million people worldwide and kills 1.4 million people every year.

The European Commission has authorised eight medicines for the treatment of chronic (long-term) hepatitis B and eight medicines for chronic hepatitis C on the recommendation of the Agency's Committee for Medicinal Products for Human Use (CHMP).

Among the medicines for hepatitis C recently authorised, two medicines in a new class called protease inhibitors attack the hepatitis C virus directly, in contrast to older medicines which work by stimulating the immune system to attack the virus.

The European Commission has also authorised ten vaccines for protection against hepatitis B infection for use in the European Union (EU).

The CHMP is currently evaluating the benefits and risks of a new vaccine for the protection against hepatitis B infection and two antivirals, a protease inhibitor and a polymerase inhibitor, for the treatment of chronic hepatitis C.

The Agency also publishes guidelines for pharmaceutical companies, describing how they should design and carry out studies of medicines for the treatment of hepatitis B and C. The Agency released a draft guideline on the clinical evaluation of medicinal products for the treatment of chronic hepatitis C in 2011 and a draft guideline on the clinical investigation of hepatitis-B immunoglobulins in 2012 for six-month public consultations. Comments received on these draft documents are currently under review.

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