The Cure That Kills11 April 2008 Laura Baker
Healthcare workers and patients in the developing world are still exposed to infection during injection procedures. Ron Stoker and Laura Baker examine efforts to bring Africa's poor record on injection safety to an end.
A hospitalised patient becomes agitated and tries to remove the intravenous (IV) catheters in his arm. Several hospital staff members struggle to restrain the patient. During the struggle, an IV connector needle is pulled and exposed. One of the nurses recovers the needle and attempts to reinsert it when the patient kicks her arm, pushing the needle into the hand of a second nurse. The nurse who sustains the needlestick injury tests positive for HIV several months later.
A tragic slip like this can have serious or even fatal consequences. Needles and syringes are still claiming lives and spreading infection when they should be saving them. And while laws are rolling out to protect health professionals in Europe and North America, health workers in resource-poor developing countries are still being exposed to occupational harm.
This article examines the health risks posed by unsafe injections in Africa and outlines some of the programmes that are helping reduce these risks.
Needlestick injuries are among the most common injuries to healthcare professionals all over the world. The World Health Organisation (WHO) reported, in its 2002 World Health Report, that of the 35 million health workers in the world, two million experience a percutaneous exposure to infectious diseases every year. WHO regional reports suggest that, on average, a health worker receives four needlestick injuries per year.
The scale of the problem has prompted some governments to respond with policies to protect healthcare workers from this occupational hazard, most recently in the EU. But implementation lags behind policy, and in the meantime, infections quietly spread, while the isssues of stigma and non-disclosure remain.
HIV infection is still the headline grabber, but the spread of hepatitis is arguably the bigger problem. Over 40% of hepatitis B and C cases in healthcare professionals around the world are due to needlestick accidents.
Such accidents are tragic, but the deeper tragedy is that it is not just accidents that are causing disease and trauma. The practice of deliberately reusing syringes, whether through industrial-scale illegal recycling or bedside reuse, remains rife in many developing regions of the world. WHO estimates that syringes are reused seven times on average in developing countries.
Combine this with a strong tendency for doctors to over-prescribe injections and for patients to demand injections and you have a silent epidemic of iatragenic infection. WHO estimates that 1.3 million people die every year as a result of these infections. Unlike needlestick injuries, these infections are not accidents.
The problem is exacerbated by the fact that many patients don't know where the illnesses that afflict them come from. There is no reason for them to associate medical treatment they have received with subsequent illness. Much disease goes unreported and untreated. Equally, many patients are unaware of the simple protective steps that can save their lives when they visit a local doctor or quack – such as making sure that the syringe comes from a sealed packet and that it is disabled and put in a sharps box after use.
The real tragedy is that the agent of infection is often medical treatment itself. This was the case in an infamous schistosomiasis campaign in Egypt, when the reuse of syringes led to a doubling of the hepatitis C rate, and also in Russia and Romania, where scores of children were infected with HIV as a result of medical treatment.
However, there are a couple of bright spots in this rather bleak picture. Two public health programmes have done more than any so far to end unsafe injection practices around the world and prevent this wholly unnecessary burden of disease. The first is the immunisation campaign by UNICEF, WHO and partners, who since 1999 have implemented a policy of using only auto-disable syringes, bundled with safe-disposal boxes, for immunisation campaigns. These syringes disable themselves so that they no longer function after one injection – there is a physical barrier to their reuse. Over a billion of these safety syringes are procured and used every year.
But immunisations represent only one in 20 injections given. The remaining 95% form a far messier, heterogeneous collection of curative injections, and they have been ignored on the whole.
The second welcome initiative is a programme by the US President's Emergency Fund for AIDS Relief (PEPFAR). This has paved the way for inroads in curative injection safety in 11 countries under the Making Medical Injections Safer project.
But why has the problem of unsafe injections – whether through deliberate syringe reuse or accident – remained unaddressed? A number of factors have been blamed for the low priority being given to finding a solution: the high cost and limited availability of safer devices; the ease of use of existing devices; the low level of general awareness of the infection risk; and, as ever, a compelling list of competing problems to solve.
Injections are one of the most commonly used – and over-used – interventions in healthcare. Recent surveys in India and Pakistan have reported that over 95% of injections given there are unnecessary. Injection safety must be the foundation of effective healthcare systems – it should be a top priority. If not, the value of medical interventions that require injections is undermined.
The medical device industry is keen to provide technology solutions that address the problem of unsafe injections – although, to date, these have come at a price. Healthcare professionals are, quite rightly, vocal about their rights, and are demanding solutions, both in terms of better training and safer devices. Unfortunately, governments have been slow to enact legislation to protect healthcare providers and slower to enforce it.
The Needlestick Safety and Prevention Act passed in the US in 2000 was belatedly followed by a similar occupational health ruling in the European parliament in 2007, but national implementation plans for the European legislation remain poorly defined. Meanwhile, healthcare professionals in the vast majority of countries remain woefully unprotected and health bodies remain free to discriminate against safe practices in the name of budgeting.
To date, safety products have been marketed as premium products to wealthy countries, whereas what is really required is a range of inexpensive solutions. Fortunately, some new products are now coming to market, from companies such as Star Syringe, that are simple and cost-effective enough to allow mass adoption in poorer countries.
So let us consider the products available to protect patients and healthcare workers from infection, caused by either syringe reuse or accidental needlestick injury.
The landmark 1999 policy shift by UNICEF and WHO required the procurement of regulated devices, and in 2005 a standard was issued by ISO for auto-disable immunisation syringes. A number of devices meet this standard, but all essentially work by having some feature that prevents refilling – the plunger of the syringe may lock after a full injection, for example. More complex devices draw the needle back into the body of the syringe so that refilling is prevented and the sharp is permanently and safely housed.
However, syringes are commodities, competing at various price points, and adding extra components adds to the cost. Moreover, the new, safer devices are designed for the narrow immunisation market. Billions of donor dollars have been poured into vaccines and their delivery to reduce the huge death toll from preventable childhood diseases, and great strides have been made in improving immunisation coverage and safety, but attention must now be turned to the great mass of largely unregulated injections: curative injections. After all, what is the point of protecting children until the age of five and then leaving them at the mercy of a sub-standard health system that routinely reuses equipment and spreads disease?
The PEPFAR programme, by applying safe injection principles to curative injections in its target countries, created the need for an ISO standard to cover injection devices for non-immunisation injections. Finally, in 2006, the 7886-3 standard was published. The standard was watered down to include so-called reuse prevention devices that do not automatically disable, like immunisation syringes, but instead require an active step to disable them, but the standard did help bring new safety products to market.
The Star Syringe-designed K1 syringe has supplied most of the PEPFAR programme's syringe needs since its inception, and the syringe is now the global standard for auto-disable syringes. K1 uses the same design mechanism regardless of the size of the syringe or dose, so unlike competing devices, it can be used for both immunisation and curative injections. The simplicity of the design makes it more cost-effective and easy to use than its rivals. K1 is produced under licence and brand marketed by 15 independent manufacturers all over the world under a technology transfer arrangement supported by the UN.
However, gaps in regulation persist. International standards should be established for a passive auto-destruct safety syringe that can only be used once.
Injection safety has been a low priority in public policy, but this situation is changing. A UK-based charity called SafePoint Trust, working with national governments, WHO, donors and other implementing agencies, has developed the Smart Injection Programme, a national programme that calls for the introduction of a simple package of four components to eradicate unsafe injections. The programme proposes:
- The universal adoption of safe injection devices that meet international standards
- The use of matching safety boxes for the disposal of injection devices
- The implementation of a training package for healthcare workers
- The introduction of an awareness programme for the general public
So far ten countries in Africa have signed up to a resolution proposed by SafePoint, calling for injection safety to be made an immediate priority and addressed according to the principles of the Smart Injection Programme, scaling up existing best practice in the countries involved. Uganda, Kenya, Zambia, Malawi and Tanzania are at the forefront of this movement. Uganda is a leading proponent of injection safety in the world, and was the first country to ban the import of standard disposable syringes in 2007 in favour of the blanket use of safety syringes. HIV rates have fallen from over 15% in the 1990s to a stable 6% today.
All too often people want to focus on complex, 'sexy' programmes at the cutting edge of medical interventions, while they ignore the mundane essentials of hygiene and basic health precautions. But as WHO's focus on clean care is showing, a back-to-basics approach is simply essential, and it is reaping rewards. An increased focus on basic steps to prevent infection, from policy level through to clinical implementation, should follow.
The Smart Injection Programme is one framework that draws in many existing players to form a coherent and universal platform for progress. Meanwhile, SafePoint is working with a whole network of established partners to bring a global resolution on injection safety to the World Health Assembly and, later, the United Nations General Assembly.
Everyone is entitled to safe and effective healthcare – it is a human right. Those who want to help stop unsafe injections of all kinds causing unnecessary harm must support the professional medical associations in calling for this resolution to be taken to the global level, so that it can afford protection to patients and healthcare professionals, regardless of where they work and live.