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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