Ensuring safe Injectible
There is a need to facilitate a safe injection environment to improve the healthcare delivery system and elucidates on the means to enable it
Today injections are among the most common of all clinical procedures. Billions and Billions of injections are administered every year to facilitate preventive and curative care. Yet, in a majority of developing countries almost half of these injections are unsafe due to reuse of single-use syringes and/ or needles, faulty technique, and poor disposal methods.
These faulty handling issues expose patients, healthcare practitioners and the public, at large, to the risk of transmission of infections, which cause a significant drain on the health of individuals, the healthcare system and the community. Unsafe injection practices exert a very significant impact on the health of patients, caregivers (healthcare practitioners) as well as the entire healthcare system.
World Health Organisation says that a safe injection does not harm the recipient, expose the provider to any avoidable risks, or result in waste that is dangerous for the community. A safe injection environment must therefore take into account the patient, the caregiver, the community and the environment. Patient safety is seriously compromised by inappropriate use of injection devices. A 2005 study to assess injection practices in India showed that nationwide 62 per cent of all injections were unsafe due to improper sterilisation, reuse or faulty administration,1 making them a leading cause of healthcare associated infections (HAIs) – infections that a patient gets from the very healthcare facility and procedure that he visited to get well.
Hence, collaborative efforts of key stakeholders are imperative to promote a safe environment for parenteral medication delivery that reduces or eliminates unwanted disease outbreaks (e.g. Hepatitis B, C) by:
a ) Raising awareness to the issues
(b) Standardising clinical best practices and
(c) Embedding comprehensive solutions that protect patients, caregivers and community across the continuum of care delivery.
Historical perspective: Eliminating re-use of needles and syringes for immunisation
WHO, PATH and UNICEF worked with the industry through the 1990s and with pioneering auto disable (AD) syringe technologies developed by Becton Dickinson (BD), UNICEF and WHO promoted their adoption throughout the world to prevent reuse of syringes during immunisation campaigns.
India was using glass syringes for vaccinating children till as late as 2005. Indian Association of Paediatricians (IAP) and BD played a key role in advocating for safe injections. Evidence of unsafe injections was generated through a massive, nationwide Government of India (GOI) study by INCLEN, led by Dr NK Arora, across various healthcare settings from private to government curative to immunisation. Highlights of the INCLEN report on the magnitude of reuse are in Table 1.
In 2005, GOI mandated the use of AD syringes in its flagship Universal Immunisation Programme (UIP), covering a cohort of approximately 26 million children per year, who have since been safe from risk of infections through re-use of syringes.
However, vaccination related injections account for only 10-15 per cent of total injections. Approximately 85-90 per cent of injections are curative injections. Although it has been over seven years since the INCLEN study was disseminated, and there have been numerous deaths attributed to syringe reuse across the country, there is no comprehensive mandate for syringes with reuse prevention features.
Characteristics of unsafe injections (% of all injections) in India
The impact of unsafe injections
Compromising Patient Safety: In the past few years, deadly outbreaks of diseases have been caused due to unsafe injection practices in this country. One of India’s deadliest outbreaks of Hepatitis B occurred in February 2009 at Modasa in Gujarat’s Sabarkantha district. Within months, 94 people had died from 593 confirmed cases in the talukas of Modasa, Idar and Meghraj. Hepatitis B had broken out simply because some private practitioners kept reusing infected syringes.1 Other incidents have also been reported. As recent as February 2012, news regarding a Hepatitis C outbreak in Fatehabad area of Haryana was reported in the local papers. A comprehensive investigation by the Department of Community Medicine, Post Graduate Institute of Medical College, Rohtak, revealed that of 8000 suspected individuals investigated clinically, biochemically and microbiologically in and around Ratia town, 1605 have been confirmed to have Hepatitis C. 70 per cent of these cases are linked to the reuse of syringes. Further investigation by National Center for Disease Control has been recommended.
Reuse of syringes happens both ‘intentionally’ i.e. due to either a profit motive of practitioners who charge a fixed consultation fee including cost of drug and syringe, and/ or due to ignorance of risks of reusing a syringe which may not have visible blood, but only ‘invisible’ body fluids or due to ‘downstream’ re-use, through repacking and resale of syringes collected by the unorganised waste collection.
In the last 20 years, emerging diseases like Hepatitis B and C and HIV have made the risks from unsafe injections and unsafe waste disposal unacceptable. WHO estimates that globally about 1.3 million2 people die of infections caused by reuse of syringes, of which estimated 300,000 are in India. National AIDS Control Organization (NACO) estimates that reuse of syringes and needles is one of the causes of new HIV cases, after unsafe sex.3
Compromising community safety: Unsafe waste disposal is especially common in India’s highly fragmented healthcare delivery system, where used syringes are often not disposed through specialised bio-medical waste agencies, but are disposed along with kitchen waste from residence-cum-clinics, or as part of municipal waste. This leads not only to the risk of diversion of the syringes for repacking and resale by unscrupulous elements, but also to the risk of infection from needle-stick injuries to the people handling such waste – often rag pickers.
India’s Central Pollution Control Board (CPCB) has issued guidelines for injection waste management, but reports indicate the rules are not always followed. Of the 3,842 healthcare providers/ facilities participating in the 2005 study of Indian injection practices, it was pointed out that satisfactory disposal of plastic syringes and disposable needles was observed only at 61.3 per cent of the facilities. It was the lowest at immunisation clinics (50.9 per cent). Nationally, only 6.2 per cent of health facilities undertook waste segregation. Less than half the health facilities (44.8 per cent) ensured satisfactory terminal disposal of injection waste, which was lowest at private health facilities (41.5 per cent). Unlike urban health facilities, rural areas were more prone to unsatisfactory waste disposal. Direct observation also showed that used plastic syringes/needles were sold to scrap dealers more often from private health facilities (15.2 per cent) than government health facilities (3.2 per cent). With widespread use of plastic syringes in India, the study stressed the significance of properly disposing such waste.4
In India, device manufacturers, healthcare facilities and waste handlers can contribute to the reduction of overall sharps waste through programmes that collect sharps waste, treat it to remove potential biohazards, recycle and recover raw materials, and incorporate them into new products. A ‘safe injection environment’ approach requires continued innovation and commitment from stakeholders—from manufacture and use, to disposal and recovery—while maintaining a high standard of care at a reasonable cost4.
The solution: a collaborative approach by key stakeholders towards comprehensive safety
In order to improve injection safety in India, the 2005 INCLEN study made several recommendations, including the following:
• Encourage universal use of (single use) pre-sterilised syringe/ needles with a mechanism for prevention of reuse
• Ensure adequate quantities of syringes/needles according to requirement
• Adhere to guidelines for injection waste management
• Institutionalise the process of training of injection prescribers and administrators
• Increase communication and awareness among health professionals and the community
• Establish follow-up studies to assess and monitor economic and clinical aspects of injection safety interventions.
It is clear that improving injection safety in a comprehensive manner cannot be addressed by any one stakeholder — it would require a sustained and coordinated effort amongst various stakeholders — government, NGOs, doctor bodies, community outreach workers, manufacturers of injectable drugs and syringes. Opportunities for improvement exist across the spectrum of the lifecycle of the syringe – from source materials and manufacture, through use and disposal.
The Central and State governments can play a key role by mandating the use of devices with reuse prevention features and improving enforcement of biomedical waste handling norms. The fact that over 75 per cent of injections are delivered by the private sector, mostly in outpatient clinics of estimated one million practitioners spread across all towns and villages, makes the task of training and regulating even more difficult in the absence of enforceable policy around this issue.
Professional medical associations and NGOs can also be instrumental by increasing awareness of the risks of unsafe injection and disposal practices. Through their support, appropriate training and education modules can be developed for all healthcare workers. By adopting and promoting best clinical practices related to comprehensive injection safety, caregivers can embrace their responsibility to do no harm to those they serve.
Manufacturers must develop product solutions and services which address patient, caregiver and community safety, while also reducing their impact on the environment. New product and process technologies are enabling the reduction of source materials and elimination of materials of concern, such as plasticisers and halogenated plastics, in the design and manufacture of medical devices. Product designs for minimal consumption of raw materials may consume fewer non-renewable resources and require less fuel to ship. Such products can spare raw materials, and have a lower impact on disposal, while meeting the highest standards for performance, safety and local regulations.
Opportunities exist for new stakeholders as well. As in the US, collaborations between manufacturers, healthcare providers and waste handlers could enable the appropriate recovery and recycling of materials that would otherwise be part of the waste stream. US hospitals generate 5.9 million tonne of waste annually, and sharps (injections, needles, blades, broken glassware) comprise about one per cent of all hospital waste (59,000 tonne). To reduce the amount of waste that ends up in a landfill, the 442-bed Rady Children’s Hospital, San Diego, recycles 19 tonne of sharps per year through an innovative programme that safely turns injection-related waste into new products.
Indeed, cultivating a truly safe injection environment calls for collaboration by manufacturers, providers, waste handlers and other stakeholders to implement comprehensive solutions across the healthcare spectrum. When it comes to the safety and welfare of patients, caregivers, the community and the environment, there are truly no shortcut