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CHAPTER ONE: INTRODUCTION
Purpose
1.1 This is the fourth report from the project 'Study of the Safety, Risks and Outcomes from the use of Injecting Paraphernalia'. The first was the Inception Report (December 2003); the second was the 'One year interim report' (December 2004), which gave the results from the laboratory study (stage one) and the third was 'Stage two interim report' (November 2005), which was a progress report on the field study (stage two). This final report collates the findings from both stage one and stage two and presents the overall conclusions from this work.
1.2 This research was originally commissioned by the Effective Interventions Unit ( EIU) of the Scottish Executive. This body has now been replaced by the Drug Misuse Research Team of the Scottish Government.
Structure
1.3 This report begins with an introduction to the study and the relevant background. Subsequently it is divided into two parts. The first part, presented in chapter two, gives an overview of the laboratory based work. Here theoretical health benefits and risks within the injection preparation process were explored, with a focus on the use of makeshift and commercially produced injecting paraphernalia. The laboratory section is presented with a non laboratory science readership in mind. Therefore full technical and scientific detail is not included, but can be obtained by contacting the author j.a.scott@bath.ac.uk.
1.4 The second part of this report presents the field based study in chapters three (methods) and four (results). This work compared self reported injection preparation and sharing practices and injecting related health. This was done by studying injecting drug users ( IDUs) in Aberdeen, where only swabs were supplied, and comparing them with IDUs in Dundee, where swabs, citric acid, spoons and filters were supplied. The report ends with a discussion ( chapter 5) which draws the findings from both stages together and gives overall conclusions. Here recommendations for service providers and commissioners are made.
Introduction to the study
Injecting paraphernalia used by IDUs
1.5 'Injecting paraphernalia' is a collective term used to describe equipment used by IDUs in the preparation and administration of drugs for injection. This equipment may include mixing vessels -which are commonly spoons, water, acids such as citric and ascorbic acid, heat sources, filters, tourniquets and swabs. Previous research examining injection preparation practices has identified and described the equipment used (Ponton & Scott, 2004; Taylor et al, 2004). Spoons and other mixing vessels are used to prepare the injections in and water acts as a vehicle for the drug(s). The purpose of the acid addition is to make soluble illicit drugs that are in the chemical form described as 'base'. In Europe brown heroin and crack cocaine are commonly in the base form (King, 1997), which although suitable for inhaling, e.g. via foil or a crack pipe, they do not readily dissolve. Hence, when these drugs are prepared for injection, IDUs add acid and heat the solution to speed up the chemical reaction. Filtering removes insoluble particles from the solution, to prevent needle blockage on administration. Tourniquets are used to raise veins and swabs are used to cleanse injecting sites, during the injection administration process.
Health concerns relating to paraphernalia use
1.6 Intravenous injecting, whether of a medicine or an illicit drug, carries risk from the method of delivery because it directly enters the blood stream. This means the substance injected bypasses the body's natural defences against harm from potentially infectious or irritant agents contained within the injection. For medicines, strict manufacturing and administration guidelines are followed in order to minimise these risks. Clearly for illicit drug injecting no such safeguards are present. The injecting paraphernalia used by IDUs is often not 'fit for purpose'. For example cigarette filters are used by IDUs, but these are designed to remove large particles (>20 microns) from smoke when it is drawn through the filter using air. They are not designed to remove smaller particles from solutions. There are several health concerns relating to the use, reuse and sharing of paraphernalia by IDUs, some of which are documented in the literature.
Hepatitis C Virus
1.7 International concern at the high levels of hepatitis C virus ( HCV) antibody positive IDUs led to suggestions at the end of the 1990's that sharing paraphernalia may transmit HCV (Crofts, 1997, Denis, 2000, Hahn, 2001). Crofts et al, 2000 detected HCV virus (by measuring RNA) on 70% of syringes, 67% of swabs, 40% of filters, 25% of spoons, and 33% of water samples. This method cannot tell if the virus is viable but still is of concern. An increasing body of international literature has found correlations between self-reported paraphernalia sharing and HCV antibody status (Hagan et al, 2001, Thorpe, 2002, Lucidarme, 2004). Mathei et al (2006) calculated an odds ration of 2.44:1 of being positive for HCV antibodies if ever having shared paraphernalia, but never having shared needles and syringes. Thiede et al (2007) showed that newer injectors tend to share paraphernalia more. Ethnographic research conducted in Glasgow by Taylor et al (2004) described the sharing of paraphernalia as a common occurrence when injectors prepare and administer drugs together. Scottish Drug Misuse Database statistics suggest that paraphernalia sharing remains common amongst IDUs, but there has been some decrease over recent years. In 2001/02 50% of injectors in new contact with services reported having shared spoons, water or filters in the past month. The 2005/6 report showed this figure had reduced to 42% ( DMIS, 2006).
Bacterial infections
1.8 Where possible medical injections are manufactured in a sterile environment and/or sterilised before use. Otherwise they are made from sterilised materials e.g. sterile granules reconstituted with sterile water. Illicit drug injections do not of course under go such procedures, making IDUs particularly vulnerable to the risks of bacterial infections from non-sterile injecting. Skin and soft tissue infections are some of the most common infections in IDUs (Gordon and Lowy, 2005). They are well documented in the literature (e.g. Haverkos and Lange, 1990, Stein, 1990, Levine, 1991). Sources of bacterial contamination could be the skin of the IDU themselves, especially if hands and injecting sites are not washed prior to use. A study of 1057 IDUs in the USA suggested that IDUs who always clean their skin before injecting were 50% less likely to suffer from abscesses than those who never cleaned their skin (Vlahov et al, 1992). Other sources of bacterial contamination could be the drugs, the paraphernalia or the injecting environment (Gordon and Lowry, 2005). These authors also suggest that 'flushing', where blood is repeatedly drawn back into the syringe after injection administration may also increase the risks of abscess. Co-existing HIV infection increases susceptibility to infections.
1.9 The Health Protection Agency ( HPA) report a growing number of acute bacterial infections seen in IDUs ( HPA, 2006). They note concern about infections with Staphylococcus aureus (both methicillin sensitive and methicillin resistant), Group A streptococci, both of which may come from the IDU's skin and through shared paraphernalia , and clostridia bacteria including Clostridium botulinum and clostridium tetani, which will come from contaminated drugs. These organisms are also noted as those commonly causing infections in IDUs by Gordon and Lowry (2005). Clostridium novyi and Clostridium perfringens were isolated in many of the cases of severe skin and soft tissue infection that lead to the deaths of drug users in Scotland and elsewhere in 2000, with contaminated drugs being the source (Gruer and Ahmed, 2001). Such bacteria cause a range of clinical symptoms from minor abscesses and soft tissue infection, to widespread soft tissue infection such as cellulitis, major systemic infections and complications such as endocarditis.
1.10 The paraphernalia used by IDUs is often 'makeshift', utilising household items such as cigarette butts as filter material, tea spoons as preparation vessels and water from taps or bottles. Acid sources can include domestic items such as citric acid from home brew and catering packs, vitamin C tablets (ascorbic acid), bottled and fresh lemon juice (citric and ascorbic acid) and vinegar (acetic acid). Clearly such items are not sterile and could potentially be a source of contamination. It is unknown what effect the heating process used in injection preparation has in terms of killing viable organisms. However an outbreak of Pseudomonas aeruginosa in IDUs in Chicago in the late 1970's was linked to the lack of heating (Shekar et al, 1985). The injections concerned were made using non sterile water and soluble tablets. Saving paraphernalia for later use could exacerbate risks, particularly if stored damp and dirty. Filters of natural origin such as cotton wool may potentially be more contaminated. The practice of saving filters for times when no drugs are available and 'bashing down' several to extract trapped drug is noted (Taylor et al, 2004). These authors also observed that homeless IDUs may prepare injections in particularly unclean environments. Additionally, sharing paraphernalia means handling of items by more than one IDU, so potentially could increase cross contamination. Administering injections to others could also increase infection risks through skin contact. There is very little in the literature detailing these risks or consequences, although they can be derived through association from work such as that of Vlahov et al (1992).
Fungal infections
1.11 Candida albicans has been isolated as a causative organism of fungal infections in IDUs. Immunocompromised status e.g. caused by HIV infection, increases the likelihood of Candida infection talking hold. The skin and pith of lemons contains Candida. In the mid 1980's an outbreak of Candida endophthalmitis, a fungal eye infection, amongst IDUs in Glasgow was attributed to the widespread use of lemon juice as an acidifier. Chignell (1992) in reviewing these and other cases notes reduced incidence since this time attributed to increased harm reduction interventions.
Vascular damage
1.12 Progressive loss of peripheral vascular access and indicators of peripheral vascular damage, such as swollen digits, are known complications of long terms injecting drug use (Gordon and Lowry, 2005). However, there is little scientific study of factors that worsen IDU vascular health in the literature. It is thought that length of time injecting is key and that over time many IDUs progress to using deeper veins in order to gain vascular access (Darke et al, 2001, Maliphant and Scott, 2005). However rate of deterioration of vascular access varies and a minority of IDUs appear to maintain peripheral access long term (Maliphant and Scott, 2005). The factors that contribute to the extent of this damage and the rate of decline are not clear. Using too much acid to prepare injections and inflaming veins through repeated use of the same vein without rest is considered by to contribute to vascular damage (Derricott et al, 1999). The injection of insoluble materials contained within the injection are linked to vascular inflammation, cardiac valve damage and the formation of hard lumps known as granulomas (Stein, 1990). These form under the skin and in systemic organs e.g. the lungs. The source of insoluble materials could be the drug substance or the preparation process, potentially from paraphernalia items themselves, e.g. fibres from makeshift filters. Talc retinopathy and the identification of cotton fibres in the eye of IDUs have been reported (O'Brien and Schroedl, 1991). The source of fibres is attributed to filters. The source of talc is reported to be adulterants in street drugs and fillers from tablets that have been injected.
The supply of paraphernalia to IDUs through needle exchange schemes
Support for the provision of paraphernalia to IDUs
1.13 Concerns around the health risks from sharing paraphernalia and using 'makeshift' paraphernalia have prompted drugs services, commissioners and policy makers to consider whether IDUs should be supplied with paraphernalia via needle exchange schemes.
1.14 The basis of the argument for supply is that the provision of adequate quantities of paraphernalia could prevent sharing and prevent the need for reuse, hence reducing HCV transmission and bacterial infections. Research has shown that the response to HIV in the UK (1987-1993) was successful in avoiding an epidemic because it combined information not to share with the means to follow this advice i.e. access to new sterile injecting equipment (Stimson, 1995, Stimson et al, 1998). Countries where information only was given were less successful in curbing the HIV spread amongst IDUs (Stimson et al, 1998). Therefore, it may be suggested that the supply of paraphernalia equipment and accompanying advice on its use, could reduce sharing and other risks.
1.15 Garden et al (2003) showed that supplying citric acid sachets attracted IDUs into needle exchange services. A vignette relating to the Glasgow Drug Crisis Centre reported by Griesbach et al (2006) also shows that citric acid availability influences IDU use of services. Attracting IDUs to services gives the opportunity to provide appropriate safer injecting interventions and signpost to treatment services. Unless drawn into services, IDUs can be a difficult to reach group. Hence this gives an additional argument made for supplying paraphernalia.
1.16 The supply of paraphernalia in the UK is governed by legislation, which was largely prohibitive until recent years.
The UK legal situation
1.17 Until August 2003 it was against the Misuse of Drugs Act (section 9A) to supply any paraphernalia to IDUs. Paraphernalia was defined legally as 'equipment that facilitated the illegal administration of a controlled drug'. Needles and syringes were exempt to prevent HIV transmission. The 'paraphernalia laws' were introduced as part of the Misuse of Drugs Regulations (1985) to stop drug dealers selling consumption kits, it was never intended to prevent harm reduction. It is known anecdotally that some needle exchange services supplied paraphernalia prior to 2003, often under local agreements with police and drug action teams ( DATs). In response to concerns about HCV transmission through paraphernalia sharing, the law was amended in August 2003 with further additions in 2005. Those who engage in drug treatment are now lawfully permitted to supply swabs, spoons/cups, filters, citric acid, ascorbic acid and sterile water in volumes less than 2ml in order to prevent harm.
Availability of paraphernalia to IDUs following the law change
1.18 The law change has given commercial impetus for companies to develop paraphernalia products. An increasing range has become available from several companies. Examples include single use sachets of acids, single use spoons and some types of filter. It is also known that following the law change, some needle exchanges continue to supply makeshift items similar to those already used by IDUs e.g. hand rolling cigarette filters. In Scotland, the 2006 national needle exchange survey showed that availability of paraphernalia from Scottish services is variable (Griesbach et al, 2006). Although in some areas coverage was good, services were found overall to be less likely to supply paraphernalia than services in England.
The need for research to underpin the supply of paraphernalia to IDUs
1.19 Increasingly it is expected by the public, commissioners and policy makers that healthcare interventions are supported by evidence to qualify their use. There is little research in the literature focusing on paraphernalia. There could be several reasons for this: Firstly, UK based research may have been inhibited by the legal restrictions on supply, as it could be difficult to attract research funding. However there is also little European work, despite paraphernalia being used and supplied there with no history of legal restrictions. Secondly, most injecting paraphernalia items are not classed as medical devices or medicines (except water for injection). This means there are no requirements for evidence of safety or effectiveness for marketing approval purposes. Hence there is little data on performance.
1.20 As said, what is known is that sharing paraphernalia is implicated in HCV transmission (1.7). Makeshift paraphernalia contributes to bacterial (1.8) and fungal (1.11) infections and may worsen vascular damage (1.12). Providing paraphernalia attracts IDUs into services (1.15). These factors advocate the supply of effective paraphernalia to IDUs. What has not been studied is whether supplying paraphernalia reduces sharing and consequently HCV transmission, or other injecting risks such as skin and soft tissue infections and vascular complications (Wright and Tompkins, 2006). This requires field based study. The theoretical efficacy and safety of different items of paraphernalia is also not established. For example to what extent does a purpose-made filter reduce insoluble particle contamination in injections and how does this compare to makeshift filters like cigarette filters? Laboratory study is necessary to establish such data. Such information is important to guide policy makers, commissioners and service providers on implementation of the paraphernalia law changes. This is particularly pertinent as the cost implications from supplying, or not supplying, depending on the impact, may be large. Such information could also inform IDU's choices and equipment selection.
1.21 This report presents both laboratory and field based work to offer an introduction to establishing an evidence base to guide paraphernalia supply decisions.
Aims of the study
1.22 To test paraphernalia items and injection preparation methods in the laboratory to quantify the theoretical benefits and/or risks that they present to health, thereby identifying from those tested the items of paraphernalia and preparation methods that present the least theoretical risk to individual health.
1.23 To conduct an investigation into the impact that paraphernalia supply is making on sharing and health in the practice setting and compare this with non-supply.
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