Response to the MHRA consultation on increasing the 2ml limit on the size of water for injections ampoules that can be supplied to injecting drug users

At the end of April 2011 we were asked by the MHRA, as part of an industry consultation excercise, to comment on a proposal to amend the Medicines Act to allow quantities of Water for Injections greater than 2mL to be distributed by drug services to injecting drug users. Below, in full, is our response to that consultation, that also includes comment on the status of Bacteriostatic water, and Naloxone.

2nd May 2011

Water for Injections
There have never been any problems with the availability of 2ml Water for Injections ampoules to drug users. It is the case that the only 2ml water for injections ampoules that are available are glass, and 2ml in plastic would be better, and that we haven't yet been able to source a supply of 2ml water for injections at an affordable price.

Some have argued that supplying 5ml WFI to injecting drug users in plastic is better than 2ml in glass. This argument is based on the concern that the risk of glass cuts could lead to blood borne virus infection. However, this has no real foundation in what we now know about hepatitis C infection, but rather on an outdated fear of 'environmental BBV contamination' which existed before we had our current understanding of HCV survival and transmission. It also fails to correctly evaluate the relative risk of occasional blood in the environment from cuts, with the risk of blood contamination from used syringes in part-used vials, which is much greater because infected blood can be delivered directly into the blood stream of another injector.

Average volumes of water as a diluant used in injections are around 1ml – so 5ml ampoules have great potential for sharing, and we know from ethnographic research and surveys that sharing of water is common. If the intention is to restrict supply to volumes which can't be shared, then the limit should be left at 2mls.

Some services are currently supplying 5ml plastic ampoules to their clients, so for drug services to meet the expectation that they be well enough informed to provide the most suitable product, would require clear education messages, and probably central guidance.

For us this isn't a commercial issue: we could sell 5ml ampoules as well, but have chosen not to because of the increased risk of blood borne virus transmission that is posed by a 5ml amp as compared a 2ml ampoule.

It is therefore our view that the original ACMD request that the Medicines Act should be altered to permit a maximum of 2mls to be supplied to injecting drug users was correct, and that nothing has happened in the interim to change this.

Bacteriostatic water
While you are considering the issue of water, there has been a growing trend of injectors of performance and image enhancing drugs making up multi-dose vials of human growth hormone, and melanotan 2, which are kept in the fridge and injected over a period of days. The product they request for this purpose is Bacteriostatic water, which is also a POM.

Giving drug services the same freedom to supply bacteriostatic water as they have with 2ml WFI would provide an opportunity for engagement with a different population that is also at risk of blood borne virus transmission and other drug related harms, including bacterial infections from solutions that are prepared in advance and stored.

We recognise that some of the difficulties we described with supplying 5ml (or even 10ml) WFI exist with bacteriostatic water, but it shouldn't be hard to restrict inappropriate supply of this very different product to injectors of illicit heroin.

The changing of the regulations that govern WFI made a huge difference in it's availability to injecting drug users, with clear benefits to health.

There is a growing body of evidence that Naloxone distribution to injecting opiate users has significant potential to save lives, and as it is a drug with no hazardous side effects, and no abuse potential, it is our view that allowing supply under the same rules that govern WFI would achieve significant benefits, with no risk. I hope that it would be within the scope of your review to consider giving Naloxone the same status as WFI, as this is something we would strongly support.

Andrew Preston
Exchange Supplies.


Exchange Supplies,
1 Great Western Industrial Centre,
Dorchester, Dorset DT1 1RD, UK

01305 262244