National Australian Drug & Alcohol Testing REGISTER

ACT Government
Review of Alcohol and Drug Driving Laws

SUBMISSION

Is Australia the most advanced country in oral fluid drug testing,
or are we just being used as a testing site and dumping ground?

Workplace Drug Testing

In 1988, the US National Institute on Drug Abuse (NIDA) established the world's first mandatory guidelines for federal workplace drug testing programs. These guidelines defined the urine cut-off levels and introduced certification of medical review officers (MRO) and drug testing laboratories. All subsequent drug testing standards in Australia, UK and Europe (including Australia's first urine drug testing standard - AS 4308 - in 1995), are based on this "gold standard" as it became known.

In April 2004 - after seven years of research and development - the US Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice for public comment in the Federal Register that proposed inclusion of alternative specimens (oral fluid, sweat and hair) and on-site screening tests. The new guidelines deemed oral fluid-based on-site testing to be:

                                         - most suited for suspicion and post accident
                                         - least suited for random testing
                                         - not suited for follow-up and return to duty

The guidelines also expressed concern about the lack of FDA-approved on-site testing devices, and the need for a positive oral fluid test to be confirmed by an additional urine test, to protect the worker against incorrect ("false positive") test results for marijuana/cannabis (THC).

However, in June 2006, the proposed guidelines were withdrawn (after nine years in the making!). Around the same time, two US producers of promising on-site test devices withdrew their products from the market: Impact (LifePoint) and UpLink (OraSure).

In Australia, in November 2003, the WA Industrial Relations Commission (WAIRC) ruled that oral fluid testing was not an option, and not to replace urine testing, as there was no Australian Standard in place for oral fluid testing and no reliable on-site testing kit available for oral fluid.

Then, in November 2006, Standards Australia produced AS 4760 - the world's first and only oral fluid drug testing standard. Yet, to this date, no laboratory has been NATA accredited to this standard, which was headed by prominent forensic experts from the Victorian Institute of Forensic Medicine (VIFM).

As with random breath testing, roadside drug testing is a high-volume screening process aimed at separating impaired drivers from non-impaired drivers, on the spot.

While the relationship between oral fluid, breath and blood alcohol concentrations and impairment is well known, very little is known about the relationship between the various drug compounds and drug levels in oral fluid and impairment. And, although oral fluid may well have a blood-equivalent detection window somewhat shorter than urine, a positive oral fluid test is no proof of impairment.

A second, positive, GC-MS-confirmed urine test (as proposed by SAMHSA) will certainly prove the presence and levels of drug metabolites - and "recent use" - but is still no proof of impairment.

Oral fluid-based on-site tests are not a new phenomenon, but have been "around the corner" for 20 years: Australasian Centre for Policing Research. However, numerous scientific evaluation studies have found that oral fluid-based on-site testing kits and devices have problems with detecting marijuana or cannabis (THC), which accounts for over 50% of all positive drug tests in Australia. Other drug classes can be detected with some accuracy.

Consequently, due to inadequate performance characteristics, no oral fluid-based on-site testing kit or device, testing for all major drug classes, has ever been FDA approved or DOT approved or CLIA waived. In contrast, dozens of urine testing kits have achieved FDA status for their accuracy and reliability.

There are over a dozen oral fluid-based on-site tests on offer in Australia: Drug Testing Register. Three of them shall be commented upon (the first two known to be used in roadside drug testing in Australia):

Cozart (England): An electronic hand-held device which has been on the market for nearly 10 years. It is not employed for roadside drug testing by the UK Home Office, but in Italy, in a three month roadside campaign. The Melbourne-based distributor has these Facts:

Integrity Sampling is the innovator of saliva based drug testing in this country!
In 7 years we have conducted well over 120,000 tests, Australia wide!
No test result has ever been contested in any Workplace Tribunal in this time!
Each State office is run by ex Police, who know how to deal calmly with employees!
Our experience with forensics and continuity of samples is unmatched!

Drugwipe (Germany): A single-use test kit which detects drugs in oral fluid or sweat. According to the manufacturer, Drugwipe is employed for roadside drug testing in several countries. The Melbourne-based distributor claims that: "The drug testing devices are highly accurate and reliable, having undergone rigorous testing." A claim which is not supported by independent research.

OraLine (USA): A single-use test kit and the only oral fluid multi-drug test to have filed for FDA clearance. Had it succeeded, it would have been the biggest breakthrough in drug testing history. But it failed. Thus, it cannot be used for workplace drug testing in the USA and is limited to forensic use only. The manufacturer, Sun Biomedical Laboratories, was acquired by the Perth-based Harrington Group in 2006 and is listed on the Australian Stock Exchange (under symbol "SBN").

Although workplace and roadside are different domains and jurisdictions, it is becoming increasingly difficult for the average person to understand why a drug testing regime which is inferior in the workplace is superior at the roadside.

What is the difference between testing a pilot, captain, train driver, bus driver, truck driver and coal miner? And what are the implications of conflicting test results from being oral fluid tested by a police officer on the way to/from work and urine tested by an OHS officer at work?

Clearly, police and forensic standards are making inroads in the workplace sector. In the WAIRC case, the Transport Workers' Union demanded saliva (oral fluid) testing instead of urine testing with reference to the Victorian Police's trial of saliva testing as a means of testing whether motorists are under the influence of drugs (29). The commissioner concluded that this experiment was not without significance, but that there is a significant difference between trialling a testing method and actually adopting that method (48).

So far, no industrial commission has ruled in favour of oral fluid drug testing.

An impairment-based, random roadside drug testing regime - built on oral fluid - is not viable. All states and territories need to coordinate their efforts and establish a robust, national roadside drug testing code.

Apart from roadside drug testing, all states and territories need to establish a drug testing office to coordinate, optimise and harmonise all drug testing programs (arrestees, drug courts, prisons, police and prison officers, rail, ferry and bus services, public and private workplaces etc). Ideally, at federal level, a peak drug testing authority should be formed.

As an alternative to exhaustive lawsuits and workplace tribunals, an independent MRO body is needed, so victims of "false positive" drug tests can appeal their results and lodge complaints over dubious products and practises. Without regulations, anyone can sell anything over the internet.

On the provider side, there is a need for a self-administered drug testing register, where providers of drug and alcohol testing products and services can register their companies and declare their test kits and devices. This will enable suppliers to submit data, studies, performance characteristics, approvals, certifications and accreditations and substantiate their claims publicly. To bring reluctant providers out of their comfort zone, only registered products and providers are to be considered by purchasing officers and government contracts.

Last, but not least, the drug testing results: A national database, where all drug testing authorities, agencies & workplaces can register their profile and D&A policy and submit their monthly records, is needed. In addition to getting impaired drivers off the road, there is a need for establishing a set of uniform reference data to be able to monitor the drug testing statistics and trends on a national level, across industries and jurisdictions. As the National Transport Commission pointed out in a (2004) Discussion Paper (Drug and Alcohol Control within the Rail Industry): "Whilst data exists, the (paper based) data itself is managed in different ways across jurisdictions and any statistical analysis of industry trends is difficult to accomplish." and "The lack of data hinders any meaningful assessment of current management approaches."

Government involvement, comments and recommendations to the new draft register are needed:

A parallel development is taking place in our new intergovernmental health workforce reform, with a single national registration and accreditation scheme for health professionals: Council of Australian Governments (COAG).

In preparation of this submission, every effort has been made to ensure it is factual and up to date. If inaccurate, in any way, your feedback will be greatly appreciated and enable us to correct the live document on our website.