Download drug testing protocol

1
DRUG TESTING
FOR RESTRICTED PATIENTS
March 2015
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
2
CONTENTS
1.
BACKGROUND
3
2.
CHAIN OF CUSTODY
5
2.1
Procedures
8
2.2
Window of Detection
13
2.3
Positive results / Confirmation
15
PRESCRIBED MEDICINE & OVER THE COUNTER
REMEDIES
16
4.
NEW PSYCHO ACTIVE SUBSTANCES
17
5.
REFERENCES
18
6.
APPENDICES
20
7.
MEMBERSHIP
32
3.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
3
1. BACKGROUND & INTRODUCTION
The abuse of illicit substances is extremely common amongst forensic psychiatry
populations and is recognised as one of the most potent risk factors for
interpersonal violence (Swanson et al 1990 & Monahan et al 2001). Substance
misuse in mentally disordered individuals is also associated with increased risk of
relapse of psychosis, increased frequency of hospitalisation, poorer compliance
with treatment and impairment of the integrity of therapeutic regimes in hospitals
(Jablensky et al 1992 & Cantwell et al 1996). Hence treatment and management
of substance misuse problems are key to ensuring good therapeutic outcomes
and maintaining public safety. Detection of substance misuse is the first step in
this process and hence a consistent and legally defensible approach to same is
essential.
The Scottish Government has highlighted substantial variability in drug testing
protocols across health boards and has sought assistance from the Forensic
Network in preparing guidance which will inform local drug testing procedures.
Specifically some of the areas where guidance is required are the following:
consensus on the chain of custody; steps to be taken where there is a dilute
sample; the types of first line drug testing undertaken; steps to be taken
following a positive first line test; confirmatory analysis (including GCMS, Gas
Chromatography Mass Spectrometry); comparison with approaches used in
DTTOs (Drug Testing and Treatment Orders); how to deal with ‘poppy seed
bread’ and positive opiate tests; guidance on over the counter medicines.
A short-life working group was convened and met between June 2014 and March
2015 to consider such matters. At an early stage the group considered its remit
and decided to concentrate on drug testing for Restricted patients (those patients
subject to a Compulsion Order and Restriction Order (CORO) or Transfer for
Treatment Direction (TTD). The reasons for this were that this group is well
circumscribed, presents a real risk of serious harm to the public in the absence of
the CORO or TTD, and in respect of whom decisions regarding suspension of
detention, conditional discharge and recall to hospital often involve consideration
of drug test results.
Forensic Community Services also manage individuals who are not managed by
mental health legislation but are subject to statutory criminal justice orders,
Probation, Non-Parole Licence and Life–Licence. These orders also place
conditions on the individual and mandatory illicit drug testing can be one. The
result of positive testing can be a revocation of such orders and a return to
prison.
It is expected that the undernoted guidance will be piloted within a small number
of health board areas before being applied on a national basis.
LEGAL BASIS FOR DRUG TESTING
Section 286 of the Mental Health (Care and Treatment) (Scotland) Act 2003
allows the Scottish Ministers to make regulations which authorise the taking of
swabs and samples of blood or body fluid from specified patients. Those
regulations are the Mental Health (Safety and Security) (Scotland) Regulations
2005/464 as amended by SSI 2012/211. Patients who are detained in the State
Hospital, Orchard Clinic, Rowanbank and Rohallion Medium Secure Service are
automatically ‘specified persons’. Patients detained in other hospitals must have
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
4
been recorded in a reasoned opinion by their RMO, within the last 6 months, as
having “sought, or being likely to seek any item which is likely to be prejudicial to
the health or safety or any person or to the security or good order of the
hospital”.
For all specified persons, the patient (or in the case of (iii) and (iv), the named
person where telling the patient would be prejudicial to the patient’s health or
treatment) must be told:
(i) that they are a specified person;
(ii) if applicable, the date on which the RMO’s opinion to that effect was recorded;
(iii) that as a specified person they are subject to the measures in regulation 4
(which includes the taking of swabs, blood and body fluid); and
(iv) that a specified person has a right to review and re-assessment.
Any patient who is not detained can be asked to consent to the taking of swabs
and samples. Consent must be informed and freely given. For those patients who
are granted suspension of detention (sus) from hospital, conditions can be
attached to the sus by the RMO (see section 224 (7) of the 2003 Act). Likewise
the Tribunal may impose such conditions as it sees fit on a patient’s conditional
discharge from hospital (see s193(7)). Such conditions can require abstinence
from non-prescribed substances. In order to confirm ongoing abstinence, the
patient can be asked to consent to testing. Should such consent be withheld,
consideration can be given to revoking or refusing to grant suspension of
detention, recommending a variation to the conditions of discharge or to recalling
the patient from conditional discharge.
It should be noted that any decision taken to suspend or limit a patient’s
unescorted sus in the community or to recall a patient to hospital will engage
their right to a private and family life (see article 8 of the European Convention
on Human Rights). The decision must therefore be in accordance with the
relevant law, necessary for the prevention of crime or disorder or for the
protection of health and proportionate. Before taking a decision further to a
positive drugs test (see Section 2.3 and Appendix 7), it is therefore crucial for
clinicians to ensure, in so far as possible, the accuracy of the test result, and to
take account of all relevant background information (patient’s explanation, history
of drug misuse, presentation, events preceding the positive test, care plan and
risk assessment etc) before considering the range of potential options. The
decision taken must be proportionate and involve the minimum restrictions on the
freedoms of the patient as are necessary in the circumstances.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
5
2. CHAIN OF CUSTODY FROM COLLECTION TO TESTING
SERVICES
The results of illicit drug testing may be subject to legal challenge by the patient
and their legal team, and as such, the procedure for testing of illicit drugs in
‘forensic’ patients must be fully justifiable and chain of custody must be
maintained.
Point of care testing for illicit substances is used in order to give a rapid picture of
recent drug use. Point of care testing of urine is fairly reliable and can give an
accurate representation of illicit drug use over the preceding few days dependent
on the drug being tested for. However, in terms of the medico-legal aspects of
testing and results being fully justifiable, any positives on point of care tests must
be sent to biochemistry (toxicology) for confirmation. In addition, lab based tests
can also confirm the substance used e.g. a positive on a point of care opiate test
would not give any indication of the opiate used, whereas a lab-based test is able
to differentiate between, for example, codeine and heroin. Laboratory tests will
also routinely measure the urine creatinine which will give an idea of whether the
sample has been diluted or flushed. In addition, there is a potential for false
positive or false negative results on near-patient tests, and sending samples to
the laboratory for interpretation of results is good practice.
The following safeguards have been highlighted in order for ‘forensic samples’ to
be dealt with appropriately:

The need for two samples, one for immediate testing by biochemistry and
a second sample which is available on request for independent testing.

The need for tamper-evident seals to prevent risk of interference between
collection of sample and delivering to laboratory.

The development of a tamper-evident pack with all equipment required for
testing sealed within an outer bag and protected from contamination prior
to the testing being carried out.

Extra safety measures including the use of a sample collection device with
inbuilt temperature gauge which will help determine adulterated samples.

Highlighting samples as ‘forensic sample’ in order that there is no doubt
about the testing requirements when the sample reaches biochemistry.

A drug screening proforma and receipt form has been developed to ensure
the chain of custody requiring signatures of staff supervising the sample,
delivering the sample to the laboratory and receiving the sample.
Please see appendix 1
FOR COMMUNITY SAMPLES WE RECOMMEND SPECIFIC STAFF LOCALLY
ARE ALLOCATED RESPONSIBILITY FOR THE FOLLOWING:
ensure identification of donor and adequate supervision of sample
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
6






use of sealed and tamper-evident community urine collection
containing (see appendix 2 for procedure):
a sealed sample collection device with inbuilt temperature gauge
nitrile gloves
2 vacutainers and collection device
Tamper-evident seals
Transfer bag and request form marked ‘FORENSIC SAMPLE’
kit

Sample will be alloquoted into 2 separate vacutainer devices and sealed
with tamper-evident seals marked ‘A’ and ‘B’

Request form to be filled out in full including CHI number and any
medications prescribed that could be detected as part of the urine drug
screen.

A chain of custody form must be completed to include who has supervised
sample, who has delivered it and who has signed for receipt of it at the
laboratory (see appendix 3).

Sample taking should be on a random basis i.e. there should not be an
identifiable pattern of sampling.
RESPONSIBILITY OF LABORATORY BIOCHEMISTRY STAFF

Sign and date the Drug Screening proforma to confirm receipt of the
sample. Photocopy the proforma and file it in the folder (labelled – for
example - Forensic Mental Health Teams Drug Proforma for Chain of
Custody, or a similar locally agreed title).

Open the package. Check that the samples are correctly labelled and that
the patient's details on the tubes match those on the proforma. Check that
the tamper-evident seals are intact.

If not, do not analyse and pass the patient details to the Duty Toxicologist
who will contact the Clinical Team.

The tamper-evident seals on the samples have integral lab numbers so
there is no need to re-number the samples.

Book in the patient demographics of the sample for the standard drug
screen and any other generic drugs of abuse screens requested. If there
are other requests that you are not certain of, contact the Duty
Toxicologist.

Carry out generic screening tests on the A sample. Do NOT use the B
sample.

Positive amphetamines and opiates are automatically confirmed. If there is
insufficient sample for confirmations do NOT open sample B. Instead pass
the patient details to the Duty Toxicologist who will contact the clinical
team for guidance on what they want done.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
7

There may be a need for further tests on a sample e.g. confirmation of
other positive screening tests and analysis of other drugs not analysed
here. This may involve sending away samples to external laboratories. The
Duty Toxicologist will discuss this with the Clinical Team as there may be a
charge for these tests.

Both ‘A’ and ‘B’ samples will be retained for 3 months in a labelled sample
rack in the cold room. Samples are stable at 4C but for longer periods,
the samples should be stored frozen. The Clinical Team will inform us of
samples that they would like retained for longer than 3 months.

The B sample will be kept sealed and will be available for independent
testing by legal teams if requested (within 3 months)
If the patient’s legal team wish to have the sample subject to independent
testing, they should put this in writing to the RMO. The Clinical Team will then
communicate this request to biochemistry. The sample will be released to a
nominated lab to protect the integrity of the sample. The patient’s legal team will
pay for independent testing.
Arrangements should be made with the local laboratory regarding opening times
for sample delivery, including arrangements for out of hours and Friday/weekend
samples.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
8
2.1. PROCEDURE
OBTAINING A URINE/ORAL FLUID TEST (OFT) SAMPLE FOR SUBSTANCE
MISUSE TESTING AND ASSOCIATED PROCEDURES AND PROTOCOLS
N.B. Consent must be informed and freely given by patient
PURPOSE
To ensure that the frequency of substance misuse testing is tailored to the
patients needs and that any restrictions placed on the patient in relation to
alcohol and/or drugs are properly monitored and reported. The process will
involve the following;



Standard procedures are followed for sampling, testing, chain of custody
and reporting
Response to positive results is appropriate
Testing results are appropriately monitored, recorded and reported
TESTING FREQUENCIES
The frequency of testing should be based on clinical and risk assessment by the
patients Multi-disciplinary team. As part of the through-care process the Scottish
Government Restricted Patients Branch may request specific testing procedures
and frequency of testing as a condition of the patients restrictions.
Depending on the service, urine or oral fluid testing (OFT) maybe used for
assessing use of non-prescribed substances.
The following represent
recommended guidelines in respect of both testing methods.
URINE
1. All inpatients will be subject to random urine drug screening.
2. With reference to the patient’s risk assessment, the patient will be
categorised as high or low risk in relation to potential illicit drug
misuse. This will be recorded in the patient’s care plan and regularly
updated.
3. All patients will be entered on to the monthly urinalysis projection form.
4. Targeted urine drug screening will be employed if staff have reason to
suspect that illicit drugs are being abused.
5. Urine samples for drug screening will be collected in the following way:

Nurse will collect sterile drugs of abuse screen equipment. Fill
in biochemistry form and tamper evident labels. There is no
requirement to write on the label of the specimen bottle as all of
the relevant information is written on the tamper evident seal.
Please ensure that the CHI number is recorded on the
biochemistry form.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
9

Gloves must be worn. Sample pot will have lid removed. Patient
will then be supplied with the sterile collection pot to submit
sample of urine into.

Patients will be observed AT ALL TIMES when submitting
sample, in order to ensure validity of sample. During this
procedure, observation takes precedence over privacy. We
recommend that the nurse observing the sampling procedure is
of the same sex as the patient. The nurse supervising will fill in
the drug screen proforma to say that they witnessed the sample
being taken.

Nurse will ensure that a minimum of 20mls of urine is
obtained for the sample, ensuring that there is sufficient to fill 2
bottles to the max level.

Urine sample will either be dip tested in the ward or will be
transferred in to 2 specimen bottles using the vacu urine
transfer kit to ensure no contamination from the handler. Gloves
can be removed once the sample is in the vacutainer. Any
remaining sample is discarded prior to labelling. Samples cannot
be contaminated unless the bottles are opened. Once samples
are in white topped bottle the tamper proof seals are placed
over the top of the bottle to ensure nothing can be altered with
the specimen. The seals are clearly labelled A and B. The
additional barcode on the seal sheet should be placed in the top
right hand corner of the biochemistry form. Along with
biochemistry form, clearly marked for drugs of abuse screening,
bottles are placed into biochemistry form bag and sealed.
Samples and biochemistry form can then put into the bio hazard
transit bag that is provided along with the absorbent cloth that
is there to absorb any spills in the bag should this happen. The
transit bag should then be placed in a brown envelope marked
for biochemistry.

Any specimens that pose a hazard, i.e. HIV or Hepatitis B and C,
should be clearly labelled to alert staff to the hazard prior to
sending.
6. A record of the samples being obtained and sent will be recorded in the
patient’s notes and on the patient’s individual record of drug screens
sheet in their care plan. There are 2 additional numbered stickers which
correspond with the barcode on the tamper evident label. These
stickers should be placed beside the entries in the patient notes/record
of drug screen.
7. Samples will be transported to the lab by the locally agreed staff member
as laid out in the chain of custody protocol.
8. The results of the urinalysis will be documented in the patient’s notes,
the individual drug screens sheet and will be discussed at the next
Multi-Disciplinary Team meeting.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
10
9. If a patient refuses to submit a sample for urinalysis the nurse in charge
will discuss fully with the Multi-Disciplinary Team. The associated potential
increase in risk may result in the patients level of access being reassessed
10. A record of the sample being obtained and sent will be recorded in the
patient’s notes and on the urinalysis register.
11. The results of the urinalysis will be documented in the patient’s notes
and on the urinalysis register
12. If positive patient will be retested and results discussed at MultiDisciplinary Team meeting.
13. If negative this will be discussed at next Multi-Disciplinary Team
meeting.
14. If a positive result is received, suspension of detention will be stopped
immediately and the Responsible Medical Officer informed at the
earliest opportunity.
Please see appendix 4 for further information.
The transportation of samples will follow locally agreed procedures.
A list of examples of sampling components can be found in appendix 5.
Please note the components outlined in appendix 5 are examples only. Other
providers are available. Such examples should not be considered an endorsement
by this group, the Forensic Network or Scottish Government. The components
used in practice should be selected in conjunction with the laboratory performing
the tests.
OFT
Staff should follow guidance from their OFT provider and must have completed
relevant training.
PROCEDURE FOR ORAL FLUID TESTING
The staff member administering the test must check the expiry dates on the
outer and inner packaging before removing the collection pad and vial from the
pack.
The patient should be given a full explanation of the procedure.
The staff member must ensure that the patient’s mouth is empty and that they
have not eaten, drank or smoked for ten minutes prior to the planned test time.
COLLECTION OF SAMPLE
Staff should follow guidance from their OFT provider.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
11
OFT PROCESSING ON WARD
When complete, the sample must be taken from the patient and immediately
placed in a labelled container, it must be sealed in the appropriate manner and
the protocol followed in terms of labelling the sample. Both the patient and staff
member must sign across the seal. All information should be documented in the
patients notes. Chain of custody procedures should be followed as per section 2.
OFT PROCESSING OFF WARD
OFT samples should then be sent for laboratory testing as detailed in local
protocols. The testing agency will maintain appropriate chain of custody
information and documentation.
ORAL FLUID TESTING IN SCOTTISH FORENSIC SERVICES
While forensic services are familiar with urine testing methods, oral fluid testing
(OFT) has been successfully piloted at the State Hospital (MacCall et al 2013).
Significant benefits were found in relation to offering patients choice, patient
dignity and time savings. Patients at The State Hospital have since 2010 been
given the choice of either urine or OFT and OFT is now the preferred method of
testing, representing approximately 80% of all drug testing carried out at The
State Hospital. OFT is legally robust, has for many years been used in court
imposed Drug Testing & Treatment Orders (DTTOs) and is accepted by the
Scottish Government Health Department. We would encourage Forensic Services
to locally consider the value of OFT as a method of testing for illicit drugs,
alongside traditional urine testing.
POST SAMPLING PROCEDURES
The fact that a urine sample/OFT has been requested and provided (or not)
should be recorded in the patient’s notes. Refusal to provide a urinalysis/OFT
sample should be discussed with the staff member in Charge and the patients
RMO and Clinical team. The Scottish Government Restricted Patients Branch must
be notified of all refusals by a restricted patient to provide a sample when
requested.
AUDIT, RECORDS AND REPORTING
All areas caring for restricted patients will keep a cumulative record of all samples
taken and results within a centralised recording system. This will provide an
immediately accessible record of all tests taken and subsequent results. Details
will also be recorded within the individual patient’s notes.
The whole process should be audited on at least an annual basis and a report
provided through local governance systems.
Positive results will be notified immediately to the patients RMO and Clinical
Team. All positive results or failure to supply a sample must be communicated to
the Scottish Government Restricted Patient Team Mental Health and Protection of
Rights Division immediately.
Following a positive result a local Datix must be completed.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
12
REFUSAL, FAILURE TO PROVIDE A SAMPLE OR TAMPERING WITH
SAMPLES.
The Mental Health (Safety and Security in Hospital)(Scotland) Regulations 2005
Section 286(1)(b) allow the taking of samples from a patient externally by
swabbing from the mouth or body fluids. The patient’s cooperation and consent
should always be sought, as a sample cannot be taken against the patients will.
Any refusals, delays in providing samples or incidents of tampering with samples
must be notified the patients Multi Disciplinary Team immediately for monitoring
purposes.
The urinalysis/OFT process is not mandatory, and patients may refuse, or fail, to
provide a sample when requested to do so. Clinical Teams should be alert to the
possibility that either of these events is an attempt to allow time to obtain a clear
sample from someone else or to try other ways to avoid giving a genuine sample.
A team’s response to any of these events should be based on the likelihood of the
patient abusing substances.
The Scottish Government Restricted Patients Branch must be notified immediately
of all refusals. A clear and detailed action plan should be prepared by the
patients Multi Disciplinary Team in relation to actions required to obtain a sample.
Any actions taken in relation to minimising the risk of the patient obtaining or
using illicit substances must be clearly stated in the patients plan of care and fully
communicated to the patient.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
13
2.2 WINDOW OF DETECTION
It is important for practitioners to be aware of the limits of detection of nonprescribed drugs, including the periods in which substances are detectable post
use in urine and OFT. The windows of detection differ and as a guide these are
outlined below in tables 1 & 2. Please refer to your own laboratory or OFT
provider for specific guidance in relation to your local sampling methods.
URINE
Table 1: Drug Misuse and Dependence: UK Guidelines on Clinical Management
Approximate durations of detectability of selected drugs in urine.
NOTE – detection times are only very approximate and highly dependent upon on
dose, frequency, route of administration and urine excretion and concentration.
ORAL FLUID
The detection times seen with oral fluid differ from those seen with urine testing
(Figure 1). For many drugs the detection window for oral fluid and urine are
broadly similar but with oral fluid detection starting earlier (within a few minutes
of use). Urine testing often misses recent use and may not detect until 6-8 hours
after use but where metabolites are excreted, will tend to detect up to 3 days.
(Long term, high level use of cannabis or benzodiazepines has been reported to
remain detectable for several weeks in urine). Table 2 gives a comparative guide
to detection windows in OFT vs urine.
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
14
Figure 1: Comparative detection windows
Oral Fluid
Urine
Table 2: Comparative detection OFT vs urine, Altrix 2001
Drug Class
urine
Detection time in oral fluid
Detection time in
The appendices contain photos of specific kits with descriptions of the companies that make them.
There is already a ‘disclaimer’ saying that these are illustrative only the recommendation is if they are
not used something similar is.
15
2.3 POSITIVE RESULTS AND CONFIRMATION
Most first line methods (which include point of care testing) of drug testing
involve an immunoassay test, whereby antibodies bind to a compound causing a
measurable change in a label. Cross reactivity with other compounds can cause
false positives (or sometimes false negatives) thus any positive tests on
immunoassays should be confirmed using more sophisticated analysis. Gas
Chromatography-Mass Spectrometry (GC-MS) is the ‘’gold standard’’ method of
confirmation and Liquid Chromatography with Mass Spectrometry/Mass
Spectrometry (LC-MS/MS) is a recognised alternative. These tests are more
expensive but are legally defensible and should always be used where
immunoassay tests are positive and the suspected drug use has material
consequences for decisions affecting the patients freedom. Further details of
confirmation methods are available in appendix 6.
It should be noted that different laboratories may have different cut-offs for a
positive result during screening by immunoassay (e.g. Amphetamine). This may
reflect subtle differences in the specificity of the antibody used within the assay
by different kit manufacturers, but also assay rationale. The Substance Misuse
and Mental Health Service Administration (SAMSHA) cut-off for a positive
Amphetamine result is 1000µg/L; European Workplace Drug Testing (EWDTS)
guidelines suggest 500 µg/L. As such, a sample may give a positive result in one
laboratory and negative in another.
Clarification should be sought by the
requester from the laboratory or (in the case of point of care testing) the
manufacturer as to which cut-offs are being used.
While each case needs to be considered on its individual merits we provide some
guidance on possible outcomes arising from patients refusal to provide a sample,
failure to provide a satisfactory sample/tampering with the sample and if a
positive drug test is returned. This guidance is included in appendix 7.
16
3. PRESCRIBED MEDICINES & OVER THE COUNTER REMEDIES
The immunoassay is a quick, convenient and highly sensitive test which is used in
point of care screening for drugs of misuse. However due to the lack of specificity
of the immunoassay there are a number of agents which have potential to cause
a false positive result. A ‘false positive’ may occur where the person has not
taken the illicit substance being tested but the test result shows positive for the
substance.
A wide range of substances, including over-the-counter (OTC) and prescribed
medicines can produce false positives. It is therefore important to note all
medicines which the patient is taking and consider the possibility of a false
positive result. A full list of medications which have the potential to cause false
positive results is available in appendix 8. If the patient is taking one of these
medications, a more specific confirmation test may be indicated.
17
4. NEW PSYCHO ACTIVE SUBSTANCES
New Psychoactive Substances (NPS) are defined by the United Nations Office on
Drugs and Crime (UNODC) as being "substances of abuse, either in pure form or
a preparation, that are not controlled by the 1961 Convention on Narcotic Drugs
or the 1971 Convention on Psychotropic Substances, but which may pose a public
health threat." (SMART 2013)
NPS are more commonly referred to by terms such as "legal highs", "herbal
highs", "bath salts" or "club drugs". Their number is proliferating - from 166
estimated to be available in 2009 to 251 by mid 2012 - and their use widespread
with half a million people in UK reporting having used a club drug in 2012.
(SHINE 2012)
A guide to some of the commonly used "recreational psychoactive substances in
the UK" is provided by The Drugs Wheel accessible at www.thedrugswheel.com.
Forensic analysis of NPS samples in vitro is complicated by a number of factors –
e.g subtle changes in drug formulation; uncontrolled, messy synthesis with
variable precursor sources; lack of reliable information on packaging; difficulties
with sample extraction/homogeneity of sample – making this a highly
challenging, rapidly evolving area of work. This reality means that, at the time of
writing, it is not possible to test for the majority of these substances and
guidance should be sought from the laboratory providing testing.
18
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(2002).
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8-36 (2002).
Fitzgerald et al. (1999). Broad Spectrum Drug Identification Directly from Urine,
Using Liquid Chromatography-Tandem Mass Spectrometry. Clinical Chemistry Vol
45 pp 1224-1234.
Heit & Gourlay (2004). Urine Drug Testing in Pain Medicine. Journal of Pain and
Symptom Management. Vol 27 (3) pp 260-267.
Jablensky A, Sartorius N, Emberg C. (1992) Schizophrenia: manifestations,
incidence and course in different cultures. Psychological Medicine Supplement Vol
20 p79.
MacCall CA, Ritchie G, Sood M, (2013) Oral Fluid Testing as an alternative to
urine testing for drugs of abuse in inpatient forensic settings: giving patients
choice. Scottish Medical Journal 58 (2) pp 99-103.
Manchikanti et al. (2011). Comparative Evaluation of the Accuracy of
Immunoassay with Liquid Chromatography Tandem Mass Spectrometry
(LC/MS/MS) of Urine Drug Testing (UDT) Opioids and Illicit Drugs in Chronic Pain
Patients. Pain Physician. Vol 14 pp 175-187.
Monahan J, Steadman HJ, Silver E, Appelbaum PS, Robbins PC, Mulvey EP et al.
Rethinking Risk Assessment: the McArthur Study of Mental Disorder and Violence.
New York: Oxford University Press, 2001.
Pesce et al. (2010). An Evaluation of the Diagnostic Accuracy of Liquid
Chromatography-Tandem Mass Spectrometry Versus Immunoassay Drug Testing
in Pain Patients. Pain Physician. Vol 13 pp 273-281.
Reisfield et al. (2007). Rational Use and Interpretation of Urine Drug Testing in
Chronic Opioid Therapy. Annals of Clinical & Laboratory Science. Vol 37 pp 301314.
19
SHINE 2012 Final Report from Project NEPTUNE:
http://www.health.org.uk/media_manager/public/75/programme_library_docs/Sh
ine%202012%20final%20report%20-%20NEPTUNE%20CNWL.pdf
SMART
2013.
The
Challenge
of
New
Psycoactive
Substances,
UNODC,2013:http://www.unodc.org/documents/scientific/NPS_2013_SMART.pdf)
Stout et al. (2009). A Comparison of the Validity of Gas Chromatography–Mass
Spectrometry and Liquid Chromatography–Tandem Mass Spectrometry Analysis
of Urine Samples for Morphine, Codeine, 6-Acetylmorphine, and Benzoylecgonine.
Journal of Analytical Toxicology. Vol 33 pp 398-408.
Stout et al. (2010). A Comparison of the Validity of Gas Chromatography–Mass
Spectrometry and Liquid Chromatography–Tandem Mass Spectrometry Analysis
of
Urine
Samples
II:
Amphetamine,
Methamphetamine,
(±)-3,4Methylenedioxyamphetamine, (±)-3,4-Methylenedioxymethamphetamine, (±)3,4-Methylenedioxyethylamphetamine, Phencyclidine, and (±)-11-nor-9-CarboxyΔ9-tetrahydrocannabinol. Journal of Analytical Toxicology. Vol 34 pp 430-443.
Swanson JW, Holzer CE, Ganju VK, Jono RT. (1990) Violence and Psychiatric
Disorder in the Community: Evidence from the Epidemiological Catchment Area
Surveys. Hospital and Community Psychiatry. Vol 41 pp 761-70.
Wu et al. (1994). Characterization of Drug Interferences Caused by Co-elution of
Substances in Gas Chromatography/Mass Spectrometry Confirmation of Targeted
Drugs in Full-Scan and Selected-Ion Monitoring Modes. Clinical Chemistry. Vol 40
pp 216-220.
Vincent, EC., et al (2006) Amphetamine positive urine toxicology screen
secondary to atomoxetine. The Journal of Family Practice. Vol 55 pp 893-897
20
APPENDIX 1
Example Chain of Custody Procedure
Labelling & Packaging
21
APPENDIX 2
Safe Secure Environment
Approved by
Date Approved:
Review Date:
PAGE: 1 of 2
SUBJECT: Example Procedure for Collection of Sterile Supervised Urine
Sample in the Community
Main Principles:



Part of agreed treatment plan
Same sex worker recommended
2 samples to be obtained for medico-legal purposes.
Equipment










1
2
Gloves x 4 (2 sets)
1 x Sterile Collection Kit
2 x vacuette / vacutainers for samples A + B
1 x connector
1 x sample pipette
1 x Biochemistry Form
2 x Tamper proof labels
1 x Tamper proof transport bag
1 x Sharps box
2 x Chain of Custody Form
Advise client of the nature and purpose of sample collection and obtain
consent.
Once consent obtained, escort client to bathroom.
3
Supervising nurse to be in position where they can observe and hear a stream
of urine.
4
Client to be offered use of rubber gloves.
5
Client to be given sterile collection pot and advised to remove foil lid.
6
Once the sample is collected, the temperature on the pot should be observed
and noted. A temperature of between 36 and 38 degrees Celsius should be
expected, as per core body temperature. This will be indicated by a green /
tan dot. (Temperatures outwith this range could indicate the sample is not
genuine). A minimum of 20 mls of urine is required to enable 2 samples to be
sent to the laboratory.
7
The supervising nurse should use the second set of rubber gloves and remove
the sample pot from the client. The pipette should be attached to the
connector and placed in sample pot.
8
2 x vacutainers should then be attached to the connector, providing 2 x
samples
22
9
The connector should be disposed of in the sharps box, any remaining urine
should be flushed away and the pot and pipette rinsed out for disposal in
household waste.
10
Rubber gloves should be removed and the client and nurse can wash their
hands.
11
Both the client and supervising nurse should keep the specimen in view at all
times prior to it being sealed and labelled.
12
The tamper proof security labels should be hand written, legibly in black or
blue ink.
13
The biochemistry form should be handwritten by the supervising nurse (in the
same handwriting as completed on both samples). Labels should NOT be used.
14
Tamper Proof Security Seals should be placed over the vacutainer caps and
down the sides of the bottles. The client (donor) should sign the seal. The
supervising nurse should write Sample A and Sample B on each of the bottles.
15
The matching bar codes should be attached to the biochemistry form on the
top right hand corner (where it states Laboratory Use Only)
16
Once the client and supervising nurse are satisfied that the samples are
secure, both samples A & B should be placed in the bag attached to the
biochemistry form.
17
The form and enclosed samples should finally be placed in the tamper proof
bag and sealed ready for transport to the laboratory.
18
The Samples should be taken directly to the relevant hospital and handed into
the Laboratory. Two Chain of Custody forms should be completed and a copy
placed in the client’s case notes (appendix 3).
19
A record of the collection details should be recorded in the client’s
multidisciplinary case notes.
23
APPENDIX 3
EXAMPLE DRUG SCREENING PROFORMA /CHAIN OF CUSTODY FORM
Client Name :
……………………………………………
CHI No :
……………………………………………
Consultant / RMO :
……………………………………………
Type of Sample:
……………………………………………
Screening for :
Alcohol
Methadone
Amphetamines
Methamphetamine
Benzodiazepines
Opiates
Buprenorphine
Opiate Confimation
Cannabinoids
Full Illicit Drug Screen
Sample supervised by :
……………………………………………
Designation :
……………………………………………
Date :
……………………………………………
Sample Delivered by :
……………………………………………
Designation :
……………………………………………
Date :
……………………………………………
Sample Received by :
……………………………………………
Designation :
……………………………………………
Date :
……………………………………………
24
APPENDIX 4 – EXAMPLE
COLLECTION METHOD
FLUID
&
URINE
SAMPLE
25
APPENDIX 5
Example Forensic Sampling Components
(as used in Greater Glasgow & Clyde)
N.B. The information below is included as an example of where components for forensic
sample collection may be sourced. Other providers are available. Such examples should
not be considered an endorsement by this group, the Forensic Network or Scottish
Government. The components used in practice should be selected in conjunction with the
laboratory performing the tests.
Sample collection tubes:
Greiner Bio-One Vacuette 6mL, 13x100, Z No Additive
1200 pack, Item No. 456085
Sample transfer device:
Greiner Bio-One Urine Transfer Device Short
600 pack, Item No. 450251
W: www.gbo.com/preanalytics
Chain of Custody Labels are ordered from:
PFC Group Ltd
Roman Way
Berry Hill Industrial Estate
Droitwich
Worcestershire
WR9 9AJ
PFC Contact – Terry Brimelow
T: 01905 797000
F: 01905 797274
E: [email protected]
W: www.pfcmultichannel.co.uk
Chain of Custody Kits to be used in the community are ordered from:
Agriyork 400 Limited,
5 Lockwood Court,
Pocklington,
York,
YO42 2QW.
T: 01759 306580
F: 01759 306590
E: [email protected]
W: www.Agriyork.co.uk
Community chain of custody kits contain:
1 x Sterile urine collection container (supplied by Agriyork)
1 x Pair of examination gloves (supplied by Agriyork)
1 x Urine transfer device (supplied by laboratory)
2 x Vacuette collection tubes (supplied by laboratory)
1 x Chain of custody (A & B) label (supplied by laboratory)
1 x Laboratory request form (supplied by laboratory)
These are sealed in a bag by Agriyork that is opened in front of the patient before sample
collection
26
APPENDIX 6
Drug testing may be undertaken for a number of reasons, e.g. compliance
testing, employment screening or drugs of abuse treatment programs. A number
of guidelines for such testing are available (Heit & Gourlay 2004)
Immunoassay screening
For reasons of throughput, expense etc, an initial screen is usually by
immunoassay performed either within a laboratory (using an automated analyser)
or via Point of Care Testing (POCT) in a side-room setting using ‘dipstick’
technology. Immunoassay is based on the fact that antibodies are raised against
structural features of a compound (Reisfield et al 2007). Binding of the drug being
tested to the antibody causes a measureable change in a label. Cross-reactivity
with other compounds with a similar (or even dissimilar) chemical structure
allows testing of a class of compounds (e.g. Opiates). However, a disadvantage is
that false-positive – or in some cases false negative – results can occur (Pesce et
al 2010 & Manchikanti et al 2011). For this reason, positive immunoassay results
should be confirmed by an alternative methodology. Such tests are usually
laboratory based, are low through-put, require complex analysers and skilled
result interpretation and are hence more expensive. It has been widely accepted
for some time that Gas Chromatography-Mass Spectrometry (GC-MS) is the
‘gold-standard’ method for confirmation.
GC-MS confirmation
GC-MS is the combination of two analytical methods to form a single analysis.
The compounds within the sample are separated by gas chromatography
depending upon the volatility within a gas phase as well as the interaction with a
capillary column and an inert gas (usually either helium or hydrogen) mobile
phase. As such, there is more than one competing force upon the molecule
resulting in separation. Once separated, the compounds enter the mass
spectrometer detector where they are bombarded with electrons causing
fragmentation and charged ion formation. A mass filter (usually a quadrapole) will
allow only ions of a certain mass to reach the detector. As the mass filter can be
programmed, a scan throughout the required mass range is possible. As
fragmentation occurs in a predictable and consistent manner, a ‘fingerprint’
spectrum characteristic for each compound is formed. This spectrum can be
compared to a library for identification of the compound present.
There are complications to GC-MS analysis however. Firstly, pre-analytical sample
preparation is usually necessary (e.g. solid-phase extraction) to remove as many
interfering substances etc which is time-consuming and can be technically
demanding. Secondly, the process requires that the compound is easily ionised
and thermally stable. If not the case, chemical alteration of the compound (e.g.
derivatisation in the case of opiates) may be necessary. Thirdly, in order to
confirm the presence of a particular compound, the compound must have a
library entry. This requires the availability of a pure certified reference material
(CRM) – which may not always be the case.
LC-MS/MS confirmation
Recently, liquid-chromatography with mass spectrometry/mass spectrometry (LCMS/MS) has been recognised as an alternative to GC-MS for result confirmation.
The technique uses High Performance Liquid Chromatography (HPLC) with a liquid
mobile phase. Within the mass spectrometer, there are 2 quadrapole mass filters
27
in line (hence why the technique is also referred to as tandem mass
spectrometry) separated by a hexapole containing an inert gas (usually argon or
nitrogen). Within the hexapole, the application of a charge causes fragmentation
of the ions. By means of varying the charges applied to either (or indeed both) of
the quadrapole mass filters, a number of detection options are available.
LC-MS/MS is more sensitive than GC-MS, and as a liquid mobile phase is used,
the compounds do not need to be thermally stable as in GC-MS – hence
derivatisation may not be required. The choice of mobile phases used (e.g.
gradients etc) further increases the flexibility of the method. There is, however, a
well characterised effect in that sensitivity is subject to matrix effects (i.e. the
sample matrix can enhance or suppress the ionisation of the compounds being
analysed). This may be important as LC-MS/MS ionisation is more gentle
compared to GC-MS. In most cases, a ‘spectrum’ is not produced in the same way
as by GC-MS, but the fragmentation pattern produced is deemed to be sufficiently
specific for compound identification. Studies have indicated that a similar range of
compounds detected by GC-MS can also be detected by LC-MS/MS. It is possible
to combine a screen and identification within the same run by LC-MS/MS due to
higher throughput as well as the chromatography and mass spectrometry
elements employed. However, a drawback (compared to immunoassay screening)
is that this is a targeted screen (i.e. only specific compounds looked for will be
detected).
28
APPENDIX 7 – EXAMPLES OF DECISION MAKING ON POSITIVE RESULTS
1
Refusal
(initially as failure to provide)
Try to ascertain why the patient is
refusing and encourage to provide
sample. If the patient continues to
refuse inform the patient that he/she
will be regarded the same as if he had
provided a positive result
2
Discuss with Scottish Government
3
Increased observation
4
Requirement for a number of clear
samples
5
Supervised calls
6
Supervised mail
7
Special visits
8
Consider appropriateness of all visitors
(special attention to child visits)
Consider off ward placements
9
10
Consider appropriateness of suspension
of detention
11
Removal of open door
Failure to provide a satisfactory
sample / Tampering with sample
Try to ascertain why the patient is
refusing and encourage to provide
sample. If the patient continues to
refuse inform the patient that
he/she will be placed on enhanced
levels of observation until acceptable
sample provided
Discuss with Scottish
Government
Supervision of toilet access until
acceptable sample provided (for
urine sample)
Supervision of fluids until acceptable
sample provided (for urine sample)
A positive result is returned
Full consideration should be given in
terms of Risk prior to making
decisions on any of the above
Full consideration should be given in terms of Risk
prior to making decisions on any of the above
Discuss with the patient to try and ascertain the
substance the patient believes he has taken and the
amount he has used. Try to identify the source of the
substance/substances.
Obtain an immediate sample to confirm or otherwise
continuing substance use
Discuss with Scottish Government
Place on enhanced levels of observation until full
discussion can be arranged with the patients RMO &
CTM
Keep the patient on the ward & consider the need for
special visits
29
12
Removal of grounds access/revoke
suspension of detention
Remain on ward until acceptable
sample provided
Closely monitor physical signs for any adverse
consequences.
13
Consider variation of conditions of
discharge/recall to hospital
CPN to discuss with clinical team and
carry out further visit.
Consider variation of conditions of
discharge/recall to hospital
CPN to discuss with clinical team and
carry out further visit.
Consider variation of conditions of discharge/recall to
hospital
14
30
Appendix 8 – Medicines including OTC with potential to cause
false positives
Substance
Screened
being
Amphetamine
Agents with potential to
cause
false
positive
immunoassay
OTC
medicines
containing
ephedrine,
pseudoephedrine,
phenylephrine
&
phenylpropanolamine
Selegiline & amantadine
Dexamfetamine,
lisdexamfetamine
methylphenidate
Phenothiazines
chlorpromazine
Promethazine
Note
Available
as
OTC
products e.g. Actifed,
Sudafed, Benadryl,
Sinutab, Beechams,
Lemsip, Benalyn
Produce amphetamine
metabolites
Contain amphetamines
&
including
Available
as
antihistamine
OTC
products
e.g.
Phenergan,
Avomine, Sominex
Labetalol
Ranitidine
Available
as
OTC
product e.g. Zantac
Available
as
OTC
product e.g. Colofac
Zyban prescribed for
smoking cessation
Mebeverine
Bupropion
Antidepressants
including
trimipramine & trazodone
Benzodiazepines
Cannabinoids
Ofloxacin
Metformin
Sertraline
Efavirenz
NSAIDs including ibuprofen &
naproxen
Efavirenz
Proton pump inhibitors
Cocaine
Hemp containing food items
Derivatives of coca plant
Ibuprofen
OTC
available
Available
as
OTC
products e.g.Losec
Derived from the same
plant as cocaine
Topical anaesthetics
Opioids
OTC
medicines
codeine
containing
Poppy seeds
Quinolone antibiotics including
ofloxacin
OTC
medicines
cough,
pain
diarrhoea
for
and
31
Methadone
Buprenorphine
Rifampicin
Cardiac
medicines
including
verapamil
Opioid
analgesics
including
pentazocine and tapentadol
naloxone
Psychotropics
including
levomepromazine,
chlorpromazine, clomipramine,
quetiapine
Verapamil
Antihistamines: doxylamine &
diphenhydramine
Available
as
OTC
products
e.g.
Benadryl, Nytol
Opioid
analgesics
including
codeine,
dihydrocodeine,
morphine and tramadol
Antipsychotics
inclucing
amisulpride and sulpiride
NB. This list is not exhaustive but based on the available evidence
http://jat.oxfordjournals.org/content/38/7/387.full
32
MEMBERSHIP TABLE
NAME
Dr Callum A MacCall (Chair)
DESIGNATION
Consultant Forensic Psychiatrist & Lead
Clinician
ORGANISAITON
The State Hospital
Graeme Chalmers
Principal Clinical Biochemist
NHS Greater Glasgow & Clyde
Vivienne Gration
Manager
The Forensic Network
Jean Logan
Lead Pharmacist, Mental Health &
Substance Misuse
NHS Forth Valley
Dr Oliver Aldridge
Medical Lead
Edinburgh, Midlothian and East Lothian
DTTO Services
Claire Meikle
Solicitor
Scottish Government Legal Directorate
Gordon Ritchie
Consultant Nurse
NHS Tayside
Dr Roy Talbot
Principal Clinical Scientist
NHS Greater Glasgow & Clyde
Shona Hendry
Service Manager
NHS Greater Glasgow & Clyde