DRUG TESTING PROTOCOL - Forensic Network



DRUG TESTING

FOR RESTRICTED PATIENTS

March 2015

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

3. PRESCRIBED MEDICINE & OVER THE COUNTER

REMEDIES 16

4. NEW PSYCHO ACTIVE SUBSTANCES 17

5. REFERENCES 18

6. APPENDICES 20

7. MEMBERSHIP 32

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 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.

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

• use of sealed and tamper-evident community urine collection kit 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’

• 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.

• 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.

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.

• 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.

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 Multi- Disciplinary 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.

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.

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.

2.2 WINDOW OF DETECTION

It is important for practitioners to be aware of the limits of detection of non-prescribed 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.

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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.

Figure 1: Comparative detection windows

Oral Fluid

Urine

Table 2: Comparative detection OFT vs urine, Altrix 2001

Drug Class Detection time in oral fluid Detection time in urine

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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.

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.

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 .

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.

REFERENCES

Abraham, A., Luty, J. (2010) Testing for illicit drug use in mental health services. Advances in psychiatric treatment. Vol 16 pp 369-379

Cantwell R, Harrison G. (1996) Substance misuse in the severely mentally ill. Advances in Psychiatric Treatment. Vol 2 pp 117-124.

Department of Health and Human Services. Mandatory guidelines for federal workplace drug testing programs; final guidelines notice. Fed Regist 1988; 53; 11969-11989.

Department of Health (England) and the devolved administrations (2007). Drug Misuse and Dependence: UK Guidelines on Clinical Management. London: Department of Health (England), the Scottish Government, Welsh Assembly Government and Northern Ireland Executive

European Laboratory Guidelines for Legally Defensible Workplace Drug Testing (2002).

European Union Decision 2002/657/EC 17.8.2002, Off. J. Eur. Communities 221 9 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 301-314.

SHINE 2012 Final Report from Project NEPTUNE:

SMART 2013. The Challenge of New Psycoactive Substances, UNODC,2013:)

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, (±)-3,4-Methylenedioxyamphetamine, (±)-3,4-Methylenedioxymethamphetamine, (±)-3,4-Methylenedioxyethylamphetamine, Phencyclidine, and (±)-11-nor-9-Carboxy-Δ9-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

APPENDIX 1

Example Chain of Custody Procedure

Labelling & Packaging

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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 |

| |

|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 |

|1 |Advise client of the nature and purpose of sample collection and obtain consent. |

|2 |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 |

|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. |

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 : |…………………………………………… |

APPENDIX 4 – example fluid & urine sample collection method

[pic]

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: 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: terry.b@pfcgroup.co.uk

W: 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: sales@agriyork.co.uk

W: 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

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 (LC-MS/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 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).

APPENDIX 7 – EXAMPLES OF DECISION MAKING ON POSITIVE RESULTS

| |Refusal |Failure to provide a satisfactory sample / Tampering with |A positive result is returned |

| |(initially as failure to provide) |sample | |

|1 |Try to ascertain why the patient is refusing and encourage to |Try to ascertain why the patient is refusing and encourage|Discuss with the patient to try and ascertain the substance the patient believes he |

| |provide sample. If the patient continues to refuse inform the |to provide sample. If the patient continues to refuse |has taken and the amount he has used. Try to identify the source of the |

| |patient that he/she will be regarded the same as if he had |inform the patient that he/she will be placed on enhanced |substance/substances. |

| |provided a positive result |levels of observation until acceptable sample provided | |

| | | |Obtain an immediate sample to confirm or otherwise continuing substance use |

|2 |Discuss with Scottish Government |Discuss with Scottish Government |Discuss with Scottish Government |

|3 |Increased observation |Supervision of toilet access until acceptable sample |Place on enhanced levels of observation until full discussion can be arranged with |

| | |provided (for urine sample) |the patients RMO & CTM |

|4 |Requirement for a number of clear samples |Supervision of fluids until acceptable sample provided |Keep the patient on the ward & consider the need for special visits |

| | |(for urine sample) | |

|5 |Supervised calls |Full consideration should be given in terms of Risk prior |Full consideration should be given in terms of Risk prior to making decisions on any |

| | |to making decisions on any of the above |of the above |

|6 |Supervised mail | | |

|7 |Special visits | | |

|8 |Consider appropriateness of all visitors (special attention to | | |

| |child visits) | | |

|9 |Consider off ward placements | | |

|10 |Consider appropriateness of suspension of detention | | |

|11 |Removal of open door | | |

|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 |Consider variation of conditions of discharge/recall to |Consider variation of conditions of discharge/recall to hospital |

| |hospital |hospital | |

|14 |CPN to discuss with clinical team and carry out further visit. |CPN to discuss with clinical team and carry out further | |

| | |visit. | |

Appendix 8 – Medicines including OTC with potential to cause false positives

|Substance being Screened |Agents with potential to cause false positive |Note |

| |immunoassay | |

|Amphetamine |OTC medicines containing ephedrine, |Available as OTC products e.g. |

| |pseudoephedrine, phenylephrine & |Actifed(, Sudafed(, Benadryl(, |

| |phenylpropanolamine |Sinutab(, Beechams(, Lemsip(, Benalyn(|

| |Selegiline & amantadine |Produce amphetamine metabolites |

| |Dexamfetamine, lisdexamfetamine & methylphenidate |Contain amphetamines |

| |Phenothiazines including chlorpromazine | |

| |Promethazine |Available as antihistamine OTC |

| | |products e.g. Phenergan(, Avomine(, |

| | |Sominex( |

| |Labetalol | |

| |Ranitidine |Available as OTC product e.g. Zantac( |

| |Mebeverine |Available as OTC product e.g. Colofac(|

| |Bupropion |Zyban( prescribed for smoking |

| | |cessation |

| |Antidepressants including trimipramine & trazodone| |

| | | |

| |Ofloxacin | |

| |Metformin | |

|Benzodiazepines |Sertraline | |

| |Efavirenz | |

|Cannabinoids |NSAIDs including ibuprofen & naproxen |Ibuprofen available OTC |

| |Efavirenz | |

| |Proton pump inhibitors |Available as OTC products e.g.Losec( |

| |Hemp containing food items | |

|Cocaine |Derivatives of coca plant |Derived from the same plant as cocaine|

| |Topical anaesthetics | |

|Opioids |OTC medicines containing codeine |OTC medicines for cough, pain and |

| | |diarrhoea |

| |Poppy seeds | |

| |Quinolone antibiotics including ofloxacin | |

| |Rifampicin | |

| |Cardiac medicines including verapamil | |

| |Opioid analgesics including pentazocine and | |

| |tapentadol | |

| |naloxone | |

|Methadone |Psychotropics including levomepromazine, | |

| |chlorpromazine, clomipramine, quetiapine | |

| |Verapamil | |

| |Antihistamines: doxylamine & diphenhydramine |Available as OTC products e.g. |

| | |Benadryl(, Nytol( |

|Buprenorphine |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 |

| |

MEMBERSHIP TABLE

|NAME |DESIGNATION |ORGANISAITON |

|Dr Callum A MacCall (Chair) |Consultant Forensic Psychiatrist & Lead Clinician |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 |

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