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1.  Effectiveness and Cost Effectiveness of Expanding Harm Reduction and Antiretroviral Therapy in a Mixed HIV Epidemic: A Modeling Analysis for Ukraine 
PLoS Medicine  2011;8(3):e1000423.
A cost-effectiveness study by Sabina Alistar and colleagues evaluates the effectiveness and cost effectiveness of different levels of investment in methadone, ART, or both, in the mixed HIV epidemic in Ukraine.
Background
Injection drug use (IDU) and heterosexual virus transmission both contribute to the growing mixed HIV epidemics in Eastern Europe and Central Asia. In Ukraine—chosen in this study as a representative country—IDU-related risk behaviors cause half of new infections, but few injection drug users (IDUs) receive methadone substitution therapy. Only 10% of eligible individuals receive antiretroviral therapy (ART). The appropriate resource allocation between these programs has not been studied. We estimated the effectiveness and cost-effectiveness of strategies for expanding methadone substitution therapy programs and ART in mixed HIV epidemics, using Ukraine as a case study.
Methods and Findings
We developed a dynamic compartmental model of the HIV epidemic in a population of non-IDUs, IDUs using opiates, and IDUs on methadone substitution therapy, stratified by HIV status, and populated it with data from the Ukraine. We considered interventions expanding methadone substitution therapy, increasing access to ART, or both. We measured health care costs, quality-adjusted life years (QALYs), HIV prevalence, infections averted, and incremental cost-effectiveness. Without incremental interventions, HIV prevalence reached 67.2% (IDUs) and 0.88% (non-IDUs) after 20 years. Offering methadone substitution therapy to 25% of IDUs reduced prevalence most effectively (to 53.1% IDUs, 0.80% non-IDUs), and was most cost-effective, averting 4,700 infections and adding 76,000 QALYs compared with no intervention at US$530/QALY gained. Expanding both ART (80% coverage of those eligible for ART according to WHO criteria) and methadone substitution therapy (25% coverage) was the next most cost-effective strategy, adding 105,000 QALYs at US$1,120/QALY gained versus the methadone substitution therapy-only strategy and averting 8,300 infections versus no intervention. Expanding only ART (80% coverage) added 38,000 QALYs at US$2,240/QALY gained versus the methadone substitution therapy-only strategy, and averted 4,080 infections versus no intervention. Offering ART to 80% of non-IDUs eligible for treatment by WHO criteria, but only 10% of IDUs, averted only 1,800 infections versus no intervention and was not cost effective.
Conclusions
Methadone substitution therapy is a highly cost-effective option for the growing mixed HIV epidemic in Ukraine. A strategy that expands both methadone substitution therapy and ART to high levels is the most effective intervention, and is very cost effective by WHO criteria. When expanding ART, access to methadone substitution therapy provides additional benefit in infections averted. Our findings are potentially relevant to other settings with mixed HIV epidemics.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
HIV epidemics in Eastern Europe and Central Asia are mainly driven by increasing use of injection drugs combined with heterosexual transmission. In the Ukraine, in 2007, there were 82,000 officially registered people living with HIV—three times the number registered in 1999—and an estimated 395,000 HIV infected adults. The epidemic in Ukraine, like other countries in the region, is concentrated in at-risk populations, particularly people who inject drugs: in 2007, an estimated 390,000 Ukrainians were injecting drugs, an increase in drug use over the previous decade, not only in Ukraine, but in other former USSR states, owing to the easy availability of precursors for injection drugs in a climate of economic collapse.
The common practices of people who inject drugs in Ukraine and in other countries in the region, such as social injecting, syringe sharing, and using common containers, increase the risk of transmitting HIV. Public health interventions such as needle exchange can limit these risk factors and have been gradually implemented in these countries. In 2007, Ukraine approved the use of methadone substitution therapy and the current target is for 11,000 people who inject drugs to be enrolled in substitution therapy by 2011. Furthermore, since treatment for HIV-infected individuals is also necessary, national HIV control plans included a target of 90% antiretroviral therapy (ART) coverage by 2010 but in 2007 less than 10% of the 91,000 eligible people received treatment. Although the number of people who inject drugs and who receive ART is unknown, physicians are often reluctant to treat people who inject drugs using ART owing to alleged poor compliance.
Why Was This Study Done?
As resources for HIV interventions in the region are limited, it is important to investigate the appropriate balance between investments in methadone substitution therapy and ART in order to maximize benefits to public health. Several studies have analyzed the cost effectiveness of methadone substitution therapy in similar settings but have not considered tradeoffs between ART and methadone substitution therapy. Therefore, to provide insights into the appropriate public health investment in methadone substitution therapy and ART in Ukraine, the researchers evaluated the public health effectiveness and cost effectiveness of different strategies for scaling up methadone substitution therapy and/or expanding ART.
What Did the Researchers Do and Find?
The researchers developed a model to accommodate different population groups: people who inject drugs on substitution therapy with methadone; people who inject opiates and do not take any substitution therapy; and people who do not inject any drugs, hence do not need substitution therapy. The researchers inputted Ukraine country-level data into this model and used current HIV trends in Ukraine to make rational assumptions on possible future trends and scenarios. They considered scenarios expanding methadone substitution therapy availability, increasing acces to ART, or both. Then, the researchers measured health care costs, quality-adjusted life years (QALYs), HIV prevalence, infections averted, and incremental cost effectiveness for the different scenarios. They found that after 20 years, HIV prevalence reached 67.2% in people who inject drugs and 0.88% in people who do not inject drugs without further interventions. Offering methadone substitution therapy to 25% of people who inject drugs was the most effective strategy in reducing prevalence of HIV and was also the most cost effective, averting 4,700 infections and adding 75,700 QALYs versus the status quo at $530/QALY gained. Expanding both methadone substitution therapy and ART was also a highly cost effective option, adding 105,000 QALYs at US$1,120/QALY gained versus the methadone substitution therapy-only strategy. Offering ART to 80% of eligible people who did not inject drugs, and 10% of people who injected drugs averted only 1,800 infections, and added 76,400 QALYs at $1,330/QALY gained.
What Do These Findings Mean?
The results show that methadone substitution-focused therapeutic scenarios are the most cost effective, and that benefits increase with the scale of the project, even among people who do not inject drugs. This makes a methadone substitution strategy a highly cost-effective option for addressing the growing HIV epidemic in Ukraine. Therefore, if it is not feasible to invest in large-scale methadone substitution programs for any reason, political circumstances for example, providing as much methadone substitution as is acceptable is still desirable. While substitution therapy appears to avert the most HIV infections, expanded ART provides the largest total increase in QALYs. Thus, methadone substitution therapy and ART offer complementary benefits. Because the HIV epidemic in Ukraine is representative of the HIV epidemic in Eastern Europe and Central Asia, the cost-effective strategies that the researchers have identified may help inform all decision makers faced with a mixed HIV epidemic.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000423.
Alliance provides information on its work supporting community action on AIDS in Ukraine
USAID provides an HIV/AIDS Health Profile for Ukraine
UNICEF provides information about its activities to help Ukraine fight rising HIV/AIDS infection rates
International Harm Reduction Association provides information about the status of harm reduction interventions such as methadone substitution therapy around the world
doi:10.1371/journal.pmed.1000423
PMCID: PMC3046988  PMID: 21390264
2.  The nature of methadone diversion in England: a Merseyside case study 
Background
Methadone maintenance treatment (MMT) is a key element in treatment for opiate addiction; however concerns about the diversion of methadone remain. More current empirical data on methadone diversion are required. This research investigated the market for diverted methadone in Merseyside, UK, in order to provide a case study which can be transferred to other areas undertaking methadone maintenance treatment on a large scale.
Methods
Questionnaires were completed (in interview format) with 886 past year users of methadone recruited both in and out of prescribing agencies. Topic areas covered included current prescribing, obtaining and providing methadone, reasons for using illicit methadone and other drug use.
Results
Large proportions of participants had obtained illicit methadone for use in the past year with smaller proportions doing so in the past month. Proportions of participants buying and being given methadone were similar. Exchange of methadone primarily took place between friends and associates, with 'dealers' rarely involved. Gender, age, whether participant's methadone consumption was supervised and whether the aims of their treatment had been explained to them fully, influenced the extent to which participants were involved in diverting or using diverted methadone.
Conclusion
Methadone diversion is widespread although drug users generally do not make use of illicit methadone regularly (every month). The degree of altruism involved in the exchange of methadone does not negate the potential role of this action in overdose or the possibility of criminal justice action against individuals. Treatment agencies need to emphasise these risks whilst ensuring that treatment aims are effectively shared with clients to ensure adherence to treatment.
doi:10.1186/1477-7517-9-3
PMCID: PMC3285516  PMID: 22243982
Methadone; diversion; treatment; supervision
3.  Methadone maintenance in general practice: patients, workload, and outcomes. 
BMJ : British Medical Journal  1994;309(6955):641-644.
OBJECTIVE--To assess recruitment to and work-load associated with methadone maintenance clinics in general practice; to investigate the characteristics of patients and outcomes associated with treatment. DESIGN--Study of case notes. SETTING--Methadone maintenance clinics run jointly by general practitioners and drug counsellors in two practices in Glasgow. PARTICIPANTS--46 injecting drug users receiving methadone maintenance during an 18 month period, 31 of whom were recruited to clinic based methadone maintenance treatment and 15 of whom were already receiving methadone maintenance treatment from the general practitioners. Mean (SD) age of patients entering treatment was 29.6 (5.5) years; 29 were male. They had been injecting opiates for a mean 9.9 (5.1) years, and most had a concurrent history of benzodiazepine misuse. Average reported daily intake of heroin was approximately 0.75 g. Participants in treatment had high levels of preexisting morbidity, and most stated that they committed crime daily. RESULTS--2232 patient weeks of treatment were studied. Mean duration of treatment during the study period was 50.7 (21.1) weeks and retention in treatment at 26 weeks was 83%. No evidence of illicit opiate use was obtained at an average of 78% of patients' consultations where methadone had been prescribed in the previous week; for opiate injection the corresponding figure was 86%. CONCLUSIONS--Providing methadone maintenance in general practice is feasible. Although costs are considerable, the reduction in drug use, especially of intravenous opiates, is encouraging. Attending clinics also allows this population, in which morbidity is considerable, to receive other health care.
PMCID: PMC2541511  PMID: 8086989
4.  Changes in HIV Incidence among People Who Inject Drugs in Taiwan following Introduction of a Harm Reduction Program: A Study of Two Cohorts 
PLoS Medicine  2014;11(4):e1001625.
Kenrad Nelson and colleagues report on the association between HIV incidence and exposure to a national harm-reduction program among people who inject drugs in Taiwan.
Please see later in the article for the Editors' Summary
Background
Harm reduction strategies for combating HIV epidemics among people who inject drugs (PWID) have been implemented in several countries. However, large-scale studies using sensitive measurements of HIV incidence and intervention exposures in defined cohorts are rare. The aim of this study was to determine the association between harm reduction programs and HIV incidence among PWID.
Methods and Findings
The study included two populations. For 3,851 PWID who entered prison between 2004 and 2010 and tested HIV positive upon incarceration, we tested their sera using a BED HIV-1 capture enzyme immunoassay to estimate HIV incidence. Also, we enrolled in a prospective study a cohort of 4,357 individuals who were released from prison via an amnesty on July 16, 2007. We followed them with interviews at intervals of 6–12 mo and by linking several databases. A total of 2,473 participants who were HIV negative in January 2006 had interviews between then and 2010 to evaluate the association between use of harm reduction programs and HIV incidence. We used survival methods with attendance at methadone clinics as a time-varying covariate to measure the association with HIV incidence. We used a Poisson regression model and calculated the HIV incidence rate to evaluate the association between needle/syringe program use and HIV incidence. Among the population of PWID who were imprisoned, the implementation of comprehensive harm reduction programs and a lower mean community HIV viral load were associated with a reduced HIV incidence among PWID. The HIV incidence in this population of PWID decreased from 18.2% in 2005 to 0.3% in 2010. In an individual-level analysis of the amnesty cohort, attendance at methadone clinics was associated with a significantly lower HIV incidence (adjusted hazard ratio: 0.20, 95% CI: 0.06–0.67), and frequent users of needle/syringe program services had lower HIV incidence (0% in high NSP users, 0.5% in non NSP users). In addition, no HIV seroconversions were detected among prison inmates.
Conclusions
Although our data are affected by participation bias, they strongly suggest that comprehensive harm- reduction services and free treatment were associated with reversal of a rapidly emerging epidemic of HIV among PWID.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
About 35 million people worldwide are currently infected with HIV, the virus that causes AIDS, and about 2.3 million people become newly infected every year. HIV is mainly transmitted through unprotected sex with an infected partner. However, people who inject drugs (PWID) have a particularly high risk of HIV infection because blood transfer through needle and syringe sharing can transmit the virus. It is estimated that 5%–10% of all people living with HIV are PWID. Indeed, in some regions of the world the primary route of HIV transmission is through shared drug injection equipment and the prevalence (the proportion of a population that has a specific disease) of HIV infection among PWID is very high. In Asia, for example, more than a quarter of PWID are HIV positive. Because the high prevalence of HIV among PWID poses a global health challenge, bodies such as the Joint United Nations Programme on HIV/AIDS endorse harm reduction strategies to prevent risky injection behaviors among PWID. These strategies include the provision of clean needles and syringes, opioid substitution therapy such as methadone maintenance treatment, and antiretroviral treatment for HIV-positive PWID.
Why Was This Study Done?
Although harm reduction strategies for combating HIV epidemics among PWID have been implemented in several countries, few large-scale studies have examined the association between HIV incidence (the proportion of new cases of HIV in a population per year) and exposure to harm reduction programs among PWID. In this cohort study (an investigation that determines the characteristics of a group of people and then follows them over time), the researchers determine the association between harm reduction programs and HIV incidence among PWID in Taiwan. HIV infections used to be rare among the 60,000 PWID living in Taiwan, but after the introduction of a new HIV strain into the country in 2003, an HIV epidemic spread rapidly. In response, the Taiwanese government introduced a pilot program of harm reduction that included the provision of clean needles and syringes and health education in July 2005. The program was expanded to include methadone maintenance treatment in early 2006 and implemented nationwide in June 2006.
What Did the Researchers Do and Find?
The researchers enrolled two study populations. The first cohort comprised 3,851 PWID who were incarcerated for illicit drug use between 2004 and 2010 and who tested positive for HIV upon admission into prison. By using the BED assay, which indicates whether an HIV infection is recent, the researchers were able to determine the HIV incidence among the prisoners. In 2004, the estimated HIV incidence among prisoners with a history of drug injection was 6.44%. The incidence peaked in 2005 at 18.2%, but fell to 0.3% in 2010.
The second study population comprised 2,473 individuals who were HIV negative on January 1, 2006, and who had been incarcerated for drug use crimes but were released on July 16, 2007, during an amnesty. The researchers regularly interviewed these participants between their release and 2010 about their use of harm reduction interventions, and obtained other data about them (for example, diagnosis of HIV infection) from official databases. Analysis of all these data indicated that, in this cohort, attendance at methadone maintenance treatment clinics and frequent use of needle and syringe services were both associated with a significantly lower HIV incidence.
What Do These Findings Mean?
These findings suggest that the introduction of a comprehensive harm reduction program in Taiwan was associated with a significant reduction in the HIV incidence rate among PWID. These findings must be interpreted with caution, however. First, because the participants in the study were selected from PWID with histories of incarceration, the findings may not be representative of all PWID in Taiwan or of PWID in other countries. Second, PWID who chose to use needle and syringe services or methadone maintenance treatment clinics might have shared other unknown characteristics that affected their risk of HIV infection. Finally, some of the reduction in HIV incidence seen during the study is likely to be associated with the availability of free treatment, which has been offered to all HIV-positive individuals in Taiwan since 1997. Despite these limitations, these findings suggest that countries with a high prevalence and incidence of HIV among PWID should provide comprehensive harm reduction services to their populations to reduce risky drug injection behaviors.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001625.
Information is available from the US National Institute of Allergy and Infectious diseases on HIV infection and AIDS
NAM/aidsmap provides basic information about HIV/AIDS, and summaries of recent research findings on HIV care and treatment
Information is available from Avert, an international AIDS charity, on many aspects of HIV/AIDS, including information on injecting drug users and HIV/AIDS and on harm reduction and HIV prevention (in English and Spanish)
The US National Institute on Drug Abuse also provides information about drug abuse and HIV/AIDS (in English and Spanish)
The 2013 UNAIDS World AIDS Day report provides up-to-date information about the AIDS epidemic and efforts to halt it
Personal stories about living with HIV/AIDS are available through Avert, Nam/aidsmap, and Healthtalkonline
doi:10.1371/journal.pmed.1001625
PMCID: PMC3979649  PMID: 24714449
5.  Prescribing injectable and oral methadone to opiate addicts: results from the 1995 national postal survey of community pharmacies in England and Wales. 
BMJ : British Medical Journal  1996;313(7052):270-272.
OBJECTIVE--To establish the extent of prescribing injectable and oral methadone to opiate addicts and the practice characteristics and dispensing arrangements attached to these prescriptions. DESIGN--National survey of 25% random sample of community (high street) pharmacies through postal questionnaire, with four mailings. SETTING--England and Wales. SUBJECTS--1 in 4 sample of all 10,616 community pharmacies, stratified by family health services authority. MAIN OUTCOME MEASURES--Data were collected on each prescription for controlled drugs currently being dispensed by pharmacies to misusers, describing the drug, form, dose, source (general practice or hospital; and NHS or private), and numbers of dispensing pick ups a week. RESULTS--Methadone was the opiate most commonly dispensed to misusers (96.0% of 3846 opiate prescriptions). 79.6% of methadone prescriptions were for the oral liquid form, 11.0% for tablet, and 9.3% for injectable ampoules. More than one third of all methadone prescriptions were for weekly or fortnightly pick up, with a further third being for daily pick up. Tablets and ampoules were even less likely to be dispensed on a daily basis. Private prescriptions were significantly more likely than NHS ones to be for tablets or ampoules, to be for substantially higher daily doses, and to be collected on a weekly or fortnightly basis. CONCLUSIONS--The distinctively British practice of prescribing injectable methadone was found to be widespread and, contrary to guidance, to be as prevalent in non-specialist as specialist settings. In view of the frequent crushing and injecting of methadone tablets, clearer more authoritative guidance is needed on the contexts in which injectable methadone (tablets as well as ampoules) should be prescribed and on the responsibilities for monitoring and supervision which should be attached.
PMCID: PMC2351715  PMID: 8704540
6.  Role of community pharmacies in relation to HIV prevention and drug misuse: findings from the 1995 national survey in England and Wales. 
BMJ : British Medical Journal  1996;313(7052):272-274.
OBJECTIVES--To establish activity levels of community (high street) pharmacies in the provision of HIV prevention services to drug misusers and to compare these findings with the levels identified in 1988. DESIGN--Self completion questionnaire (four mailings) to a random 1 in 4 sample of all community pharmacies, stratified by family health services authority. SETTING--England and Wales. SUBJECTS--Data provided by pharmacist in charge of the dispensary, on service provision at the pharmacy. MAIN OUTCOME MEASURES--Quantitative reports of current activity levels for (a) dispensing of controlled drugs to drug misusers, (b) sale of needles and syringes, (c) needle and syringe exchange. RESULTS--74.8% response rate (1984/2654). In 1995, 50.1% (992/1980) of pharmacies were dispensing controlled drugs (mostly methadone), compared with 23.0% (562/2457) in 1988; 34.5% (677/1962) of pharmacies were selling injecting equipment, compared with 28.0% (676/2434) in 1988; 18.9% (366/1937) were providing a needle exchange service, compared with 3.0% (65/2415) in 1988. CONCLUSION--Activity levels increased substantially across all three service areas. Increased activity included greater individual activity as well as higher proportions of pharmacies participating. The network of community pharmacies represents an underused point of contact for this Health of the Nation target population.
PMCID: PMC2351660  PMID: 8704541
7.  Optimum Methadone Compliance Testing 
Executive Summary
Objective
The objective of this analysis was to determine the diagnostic utility of oral fluid testing collected with the Intercept oral fluid collection device.
Clinical Need: Target Population and Condition
Opioids (opiates or narcotics) are a class of drugs derived from the opium poppy plant that typically relieve pain and produce a euphoric feeling. Methadone is a long-acting synthetic opioid used to treat opioid dependence and chronic pain. It prevents symptoms of opioid withdrawal, reduces opioid cravings and blocks the euphoric effects of short-acting opioids such as heroin and morphine. Opioid dependence is associated with harms including an increased risk of exposure to Human Immunodeficiency Virus and Hepatitis C as well as other health, social and psychological crises. The goal of methadone treatment is harm reduction. Treatment with methadone for opioid dependence is often a long-term therapy. The Ontario College of Physicians and Surgeons estimates that there are currently 250 physicians qualified to prescribe methadone, and 15,500 people in methadone maintenance programs across Ontario.
Drug testing is a clinical tool whose purpose is to provide objective meaningful information, which will reinforce positive behavioral changes in patients and guide further treatment needs. Such information includes knowledge of whether the patient is taking their methadone as prescribed and reducing or abstaining from using opioid and other drugs of abuse use. The results of drug testing can be used with behavior modification techniques (contingency management techniques) where positive reinforcements such as increased methadone take-home privileges, sustained employment or parole are granted for drug screens negative for opioid use, and negative reinforcement including loss of these privileges for drug screens positive for opioid used.
Body fluids including blood, oral fluid, often referred to as saliva, and urine may contain metabolites and the parent drug of both methadone and drugs of abuse and provide a means for drug testing. Compared with blood which has a widow of detection of several hours, urine has a wider window of detection, approximately 1 to 3 days, and is therefore considered more useful than blood for drug testing. Because of this, and the fact that obtaining a urine specimen is relatively easy, urine drug screening is considered the criterion measure (gold standard) for methadone maintenance monitoring. However, 2 main concerns exist with urine specimens: the possibility of sample tampering by the patient and the necessity for observed urine collection. Urine specimens may be tampered with in 3 ways: dilution, adulteration (contamination) with chemicals, and substitution (patient submits another persons urine specimen). To circumvent sample tampering the supervised collection of urine specimens is a common and recommended practice. However, it has been suggested that this practice may have negative effects including humiliation experienced by patient and staff, and may discourage patients from staying in treatment. Supervised urine specimen collection may also present an operational problem as staff must be available to provide same-sex supervision. Oral fluid testing has been proposed as a replacement for urine because it can be collected easily under direct supervision without infringement of privacy and reduces the likelihood of sample tampering. Generally, the results of oral fluid drug testing are similar to urine drug testing but there are some differences, such as lower concentrations of substances in oral fluid than urine, and some drugs remain detectable for longer periods of time in urine than oral fluid.
The Technology Being Reviewed
The Intercept Oral Specimen Collection Device (Ora-Sure Technologies, Bethlehem, PA) consists of an absorbent pad mounted on a plastic stick. The pad is coated with common salts. The absorbent pad is inserted into the mouth and placed between the cheek and gums for 3 minutes on average. The pad absorbs the oral fluid. After 3 minutes (range 2min-5 min) the collection device is removed from the mouth and the absorbent pad is placed in a small vial which contains 0.8mL of pH-balanced preservative, for transportation to a laboratory for analysis. It is recommended that the person undergoing oral fluid drug testing have nothing to eat or drink for a 10- minute period before the oral fluid specimen is collected. This will remove opportunity for adulteration. Likewise, it is recommended that the person be observed for the duration of the collection period to prevent adulteration of the specimen. An average of 0.4 mL of saliva can be collected. The specimen may be stored at 4C to 37C and tested within 21 days of collection (or within 6 weeks if frozen).
The oral fluid specimen must be analyzed in a laboratory setting. There is no point-of-care (POC) oral fluid test kit for drugs of abuse (other than for alcohol). In the laboratory the oral fluid is extracted from the vial after centrifugation and a screening test is completed to eliminate negative specimens. Similar to urinalysis, oral fluid specimens are analyzed first by enzyme immunoassay with positive specimens sent for confirmatory testing. Comparable cut-off values to urinalysis by enzyme immunoassay have been developed for oral fluids
Review Strategy
 
Research Question
What is the diagnostic utility of the Intercept oral specimen device?
Inclusion criteria:
Studies evaluating paired urine and oral fluid specimens from the same individual with the Intercept oral fluid collection device.
The population studied includes drug users.
Exclusion criteria:
Studies testing for marijuana (THC) only.
Outcomes:
Sensitivity and Specificity of oral fluid testing compared to urinalysis for methadone (methadone metabolite), opiates, cocaine, benzodiazepines, and alcohol.
Quality of the Body of Evidence
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A description of the GRADE system is reported in Appendix 1.
Summary of Findings
A total of 854 potential citations were retrieved. After reviewing titles and abstracts, 2 met the inclusion and exclusion criteria. Two other relevant studies were found after corresponding with the author of the 2 studies retrieved from the literature search. Therefore a total of 4 published studies are included in this analysis. All 4 studies carried out by the same investigator meet the definition of Medical Advisory Secretariat level III (not a-randomized controlled trial with contemporaneous controls) study design. In each of the studies, paired urine and oral fluid specimens where obtained from drug users. Urine collection was not observed in the studies however, laboratory tests for pH and creatinine were used to determine the reliability of the specimen. Urine specimens thought to be diluted and unreliable were removed from the evaluation. Urinalysis was used as the criterion measurement for which to determine the sensitivity and specificity of oral fluid testing by the Intercept oral fluid device for opiates, benzodiazepines, cocaine and marijuana. Alcohol was not tested in any of the 4 studies. From these 4 studies, the following conclusions were drawn:
The evidence indicates that oral fluid testing with the Intercept oral fluid device has better specificity than sensitivity for opiates, benzodiazepines, cocaine and marijuana.
The sensitivity of oral fluids testing with the Intercept oral fluid device seems to be from best to worst: cocaine > benzodiazepines >opiates> marijuana.
The sensitivity and specificity for opiates of the Intercept oral fluid device ranges from 75 to 90% and 97- 100% respectively.
The consequences of opiate false-negatives by oral fluid testing with the Intercept oral fluid device need to be weighed against the disadvantages of urine testing, including invasion of privacy issues and adulteration and substitution of the urine specimen.
The window of detection is narrower for oral fluid drug testing than urinalysis and because of this oral fluid testing may best be applied in situations where there is suspected frequent drug use. When drug use is thought to be less frequent or remote, urinalysis may offer a wider (24-48 hours more than oral fluids) window of detection.
The narrow window of detection for oral fluid testing may mean more frequent testing is needed compared to urinalysis. This may increase the expense for drug testing in general.
POC oral fluid testing is not yet available and may limit the practical utility of this drug testing methodology. POC urinalysis by immunoassay is available.
The possible applications of oral fluid testing may include:
Because of its narrow window of detection compared to urinalysis oral fluid testing may best be used during periods of suspected frequent or recent drug use (within 24 hours of drug testing). This is not to say that oral fluid testing is superior to urinalysis during these time periods.
In situations where an observed urine specimen is difficult to obtain. This may include persons with “shy bladder syndrome” or with other urinary conditions limiting their ability to provide an observed urine specimen.
When the health of the patient would make urine testing unreliable (e,g., renal disease)
As an alternative drug testing method when urine specimen tampering practices are suspected to be affecting the reliability of the urinalysis test.
Possible limiting Factors to Diffusion of Oral Fluid Technology
No oral fluid POC test equivalent to onsite urine dips or POC analyzer reducing immediacy of results for patient care.
Currently, physicians get reimbursed directly for POC urinalysis. Oral fluid must be analyzed in a lab setting removing physician reimbursement, which is a source of program funding for many methadone clinics.
Small amount of oral fluid specimen obtained; repeat testing on same sample will be difficult.
Reliability of positive oral fluid methadone (parent drug) results may decrease because of possible contamination of oral cavity after ingestion of dose. Therefore high methadone levels may not be indicative of compliance with treatment. Oral fluid does not as yet test for methadone metabolite.
There currently is no licensed provincial laboratory that analyses oral fluid specimens.
Abbreviations
2-ethylidene- 1,5-dimethyl-3,3-diphenylpyrrolidine
enzyme immunoassay
Enzyme Linked Immunosorbent Assay (ELISA),
Enzyme Multiplied Immunoassay Test (EMIT)
Gas chromatography
gas chromatography/mass spectrometry
High-performance liquid chromatography
Limit of Detection
Mass spectrometry
Methadone Maintenance Treatment
Oral fluid testing
Phencyclidine
Point of Care Testing
tetrahydrocannabinol
11-nor-delta-9-tetrhydrocannabinol-9-carboxylic acid
urine drug testing
PMCID: PMC3379523  PMID: 23074492
8.  Safe storage of methadone in the home - an audit of the effectiveness of safety information giving 
Background
Accidental poisoning by methadone occurs, particularly as a result of children ingesting a parent's methadone. Health care professionals have a responsibility to provide information and guidance to methadone users on safe storage of methadone. The objective of the study was to audit the effectiveness of information giving on the safety of methadone consumption, dose measurement and storage, and the effectiveness of sources of advice available for patients.
Methods
The study was undertaken prior to the introduction of a scheme for the supervised consumption of methadone, in the setting of an NHS Methadone clinic serving a district population of 490,000 in the UK. 185 consecutive patients attending a methadone clinic to collect a methadone prescription were the subject of an anonymous survey. Issues of safety of methadone consumption, storage and safety information provisions were assessed. A telephone survey of the community pharmacists dispensing the methadone covered the availability of measuring devices and provision of advice on safety was undertaken.
Results
Methadone was stored in a variety of locations, a cupboard being most frequent. 95 patients (60.1%) had children either living in or visiting their home. All stored their methadone in a bottle with a child resistant lid; the majority measured doses using either the container supplied by the pharmacist or a plastic measure. 126 patients (78%) confirmed that a pharmacist provided a measuring container on their first visit, 24 (15%) were given a measure on every visit to the pharmacist. Advice on safe storage was recalled by 30% of the patients, and advice on measuring methadone by 28%. Methadone was seen as potentially dangerous by 82% of the patients.
Conclusion
The risks resulting from unsafe storage of methadone may be reduced by daily instalment prescribing and provision of measuring containers on request. Recall of provision of information on safety issues is poor and the adoption of a standard policy on provision information should be seen as a priority. A re-audit of safety of storage of methadone is recommended following the introduction of a standard policy on information provision.
doi:10.1186/1477-7517-2-9
PMCID: PMC1187912  PMID: 15987515
9.  Health and Human Rights Concerns of Drug Users in Detention in Guangxi Province, China 
PLoS Medicine  2008;5(12):e234.
Background
Although confinement in drug detoxification (“detox”) and re-education through labor (RTL) centers is the most common form of treatment for drug dependence in China, little has been published about the experience of drug users in such settings. We conducted an assessment of the impact of detention on drug users' access to HIV prevention and treatment services and consequent threats to fundamental human rights protections.
Methods and Findings
Chinese government HIV and anti-narcotics legislation and policy documents were reviewed, and in-depth and key informant interviews were conducted with 19 injection drug users (IDUs) and 20 government and nongovernmental organization officials in Nanning and Baise, Guangxi Province. Significant contradictions were found in HIV and antinarcotics policies, exemplified by the simultaneous expansion of community-based methadone maintenance therapy and the increasing number of drug users detained in detox and RTL center facilities. IDU study participants reported, on average, having used drugs for 14 y (range 8–23 y) and had been confined to detox four times (range one to eight times) and to RTL centers once (range zero to three times). IDUs expressed an intense fear of being recognized by the police and being detained, regardless of current drug use. Key informants and IDUs reported that routine HIV testing, without consent and without disclosure of the result, was the standard policy of detox and RTL center facilities, and that HIV-infected detainees were not routinely provided medical or drug dependency treatment, including antiretroviral therapy. IDUs received little or no information or means of HIV prevention, but reported numerous risk behaviors for HIV transmission while detained.
Conclusions
Legal and policy review, and interviews with recently detained IDUs and key informants in Guangxi Province, China, found evidence of anti-narcotics policies and practices that appear to violate human rights and imperil drug users' health.
Based on their review of Chinese government legislation and policy documents, and using interviews with recently detained injection drug users and officials in Guangxi Province, Elizabeth Cohen and Joseph Amon find evidence of antinarcotics policies and practices that may compromise the health and human rights of drug users.
Editors' Summary
Background.
Ever since the AIDS (acquired immunodeficiency syndrome) epidemic began, needle sharing by injection drug users (IDUs) has been a major transmission route for the human immunodeficiency virus (HIV), the blood-borne virus that causes AIDS. In China, for example, the AIDS epidemic began in earnest in 1989 when 146 HIV-positive IDUs were identified in Southwest Yunnan. By 1998, HIV infections had been reported throughout China, 60%–70% of which were in IDUs. These days, nearly half of new HIV infections in China are associated with injection drug use and 266,000 of the 700,000 HIV-positive people in China are drug users. Faced with these figures, the Chinese government has recently introduced measures to reduce HIV transmission among the estimated 3–4 million IDUs in China. These measures include increased provision of methadone maintenance treatment clinics and needle exchanges and the establishment of HIV prevention programs that target IDUs.
Why Was This Study Done?
Alongside these progressive public-health practices, China has extremely punitive anti-narcotics policies. IDUs are routinely confined without legal review in drug detoxification centers or sent to re-education through labor (RTL) centers, sometimes for many years. In 2005, these centers housed more than 350,000 drug users yet little is known about the conditions in these centers or how the Chinese anti-narcotic policy affects human rights or access to HIV prevention and treatment services. In this study, the researchers investigated these issues by interviewing IDUs and “key informants” (government officials and members of nongovernmental organizations [NGOs] who provide services to IDUs) about their experiences of detoxification centers and RTL centers in two cities in Guangxi Province, China.
What Did the Researchers Do and Find?
The researchers recruited 19 IDUs who had been recently confined in a detoxification center or RTL center and 20 key informants (including a doctor at a detoxification center and a former RTL center guard). In the interviews the researchers used a semi-structured questionnaire to ask the participants about their experiences of detoxification centers and RTL centers. All the IDUs reported that they were repeatedly tested for HIV while in detention but never given their test results even when they asked for them. Key informants confirmed that repeated HIV testing without result disclosure is the current policy in detoxification centers and RTL centers. All the IDUs expressed concerns about inadequate access to health care in detention. In particular, most of the IDUs who were taking antiretroviral drugs before detention were unable to continue their treatment during detention, although two received antiretroviral drugs by negotiating with their guards. The IDUs and key informants also both noted that very little information or means of HIV prevention was provided in the detoxification centers and RTL centers and that HIV-related risk behaviors, including injection drug use and unsafe sex, occurred in both types of center. Finally, the IDUs reported that their fear of being recognized by the police and detained even if not taking drugs prevented them from seeking HIV tests, HIV treatment, and help for their drug addiction.
What Do These Findings Mean?
This study has several limitations in addition to its small size. For example, because the IDUs were self selected—they responded to posters asking if they would be interviewed—their views may not be representative of all IDUs. Similarly, the key informants who were interviewed might have had different opinions from those who chose not to participate. Furthermore, the results reported here cannot be generalized to other areas of China. Nevertheless, the consistent experiences reported by the IDUs and confirmed by the key informants suggest that China's anti-narcotic policies and practices violate the human rights of IDUs and put their health in danger by making it hard for them to access HIV prevention and treatment or adequate treatment for their drug addiction. This situation, if not remedied, is likely to jeopardize China's attempts to control its HIV epidemic.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050234.
This study is further discussed in a PLoS Medicine Perspective by Steve Koester
Avert, an international AIDS charity, provides information on all aspects of HIV/AIDS, including HIV and AIDS in China and HIV prevention, harm reduction, and injecting drug use
The UNAIDS 2008 Country Progress Report provides up-to-date details about the AIDS situation in China
HIVInSite provides links to more information about HIV/AIDS in China.
Human Rights Watch works on health and human rights and human rights developments in China
The US National Institute on Drug Abuse provides a booklet entitled Principles of Drug Addiction Treatment: A Research Based Guide (in English and Spanish)
UN Office on Drugs and Crime has information on HIV/AIDS in prisons
doi:10.1371/journal.pmed.0050234
PMCID: PMC2596857  PMID: 19071954
10.  Promethazine Misuse among Methadone Maintenance Patients and Community-Based Injection Drug Users 
Journal of addiction medicine  2013;7(2):96-101.
Objective
Promethazine has been reported to be misused in conjunction with opioids in several settings. Promethazine misuse by itself or in conjunction with opioids may have serious adverse health effects. To date, no prevalence data for the nonmedical use of promethazine has been reported. This study examines the prevalence and correlates of promethazine use in two different populations in San Francisco, California, USA: methadone maintenance clinic patients and community-based injection drug users (IDUs).
Methods
We analyzed urine samples for the presence of promethazine and reviewed the clinical records for 334 methadone maintenance patients at the county methadone clinic. Separately, we used targeted sampling methods to recruit and survey 139 community-based opioid IDUs about their use of promethazine. We assessed prevalence and factors associated with promethazine use with bivariate and multivariate statistics.
Results
The prevalence of promethazine positive urine samples among the methadone maintenance patients was 26 percent. Only 15 percent of promethazine positive patients had an active prescription for promethazine. Among IDUs reporting injection of opiates in the community-based survey, 17 percent reported having used promethazine in the past month; 24 percent of the IDUs who reported being enrolled in methadone treatment reported using promethazine in the past month.
Conclusions
The finding that one quarter of methadone maintenance patients in a clinic or recruited in community settings have recently used promethazine provides compelling evidence of significant nonmedical use of promethazine in this patient population. Further research is needed to establish the extent and nature of nonmedical use of promethazine.
doi:10.1097/ADM.0b013e31827f9b43
PMCID: PMC3618500  PMID: 23385449
Promethazine; Methadone; Opiate Addiction; Opiate Substitution Treatment; Injection Drug User
11.  Provision of opioid substitution therapy services in Australian pharmacies 
The Australasian Medical Journal  2011;4(4):210-216.
Opioid dependence, despite being the subject of significant public funding, remains a costly burden to Australian society in human and economic terms. The most cost-effective public health strategy for managing opioid dependence is opioid substitution therapy (OST), primarily through the use of methadone or buprenorphine. Supervised dispensing of OST from specialist clinics and community pharmacies plays a crucial role in enhancing compliance, monitoring treatment and reducing diversion. Australia, compared with other countries in the world, ranks very high in illicit opioid use; hence there is a great demand for OST.
The utilisation of community pharmacies for stable patients has many advantages. For public clinics, patient transfer to community pharmacies relieves workload and costs, and increases capacity for new OST patients. From a patient’s perspective, dosing at a pharmacy is more flexible and generally more preferable. Pharmacists stand to gain clientele, profit and receive small incentives from state governments in Australia, for their services. Yet, many “unmet needs” exist and there is a high demand for more involvement in OST service provision in community pharmacy in Australia.
In the UK there has been a steady increase in community pharmacy provision of OST, and pharmacists appear ready to provide further healthcare services to these patients.
The role of pharmacy in some countries in Europe, such as Germany, is less prominent due to their approach to harm minimisation and the complex, variable nature of OST provision across the European Union (EU). The provision of OST by pharmacists in the USA on the other hand is of lesser frequency as the healthcare system in the USA encourages detoxification clinics to handle cases of illicit drug addiction.
At a time when harm minimisation strategies constitute a topic of considerable political and public interest, it is important to understand the scope and variability of pharmacy involvement in drug policy in Australia. Hence, this review highlights the role of pharmacists in OST and explores the scope for expanding this role in the future.
doi:10.4066/AMJ.2011.706
PMCID: PMC3562900  PMID: 23393513
Opioid Substitution Therapy services; Australian pharmacies.
12.  Role of community pharmacies in prevention of AIDS among injecting drug misusers: findings of a survey in England and Wales. 
BMJ : British Medical Journal  1989;299(6707):1076-1079.
OBJECTIVE--To determine the current and potential roles of community pharmacists in the prevention of AIDS among misusers of injected drugs. DESIGN--Cross sectional postal survey of a one in four random sample of registered pharmacies in England and Wales. SETTING--Project conducted in the addiction research unit of the Institute of Psychiatry, London. SUBJECTS--2469 Community pharmacies in the 15 regional health authorities in England and Wales. MAIN OUTCOME MEASURES--Willingness of pharmacists to sell injecting equipment to known or suspected misusers of drugs; pharmacists' attitudes to syringe exchange schemes, keeping a "sharps" box for use by misusers of drugs, and offering face to face advice and leaflets; and opinions of community pharmacists on their role in AIDS prevention and drug misuse. RESULTS--1946 Questionnaires were returned, representing a response rate of 79%. This fell short of the target of one in four pharmacies in each family practitioner committee area in England and Wales, and total numbers of respondents were therefore weighted in inverse proportion to the response rate in each area. The findings disclosed a substantial demand for injecting equipment by drug misusers. After weighting of numbers of respondents an estimated 676 of 2434 pharmacies were currently selling injecting equipment and 65 of 2415 (3%) were participating in local syringe exchange schemes; only 94 of 2410 pharmacies (4%) had a sharps box for used equipment. There was a high degree of concern among pharmacists about particular consequences of drug misusers visiting their premises, along with a widespread acceptance that the community pharmacist had an important part to play. CONCLUSIONS--Promoting the participation of community pharmacists in the prevention of AIDS among misusers of injected drugs is a viable policy, but several problems would need to be overcome before it was implemented.
PMCID: PMC1837978  PMID: 2511969
13.  Displacement of Canada's largest public illicit drug market in response to a police crackdown 
Background
Law enforcement is often used in an effort to reduce the social, community and health-related harms of illicit drug use by injection drug users (IDUs). There are, however, few data on the benefits of such enforcement or on the potential harms. A large-scale police “crackdown” to control illicit drug use in Vancouver's Downtown Eastside provided us with an opportunity to evaluate the effect.
Methods
As part of our ongoing prospective cohort study of IDUs in Vancouver, we examined data collected from 244 IDUs in the 3 months before the police crackdown and from 142 IDUs in the 3 months after the start of the crackdown, on Apr. 7, 2003. All study subjects were active drug users. We also examined external data on needle exchanges and syringe disposal.
Results
The 2 groups of IDUs were statistically similar: they were mainly young (mean age 39 years) and male (63%), and they had injected illicit drugs for 13 years on average. Ethnic background and the proportion homeless were also similar. There were no statistically significant reported differences (all p > 0.1) in the street price of heroin, cocaine or “crack” in the 2 periods. In the 3-month periods before and after the crackdown, respectively, the rates of daily heroin injection were 27.9% and 26.8%, daily cocaine injection 28.7% and 27.5%, and daily crack use 59.4% and 60.6% (all p > 0.1). The proportions of study subjects receiving methadone treatment, 41.0% and 44.4% (p = 0.516), did not differ. However, the proportions reporting a change in where drugs were used, 22.5% and 33.8% (p < 0.05), and the proportions reporting a change in the neighbourhood of use because of police presence, 18.1% and 26.8% (p < 0.05), increased significantly. Needle-exchange data confirmed that the community levels of drug use were unchanged. Disposal statistics demonstrated that the monthly average number of used syringes found on the streets outside the traditional area of drug use increased from 784 in the 3 months before Apr. 1 to 1253 in the subsequent 3 months (p = 0.002) and the monthly average number of used syringes found in public boxes for the safe disposal of syringes decreased from 865 to 502 (p = 0.018).
Interpretation
The effort to control illicit drug use did not alter the price of drugs or the frequency of use, nor did it encourage enrolment in methadone treatment programs. Several measures indicated displacement of injection drug use from the area of the crackdown into adjacent areas of the city, which has implications for both recruitment of new initiates into injection drug use and HIV prevention efforts.
doi:10.1503/cmaj.1031928
PMCID: PMC400719  PMID: 15136548
14.  Pharmacists and harm reduction: A review of current practices and attitudes 
Canadian Pharmacists Journal : CPJ  2012;145(3):124-127.e2.
Background: Injection drug use and other high-risk behaviours are the cause of significant morbidity and mortality and thus have been the focus of many health promotion strategies. Community pharmacists are considered underutilized health providers and are often thought to be more accessible than other health professionals. The purpose of this review is to provide an overview of community pharmacists' practices as well as pharmacists' attitudes and identified barriers toward providing harm reduction services. We will highlight the major harm reduction services being offered through community pharmacies, as well as identify barriers to implementing these services.
Methods: A review of the literature from 1995 to 2011 was conducted using the electronic databases MEDLINE, PubMed and Scopus, encompassing pharmacists' involvement in harm reduction services. Keywords included pharmacist, harm reduction, disease prevention, health promotion, attitudes, competence and barriers. References of included articles were examined to identify further relevant literature.
Results: Pharmacists are primarily involved in providing clean needles to injection drug users, as well as opioid substitution. Pharmacists generally have a positive attitude toward providing health promotion and harm reduction programs and express some interest in increasing their role in this area. Common barriers to expanding harm reduction strategies in community pharmacists' practice include lack of time and training, insufficient remuneration, fear of attracting unruly clientele and inadequate communication between health providers.
Conclusion: As one of the most accessible health care providers, community pharmacists are in an ideal position to provide meaningful services to injection drug users. However, in order to do so, pharmacists require additional support in the form of better health team and system integration, as well as remuneration models.
doi:10.3821/145.3.cpj124
PMCID: PMC3567507  PMID: 23509527
15.  Methodology for the Randomised Injecting Opioid Treatment Trial (RIOTT): evaluating injectable methadone and injectable heroin treatment versus optimised oral methadone treatment in the UK 
Whilst unsupervised injectable methadone and diamorphine treatment has been part of the British treatment system for decades, the numbers receiving injectable opioid treatment (IOT) has been steadily diminishing in recent years. In contrast, there has been a recent expansion of supervised injectable diamorphine programs under trial conditions in a number of European and North American cities, although the evidence regarding the safety, efficacy and cost effectiveness of this treatment approach remains equivocal. Recent British clinical guidance indicates that IOT should be a second-line treatment for those patients in high-quality oral methadone treatment who continue to regularly inject heroin, and that treatment be initiated in newly-developed supervised injecting clinics.
The Randomised Injectable Opioid Treatment Trial (RIOTT) is a multisite, prospective open-label randomised controlled trial (RCT) examining the role of treatment with injected opioids (methadone and heroin) for the management of heroin dependence in patients not responding to conventional substitution treatment. Specifically, the study examines whether efforts should be made to optimise methadone treatment for such patients (e.g. regular attendance, supervised dosing, high oral doses, access to psychosocial services), or whether such patients should be treated with injected methadone or heroin.
Eligible patients (in oral substitution treatment and injecting illicit heroin on a regular basis) are randomised to one of three conditions: (1) optimized oral methadone treatment (Control group); (2) injected methadone treatment; or (3) injected heroin treatment (with access to oral methadone doses). Subjects are followed up for 6-months, with between-group comparisons on an intention-to-treat basis across a range of outcome measures. The primary outcome is the proportion of patients who discontinue regular illicit heroin use (operationalised as providing >50% urine drug screens negative for markers of illicit heroin in months 4 to 6). Secondary outcomes include measures of other drug use, injecting practices, health and psychosocial functioning, criminal activity, patient satisfaction and incremental cost effectiveness. The study aims to recruit 150 subjects, with 50 patients per group, and is to be conducted in supervised injecting clinics across England.
doi:10.1186/1477-7517-3-28
PMCID: PMC1613238  PMID: 17002810
16.  The cost-effectiveness of Vancouver's supervised injection facility 
Background
The cost-effectiveness of Canada's only supervised injection facility has not been rigorously evaluated. We estimated the impact of the facility on survival, rates of HIV and hepatitis C virus infection, referral to methadone maintenance treatment and associated costs.
Methods
We simulated the population of Vancouver, British Columbia, including injection drug users and persons infected with HIV and hepatitis C virus. The model used a time horizon of 10 years and the perspective of the health care system. We compared the situation of the supervised injection facility with one that had no facility but that had other interventions, such as needle-exchange programs. The effects considered were decreased needle sharing, increased use of safe injection practices and increased referral to methadone maintenance treatment. Outcomes included life-years gained, costs, and incremental cost-effectiveness ratios discounted at 5% per year.
Results
Focusing on the base assumption of decreased needle sharing as the only effect of the supervised injection facility, we found that the facility was associated with an incremental net savings of almost $14 million and 920 life-years gained over 10 years. When we also considered the health effect of increased use of safe injection practices, the incremental net savings increased to more than $20 million and the number of life-years gained to 1070. Further increases were estimated when we considered all 3 health benefits: the incremental net savings was more than $18 million and the number of life-years gained 1175. Results were sensitive to assumptions related to injection frequency, the risk of HIV transmission through needle sharing, the frequency of safe injection practices among users of the facility, the costs of HIV-related care and of operating the facility, and the proportion of users who inject in the facility.
Interpretation
Vancouver's supervised injection site is associated with improved health and cost savings, even with conservative estimates of efficacy.
doi:10.1503/cmaj.080808
PMCID: PMC2582765  PMID: 19015565
17.  Awareness of the need for safe storage of Methadone at home is not improved by the use of protocols on recording information giving 
Background
Methadone is a synthetic, narcotic analgesic used in the treatment of drug misuse. Tragedies involving children being poisoned by the accidental ingestion of methadone are no longer a rare occurrence. Following an audit of the effectiveness of the provision and recall of information to patients attending an NHS Methadone Clinic a protocol was introduced to ensure that staff documented the provision of such information and patients gave a written confirmation that they had received the information.
Methods
The study was undertaken in the setting of an NHS methadone clinic with the aim of re- auditing the storage of methadone at home following the introduction of the new protocols. 174 patients completed an anonymous questionnaire regarding where they store methadone at home and whether they recall being given advice about safe storage. Community pharmacists were contacted by telephone to assess the level of advice given to methadone patients regarding safety.
Results
Only 49 (28.2%) patients recalled being given advice about safe storage, 24 (13.8%) recalled that information was provided by clinic staff. 170 (97.7%) patients regard methadone as being dangerous. (28.2%). Methadone is most commonly stored in a cupboard (37.9%). All methadone is dispensed in a bottle with a child resistant cap on it. All patients reported they stored their methadone in the original bottle provided by the pharmacist.
Conclusion
Recall of information on safety issues is very poor. Provision of written as well as verbal information is needed. The use of printed safety information cards which patients can take away for future reference may be of use. It is the responsibility of health professionals to ensure they provide information and advice to methadone users on the safe storage of their methadone at home.
doi:10.1186/1477-7517-5-15
PMCID: PMC2390539  PMID: 18447933
18.  Attitudes toward Methadone among Out-of-Treatment Minority Injection Drug Users: Implications for Health Disparities 
Injection drug use (IDU) continues to be a significant public health issue in the U.S. and internationally, and there is evidence to suggest that the burden of injection drug use and associated morbidity and mortality falls disproportionately on minority communities. IDU is responsible for a significant portion of new and existing HIV/AIDS cases in many parts of the world. In the U.S., the prevalence of HIV and hepatitis C virus is higher among populations of African-American and Latino injection drug users (IDUs) than among white IDUs. Methadone maintenance therapy (MMT) has been demonstrated to effectively reduce opiate use, HIV risk behaviors and transmission, general mortality and criminal behavior, but opiate-dependent minorities are less likely to access MMT than whites. A better understanding of the obstacles minority IDUs face accessing treatment is needed to engage racial and ethnic disparities in IDU as well as drug-related morbidity and mortality. In this study, we explore knowledge, attitudes and beliefs about methadone among 53 out-of-treatment Latino and African-American IDUs in Providence, RI. Our findings suggest that negative perceptions of methadone persist among racial and ethnic minority IDUs in Providence, including beliefs that methadone is detrimental to health and that people should attempt to discontinue methadone treatment. Additional potential obstacles to entering methadone therapy include cost and the difficulty of regularly attending a methadone clinic as well as the belief that an individual on MMT is not abstinent from drugs. Substance use researchers and treatment professionals should engage minority communities, particularly Latino communities, in order to better understand the treatment needs of a diverse population, develop culturally appropriate MMT programs, and raise awareness of the benefits of MMT.
doi:10.3390/ijerph6020787
PMCID: PMC2672350  PMID: 19440415
Injection drug use; methadone; health disparities; HIV/AIDS
19.  Correlates of illicit methadone use in New York City: A cross-sectional study 
BMC Public Health  2008;8:375.
Background
Despite growing concern about illicit methadone use in the US and other countries, there is little data about the prevalence and correlates of methadone use in large urban areas. We assessed the prevalence and examined correlates of lifetime and recent illicit methadone use in New York City (NYC).
Methods
1,415 heroin, crack, and cocaine users aged 15–40 years were recruited in NYC between 2000 and 2004 to complete interviewer-administered questionnaires.
Results
In multivariable logistic regression, non-injection drug users who used illicit methadone were more likely to be heroin dependent, less than daily methamphetamine users and to have a heroin using sex partner in the last two months. Injection drug users who used illicit methadone were more likely to use heroin daily, share injection paraphernalia and less likely to have been in a detoxification program and to have not used marijuana in the last six months.
Conclusion
The results overall suggest that illicit (or street) methadone use is likely not a primary drug of choice, but is instead more common in concert with other illicit drug use.
doi:10.1186/1471-2458-8-375
PMCID: PMC2588458  PMID: 18957116
20.  Methadone treatment protects against HIV infection: two decades of experience in the Bronx, New York City. 
Public Health Reports  1998;113(Suppl 1):107-115.
OBJECTIVE: We undertook a study of the role of methadone maintenance in protecting injecting drug users (IDUs) from human immunodeficiency virus (HIV) infection from the earliest days of the HIV epidemic in New York City to the present. The historical context of the epidemic in the Bronx is discussed. METHODS: For close to two decades, we have been tracking changes in injecting drug use and HIV infection levels in a Bronx cohort study of IDUs. An initial sample of 622 IDUs was recruited from a methadone treatment program in 1985, with historical data going back to 1978. Behavioral interviews and HIV testing were performed and methadone treatment program records (urine toxicology and methadone dose history) were reviewed. We examined both prevalent and incident HIV infections. The sample included African Americans (24.3%), Latinos (50.3%), and white non-Latinos (24.4%). The average methadone dose was 64 milligrams (mg) per day with an average time in treatment of five and a half years. RESULTS: We found a very low rate of incident infection of 1.7 per 100 person-years observation since 1986. Because of this low rate of infection, we were unable to determine the association between methadone treatment factors and HIV seroincidence. We found that our prevalence data on the 622 IDUs enrolled from 1985 to 1988 yielded strong findings on the role of methadone maintenance in a period when most infections occurred in this population. HIV seroprevalence was 42.9%. Logistic regression analysis revealed associations of methadone dose > or = 80 mg (adjusted odds ratio = 3.07/yr, 95% confidence interval (CI): 1.23-7.68) and last year entered methadone treatment (adjusted odds ratio = 1.22/yr, 95% CI: 1.06-1.41) to HIV infection, independent of year of last cocaine injection, needle sharing in shooting galleries, number of IDU sex partners, low income, and African American of Latino ethnicity. CONCLUSIONS: Properly dosed, long-term methadone treatment was found to be a central protective factor in preventing HIV infection from the earliest days of the epidemic in New York City. It is crucial to have high quality drug treatment programs in place before an epidemic draws our attention to the inadequacies through excess and unnecessary morbidity and mortality.
PMCID: PMC1307733  PMID: 9722816
21.  The prescribing of methadone and other opioids to addicts: national survey of GPs in England and Wales 
Background
GPs occupy a pivotal position in relation to providing services to opiate misusers in the UK, and this is now cited to support initiatives in other countries.
Aims
To investigate GP involvement in the management of opiate misusers; and to examine the nature of this prescribing of methadone and other opioids.
Design
GP data collected via self-completion postal questionnaire from a 10% random sample of the 30 000 GPs across England and Wales. Patient prescription data obtained on opiate misusers treated during the preceding 4 weeks.
Setting
Primary healthcare practice in England and Wales in mid-2001.
Method
A questionnaire was mailed to a random 10% sample of GPs stratified by number of partners in the practice, with three follow-up mailshots. Data on drugs prescribed by these practitioners were also studied, including drug prescribed, form, dose and dispensing arrangements.
Results
The response rate was 66%. Opiate misusers had been seen by 51% of GPs in the preceding 4 weeks (mean of 4.1 such patients), of whom 50% had prescribed opiate-substitution drugs. This provided a study sample of 1482 opiate misusers to whom GPs were prescribing methadone (86.7%), dihydrocodeine (8.5%) or buprenorphine (4.4%). Of 1292 methadone prescriptions, mean daily dose was 36.9 mg — 47.9% being for 30 mg or less. Daily interval dispensing was stipulated by 44.6%, while 42.9% permitted weekly take-away supply.
Conclusions
In 2001 nearly three times as many GPs were seeing opiate misusers than was the case in 1985. Half were prescribing substitute-opiate drugs such as methadone (to an estimated 30 000 patients). However, there are grounds for concern about the quality of this prescribing. Most doses were too low to constitute optimal methadone maintenance; widespread disregard of the availability of supervised or interval dispensing increases the risks of diversion to the blackmarket and deaths from methadone overdose. Increased quantity of care has been achieved. Increased quality is now required.
PMCID: PMC1472740  PMID: 15970068
addiction; buprenorphine; methadone; narcotics; heroin; opiate-related disorders
22.  Factors Associated with High-Frequency Illicit Methadone Use among Rural Appalachian Drug Users 
The American journal of drug and alcohol abuse  2013;39(4):10.3109/00952990.2013.805761.
Background
In recent years there has been a sharp increase in the use of illicit methadone as well as methadone-related overdose deaths.
Objective
The purpose of this study is to describe factors associated low- and high-frequency methadone use in a cohort of rural Appalachian drug users.
Methods
Interviews assessing sociodemographics, illicit drug use and drug treatment, psychiatric disorders, health, and sociometric drug network characteristics were conducted with 503 rural drug users between 2008 and 2010. A two-level mixed effects regression model was utilized to differentiate low- (one use per month or less in the past 6 months) versus high-frequency (daily or weekly use in the past 6 months) illicit methadone users.
Results
The lifetime prevalence of illicit methadone use in this population was 94.7% (n=476) and slightly less than half (46.3%) were high-frequency users. In the mixed effects regression model, initiating illicit methadone use at a younger age was associated with high-frequency illicit methadone use. Whereas taking a prescribed medication for a physical problem, undergoing additional weeks of outpatient drug free treatment, daily OxyContin® use in the past month, and having fewer ties and second order connections in the drug network reduced the odds of high-frequency illicit methadone use.
Conclusions
Rates of illicit methadone use and high-frequency illicit methadone use among this sample of rural drug users were considerably higher than those previously reported in the literature. Health practitioners in rural areas should routinely screen for illicit opioid use, including methadone.
doi:10.3109/00952990.2013.805761
PMCID: PMC3810268  PMID: 23841864
23.  Benzodiazepine Use and Misuse Among Patients in a Methadone Program 
BMC Psychiatry  2011;11:90.
Background
Benzodiazepines (BZD) misuse is a serious public health problem, especially among opiate-dependent patients with anxiety enrolled in methadone program because it puts patients at higher risk of life-threatening multiple drug overdoses. Both elevated anxiety and BZD misuse increase the risk for ex-addicts to relapse. However, there is no recent study to assess how serious the problem is and what factors are associated with BZD misuse. This study estimates the prevalence of BZD misuse in a methadone program, and provides information on the characteristics of BZD users compared to non-users.
Methods
An anonymous survey was carried out at a methadone program in Baltimore, MD, and all patients were invited to participate through group meetings and fliers around the clinic on a voluntary basis. Of the 205 returned questionnaires, 194 were complete and entered into final data analysis. Those who completed the questionnaire were offered a $5 gift card as an appreciation.
Results
47% of the respondents had a history of BZD use, and 39.8% used BZD without a prescription. Half of the BZD users (54%) started using BZD after entering the methadone program, and 61% of previous BZD users reported increased or resumed use after entering methadone program. Compared to the non-users, BZD users were more likely to be White, have prescribed medication for mental problems, have preexistent anxiety problems before opiate use, and had anxiety problems before entering methadone program. They reported more mental health problems in the past month, and had higher scores in anxiety state, depression and perceived stress (p < .05).
Conclusions
Important information on epidemiology of BZD misuse among methadone-maintenance patients suggests that most methadone programs do not address co-occurring anxiety problems, and methadone treatment may trigger onset or worsening of BZD misuse. Further study is needed to explore how to curb misuse and abuse of BZD in the addiction population, and provide effective treatments targeting simultaneously addiction symptoms, anxiety disorders and BZD misuse.
doi:10.1186/1471-244X-11-90
PMCID: PMC3117775  PMID: 21595945
Benzodiazepines use; prescription drug misuse; methadone program; anxiety; survey study
24.  Pharmacy Syringe Purchase Test of Nonprescription Syringe Sales in San Francisco and Los Angeles in 2010 
The two main legal sources of clean needles for illicit injection drug users (IDUs) in California are syringe exchange programs (SEPs) and nonprescription syringe sales (NPSS) at pharmacies. In 2004, California became one of the last states to allow NPSS. To evaluate the implementation of NPSS and the California Disease Prevention Demonstration Project (DPDP), we conducted syringe purchase tests in San Francisco (SF) and Los Angeles (LA) between March and July of 2010. Large differences in implementation were observed in the two cities. In LA, less than one-quarter of the enrolled pharmacies sold syringes to our research assistant (RA), and none sold a single syringe. The rate of successful purchase in LA is the lowest reported in any syringe purchase test. In both sites, there was notable variation among the gauge size available, and price and quantity of syringes required for a purchase. None of the DPDP pharmacies in LA or SF provided the requisite health information. The findings suggest that more outreach needs to be conducted with pharmacists and pharmacy staff. The pharmacies' failure to disseminate the educational materials may result in missed opportunities to provide needed harm reduction information to IDUs. The varied prices and required quantities may serve as a barrier to syringe access among IDUs. Future research needs to examine reasons why pharmacies do not provide the mandated information, whether the omission of disposal options is indicative of pharmacies' reluctance to serve as disposal sites, and if the dual opt-in approach of NPSS/DPDP is a barrier to pharmacy enrollment.
doi:10.1007/s11524-012-9713-7
PMCID: PMC3675724  PMID: 22718357
Nonprescription syringe sales; IDU; SB1159; California; Pharmacy; Policy
25.  Injection Drug Users’ Perspectives on Placing HIV Prevention and Other Clinical Services in Pharmacy Settings 
In their role as a source of sterile syringes, pharmacies are ideally situated to provide additional services to injection drug users (IDUs). Expanding pharmacy services to IDUs may address the low utilization rates of healthcare services among this population. This qualitative study of active IDUs in San Francisco explored perspectives on proposed health services and interventions offered in pharmacy settings, as well as facilitators and barriers to service delivery. Eleven active IDUs participated in one-on-one semistructured interviews at a community field site and at a local syringe exchange site between February and May 2010. Results revealed that most had reservations about expanding services to pharmacy settings, with reasons ranging from concerns about anonymity to feeling that San Francisco already offers the proposed services in other venues. Of the proposed health services, this group of IDUs prioritized syringe access and disposal, clinical testing and vaccinations, and provision of methadone. Pharmacists’ and pharmacy staff’s attitudes were identified as a major barrier to IDUs’ comfort with accessing services. The findings suggest that although IDUs would like to see some additional services offered within pharmacy settings, this is contingent upon pharmacists and their staff receiving professional development trainings that cultivate sensitivity towards the needs and experiences of IDUs.
doi:10.1007/s11524-011-9651-9
PMCID: PMC3324615  PMID: 22231488
IDU; Pharmacy; California; Qualitative; Prevention services

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