Integrated care model and point of care diagnostics facilitate Hepatitis C treatment among patients receiving opioid agonist therapy: a retrospective review of medical records.

BACKGROUND: Hepatitis C virus (HCV) is common among individuals in opioid agonist therapy (OAT). HCV treatment has previously been unavailable for most HCV positive OAT patients in Finland. The removal of treatment restrictions and attempts to reach HCV elimination goals have increased the number of OAT patients needing HCV treatment. The objectives of this study were 1) to characterize Finnish HCV positive OAT patients and evaluate their eligibility for HCV treatment at addiction service units, and 2) to retrospectively review the outcomes of treated patients. METHODS: The study focused on HCV positive OAT patients (n = 235). Demographics and clinical parameters were retrospectively reviewed using the patients' medical records. The eligibility of providing HCV treatment to patients at addiction service units were evaluated based on patients' clinical characteristics, such as liver function and patterns of substance use. The outcomes of patients receiving HCV treatment were reviewed. RESULTS: Of HCV antibody positive OAT patients, 75% had chronic HCV. Of 103 HCV patients screened for liver fibrosis either with Fibroscan or APRI (aspartate aminotransferase to platelet ratio index), 83 patients (81%) had no indication of severe liver damage. Point of care (POC) HCV tests were used for 46 patients to lower the threshold of attending laboratory testing. All patients preferred POC testing to conventional blood testing. Twenty patients had received HCV treatment, 19 completed the treatment and achieved sustained virologic response (SVR) at the end of the treatment. Of the 18 patients available for evaluation of SVR at 12 weeks after the treatment (SVR12), 17 achieved SVR12. CONCLUSIONS: The integrated model consisting of HCV diagnostics and treatment at the addiction service unit was successfully implemented within normal OAT practice.

Standards for opioid use disorder care: An assessment of Nordic approaches.

AIMS: Outcomes in opioid use disorder (OUD) in Nordic countries have improved with integrated treatment and harm-reduction programmes. Approaches and the standard of care are different across the region. Evidence of treatment needs and current approaches are defined from evidence to inform development of a common standard. METHOD: Evidence of population sizes and treatment approach collected. Common standards for care (harm reduction, pharmacotherapy, psychology/social therapy) defined for each country. RESULTS: Evidence defines number in treatment; potential population needing treatment not defined for all countries. Populations sizes, treatment access (ratio in treatment programme compared to total country population) defined: Sweden 4,000 in OUD care (access ratio 40); Finland 3,000 (55); Norway 8,000 (154); Denmark 7,500 (132). Approach to treatment similar: integrated treatment programmes standard. Care provided by specialists in outpatient clinics/primary care; secondary care/inpatient services are available. Harm reduction is limited in Sweden but available and more accessible elsewhere. Treatment entry criteria: access relatively unlimited in Norway and Denmark, more limited in Finland and Sweden. Standards of care defined: easy access to high-quality services, individual planning, care not limited by time, management of relapse, education for patients, continuous engagement, holistic approach including management of comorbidities, needle equipment programmes without limit, treatment in prisons as community. CONCLUSION: There are opportunities to improve OUD care in the Nordics. Policy makers and clinicians can advance OUD care and share common success factors. Collaborative work across the Nordic countries is valuable. Further research in clinical practice development can yield important results for the benefit of patients with OUD.

Principles for managing OUD related to chronic pain in the Nordic countries based on a structured assessment of current practice.

BACKGROUND: Long-term use of opioid analgesics (OA) for chronic pain may result in opioid use disorder (OUD). This is associated with adverse outcomes for individuals, families and society. Treatment needs of people with OUD related to chronic pain are different compared to dependence related to use, and also injection, of illicit opioids. In Nordic countries, day-to-day practical advice to assist clinical decision-making is insufficient. AIM: To develop principles based on expert clinical insights for treatment of OUD related to the long-term use of OA in the context of chronic pain. METHODS: Current status including an assessment of barriers to effective treatment in Finland, Denmark, Iceland, Norway, Sweden was defined using a patient pathway model. Evidence to describe best practice was identified from published literature, clinical guidelines and expert recommendations from practice experience. RESULTS: Availability of national treatment guidelines for OUD related to chronic pain is limited across the Nordics. Important barriers to effective care identified: patients unlikely to present for help, healthcare system set up limits success, diagnosis tools not used, referral pathways unclear and treatment choices not elucidated. Principles include the development of a specific treatment pathway, awareness/ education programs for teams in primary care, guidance on use of diagnostic tools and a flexible treatment plan to encourage best practice in referral, treatment assessment, choice and ongoing management via an integrated care pathway. Healthcare systems and registries in Nordic countries offer an opportunity to further research and identify population risks and solutions. CONCLUSIONS: There is an opportunity to improve outcomes for patients with OUD related to chronic pain by developing and introducing care pathways tailored to specific needs of the population.

Hep-CORE: a cross-sectional study of the viral hepatitis policy environment reported by patient groups in 25 European countries in 2016 and 2017.

INTRODUCTION: The first World Health Organization (WHO) global health sector strategy on hepatitis B and C viruses (HBV and HCV) has called for the elimination of viral hepatitis as a major public health threat by 2030. This study assesses policies and programmes in support of elimination efforts as reported by patient groups in Europe. METHODS: In 2016 and 2017, hepatitis patient groups in 25 European countries participated in a cross-sectional survey about their countries' policy responses to HBV and HCV. The English-language survey addressed overall national response; public awareness/engagement; disease monitoring; prevention; testing/diagnosis; clinical assessment; and treatment. We performed a descriptive analysis of data and compared 2016 and 2017 findings. RESULTS: In 2017, 72% and 52% of the 25 European study countries were reported to not have national HBV and HCV strategies respectively. The number of respondents indicating that their governments collaborated with civil society on viral hepatitis control increased from 13 in 2016 to 18 in 2017. In both 2016 and 2017, patient groups reported that 9 countries (36%) have disease registers for HBV and 11 (44%) have disease registers for HCV. The number of countries reported to have needle and syringe exchange programmes available in all parts of the country dropped from 10 (40%) in 2016 to 8 in 2017 (32%). In both 2016 and 2017, patient groups in 5 countries (20%) reported that HCV treatment is available in non-hospital settings. From 2016 to 2017, the reported number of countries with no restrictions on access to direct-acting antivirals for HCV increased from 3 (12%) to 7 (28%), and 5 fewer countries were reported to refuse treatment to people who are currently injecting drugs. CONCLUSIONS: The patient-led Hep-CORE study offers a unique perspective on the readiness of study countries to undertake comprehensive viral hepatitis elimination efforts. Viral hepatitis monitoring should be expanded to address policy issues more comprehensively and to incorporate civil society perspectives, as is the case with global HIV monitoring. Policy components should also be explicitly added to the WHO framework for monitoring country-level progress against viral hepatitis.

Factors associated with non-adherence and misuse of opioid maintenance treatment medications and intoxicating drugs among Finnish maintenance treatment patients.

BACKGROUND: The intravenous (IV) use of opioid maintenance treatment (OMT) medications and other intoxicating drugs among OMT patients is a challenge for many OMT units and affects treatment outcomes. The aim of this study is to examine factors associated with IV use of OMT medications and other intoxicating drugs among Finnish OMT patients. METHODS: A cross-sectional study was conducted among all Finnish OMT patients of whom 60% (n=1508) participated. The data were collected by anonymous questionnaire. Binominal regression analysis with unadjusted and adjusted ORs was conducted to evaluate predictors for IV use. FINDINGS: Factors associated with the injection of a patient's own OMT medication were: being treated with buprenorphine-naloxone (BNX) (OR 2.60, p=0.005) with a low dose (<9.0mg/day; OR 5.70, p<0.001) and being treated in a health-care centre (OR 2.03, p=0.029). Factors associated with the injection of illicit OMT medications were: being treated with BNX (OR 5.25, p<0.001) with a low dose (<9.0mg/day; OR 2.89, p=0.017), lack of psychosocial support (OR 2.62, p<0.001) and concurrent use of psychotropic medications from illicit sources (OR 4.28, p<0.001). Associated factors for the injection of other intoxicating drugs were: concurrent use of illicit drugs (OR 1.72, p=0.015), psychotropic medications from illicit sources (OR 4.78, p<0.001) and from a doctor (OR 1.93, p=0.004). CONCLUSIONS: More effort should be made to reduce concurrent injecting use during OMT. This may be done by addressing concurrent substance use orders more effectively, by ensuring that patients receive an optimal BNX dose and by providing more psychosocial support.

Patterns of drug abuse among drug users with regular and irregular attendance for treatment as detected by comprehensive UHPLC-HR-TOF-MS.

The most severe consequences of drug abuse include infectious diseases, overdoses, and drug-related deaths. As the range of toxicologically relevant compounds is continually changing due to the emergence of new psychoactive substances (NPS), laboratories are encountering analytical challenges. Current immunoassays are insufficient for determining the whole range of the drugs abused, and a broad-spectrum screening method is therefore needed. Here, the patterns of drug abuse in two groups of drug users were studied from urine samples using a comprehensive screening method based on high-resolution time-of-flight mass spectrometry. The two groups comprised drug abusers undergoing opioid maintenance treatment (OMT) or drug withdrawal therapy and routinely visiting a rehabilitation clinic, and drug abusers with irregular attendance at a harm reduction unit (HRU) and suspected of potential NPS abuse. Polydrug abuse was observed in both groups, but was more pronounced among the HRU subjects with a mean number of concurrent drugs per sample of 3.9, whereas among the regularly treated subjects the corresponding number was 2.1. NPS and pregabalin were more frequent among HRU subjects, and their abuse was always related to drug co-use. The most common drug combination for an HRU subject included amphetamine, cannabis, buprenorphine, benzodiazepine, and alpha-pyrrolidinovalerophenone. A typical set of drugs for treated subjects was buprenorphine, benzodiazepine, and occasionally amphetamine. Abuse of several concurrent drugs poses a higher risk of drug intoxication and a threat of premature termination of OMT. Since the subjects attending treatment used fewer concurrent drugs, this treatment could be valuable in reducing polydrug abuse.

Diversion of opioid maintenance treatment medications and predictors for diversion among Finnish maintenance treatment patients.

BACKGROUND: Diversion (i.e. selling or giving away) of opioid maintenance treatment (OMT) medications is a challenge that concerns many units providing OMT worldwide and tools for prevention are needed. The object of this study was to examine the prevalence and predictors for diversion of the OMT medications buprenorphine-naloxone (BNX) and methadone (MET) among Finnish OMT patients. METHODS: A cross-sectional study was conducted among all Finnish OMT patients of whom 60% (n=1508) participated. The data were collected by anonymous questionnaires distributed through all OMT units in Finland. To evaluate predictors for diversion, we used binominal regression analysis with unadjusted and adjusted ORs. Selling and/or giving away of OMT medication was used as a dependent variable and explanatory variables were gender, age, duration of OMT, type of OMT medication and dose, dispensation method of OMT medication, place of residence and intravenous use of any intoxicating drugs during the past six months. RESULTS: Of all 1508 respondents, 7% (n=100) had sold and 12% (n=169) had given their OMT medication to others, 57% for money and 23% in exchange for other drugs. In multivariate analysis, predictors associated with diversion were BNX as OMT medication (OR 2.76, 95% CI 1.76-4.33), low (<9.0mg/day) BNX dose (OR 1.74, 95% CI 1.01-2.98), intravenous use of intoxicating drugs during the past six months (OR 4.48, 95% CI 3.13-6.43) and increasing length of OMT (OR 1.01, 95% CI 1.01-1.02). Age, place of residence or unsupervised pharmacy distribution of BNX were not associated with diversion. CONCLUSIONS: In order to reduce diversion, more interventions are needed to support patients to stop concurrent substance abuse. Increasing control measures, for example, increased supervision, are unlikely to prevent diversion. Given that sub-optimal dosing of BNX increases the risk of diversion, more attention should be paid to providing patients with an optimal medical dose.

Past-year gambling behaviour among patients receiving opioid substitution treatment.

BACKGROUND: Substance abuse and gambling problems are associated, however, studies on gambling problems among opioid substitution treatment (OST) patients are scarce. The aims of this study are to explore the association of gender, age, treatment medication and treatment program with gambling behaviour, including gambling participation and gambling problems, among OST patients. FINDINGS: All OST patients (n = 244) in three Finnish outpatient clinics were recruited in March - April 2014. The response rate was 64.3%. OST programs included two choices of orientation (rehabilitative/harm reduction) and two choices for treatment medication (methadone/buprenorphine-naloxone). Of 144 respondents, 70.1% had gambled during the past year and 12.5% were identified as potential past-year problem gamblers. Gambling was statistically significant more commonly among males (79.8%) compared with females (53.7%). Similarly patients in the rehabilitative program gambled (75.9%) more than those in the harm reduction program (50.0%). Gender, age, treatment medication or treatment program was not associated with past-year gambling problems. CONCLUSIONS: Gambling participation of the OST patients seemed to be somewhat similar compared with the Finnish general population, but gambling problems were more common among OST patients. Gender and age may not be very strong indicators of risk while screening problem gamblers among OST patients. Institution of a problem gambling screening program is recommended, and additional intervention for gambling problems should be implemented for that need as a part of OST.

[Designer drugs in Finland]. / Muunto- eli designhuumeet Suomessa.

Designer drugs are synthetic psychotropic drugs which are marketed as "legal drugs". Their emergence, rapid spreading and unpredictable effects have challenged the health and substance abuse care. The slow process of classification of an abusable drug has provided too many possibilities for spreading the designer drugs. Once a certain substance receives an illegal drugs classification, dealers and users usually move to another, slightly different molecule that is still legal. In Finland, the Narcotics Act has been amended to the effect that the addition of a new substance to the illegal drug list does not require an amendment to the law.

Bioavailability of buprenorphine from crushed and whole buprenorphine (subutex) tablets.

BACKGROUND: Buprenorphine (Subutex) is the most abused opioid in Finland. In order to curb the abuse potential of this drug, many treatment centers and prisons crush Subutex tablets before administering them to patients. To date, there are no published studies comparing the efficacy and bioavailability of crushed and whole Subutex tablets. METHODS: A total of 16 opioid-dependent patients stabilized on 24 mg of buprenorphine were enrolled in a double-blind, double-dummy, randomized cross-over study comparing crushed and whole buprenorphine tablets on a range of pharmacokinetic and pharmacodynamic variables. Buprenorphine tablets (either crushed or whole) and placebo tablets (either crushed or whole) were administered to subjects simultaneously. Buprenorphine and norbuprenorphine serum levels were measured at 30, 60, 90, 120, 180, 240 and 360 min, as well as 24 h, after tablet administration. After 1 week, the experiment was repeated in a cross-over design so that, by the end of the study, each patient had received the active drug (buprenorphine) as both crushed and whole tablets. RESULTS: Pharmacokinetic parameters (mean serum levels, C(max), T(max), AUC) of buprenorphine or norbuprenorphine did not differ significantly between crushed and whole tablets, although serum levels were slightly higher after administration of the crushed tablets. There were also no significant differences in dissolution/absorption time, withdrawal signs or opiate craving. CONCLUSION: We conclude that crushing Subutex tablets does not significantly alter serum buprenorphine or norbuprenorphine levels or the drug's clinical effect. Our results indicate that crushing Subutex tablets may be used as an alternative method to counter the risk of buprenorphine diversion.

A retrospective evaluation of patients switched from buprenorphine (Subutex) to the buprenorphine/naloxone combination (Suboxone).

BACKGROUND: In Finland, buprenorphine (Subutex) is the most abused opioid. In order to curb this problem, many treatment centres transferred ("forced transfer") their buprenorphine patients to the buprenorphine plus naloxone (Suboxone) combination product in late 2003. METHODS: Data from a retrospective study involving five different treatment centers, examining the effects of switching patients to Suboxone, were gathered from 64 opioid-dependent patients who had undergone the medication transfer. RESULTS: Most patients (90.6%) switched to Suboxone at the same dose of buprenorphine that they had been receiving as Subutex (average 22 mg). The majority of these patients (71.9%) were maintained at the same dose of Suboxone throughout the 4-week study period. During the first 4 weeks, 50% of the patients reported adverse events and at the four month time point, 26.6% reported adverse events. However, due to adverse events one patient only discontinued treatment with Suboxone during the 4-week study period, and five during the four month follow-up period. Of the 26 patients in the follow-up period, Suboxone was misused intravenously once each by 4 patients and twice by 1 patient. These 5 patients all reported that injecting Suboxone was like injecting "nothing" with any euphoria, or that it was a bad experience. CONCLUSION: We conclude that when patients are transferred from high doses (> 22 mg) of buprenorphine to the combination product, dose adjustments may be necessary especially in the later phase of the treatment. We recommend that a transfer from Subutex to Suboxone should be carefully discussed and planned in advance with the patients and after the transfer adverse events should be regularly monitored. With regard of buprenorphine IV abuse, the combination product seems to have a less abuse potential than buprenorphine alone.

Targeted nalmefene with simple medical management in the treatment of heavy drinkers: a randomized double-blind placebo-controlled multicenter study.

BACKGROUND: Clinical studies with opioid antagonists for treatment of problem drinking have mainly been conducted in specialized alcohol treatment centers, included structured psychosocial treatment, and have focused on maintaining abstinence after a period of abstinence from alcohol. METHODS: This multisite, randomized double-blind study investigated targeted nalmefene in reducing heavy drinking. Specialized alcohol treatment centers and private general practices enrolled 403 subjects (328 men, 75 women). Subjects were instructed to take nalmefene 10 to 40 mg (n=242) or placebo (n=161) when they believed drinking to be imminent. After 28 weeks, 57 subjects from the nalmefene group continued into a 24-week randomized withdrawal extension. Concomitant psychosocial intervention was minimal and no treatment goals were imposed. Alcohol consumption was recorded using the time-line follow-back method. Biochemical indicators of alcohol use were also measured. RESULTS: The mean monthly number of heavy drinking days (HDDs) during the 12-week period before inclusion was 15.5 (SD 6.9) in the nalmefene group and 16.2 (SD 6.9) in the placebo group. During treatment, the mean numbers of HDDs were 8.6 to 9.3 in the nalmefene group and 10.6 to 12.0 in the placebo group (p=0.0065). The levels of serum alanine aminotransferase and gamma-glutamyl transferase decreased in the nalmefene group compared with the placebo group (p=0.0088 and 0.0023). During the randomized withdrawal period, subjects randomized to placebo apparently returned to heavier drinking. Subjects receiving nalmefene reported more nausea, insomnia, fatigue, dizziness, and malaise than subjects on placebo. CONCLUSIONS: Nalmefene appears to be effective and safe in reducing heavy drinking, even when accompanied by minimal psychosocial support.