Safety Considerations in Cannabinoid-Based Medicine.

Cannabinoids are a diverse class of chemical compounds that are increasingly recognized as potential therapeutic options for a range of conditions. While many studies and reviews of cannabinoids focus on efficacy, safety is much less well reported. Overall assessment of the safety of cannabinoid-based medicines is confounded by confusion with recreational cannabis use as well as different study designs, indications, dosing, and administration methods. However, clinical studies in registered products are increasingly available, and this article aims to discuss and clarify what is known regarding the safety profiles of cannabinoid-based medicines, focusing on the medical and clinical safety evidence and identifying areas for future research. The two most well-studied cannabinoids are Δ9-tetrahydrocannabinol (THC), or its synthetic variants (dronabinol, nabilone), and cannabidiol (CBD). Across diverse indications, dizziness and fatigue are generally the most common adverse events experienced by patients receiving THC or combined THC and CBD. Patients receiving THC may experience adverse cognitive effects and impairment in psychomotor skills, with implications for driving and some occupations, while CBD may help to lower the psychotropic effects of THC when used in combination. Studies on dependency and addiction in a medical context are limited, but have shown inconsistent findings regarding misuse potential. Generally, the recommended route of administration is oral ingestion, as smoking medicinal cannabinoid products potentially releases mutagenic and carcinogenic by-products. There are several potential drug-drug interactions and contraindications for cannabinoid-based medicines, which physicians should account for when making prescribing decisions. The available evidence shows that, as with any other class of pharmaceuticals, cannabinoid-based medicines are associated with safety risks which should be assessed in the context of potential therapeutic benefits. Each patient should be assessed on an individual basis and physicians must rely on informed, evidence-based decision-making when determining whether a cannabinoid-based medicine could be an appropriate treatment option.

Patient-Reported Outcomes, Experiences and Satisfaction with Weekly and Monthly Injectable Prolonged-Release Buprenorphine.

INTRODUCTION: Prolonged-release buprenorphine (PRB), administered by weekly or monthly injection, for opioid dependence (OD) treatment offers the potential to address some limitations of oral therapy including stigma, difficulty in achieving consistent appropriate dosing, risk of diversion of medications, risk of overdose, and continuing use of other drugs. Patient-reported outcomes (PRO) and experiences are important in the evaluation of OD therapy success. This work aimed to document PRO during PRB therapy to guide future treatment decision-making. METHODS: Qualitative interviews were completed with people on PRB OD treatment. Twenty individuals from four treatment services in England and Wales were asked to participate. A structured interview was developed guided by a person with OD lived experience. Interviews were transcribed, coded and analyzed using iterative categorization. RESULTS: Fifteen of 20 individuals approached agreed to participate, and 14 completed interviews. The average age of participants was 42 (range 33-54) years, 13 males and 1 woman, the history of problematic opioid use was 14 years (3-25 years), time in treatment was 7 years (1-20 years), and duration on treatment with PRB was 4 months (range 1-8 months). Participants reported treatment experiences leading to coding of 277 unique comments: therapy effectiveness (77% indicated a benefit of, or satisfaction with, PRB therapy, 7% neutral/general, 16% indicated concern or questions about PRB therapy), convenience (81% benefit, 7% neutral/general, 12% concern), and overall satisfaction (81% benefit, 3% neutral/general, 16% concern). Reported benefits include cravings reduction of 10 (71%), self-care improvement of 10 (71%), relationships improvement of 9 (64%), resources management of 6 (43%), positive outlook on life of 12 (86%). Participants reported a range of positive personal experiences; challenges reported included temporary injection discomfort at treatment initiation. DISCUSSION: In this small, focused population, there was generally a positive level of treatment satisfaction with PRB. These experiences provide insights to explain potential treatment benefit to others and are useful in guiding therapy choices for others in the future.

Consensus and Controversies Between Pain and Addiction Experts on the Prevention, Diagnosis, and Management of Prescription Opioid Use Disorder.

OBJECTIVES: Prescription opioid use disorder (POUD) is an established public health crisis in many countries, and current evidence indicates it is a growing problem in Europe. Many specialists play a role, including pain and addiction medicine specialists, in the diagnosis and management of POUD, but neither group can fully address these patients' needs alone. The purpose of this consensus process was to bring together experts from pain and addiction medicine to examine the positions of both specialties. METHODS: In all, 13 international pain medicine, addiction medicine, and addiction psychiatry experts convened a meeting to formulate a set of consensus statements on the diagnosis and management of POUD. The statements were further refined by a wider group of 22 European expert clinicians. At a second meeting of all 35 participants, a set of controversy statements was also developed to recognize some of the key areas of divergent opinion. RESULTS/CONCLUSIONS: There was a high level of agreement between pain and addiction specialists. Key themes that emerged were the need to strengthen interdisciplinary communication, a desire for greater education and training for clinicians in both specialties, and mutual acknowledgment of the importance of multidisciplinary management of POUD. The blurred line between poorly managed pain and POUD was also a subject of much discussion, reflecting the difficulties in defining and diagnosing this complex condition.

Successful Treatment of Opioid Dependence with Flexible Doses of Injectable Prolonged Release Buprenorphine.

Opioid dependence (OD) may be effectively treated with well-evidenced regimens including psychosocial and pharmacotherapeutic interventions. Treatment has benefits but also limitations including risk of diversion, impact of mandatory daily supervision, and stigma. An injectable prolonged release buprenorphine with flexible dose options has recently been approved by the European Commission and is available in the UK and other European Countries. Initial positive treatment experience in patients with different clinical scenarios (patients with no recent treatment history, a transfer from oral methadone, and change from sublingual buprenorphine tablets) provides evidence of the potential benefit in a range of situations for this therapeutic option. Adoption of the injectable form was clinically successful with no withdrawal signs, nor evidence of use of other drugs. Patient reported outcomes were positive including reduction in cravings and anxiety and improved attitude, relationships, and general mood.

Recommendations for buprenorphine and methadone therapy in opioid use disorder: a European consensus.

INTRODUCTION: Management of patients with opioid use disorder (OUD) commonly includes opioid agonist therapy (OAT) as a part of an integrated treatment plan. These interventions are associated with proven benefits to the individual and society. Areas covered: The use of methadone and buprenorphine within an integrated treatment plan in the management of patients with OUD: this work provides consensus recommendation on pharmacotherapy in OUD to assist clinicians with practical decision making in this field. Expert opinion: Pharmacotherapy is recommended as part of an integrated OUD treatment approach with psychosocial interventions, with the goal of reducing risks of illicit opioid use, overdose mortality, infection with HIV or HCV, improving health, psychological and social outcomes. Access to OAT should be prioritised in the treatment of OUD. Treatment choices in OUD pharmacotherapy should be based on the needs of the individual and characteristics of medications. Recommendations for choices of OAT are based on clinical efficacy, safety, patient preference, side effects, pharmacological interactions, quality of life, dose titration potential and outcomes (control craving, ongoing opioids consumption or other drugs, and potentially psychiatric comorbidities). Special groups, pregnant women, prisoners, patients with mental health problems have specific needs which must be addressed with expert input.

Are we ready to treat hepatitis C virus in individuals with opioid use disorder: assessment of readiness in European countries on the basis of an expert-generated model.

Individuals with a history of injecting drugs have a high prevalence of chronic hepatitis C (HCV) infection. Many have a history of opioid use disorder (OUD). Despite novel treatments with improved efficacy and tolerability, treatment is limited in the group. A faculty of experts shared insights from clinical practice to develop an HCV care-readiness model. Evidence and expert knowledge was collected. Ten experts developed a model of three factors (with measures): 'healthcare engagement', 'guidance' and 'place'. Overall, 40-90% of individuals with OUD engage with drug treatment services. Ten of 12 HCV guidelines provided specific advice for the OUD population. Ten of 12 OUD care guidelines provided useful HCV care advice. In 11 of 12 cases, location of HCV/drug treatment care was in different places. This readiness assessment shows that there are important limitations to successful HCV care in OUD. Specific actions should be taken: maintain/increase access to OUD treatment services/opioid agonist therapy, updating HCV guidance, locate care in the same place and allow wider prescribing of anti HCV medicines.

Buprenorphine dosing choices in specific populations: review of expert opinion.

INTRODUCTION: Treatment of opioid dependence with buprenorphine improves outcomes. Typical dosing ranges for all patients from clinical evidence and as defined in the product information are wide. For specific groups with complex clinical scenarios, there is no clear consensus on dosing choices to achieve best possible outcomes. AREAS COVERED: The doses of buprenorphine used in 6 European countries was reviewed. A review of published evidence supported rapid induction with buprenorphine and the benefits of higher doses but did not identify clearly useful guidance on dosing choices for groups with complex clinical scenarios. An expert group of physicians with experience in addiction care participated in a discussion meeting to share clinical practice experience and develop a consensus on dosing choices. EXPERT OPINION: There was general agreement that treatment outcomes can be improved by optimising buprenorphine doses in specific subgroups. Specific groups in whom buprenorphine doses may be too low and who could have better outcomes with optimised dosing were identified on the basis of clinical practice experience. These groups include people with severe addiction, high tolerance to opioids, and psychiatric comorbidities. In these groups it is recommended to review dosing choices to ensure buprenorphine dosing is sufficient.

The Impact of Misuse and Diversion of Opioid Substitution Treatment Medicines: Evidence Review and Expert Consensus.

BACKGROUND/AIMS: Opioid substitution treatment (OST) improves outcomes in opioid dependence. However, controlled drugs used in treatment may be misused or diverted, resulting in negative treatment outcomes. This review defines a framework to assess the impact of misuse and diversion. METHODS: A systematic review of published studies of misuse and diversion of OST medicines was completed; this evidence was paired with expert real-world experience to better understand the impact of misuse and diversion on the individual and on society. RESULTS: Direct impact to the individual includes failure to progress in recovery and negative effects on health (overdose, health risks associated with injecting behaviour). Diversion of OST has impacts on a community that is beyond the intended OST recipient. The direct impact includes risk to others (unsupervised use; unintended exposure of children to diverted medication) and drug-related criminal behavior. The indirect impact includes the economic costs of untreated opioid dependence, crime and loss of productivity. CONCLUSION: While treatment for opioid dependence is essential and must be supported, it is vital to reduce misuse and diversion while ensuring the best possible care. Understanding the impact of OST misuse and diversion is key to defining strategies to address these issues.

Addressing misuse and diversion of opioid substitution medication: guidance based on systematic evidence review and real-world experience.

BACKGROUND: Opioid dependence treatment, comprising opioid substitution treatment (OST) and psychosocial intervention, is accepted to improve outcomes in opioid addiction for both the individual and public health. OST medication such as methadone or buprenorphine may be misused or diverted. This results in failure to recover from addiction, increased crime and the spread of blood-borne viruses. Worldwide, attempts to address misuse and diversion have been proposed and implemented with varying impact. METHODS: A structured, expert-led process recommended the most impact. As an initial step, a broad range of strategies were defined, and a systematic review of published literature identified 37 highly relevant sources of evidence. Experts reviewed this evidence and ranked the list of strategies for effectiveness and ease of implementation, based on their clinical experience. RESULTS/CONCLUSIONS: Three groups of strategies to address misuse or diversion are defined, depending on impact (effectiveness and ease of implementation). Preferred strategies include the promotion of access to treatment and the use of product formulations less likely to be misused. However, additional data and innovative approaches to address this complex problem are needed.

Adicción a cocaína: enfoques actuales para su abordaje terapéutico / Cocaine dependence: a new foccusing to approach therapeutic

La gran difusión producida en el consumo de cocaína constituye una nueva problemática que deben afrontar las sociedades de nuestros días. Hacía falta en la literatura científica de lengua castellana un libro que se ocupe extensamente de aspectos relacionados con el consumo de esta droga. Adicción a cocaína, es una oportuna contribución para el abordaje de estos trastornos adictivos. Contenido:La cocaína. Historia del uso y abuso de la cocaína. Farmacología. Consecuencias físicas y psíquicas del consumo abusivo de cocaína. Aspectos diagnósticos y psicopatológicos.El diagnóstico de nivel adictivo. El síndrome de abstinencia. Adicción a cocaína y psicopatología. La adicción, la personalidad y la familia. Personalidad y adicción. La familia del adicto. Algunos problemas especiales vinculados al consumo de cocaína. Los abordajes terapéuticos. Psicoterapia individual del adicto a cocaína. Terapia de familia con miembros adictos. El abordaje farmacológico