ent-dextilidine and Opioid-Related-Disorders

Tramadol and tilidine (in combination with naloxone) are used as weak opioid analgesics in Germany. Tramadol is not scheduled in the German Narcotic Drugs Act. Tilidine is scheduled, whereas Tilidine in fixed combinations with naloxone is exempt from some of the provisions of the Narcotic Drugs Act. Recent reports on misuse of both substances led to an evaluation of their potential for misuse, abuse, and dependency by the expert advisory committee established by the German Federal Government, resident at the Federal Institute for Drugs and Medical Devices.. A subcommittee formulated key questions and identified available data sources for each of these questions. Additional information was solicited where necessary, including a survey among a panel of pharmacists, a survey in an addiction clinic, analysis of prescription patterns, and information from the boards of pharmacists of the federal states and the Federal Bureau of Criminal Investigation.. Analgesic efficiency in the treatment of acute and chronic pain has been proven for both tramadol and tilidine/naloxone. For tramadol, high evidence has been confirmed in systematic reviews, and tramadol is listed in national and international guidelines on acute and chronic pain management. Animal and human studies found a low potential for misuse, abuse, and dependency for both substances. Information from 2 tramadol safety databases allowed calculation of the incidence of abuse or dependency as 0.21 and 0.12 cases per million defined daily dosages (DDDs), with lower incidences in recent years. For tilidine/naloxone, the incidence was calculated as 0.43 cases per million DDDs for oral solution and 0.18 for slow-release tablets. In an online survey among German pharmacies as well as in the reports from state pharmacy boards, fraud attempts were repeated more frequently with tilidine/naloxone than with tramadol in the last 2 years. The Federal Bureau of Criminal Investigations reported prescription fraud only with tilidine/naloxone and predominantly in the region of Berlin. Dependency on tramadol or tilidine/naloxone is reported only rarely from addiction counseling centers. One third of the patients surveyed in an addiction clinic reported experiences with tramadol or tilidine/naloxone, but mostly with duration of less than 4 weeks and with a medical prescription based on a reasonable indication. Also, occasional illegal use of opioid analgesics as a substitute of heroin was reported. An evaluation of pooled data from statutory health insurance companies found 2.5% of persons receiving at least 1 prescription of tramadol or the combination of tilidine and naloxone in 2009 (1.6% with tramadol and 1.0% with tilidine/naloxone). High usage with more than 180 DDDs per year was found in 8.6% of patients treated with tramadol and 17.2% of patients with tilidine/naloxone.. In conclusion, the subcommittee of the expert advisory committee found a low potential for misuse, abuse, and dependency for tramadol, and a low prevalence in clinical practice. Considerable less information is available for the combination of tilidine and naloxone. However, the cumulation of evidence indicated a higher risk of misuse, abuse, and dependency for tilidine/naloxone solution, but not for slow-release tablets.

Topics: Analgesics, Opioid; Drug Therapy, Combination; Fraud; Germany; Humans; Incidence; Naloxone; Opioid-Related Disorders; Pain; Self Medication; Tilidine; Tramadol

Annually published data show a continual increase in the volume of opioid prescriptions in Germany, thus indicating an intensification of opioid therapy. The majority of opioids are prescribed to treat chronic non-cancer-related pain. On the basis of current guidelines, as well as in terms of the lack of data regarding long-term use of opioids and their effectiveness beyond a period of 3 months, this development must be viewed critically. With reference to four case reports, we discuss and evaluate opioid therapy in relation to medication misuse and the development of drug dependency. Particular emphasis is placed on the administration of rapid-release and short-acting opioid preparations, which we consider to be particularly problematic.

Topics: Abdominal Pain; Adult; Analgesics, Opioid; Chronic Pain; Diabetic Neuropathies; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Utilization; Female; Fentanyl; Guideline Adherence; Headache Disorders; Humans; Long-Term Care; Male; Middle Aged; Opioid-Related Disorders; Oxycodone; Physician-Patient Relations; Practice Patterns, Physicians'; Prescription Drug Misuse; Risk Factors; Tilidine

Anesthesiologists have a well-known increased risk of substance abuse including the intravenous administration of opioids and propofol. However, katamnestic reports from the point of view of propofol-addicted anesthesiologists themselves are missing which would aid a better understanding of the dynamics and progress of addiction. This article presents an interview with a formerly addicted female anesthesiologist who after long-term abuse with oral tilidine combined with naloxone switched to intravenous administration of fentanyl and later on propofol. Several life-threatening incidents occurred but after some severe setbacks occupational rehabilitation outside the field of anesthesiology was successful following inpatient treatment. This case shows exemplarily in accordance with the current literature that warning signs in addicted physicians are often ignored by colleagues and supervisors and rehabilitation is possible under professional therapy and continuous surveillance. Additionally, this case emphasizes the necessity of controlling the distribution of propofol to reduce the life-threatening professional risk to anesthesiologists.

Topics: Adult; Analgesics, Opioid; Anesthesiology; Anesthetics, Intravenous; Female; Fentanyl; Humans; Naloxone; Opioid-Related Disorders; Physician Impairment; Physicians; Prescription Drug Diversion; Propofol; Substance Abuse, Intravenous; Substance-Related Disorders; Survivors; Tilidine

Topics: Analgesics, Opioid; Diagnosis, Differential; Humans; Male; Middle Aged; Neurologic Examination; Opioid-Related Disorders; Polysomnography; Restless Legs Syndrome; Substance Withdrawal Syndrome; Tilidine