Drug safety related to agents used for opioid maintenance therapy

Introduction There is only little data regarding drug safety related to agents used for opioid maintenance therapy (OMT). Objectives/aims To study drug safety and the reporting behaviour of adverse drug reactions (ADR) related to OMT. Methods A cross-sectional questionnaire-based telephone survey among physicians providing outpatient OMT in a federal state of Germany ( n  = 176; response rate = 55.7%) was conducted. Results Most of the respondents ( n  = 97/55.1%) reported that they observe ADR related to buprenorphine, [dihydro]codein and [levo]methdone rarely ( n  = 38/21.6%), very rarely ( n  = 39/22.2%) or never ( n  = 20/11.4%). Methadone was reported to be most frequently associated with the occurrence of ADR ( n  = 82/46.6%), followed by levomethadone ( n  = 33/18.8%), buprenorphine ( n  = 6/3.4%), and dihydrocodeine ( n  = 3/1.7%). Frequently observed ADR related to these agents were gastrointestinal, nervous system and psychiatric disorders, and hyperhidrosis. Methadone and levomethadone (not buprenorphine) were reported to be frequently associated with fatigue, weight gain, and sexual dysfunction. Only buprenorphine was reported to be frequently associated with withdrawal and rebound effects, and drug intolerance. Hundred twenty-nine participants (73.3%) stated that they never report ADR related to OMT, whereas n  = 19 (10.8%) did so when referring to ADR related to their complete medical practice (Chi 2  = 141.070; df = 1; P Conclusions Our data revealed similar patterns of ADR related to outpatient OMT as those reported in the product information or in pain therapy. Motivation to report ADR related to agents used for OMT may be reduced compared to ADR related to the general medical practice.