title: Drug safety and adverse drug reaction reporting behavior related to outpatient opioid replacement therapy: Results from a survey among physicians.
abstract: To study drug safety and the reporting behavior of adverse drug reactions (ADR) related to agents used for opioid replacement therapy (ORT) we conducted a cross-sectional questionnaire-based telephone survey among physicians who provide outpatient ORT in Germany (n=176; response rate=55.7%). Most respondents (n=97/55.1%) reported that they observe ADR related to buprenorphine, (dihydro)codeine, 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/psychiatric disorders, and hyperhidrosis. Methadone and levomethadone (not buprenorphine) were frequently associated with fatigue, weight gain, and sexual dysfunction. Hundred twenty nine participants (73.3%) stated that they never report ADR related to ORT; n=19 (10.8%) did so when referring to ADR related to their complete medical practice (X2=141.070; df=1; p<0.001). Similar patterns of ADR related to outpatient ORT as those reported in the product information or in pain therapy were found. Motivation to report ADR related to ORT may be reduced compared to ADR related to the general medical practice.
authors.affiliation: University of Ulm, Department of Psychiatry and Psychotherapy III, Leimgrubenweg 12-14, 89075 Ulm, Germany. Electronic address: maximilian.gahr@uni-ulm.de.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Gahr
authors.affiliation: University of Ulm, Department of Psychiatry and Psychotherapy III, Leimgrubenweg 12-14, 89075 Ulm, Germany.
authors.forename: Jonas
authors.initials: J
authors.lastname: Eller
authors.affiliation: University of Lübeck, Department of Psychiatry and Psychotherapy, Ratzeburger Allee 160, 23538 Lübeck, Germany.
authors.forename: Maurice
authors.initials: M
authors.lastname: Cabanis
authors.affiliation: University Medical Center of Mainz, Department of Psychiatry and Psychotherapy, Untere Zahlbacherstr. 8, 55131 Mainz, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Hiemke
authors.affiliation: University of Ulm, Department of Psychiatry and Psychotherapy III, Leimgrubenweg 12-14, 89075 Ulm, Germany.
authors.forename: Roland W
authors.initials: RW
authors.lastname: Freudenmann
authors.affiliation: University of Ulm, Department of Psychiatry and Psychotherapy III, Leimgrubenweg 12-14, 89075 Ulm, Germany.
authors.forename: Bernhard J
authors.initials: BJ
authors.lastname: Connemann
authors.affiliation: University of Ulm, Department of Psychosomatic Medicine and Psychotherapy, Albert-Einstein-Allee 23, 89081 Ulm, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Lang
authors.affiliation: University of Ulm, Department of Psychiatry and Psychotherapy III, Leimgrubenweg 12-14, 89075 Ulm, Germany.
authors.forename: Carlos
authors.initials: C
authors.lastname: Schönfeldt-Lecuona
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects*; D002047:Buprenorphine / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005858:Germany; D019538:Health Care Surveys / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008691:Methadone / Q000009:adverse effects*; D008875:Middle Aged; D058850:Opiate Substitution Treatment / Q000009:adverse effects / Q000706:statistics & numerical data*; D009293:Opioid-Related Disorders; D010045:Outpatients / Q000706:statistics & numerical data; D010820:Physicians / Q000706:statistics & numerical data*
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine; D008691:Methadone
keywords: Addiction; Buprenorphine; Levomethadone; Methadone; Pharmacovigilance