SUSPECT ADVERSE REACTION REPORT

Transcription

1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 46 DA MO YR (Year) Male massive Diarrhoe ( ): Diarrhoea ] upbeat-nystagmus ( ): Nystagmus ] ( ): Hallucinations ] ( ): Opisthotonus ] Patient nicht amnestizierbar mit diffus unkontrollierten Bewegungen ( ): Movement disorder ] massive Hyper- und Dyskinesien am gesamten Körper ( ): Hyperkinesia ] ( ): Paraphasia ] ( ): Dyskinesia ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden (Apotheker/Krankenhaus): Patient war nicht amnestizierbar mit diffus unkontrollierten Bewegungen. Massive Hyper- und Dyskinesien am gesamten Körper, Opistotonus, Paraphasien. Nach NA Zuweisung fraktionierte Gabe von insgesamt 10 mg Midazolam und 10mg Tavor, dann Umstellung auf Dexodor. Nach 3 Stunden kein signifikantes Ansprechen, daher Umstellung auf II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION þ þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 ( ): Polytoxicomania ] from 1997 to 2017 Continuing: Yes [ MedDRA 20.0 ( ): Hepatitis C ] Continuing: Yes [ MedDRA 20.0 ( ): TIA ] from 2015 Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Propofolperfusor 1% 6 ml/h. Darunter dann dauerhafte Entspannung des Muskeltonus bei stabiler kardiorespiratorischer Situation (Sauerstoffsättigung 99%, RR 160/80 mmhg, HF 90/min). A: Dauersedierung bei V.a. Opiatentzug P: Verlegung auf Intensivstation zur weitern Entzugstherapie unter Dauersedierung Folgemeldung eines Arztes Krankenhaus: Versuch des eigenständ. Reduzierens der Methadondosis, bei Verlangen nach C2 Einnahme von Selincro 18mg (Nalmefen) von der Freundin, 2h darauf massive Diarrhoe, Halluzinazionen und wellenförmigen massiven Hyper- und Dyskinesien am gesamten Körper, Opistotonus, int. ansprechbar und Paraphasien, upbeat-nystagmus. Nach NA Zuweisung fraktionierte Gabe von insgesamt 10 mg Midazolam und 10mg Tavor, dann Umstellung auf Dexdor. Nach 3 h kein signifikantes Ansprechen, daher Umstellung auf Propofol 1% 6 ml/h -> dauerhafte Entspannung des Muskeltonus bei stabiler kardiorespiratorischer Situation (So2 99%, RR 160/80 mmhg, HF 90/min), anhaltende Agitation und Wahnvorstellungen -> passagere Gabe von Sufentanil und Überwachung auf Intensiv, im Verlauf Entscheid zur weiteren Substitution durch Pollamidon 16ml/d -> hierauf vollst. Aufklaren, keine neurologischen Auffälligkeiten mehr Results of tests and procedures relevant to the investigation of the patient: Methadon, THC, Benzodiazepine positiv im Urin Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Patient nicht amnestizierbar mit diffus unkontrollierten Bewegungen [MedDRA 20.0 PT ( ): Movement disorder ] ( ): Movement disorder ] massive Hyper- und Dyskinesien am gesamten Körper [MedDRA 20.0 PT ( ): Hyperkinesia ] ( ): Hyperkinesia ] [MedDRA 20.0 PT ( ): Aphasia ] ( ): Paraphasia ] [MedDRA 20.0 PT ( ): Opisthotonus ] ( ): Opisthotonus ] [MedDRA 20.0 PT ( ): Dyskinesia ] ( ): Dyskinesia ] massive Diarrhoe [MedDRA 20.0 PT ( ): Diarrhoea ] ( ): Diarrhoea ] 2 Day recovered/resolved 2 Hour 19-JUL-2017

3 Report Page: 3 of 6 upbeat-nystagmus [MedDRA 20.0 PT ( ): Nystagmus ] ( ): Nystagmus ] 2 Day recovered/resolved 2 Hour 19-JUL-2017 [MedDRA 20.0 PT ( ): Hallucination ] ( ): Hallucinations ] 2 Day recovered/resolved 2 Hour 19-JUL-2017 * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit Normal low range Oxygen saturation 99 % Normal high range More inform. available Blood pressure 160/80 mmhg Heart rate 90 /min Blood ethanol <9,2 mg/dl Interacting Drug(s) and Dates of Administration (... continuation...) Interacting Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Selincro 18 mg 18-JUL JUL A: 18mg B: C: D: E: Oral Alcoholism Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) 82 (Film-coated tablet) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? NA * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval

4 Report Page: 4 of 6 Active drug substance name nalmefene hydrochloride Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Paraphasia ] Probable/likely [ MedDRA 20.0 ( ): Hyperkinesia ] [ MedDRA 20.0 ( ): Movement disorder ] [ MedDRA 20.0 ( ): Opisthotonus ] [ MedDRA 20.0 ( ): Dyskinesia ] [ MedDRA 20.0 ( ): Diarrhoea ] possible [ MedDRA 20.0 ( ): Nystagmus ] possible [ MedDRA 20.0 ( ): Hallucinations ] possible Interacting Drug(s) and Dates of Administration (... continuation...) Interacting Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Methadon 01-JAN JUL Year A: B: C: D: E: Oral Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Dose not changed Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval

5 Report Page: 5 of 6 Active drug substance name methadone 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 ( ): Polytoxicomania ] Yes [ MedDRA 20.0 ( ): Hepatitis C ] Yes [ MedDRA 20.0 ( ): TIA ] 2015 Unknown Zustand nach Hirnstamm-TIA Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Start End Methadon [ MedDRA 20.0 ( ): Drug [ MedDRA 20.0 (0): unbekannt ] abuse NOS ] Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents Deutschland Yes No List of documents held by sender Does this case fulfill the local criteria for an expedited report? Yes Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? Yes No Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 90 Deutschland Pharmacist 90 Deutschland Physician SENDER INFORMATION (... continuation...)

6 Report Page: 6 of 6 Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Deutschland Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 70 Height (cm) 180 Last menstrual periode Text for relevant medical history and concurrent conditions