ࡱ> U RTdbjbjnn||aa-J J $PIt!:  $T# &t  .!Z  T1ps D!0t!~&$~&~&'L Nt!~&J Q : Adverse Drug Reaction/Event Reporting FormInitial report% Follow-up Report% No. Report typeNew% Serious% Non-serious% Reporting unit typeMedical institution% Distributor% Manufacturer% Individual% Other% Patient NameGenderMale% Female%Date of birth Y0M0Dor Age Ethnic groupWeightkg Contact No.Original diseaseHospital Name Medical record No./Patient No.Past adverse drug reaction/eventYes% No% Unknown%Family adverse drug reaction/event: Yes% No% Unknown%Relevant Key Information Tobacco use history% Alcohol use history% Pregnancy% Liver disease history% Renal disease history% Allergy history% Other% DrugApproval No.Trade nameGeneric nameincluding dosage form ManufacturerLot No.DosageDose0Route0Frequency Start date/stop dateIndicationSuspect drugConcomitant drugAdverse reaction/eventOnset date00Y0 M0 DDescription of adverse reaction/event (including symptoms, signs and lab tests etc.) and actions taken:Outcome of adverse reaction/eventRecovered% Recovering% Not recovered% Unknown% Recovered with sequelae% symptom Death% Direct death reason Date of death Y M D Did reaction/event disappear or relieve after discontinuation or dose reduction? Yes% No% Unknown% No discontinuation or dose reduction%Did reaction/event recur after re-starting suspect drug? 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New adverse drug reactionIt refers to the adverse reactions not listed in the product information. If the nature, degree, consequence or frequency of adverse reactions are inconsistent with or more serious than described in the product information, the adverse reactions shall be handled as new adverse drug reaction.Reporting timeline New or serious adverse drug reactions shall be reported within 15 days of awareness date, among which the death cases shall be reported immediately and the other adverse drug reactions shall be reported within 30 days. If follow-up information is available, it shall be reported promptly.Other instructionSuspect drug: The drug(s) used by patients in relation to the occurrence of adverse reactions.Concomitant drug: any drug used by the patient during the onset of adverse drug reactions, other than suspected drugs, including drugs purchased by the patient or Chinese traditional medicine, etc.Dosage: include dose, route of administration, number of times of administration per day, e.g., 5mg, oral, twice a day.Report processingAll reports will be entered into the database and the professionals will analyze the relationship between the drug and adverse reactions/events. According to the universality or severity of the drug risk, decide whether to take relevant measures, such as adding warning information in the product information and updating information on how to use the drug safely. 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