Form for medical / pharmaceutical worker http:// Institution name Location of the institution e-mail Phone number Full Name Message type primaryfinal І. PATIENT INFORMATION Patient initials Case history / outpatient card number Date of Birth Age Sex malefemale Consequence of side effects recovery without consequencesrecovery with consequences Clinical diagnosis (indicating the code according to МКБ-10) Other important information (history, laboratory and instrumental studies, allergies, etc.) ІІ. INFORMATION ABOUT SE / LE Start of SE/ LE End of SE SE lasts Description of the SE / Indication of the LE of the drug Category of SE ІІІ. INFORMATION ABOUT SUSPECTED DRUG (SD), MANUFACTURER OF SD SD (trade name, dosage form) Manufacturer, country Series number Indication for prescription Single dose Intake frequency Method of administration Initiation of SD therapy Has the patient received SD before yesnounknown If so, what kind of SE occurred similarotherunknown ІV. INFORMATION ABOUT RELATED DRUGS (with the exception of drugs that were used to correct the effects of SE) Related drugs (trade name, dosage form) Single dose Intake frequency Method of administration Assignment date (from / to) V. MEANS OF CORRECTING SE Method of administration Cancellation of the SD. Was the cancellation of the SD accompanied by the disappearance of the SE? yesno Re-assignment of the SD or, the renewal of the SE after re-assignment of the SD was noted yesno Reducing the dose of SD (indicate by how much): Was there a resumption of SR after reducing the dose of SD yesno Correction of SR yesno Cancellation of concomitant drugs (indicate which) Drug therapy for SE (specify drugs, dose rate, duration of administration) VI. CAUSAL RELATIONSHIP BETWEEN CLINICAL MANIFESTATIONS OF SE AND SD Causal relationship between clinical manifestations of SE and SD certainprobablepossibledoubtfulnot subject to classification Full name of the notifier, phone / fax Name and location of the medical institution Assignment date SE- side effects SR-side reaction LE- lack of effectiveness SD-suspected drug
