Drug safety
DIRECTIONS FOR FORM COMPLETION
By completing this form, You can report all alleged ADR encountered during the use of the medicinal products of our company.
Please, do not hesitate to submit this form if you consider that you have observed or suffered an adverse drug reaction during treatment with any of our products.
Upon receipt of the report, we shall promptly contact You for additional information.
You should be aware that this document is confidential! The information from the reports will be handled in a strictly confidential manner and the personal details of the patient will not be reported under any circumstances.
We will be grateful for all reports submitted by physicians, dentists, pharmacists and other medical professionals.
Patients who think that they have suffered adverse drug reactions from the medicines they take, can also complete and submit this form. Please, be informed that the data and information contained in the form shall subsequently be confirmed by the respective doctor or GP.
In order for the report to be valid, please complete the mandatory cells marked //, as follows:
Patient – initials, age and sex (at least one cell must be completed). This information is vital for the adequate assessment and follow-up, as well as for avoiding redundant reports.
Adverse drug reaction – please, describe briefly the reaction (complaints), its beginning and end (state the date, month and year in the following format (dd/mm/yyyy) and the outcome of the reaction by ticking one of the options. There is a cell where you can supply additional information which you consider relevant or necessary.
Alleged medicinal product – please, record the name of the alleged medicinal product and if possible, its batch number, directions for use and dose and beginning and end of intake. In case you are on more than one medication but you suspect only one of them for the adverse reaction, complete the above only for that medicinal product. The other suspected medicinal products report under Other alleged medicinal products.
Other, non-alleged medicinal products – please, list all medicinal products you are currently using.
Data on reporting person – these data are necessary for the report to be considered authentic, as well as for feedback purposes, including confirmation of its receipt and for requesting additional information as necessary.
24-hour contact and reporting details:
Qualified Person on adverse drug reactions of Antibiotic-Razgrad AD
Master of Pharmacy Diana Pavlova
Tel. 084 613 427
Mobile 0888 49 80 65
E-mail: dpavlova@antibiotic.bg;