Drug safety monitoring
It is known, that the medicines developed for treatment of diseases, have also side effects, sometimes dangerous for life. There are no absolutely safe medicines! Moreover, the use of medicines in a wide exposition may cause various adverse reactions of drugs (ADR) which were not registered during clinical trials because of the limited quota of the patients. Revealing, registration and analysis of the ADR (Pharmacovigilance) are necessary for the subsequent specification of the drugs' indications, contra-indications, side effects, dosages, etc.
According to the Article 17 of the RA Law “On Drugs” “Health care institutions, drugstores, institutions and the organizations which are consuming and using medicines, are obliged to inform the authorized governmental body about all cases of development of unknown adverse reactions immediately”.
According to the order of the Ministry of Health, which is an authorized governmental body, ADR monitoring in RA is carried out by the Scientific Centre of Drug and Medical Technologies Expertise, which has been a member of the WHO International Program of the ADR Monitoring (Uppsala, Sweden) since 1997.
For the purpose of ADR monitoring and according to the international recommendations, the Report Form for ADR registration has been developed at the centre, and it is being actively spread among the workers of public health services.
- The Report Form is very easy for filling in, because of the use of “Yes/No” type of questions. It minimizes the time used on the Report Form filling.
- The personal information kept in the Report Form is confidential.
- As it follows from its name the Report Form concerns not only the “clear” adverse drug reaction, but also the manufacturing problem.
- The Report Form is being publicized in three languages and may be filled in in Armenian, Russian and English.
- The physician may even include non-evident or not complete information in the Report Form.
The Report Form has four sections:
A. INFORMATION ABOUT PATIENT.
This section includes the personal information of the patient: - Name, surname (may be encoded in purpose of keeping confidentiality)
- Age or date of birth
- Sex
- Weight
B. ADVERSE DRUG REACTION OR MANUFACTURING PROBLEM
This section is for the description of the adverse drug reaction or manufacturing problem and includes the following information: - Marking of adverse reaction or manufacturing problem
- Date of event
- Date of report
- Motivation for sending the report (death, life-threatening, hospitalization, disability, congenital anomaly, other)
- Description of adverse reaction or manufacturing problem
- Used diagnostic methods
- Short description and peculiarities of the disease
C. SUSPECTED DRUG(S)
This section is for pointing out the suspected drug or drugs that are related to the adverse reactions. The section includes the following information: - Name, drug form, manufacturer, batch
- Dose
- Indications for use
- Duration
D. INFORMATION ABOUT REPORTER
This information has to be introduced completely, in case it is necessary to contact the reporter for getting detailed data of the case. The section includes the following information: - Name, address, phone
- Profession
Occupation
The Report Form also contains the address of the recipient, as well as the fax and telephone number for emergency messages.
You will help thousands of patients, if you do just a single simple thing: inform us about the suspected adverse drug reactions…
HOT LINE: (+374 10) 20-05-05, (+374 96) 22-05-05
