The document outlines the objectives and tasks of pharmacovigilance, emphasizing the importance of monitoring medications post-marketing, assessing product quality, and evaluating side effects. It details the responsibilities of national pharmacovigilance centers, including data collection, communication with authorities, and training programs. Furthermore, it highlights the need for collaboration with medical professionals, the establishment of advisory committees, and the integration of pharmacovigilance with poison control centers to enhance drug safety and reporting systems.

1. Objectives and tasks of
the pharmacovigilan

2. Objectives and tasks of the pharmacovigilan
• Follow up on medicines after they are marketed
• A continuous evaluation of the quality of the
preparations
• Detection and evaluation of side effects
• Follow up on news from international bodies and
organizations and make decisions

3. Tasks of the National Center for Pharmacovigilance
1-Follow-up of medicines after marketing.
2-Follow-up on product quality reports.
3-Detection and evaluation of side effects.
4-Receiving communications.
5-Create a database of related parties.
6- Follow-up on news from bodies and organizations.
7-Make appropriate recommendations regarding the
safety of the preparations.
8-Communicate with the relevant authorities.
9-Preparing annual reports on all the center's activities.
10-Preparing and following-up training programs to carry
out the tasks of the center.

4. Uppsala Center has developed rules for the establishment
and establishment of pharmacovigilance centers and
published them in a booklet issued by the Center, in which
he explained the basic steps and what is required for the
establishment of the center. The following summarizes the
most important contents:

5. 1-Establishing relationships with the concerned
medical and pharmaceutical authorities, and the
colleges of medicine and pharmacy.
2-Design a form to write a report on the adverse
effects of drugs.
3-Producing publications to educate and inform
workers in the health and pharmaceutical sector about
the definition and objectives of pharmacovigilance and
the role of its centers.
4-Establishment of a center equipped with
qualifiedhealth professionals, a headquarters, a
telephone and a computer
connected to the international network of the Internet.
5-Begin teaching pharmacovigilance specialists the
following procedures :
•data collection and reports.
•Evaluation and coding of adverse effects of drugs.
•Coding of medicines.
•Evaluation of the causal relationship to the AE of the
drug.
•Detection of primary indications between drugs and
side effects.
•Managing dangerous factors and taking action against
them, or
providing scientific advice to the competent
authorities.
6- Create a database.
7-Organizing meetings in hospitals, colleges and
organizations.
8-Promote the importance of disclosing the adverse
effects of drugs through medical journals and
pamphlets.

6. Practical applications for organizing
the Pharmacovigilance Center
1-EMPLOYEES
Desirable experiences in the Pharmacovigilance Center include:
A-Clinical Medicine
B- Epidemiology.
C- To have a medical background
In any case, a new center for pharmacovigilance often begins with a part-time expert,
often a doctor or pharmacist, and some secretarial support. It may later become
necessary to have one expert responsible for pharmacovigilance for most of his time,
and to expand the scope of the secretariat’s work when cases of drug reporting
increase. Harmful to med
ications
2-EQUIPMENT
. MULTI-LINK TELEPHONE.
. Computer (database see 701 Word processor).
. Printer (connected to the computer).
. Databases.
. A special website on the web page.
. Fax.
. E-mail.
. Document copying machine.
CONTINUITY OF COMMUNICATION AND SERVICE IS AN ESSENTIAL
CHARACTERISTIC OF A SUCCESSFUL PHARMACOVIGILANCE CENTER,
WHICH IS WHY THE CENTER NEEDS A PERMANENT SECRETARIAT FOR
PHONE CALLS AND E-MAILS AND MAINTAINING A STABLE BASE.
Data, documenting references, coordinating activities...etc.
Secretarial continuity can be achieved through cooperation with
the relevant departments to provide them with sufficient
capacity.
3-CONTINUITY

7. Practical applications for organizing
the Pharmacovigilance Center
4-ADVISORY COMMITTEES
The presence of a multidisciplinary advisory committee is desirable to
support the Pharmacovigilance Center with regard to the quality of the
following processes:
• Collect and evaluate data.
. Data interpretation.
. Disseminate information.
Any advisory committee may represent the following disciplines:
General Medicine.
Pharmaceuticals.
Clinical pharmacology.
Epidemics science.
Pathology.
Pharmaceutical regulation and quality assurance.
Drug information.
Herbal pharmacology.
5- INFORMATION SERVICE.
Providing high-quality information to serve health care workers is
an essential duty of the Pharmacovigilance Center and a key tool
in stimulating reporting of adverse drug effects.
For this purpose and to evaluate case reports, the center must
have access to a comprehensive and up-to-date reference
database. One of the advantages of the center being located in a
large hospital is easy access to the library.
It can be linked electronically to a number of websites, such as
the Uppsala database, and to the websites of drug bulletins and
adverse drug effects bulletins issued by the World Health
Organization.
Issuing a flyer or newsletter distributed to all healthcare professionals or writing a column in a medical or pharmaceutical journal are
good ways to disseminate information.
In urgent cases, letters to a health professional can do the job. They are sent by pharmaceutical companies to health professionals to
make them aware of a specific danger and warn of it.
Poison control and drug information centers.
The Pharmacovigilance Center and the Poison Control and Drug Information Centers have things in common in organization, form and
scientific point of view.
If pharmacovigilance is initiated in a country where there are centers for poisons and drug information, it is sufficient for the
pharmacovigilance system to be linked to these centers and expensive equipment can be shared, such as
Secretarial costs, computer costs, library service, and in any case cooperation between these centers is desirable.
3-CONTINUITY

8. Evaluation of case reports
The evaluation of case reports of adverse drug effects requires
combined expertise in the branches of medicine, clinical
pharmacology, pharmacovigilance, and epidemiology.
should be known The following items To evaluate case reports:
1- Documentation quality:
A)-Completeness and integrity of the data
B)-Diagnostic quality and
follow-up.
C)- List of essential elements of case reports Encoding
(encoding)
D)-Drug names should be recorded in a systematic manner.
2-Link
To discover about A new side effect should be asked about following :
A- A new drug
as products that are less than five years old.
B-Unknown effects.
It is important to know if it is enough The effect has been described in scientific references such as
the Medication Guide, Marthandale, and Mylars Side Effects of the Drug).
You can ask the Uppsala Center for books or other sources of information
C- Serious effects

9. University education and continuing higher education of health professionals are important for issues of
Pharmacovigilance
Therefore, special materials related to the concept of Pharmacovigilance should be included in
College health programs.
Appropriate educational activities can improve knowledge such as awareness
As an incentive to report adverse effected
Education

10. * Usually case reports about the suspected effects of drugs can be influenced by all kinds of bias.
Pharmacovigilance data may be difficult to interpret.
* Signals may be unsupported by evidence and require a lot of study to confirm or refute ( the test hypothesis) and to assess
the frequency of a particular adverse effect and the need to make a regulatory decision.
* The pharmacovigilance Center has a duty to stimulate the use of data and ensure attention.
* The spontaneous reporting system is useful in detecting adverse effects that are limited and occur at the time of taking the
drug (anaphylactic shock), but it is useful in studying other types of adverse effects( cancer progression).
* Confidentiality of personal data is required ,complex details of the patient can form their own fingerprints.
* The identity of all individuals(patient, reporter, health specialist) and institutions (professional hospitals) must be kept
confidential.
* A legal obligation, because if the pharmacovigilance data is against the whistleblower, the system will co
llapse.
use data recording Restrictions: restrictions
regarding the use of data

11. 1-the competent authorities of medicines: in the country they must be informed without delay about the responses
The harmful effects of drugs and their danger.
2-local pharmaceutical companies and authorized agents of international companies should be informed about
Reactions that occur due to the use of medications or should be notified through the relevant authorities
Medicine in the country.
3-medical and pharmaceutical faculties and professional organizations should support these centers and strengthen
their role.
4-any new pharmacovigilance Center in a particular country should be linked to the WHO adverse effects monitoring
center in Uppsala, Sweden; to request technical and scientific support and exchange information and fame.
5-association with scientific academic research centers in the country.
٦-the relationship with the press, media organs and Consumer Protection Associations
Relation with other partners:relationship with
other partners