Islamic Republic of Iran
Ministry of Health and Medical Education
Food and Drug Organization
Title: Regulations for pharmacovigilance
Type:
√ Finalized
Draft
No.: D/655/1365
Date of Issue: 2010/01/11
Document No.:
Name of Office: ADR,Deputy for Drug
These instructions have been formulated with regard to the importance of reporting adverse effects
of the medicine and its outstanding role in reducing mortality rate caused by problems of
pharmaceutical products.
17-89-1 - Definitions
1 - Pharmacovigilance: is the pharmacological science and activities relating to the detection,
assessment, reporting and prevention of adverse effects of pharmaceutical drug or any other
problems associated with the drug. This knowledge is called pharmacovigilance.
2 - Adverse Drug Reaction (ADR) /Adverse Reaction / Drug Reaction: adverse drug
reaction, adverse reaction, and drug reaction are synonymous with each other. An Adverse Drug
Reaction is a harmful and adverse drug reaction that is associated with the use of given medications
at a normal dosage for prevention, diagnosis or treatment of the disease or change in physiological
function.
3 – Adverse Event or Adverse Experience (event or experience): is an unpleasant
experience that occurs subsequent to prescription of a pharmaceutical product. An unwanted event
has not necessarily casual relations with the drug.
4 - Medication errors: is any preventable medication related event that may cause or lead to
patient harm due to unpleasantly taking of the drug. Medication errors could be related to the
performance of medical practitioners, pharmaceutical products, systems and processes, including
prescribing, order communication, labeling, packaging, nomenclature, compounding, dispensing,
distribution, administration, education, monitoring and use.
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5 - Unexpected medical adverse drug reaction: is an evolution of a disease which is not
specifically mentioned in the guide sheet as an unwanted dubious symptom. The definition includes
every medical adverse drug reaction that is not compatible with the nature, severity or outcome of
the materials mentioned in the guide sheet. Also, this definition includes adverse drug reactions that
have been mentioned in the guide sheet and may with the respective drug category but has not
been specifically mentioned that it would occur which this product as well. Also it includes adverse
drug reactions that have been mentioned in the guide sheet of the product, but it has been noted
that there are no evidence available on the causality relation in this regard.
6 - Voluntary report: refers to any contact with the pharmaceutical plant, medical authorities or
other organizations that describe occurrence of a medical adverse drug reaction in a patient after
taking one or more medicinal products which has not been originated from a study case.
7- Post-registration Study: a post-registration study refers to any type of study that is
conducted after the medicine enters the market and is compatible with the conditions mentioned in
the guide sheet of the product and under normal conditions of use.
8 - Serious adverse drug reaction: is an adverse drug reaction that leads to one of the following
adverse happenings:
• Death
• Threatening life
• Disability or specific and permanent maiming
• Hospitalization
• prolonged hospitalization
• Also, serious adverse drug reactions, including congenital malformations and serious clinical
consequences resulting from drug use in circumstances other than those mentioned in guide sheet
of the product (for example overdose than the level recommended in the guide sheet) or abuse of
the medicine.
In other cases medical judgments should be made in order to specify whether a adverse drug
reaction should be considered as serious or not. Important adverse drug reactions that are not
immediately led to death or are not life threatening or do not lead to hospitalization, but have put
the patient at the risk of death are considered as serious.
17-89-2 - Minimum information reportable for drug adverse drug reactions include:
A) detectable reporter:
The reporter is detectable by name and surname, address or occupation (doctor, dentist,
pharmacist, nurse, and consumer). Note that these are the minimum acceptable data
required internationally with regard to a report. Pharmaceutical plants are expected to
provide more details in this regard.
B) Detectable patients:
Patients afflicted with adverse drug reactions are detectable by name and surname, date of
birth (or age in cases with unknown date of birth or approximate age in cases where date of
birth are both unknown), or gender. Of course, the information should be complete as much
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as possible.
C) At least one drug / substance being suspected of causing adverse drug reactions
D) At least one suspected adverse drug reaction
This minimum information, is the least information required to prepare and send the report,
but it should be noted that the pharmaceutical plant is bound to make its utmost efforts to
obtain the complementary information in this regard and send it. When information
concerning a serious adverse drug reaction is reported directly by a patient (or a relative) to
the pharmaceutical plant, the plant is obliged to make efforts to collect other relevant
information from the medical group involved in the treatment of the patient. It should be
noted that this should not cause delay in sending the initial report.
17-89-3 – Regulations for reporting medical adverse drug reactions to the Center for
Registration and Study of Adverse Drug Reaction (ADR) by producing or importing
pharmaceutical plants
1 - Duties and responsibilities of plants producing or importing medicines
A – Pharmaceutical plants producing or importing drugs are obliged to develop mechanisms
appropriate for following up adverse drug reactions in the market and send relevant report to
the Center for Registration and Study of Adverse Drug Reaction (ADR)
B – Each pharmaceutical plant producing or importing drugs, in order to abide by its
commitments before registered products, is bound to be equipped with proper system in the
field of pharmacovigilance and is obliged to employ appropriate and necessary measures in
dealing with medical problems when it is necessary.
C - Pharmaceutical plants producing or importing drugs are obliged to introduce a responsible
and trained person to the Center for Registration and Study of Adverse Drug Reaction of Iran.
The person in question should have all the required information in all aspects of
pharmacovigilance to such an extent that he/she could be capable of evaluating drug reactions,
special drug safety regulations and benefits and harms to pharmaceutical products of the
relevant pharmaceutical plant available in the Iranian drug market.
D – Person in charge of pharmacovigilance affairs at pharmaceutical plants producing or
importing drugs has the following responsibilities:
1 - Developing and maintaining an appropriate system for the collection and registration of
information related to all drug reactions that are sent to the relevant plant through different
ways.
2 – Conducting required coordination for preparing and submitting reports collected on drug
reaction to ADR Center of Iran.
3 – Responding completely and rapidly to any questions raised by the Center for Registration
and study of Adverse Drug Reaction in line with gaining access to the information required for
evaluation of the submitted reports.
E - In cases where the pharmaceutical plant in any way, or any other real or legal entity is in
charge of manufacturing the drug or other interference in the process of manufacturing or
supplying the drug, ultimately holder of the license for product and importation of drug is
responsible for reporting on the adverse drug reaction caused by using the drug.
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F - When a number of pharmaceutical plants that share similarities for a pharmaceutical product
in all its properties except for its name have received separate production or importation
licenses, each pharmaceutical plant would be responsible with regard to regulations relevant to
pharmacovigilance of its own product.
2 - Reporting drug reaction
Reports on drug reactions which have been received from all sources including medical
professions and the consumers should be forwarded to the Center for Registration and study of
Adverse Drug Reaction of Iran. Suspected adverse drug reactions which have been reported
through voluntary reporting system, suspected adverse drug reactions which have been
identified through post-marketing studies and cases that have been published in scientific
resources in the world, are subject to this act.
Voluntary reports of suspected adverse drug reactions which have been reported to the
pharmaceutical plant should be forwarded to the pharmacovigilance center, even if the
pharmaceutical plant does not agree with the assessment of the reporter over the causality
relation that has been performed, or the reporting person has not performed causality
assessment at all. Even if the pharmaceutical plant will be informed that the adverse drug
reactions are related to one of the products of the plant which have been directly reported to
ADR Center of Iran, the pharmaceutical plant is still obliged to report the drug reaction to the
ADR Center while it should also inform the Center that the case might have already been
reported. In such cases it is necessary that the pharmaceutical plant report all its details,
including any registration number that has been provided to the reporter by the ADR Center, to
the ADR Center to help identify the duplicate reporting.
In order to expedite the reporting process of adverse drug reactions, pharmaceutical plants are
recommended to initially prepare a report which contains the least required information and
submit it and later prepare their supplementary report including the details. Adverse drug
should be reported regardless of the method and type of using the drug suspected to cause
symptoms that may cause reactions, even if the drug has not been used in accordance with the
cases mentioned in the guidance sheet. All clinical data related to the adverse drug reaction
which have been specified for the pharmaceutical plant should be reported to the ADR Center.
A - Immediate reporting
Immediate reports include the following cases:
Cases which lead to death
Cases which threaten life
Cases leading to disability or to specific or permanent maiming
Cases leading to hospitalization
Cases leading to prolonged hospitalization
Cases leading to congenital malformations
Immediate reports should be reported immediately and in no case reporting should last longer
than seven days after the date of receiving the report. The time for the calculation of that seven
days for immediate reporting starts upon receiving the least information needed for submitting
a report on the adverse drug reactions by one or more of the following individuals:
- Every personnel of the pharmaceutical plant, including sales representatives
- The pharmacovigilance responsible person or any of his colleagues
In cases in which the suspected adverse drug reaction is published in scientific resources of the
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time would be calculated from the moment of awareness of each personnel with the publicized
subject matter.
The pharmaceutical plant is obliged to constantly collect, at least once a week, new subject
matters in this regard while searching in scientific sources and references through domestic and
foreign data banks.
B - How to submit voluntary reports of adverse drug reactions
The pharmaceutical plant is obliged to submit cases of adverse drug reactions to the Center for
Registration and study of Adverse Drug Reaction of Iran in the following order:
1 – Serious unexpected adverse drug reactions as well as serious expected adverse drug
reactions that occur in Iran should be reported immediately. Pharmaceutical plants are not
required to immediately report on adverse drug reactions that occur abroad.
2 – Pharmaceutical plants are obliged to report following cases to ADR Center within a week:
- Specified safety issues that have been identified by the pharmaceutical plant as a result of
review and analysis of results of all data (including reported cases of adverse drug reactions
occurred abroad).
- Measures taken by legal foreign authorities in relation to pharmaceutical products together
with reasons for conducting such measures.
The starting point of one week is the moment when the pharmaceutical plant is informed, by
whatever means, of any safety issue associated with its drug.
The aforementioned safety issues usually include (not limited to) any subject about safety of
the product that has caused one of the following cases in whatever countries except for Iran:
Collection
or
suspension
of
access
to
the
product
- Adding contraindications, cautioning or warning statements to the guide sheet of the product,
reforming and changing safety reasons for a case of contraindications, cautioning or warning
statement in the guide sheet of the product.
Any suspicious increase in the abundance of serious adverse drug reactions should be reported
immediately. Grounds should be prepared for the assessment of abundance.
C – Reports on post-registration studies
Suspected serious adverse drug reactions that occur during post-registration studies in Iran and
are reported to the pharmaceutical plant, should be submitted to the ADR Center of Iran on the
basis of immediate reporting. In cases where the study has been conducted by an independent
researcher of the pharmaceutical plant, if an adverse drug reaction occurs the researcher is
obliged to report the case to the Center for Registration and study of Adverse Drug Reaction
but, if the pharmaceutical plant is informed of the study, it is obliged to report the case to the
ADR Center.
D - Contents of reports on suspected serious adverse drug reactions
The pharmaceutical plant is obliged to provide as much as possible complete data in relation to
cases of adverse drug reactions in an effort to facilitate possibility for the assessment. The
information should t be as complete as possible.
The minimum required information for a report are:
Patient profile including age, gender, name and family name
Profile of the reporter including age, gender, name and family name, and education
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Name of the suspected adverse drug reaction and name of at least one drug suspected of
causing the reaction
E – Reporting form
The reporting form acceptable by the ADR Center should be used. Each reporting form should
include the name, profession and address of the reporter. In cases where the reporter may
request his identity remain undisclosed to the ADR Center, the pharmaceutical plant is obliged
to provide maximum information about profession of the reporter and place where the report is
being prepared up to the extent which is compatible with the request of the reporter.
Each report should clearly contain the name and signature of the person who is responsible for
pharmacovigilance in the pharmaceutical plant and has already been introduced to the
Pharmacovigilance Center of Iran.
Mail address and contact numbers of Pharmacovigilance Center of Iran are as follows:
Mailing address: Tehran – P.O. Box 14185 - 948
Tel: 88923193-4
Fax: 88890857
E-mail: iadrnc@fdo.ir
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