Lecture about THE IRAQI PHARMACOVIGILANCE SYSTEM (IPhvC) based on the guidelines published by the Iraqi ministry of health

1. Alaa Fadhel Hassan (MSc. Pharm.)

2. Pharmacovigilance (PV) is defined as the science and
activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
drug-related problem.
WHO established its Programme for International Drug
Monitoring in response to the thalidomide disaster detected
in 1961. Later with WHO Collaborating Centre for
International Drug Monitoring, Uppsala; promotes PV at the
country level. At the end of 2010, 134 countries were part of
the Programme.

3. Iraqi pharmacovigilance center deal with any serious
adverse drugs events (ADRs), decrease or lack of
effectiveness , any medication errors.
The Iraqi Pharmacovigilance center (IPhvC) has been
established in the directorate of technical affairs
(DTA), Ministry of Health to be responsible for the
collection and evaluation of information on
pharmaceutical products marketed in Iraq with
particular reference to adverse reactions.

4.  Type A: Augmented pharmacologic effects - dose dependent and predictable
(medicine actions).
 Type B: Bizarre effects (idiosyncratic) - dose independent and unpredictable
(Patient reactions), characteristically occur in only a minority of patients
and display little or no dose relationship.
 Type C: Chronic effects refer to situations where the use of a medicine,
often for unknown reasons, increases the frequency of a "spontaneous"
disease. They may be both serious and common (and include malignant
tumors).
 Type D: Delayed effects (dose independent) Carcinogenicity (e.g.,
immunosuppressants) Teratogenicity (e.g., fetal hydantoin syndrome).
 Type E: End-of-treatment effects & Type F:Failure of therapy.

5.  Enhance pt. Rational and safe use of medicines.
 The assessment and communication of the risks and benefits
of drugs on the market, to support public health programmes.
 To Detect problems related to the medicines and communicate
the findings in a timely manner, that lead to the prevention of
harm and maximization of benefits.
 Promote understanding, education and clinical training in
Pharmacovigilance and its effective communication to the public.

6. ADRs have been shown to rank among the top 10
leading causes of mortality in some countries despite
the fact that most of the ADRs are preventable.
Suitable services to treat ADRs impose a high
financial burden on health care due to the hospital
care of patients with drug related problems.
Safety and efficacy surveillance of medicines has not
received the required attention.

7.  All health care professionals/workers, including clinicians,
pharmacists, dentists, nurses, traditional medicine practitioners.
 Marketing authorization holder, being primarily responsible for
the safety of their products, they are obligated to report serious
adverse drug reactions they receive about their Products to
IPvC. While the Non-serious ADRs should be included in the
periodic safety update report.
 The adverse drug reaction report does not constitute an
admission that you or any other health professional or the drug
contributed to or caused the event in any way.

8.  The 4 basic components that make a report reliable:
An identifiable pt.
An identifiable health-care professional.
An identifiable Adverse reaction or product problem.
An identifiable medicine (suspected).
 Reporting:
By website link https://primaryreporting.who-
umc.org/Reporting/Reporter?OrganizationID=IQ
By individual case sheet reports available at hospital.

11. Serious reports should be submitted in expedited
manner i.e as soon as possible & no later than 15
calendar days (best 5 calendar days).
Death repots should be submitted no later than 3 calendar
days.
Other reports could be submitted monthly (30 calendar
days).

12.  New medicines: all suspected ADRs including minor ones for 5 years
regardless the nature and intensity.
 Established medicines: all the serious ADRs including (rare/ unexpected/ fatal
or life-threatening/ permanently/ significantly disabling/ required or prolong
hospitalization/& cause a congenital anomaly).
 If an increased frequency of a given reaction is suspected.
 All suspected ADRs associated with drug-drug, drug-food/ food supplements
(including herbal and complementary products) interactions.
 ADRs occurring from overdose/medicine abuse/ medication error/ medicine
withdrawals/& medicine use in pregnancy and during lactation.
 In children under the age of 18, all suspected ADRs regardless of whether the
medicine is licensed for use in children.

13.  Submitted reports will be entered into the national database of adverse drug
reactions and be analyzed by expert reviewers regularly.
 Well - completed and duly submitted ADR reported by you may result in:
(additional investigations into the use of the medicine/ appropriate changes in
the package insert/ change the schedule of the medicine/enhancing educational
initiatives to improve the safe use of that medicine/ Other regulatory and
health promotion interventions as the situation may warrant including
withdrawal or recall).
 Report details’ are stored in a confidential database at the Iraqi
pharmacovigilance center and the analyzed report will be sent to the
Uppsala Monitoring Center (UMC).

14. SO WHEN YOU SEE ADR
TELL ME
CALL ME
SEND EMAIL
WHENEVER YOU CAN

15.  WORLD HEALTH ORGANIZATION WEBSITE, ESSENTIAL MEDICINES AND
HEALTH PRODUCTS. LINK:
HTTPS://WWW.WHO.INT/MEDICINES/AREAS/QUALITY_SAFETY/SAFETY_E
FFICACY/PHARMVIGI/EN/
 IRAQI MINISTRY OF HEALTH, GUIDELINES FOR THE IRAQI
PHARMACOVIGILANCE SYSTEM (IPHVC) INDIVIDUAL CASE SAFTEY
REPORT (ICSR) FOR HEALTH CARE PROFESSIONALS. EDITION 2012.