Transcript Title: The Dilemma of Diclofenac Injection for the

The Dilemma of Diclofenac Injection
for the Iranian Health System
Authors: Shalviri G, Cheraghali M, Gholami K,
Kamali E, Daryabari N
Institution:
Ministry of Health and Medical Education
Under-secretary for Food and Drug
Research & Development Office
Iranian Pharmacovigilance Center
Abstract
• Problem Statement: A very high prescription rate of injectables is the most
pronounced indication of irrational drug use in Iran. The Iranian Adverse
Drug Reaction Monitoring Center received 6 reports of sciatic nerve damage
following intramuscular injection of diclofenac sodium, in June 1998, and by
the end of year the number of reports increased to more than 100. Since the
reaction was a new and previously unknown ADR, the intervention of the
Center was necessary to prevent further ADRs.
• Objective: To assess the efficacy of different types of interventions to
prevent further ADRs due to intramuscular injection of diclofenac sodium.
• Design: Before/after study with no control group.
• Setting and Population: All ADR reports received by the Iranian ADR
Monitoring Center describing sciatic nerve damage induced by intramuscular
injection of diclofenac sodium, from June 1998 to June 1999.
• Intervention: Communicating with health professionals, implementing
restrictions on local production and on availability.
• Outcome Measures: Trend of injectable diclofenac usage and the ADRs.
• Results: The total quantity of diclofenac sodium used has decreased from
85 million to 60 million ampoules. The number of ADR reports received
shows an obvious reduction after intervention.
• Conclusions: In order to reduce use of diclofenac injection, a multifactorial
intervention was necessary to enforce rational drug use in the country.
Study Aims
• To assess the efficacy of different types of
interventions including:
 communicating with health professionals
 implementing restrictions on local production
 Implementing restrictions on availability
on reduction of reported adverse drug reactions
induced by intramuscular injection of diclofenac
sodium.
Background & Setting
• The high prescription rate of medicines is
one of the most common reasons for
irrational drug use, in which :
misuse and overuse of injections
seems to have an special importance
because of high rate of
adverse events
Methods
• All ADR reports received by Iranian
Pharmacovigilance Center describing
walking difficulty following intramuscular
injection of diclofenac sodium from 1996 to
2003 were assessed.
• The number of ampoules used per year was
determined based on the sale statistics.
• The trend of yearly diclofenac usage and
ADR reports were analyzed before and after
different interventions.
Results
• A total number of 161 ADRs describing walking
difficulties following intramuscular injection of
diclofenac sodium were reported to Iranian
Pharmacovigilance Center from 1996 to 2003.
• The sciatic nerve damage induced by
intramuscular injection of diclofenac sodium was
a new serious reaction not included in the
labeling of the product.
The trend of reported ADRs
Before & After First
Intervention:
First Intervention:
Alerting Letters to Health Professionals
Result:
The total number of ADRs reduced from
63 in 1998 to 39 in 1999.
The trend of reported ADRs
Before & After Second
Intervention:
Second intervention:
Discontinuing local production and distributing
Voltaren®.
Result:
There was no obvious reduction in the
reported ADRs regarding the estimated rate
for the reaction.
The trend of reported ADRs
Before & After Third
Intervention:
Third Intervention:
Changing drug use protocol and restrictions to
availability
Result:
Obvious Reduction in the number of reported
ADRs from 30 in 2001 to 18 in 2002.
Diclofenac Sodium induced Nerve Damage
and number of ampules used per year Vs
interventions
Geographical distribution of ADR
reports describing sciatic nerve
damage induced by diclofenac sodium
in Iran.
Discussion
The Interventions of the Pharmacovigilance
center was effective in preventing sciatic nerve
damage induced by diclofenac sodium.
Issuing Alerting letters to health professionals in
combination with restriction of diclofenac
usage to hospitals led to significant reduction
in irrational prescribing of this product and
finally overcome to this serious ADR.
Conclusion &
Recommendations
Different kinds of interventions including
educational communication with health
professionals and appropriate regulatory
changes in drug availability, are
necessary to promote rational drug use
in the country which will result in
reducing drug safety related morbidity
and mortality.