Pharmacovigilance improvement and Adverse Drug Reaction Reporting in Iran. By : AMIRMASOUD NIKAHD M.D.

Transcription

1 Pharmacovigilance improvement and Adverse Drug Reaction Reporting in Iran By : AMIRMASOUD NIKAHD M.D.

2 Abstract ADRs are important since they could be life-threatening and also can negatively affect quality of life. Iranian Adverse Drug Reaction Monitoring Center established in 1997 and despite sending documents, posters, pamphlets of IADRMC since 2004, there was not any increase to ADR reporting After 2007,reporting increased, but not satisfactory ( less than half of Good Reporting Rate ) Nurses participated more compared with GPs, Pharmacists, etc and 73.9% of ADRs were Injectable drugs Key words: IADRMC= Iranian Adverse Drug Reaction Monitoring Center ADR= Adverse Drug Reaction

3 Introduction Impacts of ADRs : Could be life-threatening Negatively affect quality of life Impose large costs Number of deaths caused by ADR more than deaths caused by highway accidents and breast cancer

4 Introduction ( cont. ) Pharmacovigilance : Detection Assessment Understanding Prevention of ADRs

5 IADRMC Iranian Adverse Drug Reaction Monitoring Center Established 1997 Comparison when there is intervention in ADR reporting by Clinical Pharmacists

6 Analyzed factors Affected systems / organs Implemented drugs Level of participation in healthcare providers

7 Methods Establishment of pharmacovigilance commettee in all hospitals of Mazandaran Province : 1- Manager of the hospital 2- Two specialist physicians 3- Nursing supervisor Workshops for training Official announcement to all hospitals Weekly meetings

8 Methods ( cont. ) Original Yellow cards sent to IADRMC Copy kept for pharmacovigilance office Primary goal : to assess the impact of abovementioned interventions on the rate of reporting Before 2007 ( 2004 to 2006 ) After 2007 ( 2007 to 2010 )

9 Frequency of ADR TO 2010 Number Year Frequency Percentage Unknown 45 5 total

10 Description for table yellow card completed Only 38 ADR during 2004 to 2006 Most cases in 2010 ( 237 ) Followed by 2009 ( 229 ) and 2007 ( 162 ) P-value =<0.001

11 Frequency of ADR / Rout of Administration Number Rout Frequency Percentage 1 Injection Oral Injection & Oral Topical Respiratory Intraspinal Rectal Ophthalmic Total

12 Description for table 2 Most ADRs were by Injectable drugs ( 74%) Followed by Oral drugs ( 21% ) Injectable + Oral collectively = 95% Least common rout for ADR = Ophthalmic P-value =<0.001

13 System/Organ affected by ADR Number Organ/System Frequency Percentage 1 Dermatologic General Respiratory GI CNS Injection site Cardiac others Total

14 Description for table 3 Dermatologics like rash, hair loss, itching, urticaria General like fever, chills, weakness, edema Skin Reactions were most common ( 40 %) Followed by General, Respiratory, GI and Injection site Least common ADR... Sexual dysfunction (0.1%)

15 Frequency of the most Serious ADR Number Serious ADR Drug Frequency Percent 1 Anaphylactic Ceftriaxone Penicillin Cardiac Arrest Adenosin Ceftriaxone Severe Necrosis Diclofenac Valproate Seizure Imipenem Tramadole Ciprofloxacin Anaphylaxy & Cardiac Arrest Ceftriaxone Cardiac Arrest & Seizure Ceftriaxone 2 5 Total

16 Description for table 4 Total number of SAE : 41 out of 793 The most common serious adverse event were Anaphylactic shock, Cardiopulmunary Arrest,severe necrosis and Seizure. The most common life-threatening ADR were due to ceftriaxone, Penicillin, Diclofenac and Ciprofloxacin

17 Frequency of reports 2004 to 2007 Reports Nurses GPs C-Pharmacists Specialists Reports

18 Discussion Most striking finding was improvement of ADR reporting after establishment of : Pharmacovigilance commettee in the hospitals Despite sending pamphlets, posters and documents of IADRMC since 2004 the number of ADRs was very low during 2004 to 2007

19 Discussion ( cont.) Despite sending documents, posters, pamphlets of IADRMC since 2004, there was not any increase to ADR reporting After 2007, increase, but not satisfactory ( less than half of Good Reporting Rate ) WHO : 200 ADR reporting per 1 million people per year

20 Discussion ( cont. ) Nurses participated more compared with GPs, Pharmacists, etc. Probable reasons : 1- Their role in drug administration 2- Close contact with patients 3- Close contact with physicians

21 Discussion ( cont. ) 73.9% of ADRs = Injectable drugs Considerations : 1- Not necessarily more effective than oral 2- Avoid unnecessary injections 3- Higher cost 4- Difficulty in managing ADRs

22 THANK YOU