Adverse drug reactions ppt and reporting of such reactions

Adverse drug reactions ppt

1. SERIOUS ADVERSE DRUG REACTION
reporting

2. ADVERSE DRUG EVENT (ADE)
Any untoward occurrence that may present during
medical treatment,
But
Does not necessarily have a causal relationship with
the treatment

3. GRADING OF SEVERITY OF ADVERSE DRUG REACTIONS :
Minor : No therapy, antidote or prolongation of
hospitalization is required.
Moderate: Requires change in drug therapy, specific
treatment or prolongs hospital stay.
Severe: Potentially life-threatening, causes permanent
damage or requires intensive medical treatment.
Lethal : Directly or indirectly contributes to death of the
patient.

4. PHARMACOVIGILANCE (DAUP) WHO DEFINES
The 'science and activities relating to the detection,
assessment, understanding and prevention of adverse
effects or any other drug related problems’
The information generated is useful in educating doctors and
in the official regulation of drug use.
It has an important role in rational use of medicines, as it
provides the basis for assessing safety of medicines.
India joined WHO in 1998
Ministry of health and family welfare, Govt of India has
initiated a nation wide Pharmacovigilance programme for
protecting health of patients by assuring drug safety in 2010

6. SERIOUS ADVERSE EVENT
•Serious Adverse Event (SAE):
•Any adverse event that:
•Results in death
•Is life threatening, or places the participant at
immediate risk of death from the event as it
occurred
•Requires or prolongs hospitalization
•Causes persistent or significant disability or
incapacity
•Results in congenital anomalies or birth defects
•Is another condition which investigators judge to
represent significant hazards

12. ADR reporting
•Adverse Events, Serious Adverse Events, and
Unanticipated Problems have specific reporting
procedures.
•Adverse Event Reporting
•All AEs are collected on an Adverse Event Form,
either in paper or electronic format. All AEs
experienced by the participant during the time
frame specified in the protocol (e.g., from the
start of intervention through the end of the
study) are to be reported, as outlined in the
protocol. The reporting requirements to the IRB,
to the CDSCO and to the FDA (in case of drug and
device studies) may differ and must be complied
with

13. •All SAEs, unless otherwise specified in the protocol and
approved by the IRB and CDSCO (as applicable),
require expedited reporting by the Principal
Investigator to the study's safety monitoring bodies.
An expedited report of an SAE can be submitted by
telephone, fax, or email and must be reported to the
independent safety monitoring body (i.e., Safety
Officer) and the NIA within 24 hours of the event being
reported to the Investigator or as specified in the
protocol.
• CDSCO – Central Drugs Standard Control Organization.

14. •The expedited report should be followed by a
detailed, written SAE report as soon as possible.
Follow up information may be required and
asked for by the independent safety monitoring
body directly, or through its representative.
•Site principal investigators, who confirmed that
SAEs occurred in their trial are required to
report the SAEs to CDSCO and also their trial
sponsor and ethics committees.

16. Process flow for SAE reporting
•After obtaining Clinical trial no objection certificate
and registering at Clinical trials registry India ( CTRI ),
the sponsor may initiate the trial and shall monitor the
clinical trial in all the participating sites.
•To report SAE on SUGAM portal , sponsor shall
mandatory follow the below mentioned steps to build
up the database and for proper linking of data
•Add site investigator
•Site investigator mapping
•Initiate clinical trial

17. •SAE reported
•
•To report serious adverse event there are
three types of forms
•SAE reporting (24 hour report by PI )
•SAE reporting (14
th
day due analysis by PI & S )
•SAE reporting (30 th day report by EC )

25. •PHARMACOVIGILNCE SOFTWARE

30. •The Uppsala Monitoring Centre (Sweden) is the international
collaborating centre.
•In India,
–National centre is located at Ghaziabad
–Peripheral Centres at Medical college levels and tertiary and
above hospitals
–Reports generated by doctors, paramedical staff--to peripheral
centre...National centre...Uppsala Monitoring
Centre...Compilation of data..analysis of data..causal association is
confirmed..guidelines issued regarding the safe use of medicine or
(restricted use or withdrawal from the market)

31. PREVENTION OF ADVERSE EFFECTS TO DRUGS
•Avoid inappropriate use of drugs .
•Appropriate drug administration (Rational Therapeutics)
–Dose
–Dosage form
–Duration
–Route
–Frequency
–Technique
• Ask for previous history of drug reactions and allergies
•Always suspect ADR when new symptom arises after
initiation of treatment. ( No new drug for new symptom).
•Ask for laboratory findings like serum creatinine etc.

32. ThanksThanks