PURPOSE
The purpose of this SOP is to describe the process for Receipt, Handling, Evaluation and reporting adverse events.
SCOPE
This procedure applies for the process required for the collection, collation, analysis for all human products manufactured in XYZ Ltd.
RESPONSIBILITY
- Marketing Executives are responsible for submitting the AEFI report within time frame duration.
- Zonal Heads are responsible for direct coordination with their designated zonal medical executives & directly co - ordinated with PV officers.
- Zonal heads are also responsible for investigation of ADR/SADR Reports
- Pharmacovigilance officers are responsible for analysis of AEFI which provide the unique identification Number for each case to review the investigation report.
- QA head & QC head are responsible for investigation of case study as per their concern.
GUIDELINES
- All the event (expected or unexpected) report shall be submitted within 15 calendar days to licensing Authority.
- The report of the AEFI observed shall be quarterly submitted to CDSCO along report and action taken report for all Product wise.
PROCEDURE
Definition: Consequently, AEs can be classified into different categories-
Adverse Event: Any untoward medical occurrence (including a symptom /disease or an abnormal laboratory finding)during treatment with a pharmaceutical product in a patient or a human volunteer that does not necessarily have a relationship with the treatment being given.
Adverse Drug Reaction: A response which is noxious and unintended response related to IMP which occurs at any doses normally used in humans for prophylaxis or therapy of disease or for modification of physiological function.
Serious Adverse drug reaction/Serious Adverse Event: An AE or ADR that is associated with:
- Results in death.
- Life threatening.
- Results in permanent disability.
- Requires hospitalization or prolongation of existing hospitalization.
- Requires intervention to prevent permanent impairment/damage.
Suspected Serious Adverse Reaction: An Adverse reaction that is classed in nature as serious, which is consistent with the information about the medicinal product in question set out.
Suspected Unexpected Serious Drug Reaction: An Adverse reaction that is categorized in nature as serious and which is not consistent with the information about the medicinal product in question set out.
AEFI: Any untoward medical occurrence which follows immunization and which does not necessarily have a casual relationship with the use of vaccine .The adverse event may be any unfavorable or unintended sign, an abnormal laboratory finding, a symptom or a disease.
- Vaccine Reaction: An event caused by active component / other component of the vaccine. Example - High grade fever, anaphylaxis.
- Program Error: An event caused by an error m vaccine (preparation, handling, administration ). Example- Bacterial abscess.
- Coincidental Reaction: An event that occurs after immunization but is not caused by vaccine. Example - Pneumonia.
- Injection Reaction: An event caused by anxiety or pain from the injection itself rather than vaccine. Example- Fainting spell.
- Unknown: The cause of event can't be determined. Example- does not fit in any of the above four types.
Cluster: Two or more cases of the same event or similar events, related in time, geography and the vaccine administered.
Side Effects: Any intended effect of pharmaceutical product or IMP occurring at normal dosage which 1s related to the pharmacological properties of the drug.
Classification of AEFI:
AEFI can be classified into 5 types:
a. Vaccine Reaction.
b. Program error.
c. Coincidental Reaction.
d. Injection reaction.
e. Unknown
Active Pharmacovigilance Plan
Channels of reporting AEFI: it is essential that the medical executives identify and report all serious and non - serious adverse events. There are two channels of reporting AEFIs:
Monthly routine reporting:
This includes reporting of Post Marketing surveillance report of all vaccines. If there is no any side effects observed in the month the report shall be submitted into Annex-1. This information is collected and complied by medical executives in monthly reporting formats, these includes:
- Pain.
- Pruritus/Itching.
- Fever.
- Redness
- Headache.
Immediate Notification of serious AEFI/Side effect:
The serious AEFI 1s defined as "ANY UNTOWARD MEDICAL OCCURANCE" that result in death, hospitalization or prolongation of hospitalization, significant disability, incapacity, life threating. All serious AEFI are to be immediately notified by medical executive & notify the case by quickest means of communication e.g. telephone, messenger etc. These includes:
- Death
- Severe local pain
- Seizures.
- Life Threatening.
- Hospitalization/Prolonged
- Disability
- Congenital Anomaly
- Required intervention to prevent permanent impairment/ damage.
- Other: If any Side effects are observed, the same shall be reported immediately to PV Department.
Process of reporting AEFI:
- Serious events are need to be immediately investigated, managed and reported on standardized AEFI formats. All the serious events should be reported within 24 hours of events.
- On receipt of information about any other AEFI, the medical executive should report the same in the monthly reporting form (AEFI format). The AEFI ID shall be allotted by Pharmacovigilance personnel , it shall be in terms of AEFI/PV/XXX/YY,
Where,
AEFI- is Adverse Event Following Immunization,
PV- is Pharmacovigilance,
XXX- Tracking No starts from 001 and 1 7 indicates the current year.
Collection of Data
- Medical executives visits to primary health center/ medical institutions/ Govt. Depots/ District Hospitals.
- Entire distribution/ sales and marketing network of XYZ Ltd. is divided into 4 zones (East, West, North, South) and each zone has respective zonal head.
- If there is any serious event observed during visit. The FIR should be filled and copy of the same shall be sent to XYZ Ltd. within 24 hours of the event report. Except serious events, all the events are reported monthly.
Investigation of AEFI:
- If the reported AEFI is an event that needs investigation. The medical executive inform to the XYZ Ltd. by telephone or fax immediately.
- At times, lab testing is required to confirm or rule out the suspected cause. In such cases the incriminated vial of vaccine (if available) used to administer the vaccine should be collected and sent under cold chain to XYZ Ltd & internal investigation need to be proceed.
- If the event is due to programmatic error, action should be taken to correct wrong practices.
- On receipt of FIR from medical executive that warrant investigation, the zonal head of the concern area should initiate an investigation.
- On basis of investigation, a root cause 1s found and the corrective action is taken.
- In case of export, the reports of the events are received through the mail.
Causality Assessment:
|
Decision |
Description |
Classification |
|
Not
Related |
Temporal
relationship of the onset of events, relative to the administration of the
product, is not reasonable or due to some other cause that can explain the
occurrence of the event. |
AE |
|
Unlikely to be Related |
Temporal relationship of the onset of events,
relative to the administration of the product, is unlikely but cannot be
ruled out. |
AE |
|
Possibly
Related |
Temporal
relationship of the onset of events, relative to the administration of the
product, is reasonable, and the event could have occurred due to another
equally likely cause. |
AR |
|
Probably Related |
Temporal relationship of the onset of events,
relative to the administration of the product, is reasonable, and the event
is more likely explained because of administration of the drug than by any
other cause. |
AR |
|
Definitely
Related |
Temporal
relationship of the onset of events, relative to the administration of the
product, is reasonable, and there is no other cause to explain the event, or
a re-challenge is positive. |
AR |
- In both cases, Event is expected or unexpected, Analyze the causality & seriousness of event.
|
Causality Assessment |
Seriousness |
|
1. Not
related |
1. Result in
Death |
|
2. Unlikely to be related |
2.
Life-threatening |
|
3. Possibly
related |
3.
Disability |
|
4. Probably related |
4.
Requires Hospitalization |
|
5.
Definitely related |
5.
Congenital anomaly/Birth defect |
|
6.
Not serious |
AEFI During Clinical Trial:
- As with other vaccines, in rare cases anaphylactic shock may occur in susceptible individual. The mainstay m the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving. It should be used at the first suspicion of anaphylaxis. The vaccines should remain under observation for not less than 30 minutes for possibility of occurrence of rapid allergic reactions. Hydrocortisone and antihistaminic should also be available in addition supportive measures such as oxygen inhalation.
- In case of pain antinflammatory drug should be prescribed by the doctor.
- Id fever occurs, then antipyratic drug should be given to the volunteer as per the prescription of the doctor.
- All the adverse events should be informed to PI/ COPI etc.
- If there is a serious adverse event observed during clinical trial, then PI along with Pharmacovigilance personnel should be informed to DCG(I).
DOCUMENTATION
- Post marketing surveillance form with safety assessment.
- Side Effects reporting Form.
- AEFI Reporting Form.
IMPLEMENTATION
Develop/ modify relevant SOPs if applicable.
Trained the staff if applicable.
ABBREVIATION
ADR - Adverse Drug Reaction.
AE - Adverse Event
AEFI - Adverse Event Following Immunization.
IMP - Investigation Medicinal product
PV - Pharmacovigilance
SADR - Serious adverse Drug reaction
SAE - Serious Adverse Event
SUSAR - Suspected Unexpected Serious Adverse reaction
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