Instructions

to fill the Adverse Event/Product Complaint Reporting Form

Dear Consumer/Health care professional,
You have been provided here with instructions to fill all the sections of the form. Apart from this, there is a ready access to specific instructions in different sections of the form when you fill the form online. It is compulsory to fill all the information marked in *.

Reporter Details
  • Name:
    Please provide your name since you are reporting the event.
  • Occupation:
    Please mention your occupation as doctor, nurse, pharmacy etc. and specialty area you are working in.
  • Address:
    Complete and accurate address and contact nos. is essential in case required to contact for more information.
Patient's Information
  • Name or Initials:
    Enter name or initials accurately. This is essential to facilitate identification and to locate the patient if needed.
  • Age or Date of Birth:
    Provide the most precise information available. Enter the birth date, if known or age in years.
  • Gender:
    Select appropriate option of gender.
  • Weight:
    Weight is to be entered.
  • Height:
    Height is to be entered.
  • Address:
    Complete and accurate address and contact nos. are essential in case required to contact for more information.
Suspect Products Information
  • You can provide information on more than one suspect product but essentially one of them should be a Biocon product.
  • Please provide accurate names of the suspected medicinal product (brand name and generic name), the dosage form it is available for use (tablet/injection/liquid/syrup/solution etc.), and strength in mg or mg/ml or as appropriate (example 500mg or 25 mg/ml).
  • Provide accurate lot no / batch no., manufacturing and expiry dates.
  • Check the box provided for Yes if you have sent the sample of the product to Biocon for further investigations/evaluation. Mention the date of sending the sample.
  • If accurate dates of use are not known please provide the approximate duration of use in hours/days/weeks/months or years.
  • The medical condition (indication) for which the drug was given when this event occurred should be provided.
Product related problem:
  • Provide the reason of lodging this product complaint by checking the appropriate box like whether the product was unstable when in use (i.e. there was change in colour or sedimentation seen), contaminated or was a counterfeit product, product didn’t work or product confusion (by name, labeling, design or packaging), labeling problems caused by printing errors or omissions . If complaint is any other than this please specify the complaint in space provided.
  • Only one adverse event/side effect should be reported in one form. If more than one adverse event/side effect, use another form.
  • Indicate whether the event you are going to report is adverse event/side effect of a product complaint or a others like product use error.
Adverse Event/Side Effect Information
  • Enter the date and time of onset of adverse event/side effect, date and time of end of adverse event (if the adverse event is stopped). If accurate dates are not known please provide the approximate duration of the event.
Event Description or product complaint description:
  • If you are lodging a product complaint explain here in detail the same.
  • Indicate clearly the adverse event name or diagnosis of the event (if you are health care professional).
  • Describe the event with detailed description of what happened and a summary of all relevant clinical information
  • Provide results of relevant tests and laboratory data. Make a point to include.
  • All appropriate information, including relevant negative test and laboratory findings, in order to most completely convey how the medical work-up/assessment that led to strong consideration of medical-product-induced adverse event. If available, also include: Any pre- and post-event medication levels and dates (if applicable),
    Synopsis of any relevant autopsy, pathology or lab reports, if preferred, copies of any reports may be submitted as attachments, with all confidential information deleted.
  • You can upload the related reports of lab investigations and physicians notes with the online reporting form.
  • Treatment of adverse events/side effect: All medications that were used to treat the adverse event should be listed (Name of the medicinal product, Generic name, indication, route of administration, dose and frequency). Information on whether the treatment medication and procedures are continuing or not should be
    entered.
  • Concomitant medications:The information of medications used along with suspect product and relevant information on condition for which concomitant medication were given should be filled.
Severity And Causality:
If you consider the adverse event/side effect or product complaint as serious please check YES. Refer to following information for clarifying the reason why you consider the event to be serious. This will be filled if the physician is reporting the event.

  • Death:
    Check if the patient has died.
  • Life-threatening:
    Check if suspected that the patient was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death,
    if it was more severe.
  • Hospitalization (initial or prolonged):
    Check if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
    • DO check if:
  • A patient is admitted to the hospital for only one day, even if discharged on the same day.
  • An emergency room/ casualty visit which may or may not have been resulted in admission to the hospital An emergency room/ casualty visit which may or
    may not have been resulted in admission to the hospital.
  • Persistent / Significant Disability:
    Check if the adverse event resulted in a substantial disruption of a person’s ability to perform normal life functions.
  • Congenital Anomaly/ Birth Defect:
    Check if suspected that exposure to product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
  • Other Medically significant condition:
    Check when, based on appropriate medical judgment, the event may jeopardize the patient and may require medical or surgical intervention to prevent one
    of the other outcomes. Examples include bronchospasm requiring emergency treatment convulsions that do not result in hospitalization, or
    the development of drug dependency or drug abuse.
  • Causality term Assessment criteria:
    Causality assessment would be made by healthcare professional.
Certain
  • Event or laboratory test abnormality, with plausible time relationship to drug intake cannot be explained by disease or other drugs.
  • Response to withdrawal plausible (pharmacologically, pathologically).
  • Event definitive pharmacologically or phenomenologically (i.e. an objective and specific medical disorder or a recognised pharmacological phenomenon).
  • Rechallenge satisfactory,if necessary.
Probable /Likely
  • Event or laboratory test abnormality, with reasonable time relationship to drug intake.
  • Unlikely to be attributed to disease or other drugs.
  • Response to withdrawal clinically reasonable.
  • Rechallenge not required.
Possible
  • Event or laboratory test abnormality, with reasonable time relationship to drug intake.
  • Could also be explained by disease or other drugs.
  • Information on drug withdrawal may be lacking or unclear
Unlikely
  • Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable (but not impossible).
  • Disease or other drugs provide plausible explanations.
Conditional / Unclassified
  • Event or laboratory test abnormality.
  • More data for proper assessment needed, or.
  • Additional data under examination.
Unassessable/Unclassifiable
  • Report suggesting an adverse reaction.
  • Cannot be judged because information is insufficient or contradictory.
  • Data cannot be supplemented or verified.
Outcome of the event
  • Check the appropriate block to indicate the outcome of the event - whether recovered completely, not recovered, recovered with sequelae or fatal and provide dates where ever they are required to be filled in the form.
  • If the information for all of the above is not available, check in the block for unknown.
  • Check in the appropriate block to indicate whether the event appeared again after stopping the therapy and whether the events reappear again after rechallenge of the drug.
  • If it reappeared, how long the treatment lasted until reappearance.
  • Utilize the field provided for giving the rationale for relationship of the SAE to the study drug. This is to be filled by health care professional.