For VOLUNTARY reporting of Adverse Drug Reactions by Healthcare Professionals

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

Download link - http://ipc.nic.in/showfile.asp?lid=416&EncHid=

Serious Event or Serious Suspected Adverse Reaction-Pharmacovigilance Practice

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes

• Death
• A life-threatening adverse event
• Inpatient hospitalization, or prolonged of existing hospitalization
• A persistent disability to conduct normal functions
• A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

A Life Threatening Adverse Drug Experience
Any event that occurred due to the use of drug, if it places the patient or the subject at immediate risk of death or if the product or drug is continued it may result in death is described as a life threatening adverse event.
Some of the examples are:

• Hemorrhaging and internal bleeding with rapid drop in blood pressure,
• Loss of consciousness from increase in pressure on the brain etc.

Hospitalization
Any event that occurred due to which the patient/subject is admitted to the hospital for longer than 24 hours or if the stay in the hospital is prolonged due to the adverse event.
Disability
Any event that occurred due to which the patient/subject is unable to conduct normal life functions
Examples are

• Loss of speech,
• Fatigue( if the subject cannot get out of bed at all),
• Loss of memory,
• Paralysis etc

Congenital Anomaly
Exposure to a medical product before conception or during pregnancy results in an adverse outcome in the child is described as congenital anomaly. Thalidomide is the best example of a drug causing congenital anomalies with babies born with deformed arms and legs.

Author- Sirisha Boidapu, Pharmacist, PV Professional

FDA IND Review Team-Different background people working together

The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.

-Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.
-Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.
-Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data. 
-Pharmacologist: Reviews preclinical studies.
-Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
-Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.
-Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Designing Clinical Trials Researchers design clinical trials

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives.

Then, they decide:-

-Who qualifies to participate (selection criteria)
-How many people will be part of the study
-How long the study will last
-Whether there will be a control group and other ways to limit research bias
-How the drug will be given to patients and at what dosage
-What assessments will be conducted, when, and what data will be collected
-How the data will be reviewed and analyzed Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Key concepts to be considered in expedited reports : Pharmacovigilance Practice

The following list of items are to be included in CIOMS form and submitted to regulatory bodies :

1. Patient details (vitals)
2. Suspected medical product( brand name,batch number, dosage form and strength,dosage regimen, route of administration, international non propiatory name, starting date and time , stopping date and name )
3. Details of the adverse drug reaction (starting date, onset of reaction , stopping date and time and duration of reaction )
4. Details of reporter (name, address, telephone number , profession)
5. Details of the sponsor (source of report, country in which event occurred ,name and address of sponsor , sponsor identification number ).

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.