Frequently asked question in Pharmacy interview

 Frequently asked question in Pharmacy interview

1.  Name some data elements in ICSR? 

Patient demographics: Age, gender and race. Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event onset date, seriousness criterion, event end date and latency.

2. What should a narrative consist of?

A narrative should consist of precise and concise information about the source of report, patient demographics, patient’s medical history, concomitant medications, suspect product details and adverse event details in an orderly manner. 

3. What are the due dates for safety reporting?

Safety reporting due dates are 7days for IND Reporting and 15 days for NDA Reporting

4. What is Spontaneous reporting?

Spontaneous (or voluntary) reporting means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns. Reporting is entirely dependent on the initiative and motivation of the potential reporters. This is the most common form of pharmacovigilance, sometimes termed passive reporting. In some countries this form of reporting is mandatory. Clinicians, pharmacists and community members should be trained on how, when, what and where to report.

5. Suitable methods of reporting:

Telephone
Fax
E-mail
Internet

6. What to report in PV?

Patient details (Name, Address:, Sex, Date of birth, Weight and height).
Patient medical history of significance.
Details of medicines (this may be the brand or generic name, preferably
brand) and formulation, mode of administration (e.g. oral, rectal, or
injection), Indication(s) for use, dose).
Reaction details (Date of onset, outcome: resolved, resolving, no change,
disabling, worsening, death (with date), or congenital anomaly, Effect of
rechallenge).
 Reporter details
 Date and place of report 

7. What is Cemflow?

CemFlow is a tool maintained by the UMC for database management in cohort event monitoring (CEM). It is web based and the fields match the data elements on the questionnaires. There are screens for patient demographics, treatment initiation, treatment review and assessment of events. CemFlow as a tool for data entry into an online database maintained by the UMC (Uppsala Monitoring Centre) for CEM. CemFlow provides for entry of cohort data as well as the events.

8. Seriousness criteria based on intensity?

not severe, mild, moderate, severe.

9. Synonyms for relatedness (causality-related)?

Related: Certain, possible, probable, likely

10. Synonyms for relatedness (causality- unrelated)?

Not related: Unlikely, Unclassified (or conditional), Unassessable.