So Please Circle the Most Appropriate Answer(S)

So Please Circle the Most Appropriate Answer(S)

We would greatly appreciate your taking the time to complete our questionnaire, which will be invaluable in helping to identify the knowledge of healthcare professionals pharmacovigilance concept.

The questionnaire should take approximately 10 minutes to complete; any individual identifying information will be kept confidential.

So please circle the most appropriate answer(s)

  1. Background information

Profession:

  • Pharmacist
  • Physician
  • Nurse
  • Other: ……………………………………………………………………..

Hospital: ……………………………………………………………………

Department: ……………………………………………………………….

  1. Questions

1.The most appropriate definition of pharmacovigilance is:
a.The science of monitoring adverse drug reactions (ADR’s) happening in a hospital.
b.The process of improving the safety of drugs.
c.The detection, assessment, understanding & prevention of adverse effects.
d.The science of detecting the type & incidence of ADR after drug is marketed.
2.The most appropriate purpose of Pharmacovigilance is:
  1. To identify safety of drugs.
  2. To calculate incidence of ADR’s.
  3. To identify predisposing factors to ADR’s.
  4. To identify unrecognized ADR’s.

3.The following type of study is used to monitor safety of new drugs once they are launched in the market:
  1. Meta analysis.
  2. Post Marketing Surveillance (PMS) studies.
  3. Population studies.
  4. Regression analysis.

4.The following scales is the most commonly used to establish the causality of an ADRs:
  1. Hartwig scale
  2. Naranjo algorithm
  3. Schumock and Thornton scale
  4. Karch & Lasagna scale

5.Rare ADRs can be identified in the following phase of a clinical trial
a.During phase-1 clinical trials
b.During phase-2 clinical trials
c.During phase-3 clinical trials
d.During phase-4 clinical trials
6.The healthcare professionals responsible for reporting ADR in a hospital is/are
a.Physician
b.Pharmacist
c.Nurses
d.All of the above
7.The following factors discourage you from reporting Adverse Drug Reactions
Strongly agree / Agree / Disagree / Strongly disagree / Don’t know
  1. No money compensation

  1. Lack of time to report ADR

  1. A single unreported case may not affect ADR database

  1. Difficult to decide whether ADR has occurred or not

8.A serious adverse Event in Saudi Arabia should be reported to the Regulatory body within
  1. One day
  2. Seven calendar days
  3. Fifteen calendar days
  4. Fourteen calendar days

9.The reporting is a professional obligation for you.
a.Yes
b.No
c.Don’t know
10.The regulatory body In Saudi Arabia which is responsible for monitoring of ADRs:
a.Central Drugs Standard Control Organization.
b.The National Pharmacovigilance and Drug Safety Center.
c.Office Of Pharmacovigilance at the Ministry of Health (MOH).
d.The National Drug Information and Poisoning Center.
11.What is your opinion about establishing ADR monitoring center in every hospital?
  1. Should be in every hospital
  2. Not necessary in every hospital
  3. One in a city is sufficient
  4. Depends on number of bed size in the hospitals.

12.The following is the (WHO* online database) for reporting ADRs?
a.ADR advisory committee
b.Medsafe
c.Vigibase
d.Med watch
-WHO*: world health organization
13.The international center (WHO ADRs database) for adverse drug reaction monitoring is located in:
  1. United States of America
  2. Australia
  3. France
  4. Sweden

14.The reporting of adverse drug reaction is necessary.
a.Yes
b.No
c.Don’t know
15.Have you ever come across with ADR?
a.Yes
b.No
c.Don’t know
16.I have been informed by pharmacy staff about reporting ADRs.
a.Yes
b.No
c.Don’t know
17.Does your institution have a process in place to identify high-risk or high-alert medications, which have a higher risk of causing errors or other adverse outcomes or a narrow margin of safety (e.g., insulin, opiates and narcotics, anticoagulants, concentrated electrolytes)?
a.Yes
b.No
c.Don’t know
18.Do you think Pharmacovigilance should be taught in detail to healthcare professionals?
a.Yes
b.No
c.Don’t know

Thanks for your participation

1 | Page

Top View