The Concept of Pharmacovigillance
Session 8: The Concept of Pharmacovigillance:
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
2 05 minutes Presentation Explanation of Pharmacovigillance
3 15 minutes Presentation Definition of Terms in Pharmacovigillance
15 minutes Presentation and
4 Aims of Pharmacovigillance
Buzzing
5 10 minutes Presentation Key Partners in Pharmacovigillance
50 minutes Presentation and
6 Importance of Pharmacovigillance
Group discussion
7 10 minutes Presentation Key Points
8 10 minutes Presentation Evaluation
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
62
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Pharmacovigillance(5 minutes)
and vigilare(Latin for to keep watch). As such, pharmacovigillance heavily focuses on
adverse drug reactions.
assessment, understanding and prevention of adverse effects or any other drug-related
problem(According to WHO definition)
The processes involved in the clinical development of medicines once put onto the market; a
medicine leaves the secure and protected scientific environment of clinical trials and is
legally set free for consumption by the general population. At this point, most medicines
will only have been tested for short-term safety and efficacy on a limited number of
carefully selected individuals.
STEP 3: Definition of Terms in Pharmacovigillance (15 minutes)
The following are some of pharmacovigillance terminologies as adopted in TFDA guideline:
potentially harmful and unintended and which occurs at doses normally used in human for
prophylaxis, diagnosis or therapy of a disease or for the modification of physiological
function in which individual factors may play an important role.
treatment with a pharmaceutical product, but which does not necessarily have a causal
relationship with the treatment.
undertaking a specific course of action.
of the event and does not refer to an event, which hypothetically might have caused death if
it was more severe.
dose, may result in death, is life threatening (such as Stevens-Johnson Syndrome), requires
patient hospitalization or prolongation of existing hospitalization, causes a congenital
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
63
anomaly or birth defect, results in persistent or significantly is ability or incapacity, or
require intervention to prevent permanent impairment or damage.
man for medical treatment which is related to the pharmacological properties of the product
and in which there is no deliberate overdose.
not mentioned in the summary of product characteristic or market authorization, or expected
from characteristics
or microbiologic origin (such as blood products, vaccines, insulin).
patients and other volunteers) in order to discover or verify the effects of and/or identify any
adverse reaction to investigational products, and/or to study the absorption, distribution,
metabolism and excretion of the products with the objective of ascertaining their efficacy
and safety.
methods, for example in pre-clinical research conditions (opposite of hazard).
an effect of given intensity.
suspected adverse drug reaction related to the administration of one or more medicinal
products to an individual patient.
different practitioners.
compare results with the effects of the active drug.
time, examining their rates of disease.
a country with the clinical and scientific expertise to collect,
collate, analyse and give advice on all information related to drug safety.
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
64
STEP 4: Aims of Pharmacovigillance (15 minutes)
Activity: Buzzing (5minutes)
ASK students to pair up and buzz on the following questions for 5 minutes
ALLOW few pairs to respond and let other pairs add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
o To improve patient care and safety in relation to the use of medicines, and all medical
and paramedical interventions;
o To improve public health and safety in relation to the use of medicines;
o To contribute to the assessment of benefit, harm, effectiveness and risk of medicines,
encouraging their safe, rational and more effective (including cost-effective) use;
o To promote understanding, education and clinical training in pharmacovigillance and its
effective communication to health professionals and the public
o To identify and quantifynew adverse drug reactions (ADRs)
o To identify risk factors and populations at risk
o To detect increase in frequency of known ADRs
o To detect drug interactions
o To monitorbenefit-risk profile of a medicines and ensure that they remain within
acceptable bounds
o ADR profile of medicines within therapeutic class
o To contribute to good clinical practice in pharmacotherapy
o To prevent patients from unnecessary harm
STEP 5: Key Partners in Pharmacovigillance (10 minutes)
effective collaboration between the key players in the field of pharmacovigillance.
o Government
o Industry
o Hospitals and academia
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
65
o Medical and pharmaceutical associations
o Poisons and medicines centres information
o Health professionals
o Patients
o The media
o World Health Organization
STEP 6: Importance of Pharmacovigillance (50 minutes)
Activity: Small group discussion (15minutes)
ASK student to form small groups and answer the following question for 15 minutes
ALLOW students to discuss for 15 minutes
WRITE their responses to the flip chart/ board
CLARIFY and SUMMARIZE by using the content below
of medicinal products)
o Pharmacovigillance is important study to all partners of pharmacovigillance, since it
help to ensure; Equity of access to essential drugs Drug quality and safety
and rational use of drugs.
o Pharmacovigillance is important study to country‘s drug authority
a new medicine must pass three hurdles before its approval by the national drug
regulatory authority.
o It help to provide Sufficient evidence required to show the new drug to be of good
quality, effective, and safe for the purpose or purposes for which it is proposed.
o Pharmacovigillance is important study post marketing researchers
o It help to detect drug interactions measuring the environmental burden of
medicines used in large populations
o It help assess the contribution of ‗inactive‘ ingredients (excipients) to the safety
profile
o It help to compare safety profiles of similar medicines
o Pharmacovigillance is important study of train in health professionals
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
66
STEP 7: Key Points (10 minutes)
understanding and prevention of adverse effects or any other drug-related problem.
Poisons and medicines centres information, Health professionals, Patients and the media
health and to promote understanding and education
potentially harmful and unintended and which occurs at doses normally used in human for
prophylaxis, diagnosis or therapy of a disease or for the modification of physiological
function in which individual factors may play an important role.
STEP 8: Evaluation (10 minutes)
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
67
References
Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of
pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).
The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the
Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349
WHO Operational package for assessing, monitoring and evaluating country pharmaceutical
situations. (2015, November 20). Retrieved from
https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
68
Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP
