Transcript Quality Problems with Antimalarials

PHARMACOVIGILANCE
PLAN FOR TANZANIA
PREPARED BY EMMA &
MARY
10TH SEPTEMBER 2004
PLAN
Justification for monitoring of drugs.
To make sure that drugs for the public
health use are of acceptable quality,
safety and efficacious.
All drugs circulating in the market are
supposed to be monitored.
Reports to be investigated
Every report need a follow up because
they play part and parcel of safety
monitoring of drugs.
Cont….
The following reports need to be
investigated: clusters, Unexpected,
Unusual and non compliance reports.
Investigation should be on:
Group of individuals affected.
Quality of the products.
Outcome of the treatment.
Frequency of occurrence of the ADR including
causal relationship.
Cont….
Roles and responsibilities in
monitoring.
Tanzania Food and Drugs Authority
The roles of the authority is to monitor
safety of all drugs in the country.
The system of collecting information
(reports) is in place. From sentinel
centres and from healthcare providers to
TFDA.
Cont……
The plan is to encourage patients to report to
TFDA and zonal offices (to be established).
Manufacturers and product registrants have the
responsibility of monitoring their products and
send reports to TFDA.
Feedback reports from TFDA will be sent to all
including the media depending on circumstances.
In addition…
All health workers have the responsibility of
monitoring proper management of drugs at their
capacity (reporting of suspected quality problems
and drug administration).
cont…
Monitoring Processes
Spontaneous monitoring:
 Is in place for all registered
pharmaceuticals products and those
registered for study.
Cohort studies:
 Will be a priority especially with ART
Programme.
Registries:
 If record keeping system is improved,
monitoring using registries will be
incorporated.
Reporting of events or reactions
As soon as the patients are using the drugs
the reporting on adverse reactions will
continue to be encouraged.
With ARVs and drugs which are on studies
the reporting on adverse events and
adverse reactions is encouraged.
What should be the timelines for submitting;
Initial reports,
Three days after filling of the forms, these
should be posted.
Investigations reports,
As soon as possible when the investigation
is still on progress.
Aggregate reports?
Bi annual.
6. How do you manage non-serious ADRs?
Both serious and non serious ADRs are
encouraged to be reported.
7. What are the resources available?
Based on resources, size of country and
nature of public health structures
There is drug regulatory authority.
Functional Pharmacovigilance centre.
Organized health systems in place.
Government commitment on Public
health programs.
8. What are the critical success factors to
achieve the system and its objectives?
Inadequate human resource, five more
people need to be recruited.
Financial resource is not adequate to
perform all the pv activities.
Infrastructure and equipment need to be
improved
More support is needed from the upper
to the lower level.
Technical support to conduct more
activities eg research.
TRAINING STRATEGIES
Training of TOTs (Regional Health
Management Teams).
Facilitators from the PV centre and TFDA.
Training Curriculum preparation.
Preparation of Training materials
Meeting of the facilitators and experts to
agree on the training materials and
curriculum.
Curriculum
Contents:
Introduction:
The definition of pharmacovigilance
Importance of pharmacovigilance in Public
health.
Magnitude of the adverse effects of drugs
The importance of monitoring adverse
drugs reactions.
Contents cont…
The pharmacological basis of adverse drug
reactions and classification of ADR based on
etiology.
How to recognize ADR
Principle of efficient reporting.
When and what to report.
How to report.
Ways of improving ADR monitoring and
reporting
Communication on feedback of the reports.
Curriculum cont…
Each session will consist of thirty participants
with four facilitators.
Training methods
Participatory, Role plays and Group
discussion
Number of hours for the training:
The training session is expected to take 3
days or a total of 24 hours.
Training Schedule
Training will be conducted in the six zones which
will consist of four regions each with seven
participants. (TOT). These training will be
covered within three months.
Sensitization of the trained professionals will be
done on quarterly basis.
During annual professionals meetings there will
be a session to remind health workers the
importance of ADR reporting.
Training of TOTs
The objective of Training in general is to
ensure that health workers are well
educated on the importance of safety
monitoring of drugs as well as to increase
the reporting of adverse drug reactions.
Trained TOT will help in training other
health workers in their respective regions.
To the community…..
The use of media will be of emphasis:
Different communication channels will be
used, leaflets, posters, radios, magazines
etc.
To the retail pharmacies, the pharmacists
will be encouraged to sensitize their
customers on reporting of adverse
reactions they encounter.
The objective of sensitizing communities is
to raise their awareness on the harmful
effects drugs can cause.