GUIDELINES
FOR REPORTING ADVERSE DRUG REACTIONS (PHAMACOVIGILANCE)
Pharmacovigilance is the detection, assessment and prevention
of adverse reactions to drugs and includes monitoring and
providing early warnings of adverse effects due to drugs.
The effectiveness of any pharmacovigilance activity is dependent
on the active participation of all health professionals,
as they are in the best position to report on suspected
ADRs observed in their every day patient care. All health
care professionals should report suspected ADRs as part
of their professional responsibility, even if they are doubtful
about the precise relationship between the reaction and
the given medication.
Below
are tips on spontaneous reporting:
Who
can report?
Any
healthcare professional; Pharmacists, Doctors, Nurses,
and also the general public
When
to report?
As
soon as possible even if you do not have all the details.
How
to report?
Download
and print the attached pharmacovigilance form (Adverse
Event Report Form)
The
form is made up of basically, four sections; Patient
details, Suspected product or medication(s), Details
of adverse event or product problem, and Reporter
Complete
the form as much as possible, regardless of any missing
details
Where
to report?
The
completed form should be returned to The National Centre
for Pharmacovigilance at the bottom of the form
The
National Drug Information Resource Centre (NDIRC) for
onward submission
The
Food and Drugs Board (FDB)
Through
the Regional Directors of Health or Pharmaceutical Services
Other
appropriate Ministry of Health agencies for submission
and evaluation
What
to report?
Report
on:
-
All
medicines including over the counter medicines
-
Herbal
medicines and supplements
-
Vaccines
and sera
-
For
new drugs, report all suspected reactions, be it major
or minor
-
For
well known drugs, report all serious and unexpected
adverse drug reactions
-
Adverse
interactions resulting from drug-drug, drug-food, drug-herbal
medicine, drug-disease, etc
-
Increased
frequency of a given reaction
-
Adverse
drug reactions associated with overdose, medication
error or drug withdrawal
-
Report
effects in other fields such as drugs in
-Pregnancy
-Breast-feeding
-Liver disease
-Renal disease
-Children and the elderly
-Patients with chronic disease
-Other specialised areas
-
Lack
of effect, Counterfeiting, Dependence and abuse
When
is a reaction serious?
-
Death
or life threatening (real risk of dying)
-
Hospitalisation
(initial or prolonged)
-
Disability
(significant, persistent or permanent)
-
Congenital
anomaly
-
Required
intervention to prevent permanent impairment or damage
What
happens to the information submitted?
-
The
information in the required form is handled in strict
confidence.
-
Reporting
does not indict the notifier, prescriber, dispenser,
the manufacturer or product
-
Report
received is acknowledged by NCPv and entered into a
database
-
The
information is evaluated and investigated by for causality
assessment
-
Regulatory
authorities, the Ministry of Health, Ghana Health Service
and other institutions are informed on the findings
of the report
-
Action
is then taken by the informed institutions
-
Copies
of reports evaluated and investigated are sent to Uppsala
Monitoring Centre (UMC) Database.
Note
that, the information you sent is only meant to improve
understanding and use of medicines in Ghana. Reporting an
adverse effect now will help save lives and reduce the suffering
of patients, thus, report all suspected adverse reactions
that you consider of clinical importance as soon as possible.
Download
PDF Form now 
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