Side Effects of Drugs Products, Medical Devices & Drugs | Healthcare Data Analytics Services - Pepgra Healthcare

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REPORTING SIDE EFFECTS FOR ANY MEDICAL
PRODUCTS, DEVICES OR DRUGS
An Academic presentation by Dr. Nancy Agnes,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email pepgrahealthcare_at_gmai
l.com
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Today's Discussion
In-Brief Introduction Reporting Suspected Side
Effects What is the Side Effect Actions to
Perform when you Experience Side Effects
Reporting a Side Effect Filling an Adverse Effect
Report Form Importance of Reporting Suspected
Side Effects Conclusion
OUTLINE
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In-Brief

• Humans differ in their biological reactions to
  medical products or drugs but not all adverse
  reactions associated with the use of medical
  products can be detected during clinical
  development. Even the most comprehensive clinical
  trials could not detect some adverse effects.
  H ealthcare Analytics Services captures as many
  of these adverse reactions are rare, from
  worldwide sources, is important for continued
  patient and drug safety. Pepgra lists the
  reporting of side effects and its necessities in
  their blog.

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Introduction
Drugs approved by the Food and Drug
Administration for sale must be safe, meaning
that the
drug's significance appears to be predictable
risks and should be useful.
higher than the
Both the prescription and over-the-counter
medicines possess side effects. Side effects,
also known as adverse effects, are unwanted or
unexpected events or reactions caused due to the
drug intake for therapeutics clinical
research. Contd...
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Side effects can differ from small problems like
a running nose to life-threatening conditions,
like the risk of a heart attack may get
increased. Several things can affect who does
and does not have a side effect when taking a
drug age, gender, allergies, how the body
absorbs the medication, vitamins and dietary
supplements that may be consuming for a
while. General side effects include stomach upset
, dry mouth, and dizziness says the Clinical
Biostatistics services.
Contd...
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A side effect will become severe if the result is
death or any life-threatening condition,
hospitalization for many days, disability,
permanent damage, or exposure during pregnancy,
causing disability. It is essential to contact
your doctor or pharmacy specialist if you think
you might have experienced a side effect after
using a medicine. They will let you know if you
need any medical care. They will also consider if
you need any change of treatment in all the
Clinical research organization.
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Reporting Suspected Side Effects
Many people will not experience any problems
when using medicines. However, H ealthcare data
analytics services conclude that all medications
have some risks associated with their internal
use, and very few people may experience effects
(also known as an adverse reaction).
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What
is the Side Effect
An adverse reaction is a 'gradual or immediate
response to a medical product that is deleterious
and accidental'. Healthcare data analysis
includes any harm associated with using
medications, including overdose, misuse or
medical errors.
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Actions
to Perform when you Experience Side Effects
If you think that you have experienced an adverse
reaction to a drug, you healthcare professional
need to contact your who will advise any
treatment required to treat the illness.
They will also report the issue to the
corresponding site on your behalf when a drug is
without Clinical trial Monitoring Services. If
anybody wants to directly report an adverse
reaction, they can search the healthcare
analytics on the internet. Contd...
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Anybody can report issues relating to the safety o
f medications to the online reporting
service. It includes patients, caretakers, and
common public and healthcare professionals in
the hospitals by pharmaceutical regulatory
consulting services.
Contd...
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Reporting a Side Effect
You can report a side effect in several ways
Go directly to your doctor, pharmacist
or nurse who can then notify the HPRA.
Use the online reporting service. Download a
copy of online adverse reaction report form and
email completed forms to med safety services
through online Printing our adverse reaction
report form and posting a completed copy by
Freepost.
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Filling an Adverse Effect Report Form
Specific mandatory fields are required to submit
an adverse reaction report via the online
systems successfully.
These include reporting person details and a
contact mail address.
The latter facilitates the return of a unique
report identifier number to confirm the
submitted report successfully.
The confirmation mail from the online reporting
service will also contain a information reported. PDF version of the
Contd...
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Besides, the following minimum criteria include a
'good' side effect report with h ealthcare data
analytics services An identifiable patient with
their initials/age/sex/record number) An identifi
able medical product with its name or active subst
ance if the brand is unavailable) An
identifiable reporter An identifiable reaction
Contd...
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The above information is the minimum criteria
needed for a 'good' side effect report,
additional information regarding details relating
to the reaction like medical history, other
medication consumed, the clinical study design of
a drug and action taken with the medicine useful
for pharmacovigilance literature search
services. All the additional relevant
information is beneficial in the evaluation of
the healthcare data analytics suspected adverse
reaction. Once the HPRA reviews the report, the
reporter contacts for further follow-up
information that is useful to evaluating the
identified adverse reaction, permission may be
requested to contact a healthcare professional
from the hospital or clinic directly for any
other required information.
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Importance of Reporting Suspected Side Effects
Patients are able to identify the impact of
medicines they have consumed, particularly on
their quality of life and health.
Systems for consumers or patients reporting are an
essential reporting',
tool to encourage 'spontaneous
which contributes to gain the overall
knowledge of the safety of medicine/drugs and the
patient experience.
Contd...
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The patients' role in reporting adverse drug effec
ts is a critical element of building an improved
system of pharmacovigilance services.

• The involvement of patients is now at the edge of
  the new medications for safety monitoring.

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Conclusion
Any drug can cause unwanted or unexpected side
effects. Immediate detection and recording of
side effects of drug reactions are essential so
that unrecognized hazards can be identified
promptly. The regulators will take appropriate
actions to ensure that medicines are used with
safety. It is explained in this Healthcare
Analytics Solutions with the b iomedical
research services.
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