Reporting Side Effects for any Medical Products, Devices or Drugs
Dr. Nancy Agnes, Head,
Technical Operations, Pepgra
Sales.cro@pepgra.com
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. Healthcare 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.
Keywords:
Healthcare Analytics Services, Healthcare
data analytics services, healthcare data
analysis, healthcare analytics, healthcare
data analytics, Healthcare Analytics
Solutions, healthcare data analytics
solutions
for therapeutics clinical research. 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. 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.
I. INTRODUCTION
Drugs approved by the Food and Drug
Administration for sale must be safe,
meaning that the drug's significance appears
to be higher than the predictable risks and
should be useful. 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
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II. REPORTING SUSPECTED SIDE
EFFECTS
Many people will not experience any
problems when using medicines. However,
Healthcare 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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III. 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.
V. REPORTING A SIDE EFFECT
•
•
•
IV. ACTIONS TO PERFORM WHEN
YOU EXPERIENCE SIDE EFFECTS
•
If you think that you have experienced an
adverse reaction to a drug, you need to
contact your healthcare professional 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.
Anybody can report issues relating to the
safety of medications to the online reporting
service. It includes patients, caretakers, and
common public and healthcare professionals
in the hospitals by pharmaceutical
regulatory consulting services.
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.
VI. 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 PDF version of
the information reported. Besides, the
following minimum criteria include a 'good'
side effect report with healthcare data
analytics services:
• An identifiable patient with their
initials/age/sex/record number)
• An identifiable medical product with
its name or active substance if the
brand is unavailable)
• An identifiable reporter
• An identifiable reaction
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
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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.
VII. IMPORTANCE OF REPORTING
SUSPECTED SIDE EFFECTS
•
•
•
•
Solutions with the biomedical research
services.
REFERENCES
1.
2.
Dubrall, D., Schmid, M., Alešik, E., Paeschke, N.,
Stingl, J., & Sachs, B. (2018). Frequent Adverse
Drug Reactions, and Medication Groups under
Suspicion: A Descriptive Analysis Based on
Spontaneous Reports to the German Federal
Institute for Drugs and Medical Devices from 1978
to
2016. Deutsches
Ärzteblatt
International, 115(23), 393.
Freifeld, C. C., Brownstein, J. S., Menone, C. M.,
Bao, W., Filice, R., Kass-Hout, T., & Dasgupta, N.
(2014). Digital drug safety surveillance: monitoring
pharmaceutical
products
on
Twitter. Drug
safety, 37(5), 343-350.
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 tool to
encourage 'spontaneous reporting',
which contributes to gain the overall
knowledge
of
the
safety
of
medicine/drugs and the patient
experience.
The patients' role in reporting adverse
drug effects 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.
VIII. 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
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