Evaluation of Adverse Drug Reactions
Pharmacovigilance is an arm for patient safety and care that aims to get the best results with medicines’ treatment. Unfortunately, because of many different factors, any medicine can sometimes cause adverse reactions.
As we can see, the world of 2021 is different compared to previous years. We are now cautiously reopening and trying to get into the new normal state. Pharmacovigilance will recognize the risks in the least possible time when the medicine has been marketed and will aid to build and/or classify risk factors. When communicated adequately, this data enables intelligent, evidence-based guiding with potential for stopping many adverse reactions and will finally benefit each patient to obtain optimum therapy at a more economical cost to the health system.
Adverse outcomes, preventable or otherwise affects the treatment. Mainly adverse events affect patients, but they also affect health care practitioners. Revealing information about adverse events has benefits for the patient and the physician and, ideally, strengthens the patient–physician relationship and promotes trust.
When to report
A patient should communicate if they had a notable outcome.They can go to hospital and inform the medical advisers that they stopped using medication as they have this type of adverse reaction
FDA encourages the consumers to report whenever they find any adverse reactions. If the team gets bundles of reports about the same medicine they will respond and take possible actions.
What happens after a report is made?
FDA examines all submitted reports and identifies the similar adverse events occurring with a specific medicine.
Depending on the severity of the adverse reactions, FDA may take any of the following decisions.
- Withdraw the medicine from the market
- Declare a drug safety communication to notify public
- Set some restrictions on the drug distribution
- Renovate the drug’s labelling, insert or package.
But almost everything starts with consumer feedback. Adverse event reporting allows us to do our job and report needed information back to consumers.
Types of Adverse Drug Reactions:
Mainly it is classified under
- Dose-related
- Allergic
- Idiosyncratic
In detailed it is segregated as
Type A – Augmented
Reactions which can be predicted from the known pharmacology of the drug. These are dose dependent.
Ex: Bleeding, Headache etc.,
Type B – Bizarre
These are adverse reactions that depend upon promoting the growth of certain microorganisms and cannot be predicted from pharmacology.
Ex: Anaphylaxis, Hypersensitivity
Type C – Chemical
Several adverse reactions rely upon the chemical nature of a drug rather than pharmacological properties and cause chemical irritation.
Ex: Hepatotoxicity
Type D – Delayed
These reactions occur because of the physical nature of the formulation or the method of administration.
E.g. Chemotherapy, Secondary tumours, Teratogenic effects
Type E – Exit/End of treatment
These are known as withdrawal reactions, these occur on withdrawal especially when drugs are stopped abruptly.
E.g. Phenytoin withdrawal Seizures, Steroid withdrawal
Type F – Familial
Familial dysautonomia is a hereditary sensory disorder. It is a genetic disorder that affects the development and survival of certain nerve cells.
Ex: poor muscle tone (hypotonia), frequent lung infections, and difficulty maintaining body temperature.
Type G – Genotoxicity
Several drugs can create genetic damage in humans. Distinctly, some are possibly genotoxic or carcinogenic. Few, but not all, teratogenic agents harm genetic material within the fetus.
Type H -Hypersensitivity
These are side-effects induced by hypersensitivity or allergy. They are apparently the most frequent adverse reactions after Type A reactions.
Type U – Unclassified
Some adverse reactions have a mechanism that is not known. This may constrain the introduction of new adverse reaction divisions in the future. Examples include muscular adverse effects,drug-induced taste disturbance.
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