What is Pharmacovigilance?
Hey Guys,
Many of our pharma fresher or experienced friends are looking for pharmacovigilance basic information, as I have good experience in this pharmacovigilance field, hence I decided to write to an informative post on pharmacovigilance to help them.
As we know that pharmacovigilance is a very much fast-growing field and this comes under the category of office corporate jobs, hence many pharma professionals are preferring this kind of career over the pharma marketing and manufacturing jobs. Many businesses process service (BPS) companies are hiring for the fresh or experienced pharmacy, healthcare and medical graduates for these jobs as they have lots of work and opportunities. The associates those who work in the pharmacovigilance department are called as pharmacovigilance associate, drug safety associate or some companies also gives the designation of pharmacovigilance scientist.
Now the points are divided as:
1. Definition of Pharmacovigilance.
2. Importance of pharmacovigilance.
3. Some basic terminologies in pharmacovigilance.
Definition of Pharmacovigilance (PV)
It is the science which deals with the study of the collection, detection, assessment, monitoring, and prevention of treatment adverse event and any other drug-related problem.
The term pharmacovigilance and drug safety both are similar terminologies. Here, the term pharmacovigilance is a combination of Greek and Latin words as pharmacon + vigilare, which means a medicinal product or drug and watchfulness. In pharmacovigilance, the company has a continuous watch on its products in terms of adverse events in pre-marketing and post-marketing.
Importance of Pharmacovigilance
Guys, here importance, principles, objective, significance and need all having a similar meaning...
The main objective of Pharmacovigilance is to...
Some basic terminologies in pharmacovigilance
Adverse event (AE)
It is any untoward medical occurrence that may present during treatment with the pharmaceutical product but does not have to have a causal relationship with this treatment.
Guys, if you want to make a career in pharmacovigilance then this is very important terminology in this field. You should first understand the difference between adverse events and adverse drug reactions. Please check the below terminology for an adverse drug reaction.
Adverse drug reaction (ADR)
Labeling
Hey Guys,
Many of our pharma fresher or experienced friends are looking for pharmacovigilance basic information, as I have good experience in this pharmacovigilance field, hence I decided to write to an informative post on pharmacovigilance to help them.
As we know that pharmacovigilance is a very much fast-growing field and this comes under the category of office corporate jobs, hence many pharma professionals are preferring this kind of career over the pharma marketing and manufacturing jobs. Many businesses process service (BPS) companies are hiring for the fresh or experienced pharmacy, healthcare and medical graduates for these jobs as they have lots of work and opportunities. The associates those who work in the pharmacovigilance department are called as pharmacovigilance associate, drug safety associate or some companies also gives the designation of pharmacovigilance scientist.
Now the points are divided as:
1. Definition of Pharmacovigilance.
2. Importance of pharmacovigilance.
3. Some basic terminologies in pharmacovigilance.
Definition of Pharmacovigilance (PV)
It is the science which deals with the study of the collection, detection, assessment, monitoring, and prevention of treatment adverse event and any other drug-related problem.
The term pharmacovigilance and drug safety both are similar terminologies. Here, the term pharmacovigilance is a combination of Greek and Latin words as pharmacon + vigilare, which means a medicinal product or drug and watchfulness. In pharmacovigilance, the company has a continuous watch on its products in terms of adverse events in pre-marketing and post-marketing.
Importance of Pharmacovigilance
The main objective of Pharmacovigilance is to...
- To conduct ethical drug development procedures.
- To proactively monitor and report on the quality, safety, and efficacy of medicinal products.
- To monitor the performance of the drug and track the adverse events.
- To identify the new harmful signals associated with the medicinal products.
- To reduce the disease-related economic loss.
- To identify previously unrecognized adverse events or changes in the patterns of adverse events.
- To assess the risks and benefits of marketed medicines to improve their safe and effective use.
- To prevent patients from being affected unnecessarily from the use of drugs.
- To provide information to healthcare professionals and patients to optimize the safe and effective use of medicines.
- Before to supply the product to the market the pre-marketing study was were the limited number of patients was tested, hence to get more information from the post-marketing the pharmacovigilance plays an important role.
- In clinical trials patients are selected, the population is usually clean and limited in number, conditions of use in trials differ from those in clinical practice and the duration of trials is limited.
- To gain more information regarding medicinal products from special types of populations like pregnancy cases, pediatric and elderly patients as there are limited numbers of scope available from such kind of population.
- The scope of studying the effect of medicine increases in larger populations and a lot more information can be gathered which helps in the proper evaluation of effectiveness and safety of the drug.
- To design the programs and procedures for collecting and analyzing reports from health care professionals (HCPs), patients, relatives, lawyers, journalists, etc.
- Early detection of unknown/unexpected safety problems.
- Due to the above listed same reason, the health authorities demand from the manufacturers to continue this vigilance even after launching the therapeutic product for general use.
- As preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of marketing authorization or from occupational exposure and promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public is the main objective of pharmacovigilance.
Adverse event (AE)
It is any untoward medical occurrence that may present during treatment with the pharmaceutical product but does not have to have a causal relationship with this treatment.
Guys, if you want to make a career in pharmacovigilance then this is very important terminology in this field. You should first understand the difference between adverse events and adverse drug reactions. Please check the below terminology for an adverse drug reaction.
Adverse drug reaction (ADR)
An adverse drug reaction is a response to a medicinal product that was noxious and unintended. Here, the response in this context means that a causal relationship between medicinal products and adverse events was at least a reasonable possibility.
Seriousness and severity
Professionals who are new to the clinical trial or pharmacovigilance field are often confused with the concept of 'Serious Adverse Events (SAEs)' and 'Severe Adverse Events". Severity is not synonymous with seriousness. Seriousness (not severity) considered as a guide for defining regulatory reporting obligations. However, severity is the intensity towards seriousness. In general, severity can be categorized as mild, moderate and severe. However, seriousness is categorized below as...
The FDA defines a serious adverse event (SAE) as one when the patient outcome is one of the following:
Seriousness and severity
Professionals who are new to the clinical trial or pharmacovigilance field are often confused with the concept of 'Serious Adverse Events (SAEs)' and 'Severe Adverse Events". Severity is not synonymous with seriousness. Seriousness (not severity) considered as a guide for defining regulatory reporting obligations. However, severity is the intensity towards seriousness. In general, severity can be categorized as mild, moderate and severe. However, seriousness is categorized below as...
The FDA defines a serious adverse event (SAE) as one when the patient outcome is one of the following:
- Death
- Life-threatening
- Hospitalization (initial or prolonged).
- Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
- Congenital anomaly.
- Medically significant. (Requires intervention to prevent permanent impairment or damage).
Causality
In simple meaning, causality is the relationship between medicinal products and adverse events. In adverse event report form in general, reporter provides the causality as related, not related, unknown or sometimes not reported as drug-event pair.
Labeling
This is the safety documents prepared on basis of information for healthcare providers on how to use the medicinal product safely and effectively is provided and updated by pharmaceutical companies based on their research and product knowledge. Pharmaceutical manufacturing companies notify the new or updated versions of safety reference information or labeling documents to health authorities.
Guys, this is some basic information regarding common terminologies and the importance of pharmacovigilance. I will post some more interesting topics regarding the same. If you want some information from me, then please join our social media accounts and let me know your comments.
Thanks.
Guys, this is some basic information regarding common terminologies and the importance of pharmacovigilance. I will post some more interesting topics regarding the same. If you want some information from me, then please join our social media accounts and let me know your comments.
Thanks.
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