You are herePHARMACOVIGILANCE AN OVERVIEW

PHARMACOVIGILANCE AN OVERVIEW


About Authors: * Ryali. Jithendra, Dinesh Kumar. Pandurangan, Bandaru. Sowjanya1, Vijayaraj Kumar. Perumal2
1Department of Biotechnology, Acharya Nagarjuna University, Guntur – 522 510, India,
*1-Department of Pharmaceutics, Rahul Institute of Pharmaceutical Science & Research, Chirala-523157, Andhra Pradesh, India.
2-School of Pharmacy, University College Sadaya International,Kuala Lumpur, Malaysia.

ABSTRACT:
Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. This addresses what exactly is pharmacovigilance?  What do we know of its benefits and risks, challenges and the future hold for pharmacovigilance in Indian medicine. Here the main focus on the aims and role of pharmacovigilance in medicines regulation and their Partners. This article describes and discusses the National programme of pharmacovigilance and centre in India. There role in collecting the reports ADRs of medicines. Further effectiveness and risk assessments of therapies are been discussed. The important role played by health care professional, pharmaceutical industries, media, and programmes carried by WHO. Finally the conclusion describes the major challenges and achievements for the future pharmacovigilance programme.

Reference ID: PHARMATUTOR-ART-1005

INTRODUCTION
Pharmacovigilance is an important and integral part of clinical research1. Both clinical trials safety and post marketing pharmacovigilance are critical throughout the product lifecycle. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines.” Pharmacovigilance is still in its infancy in India and there exists very limited knowledge about the discipline.

While major advancements of displine of pharmacovigilance have taken place in the western countries not much has been achieved in India. There is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product. This will enable integration of good pharmacovigilance practice in the process and procedures to help ensure regulatory compliance and enhance clinical trials safety and post marketing surveillance.

Pharmacovigilance is not new to India and has infact been going on from 19982. When India decided to join the uppasla centre for adverse event monitoring. The importance of pharmacovigilance is withdrawls the regulatory agencies, media; consumers have become more aware about the benefit and risks of medicines. “An adverse event is defined as any un toward medical occurrence that may present during treatment with a drug but which does not necessarily have a relationship with its use.” “An adverse drug reaction is any noxious, unintended and undesired effect of a drug, which occurs at a dose used in human for prophylaxis, diagnosis, therapy or modification of physiological function.” Spontaneous reporting of adverse drug reaction and adverse events is an important tool for gathering the safety information for early detection. In recent years many Indian companies are increasing the investment in research and development and are enhancing their capacity to develop and market new drugs with their own research efforts.

Further India is becoming a hub for clinical research activities due to its large population, high enrolment rate and low cost 3. Moreover, the lag period when a drug is placed for the first time on the market in USA, Europe, and Japan or somewhere in the world and its subsequent availability in India has decreased considerably. As a result, for such drugs the long term safety data is not available and the time of their marketing in India. This is clear by the fact that all the high profile drugs that have been recently withdrawn were available in Indian market. In such cases, the Indian regulatory agencies cannot count on the experience of other market to assess benefit risk balance of a drug.

There by stressing the importance of developing their own adequately designed pharmacovigilance system in India. For an effective pharmacovigilance system to be functional and efficient, all the stake holders need to be alert and attentive throughout the life cycle of a medicinal product in the market .The office of the Drugs Controller General of India(DCGI) has been making sincere attempts for the implementation the National Pharmacovigilance programme (NPP) in India. To full fill the pharmacovigilance obligations for its marketed products, as per regulations, a generic company in India is mainly to carry out the following activities. Collection monitoring, and reporting of spontaneous adverse reactions, including expedited reporting of serious unexpected adverse reactions and preparations. Pharmacovigilance help to prevent adverse drug effects: Medical science has grown in leaps and bounds since the days of Hippocrates. Modern day pharmaceutical drugs are really life saves. They have increased life expectancy and improved the quality of life for millions of people. But there is the other side of the coin as well; these drugs sometimes have very adverse effects that can even be life threating.

WHAT IS PHARMACOVIGILANCE?
There is a need to monitor the effects of drugs before and after it’s successfully tested and launched in the market. Pharmacovigilance involves monitoring and assessing the quality of drugs, detection and preventing of any adverse effects of drugs. Pharmacovigilance involves evaluating information provided by health care providers, pharmaceutical companies and patients in order to understand the risks and benefits involved with a particular drug. Pharmaceutical companies spend millions of dollars and a considerably long time in developing new drugs.

They again spend a lot of money in conducting clinical trials before the drugs are approved and launched in the market. It is recognized that information technology (IT) has entered and transformed the world of health care and clinical medicine in which the work of doctors and the care of patients proceed with higher quality, efficiency and lower costs. It is also no secret that IT has merged in to clinical safety practice and sparks the creation of worldwide pharmacovigilance systems for safety signal detection.

The IT transformative force and health it adoption have fundamentally changed the conduct of clinical research, practice of medicines, and medicinal safety monitoring. In today’s world, pharmacovigilance pushes new boundaries and it is no longer sufficient to simply report adverse events along with efficacy and quality requirements.

Regulators are demanding proactive surveillance programs that include comprehensive risk management plans and signal detection /analysis throughout a clinical products’ life cycle.

Ø  This addresses what exactly is pharmacovigilance?

Ø  What do we know of its benefits and risks?

Ø  What challenges are out there preventing its wide spread usage?

Ø  And what does the future hold for pharmacovigilance in worldwide medicine?

It is now generally accepted that part of the process of evaluating drug safety needs to happen in the post marketing phases through judgment as to whether and how this might happen lies with the regulators. The stronger the national systems of pharmacovigilance and adverse drug reaction (ADR) reporting, the more likely reasonable regulatory decisions will be made for the early release of new drugs with the promise of therapeutic advances. Care full safety monitoring is not restricted, however to new drugs or to significant therapeutic advances. It has a critical role to play in the introduction of generic medicines, and in review of the safety profile of older medicines already available as well, where new safety issues may have arises. While spontaneous reporting remains a corner stone of pharmacovigilance in the regulatory environment, and is indispensable for signal detection, the need for more active surveillance has also become increasingly clear. Without information on utilization and on the extent of consumption, spontaneous reports are unable to determine the frequency of an ADR attribution to a product or its safety in relation to a comparator.

More systematic and robust epidemiological methods that take in to account the limitations of spontaneous reporting or post marketing studies are required to address these key safety questions. They need to be incorporated in to post marketing surveillance programs. This includes the use of pharmaco epidemiologic studies.

These activities are under taken with the goal of identifying adverse events and understanding, to the extent possible, their nature, frequency, and potential risk factor. Pharmacovigilance in principle involves the identification and evaluation of safety signals. Safety signal refer to a concern about an excess of adverse events compared to what would be expected to be associated with products use.

Signals can arise from post marketing data and other sources, such as pre clinical data and events associated with other products in the same pharmacological class4 . Pharmacovigilance is particularly concerned with adverse drug reactions. Many other issues are also relevant to pharmacovigilance science are substandard medicines, medication errors, lack of efficacy reports, use of medicines for indications that are not approved and for which there is inadequate scientific basis, case reports of acute and chronic poisoning, assessment of drug related mortality, abuse and misuse of medicines, adverse interactions of medicines with chemicals, other medicines and food.

AIMS OF PHARMACOVIGILANCE:
Ø  Improve patient care and safety in relation to the use of medicines and all medical and Para medical interventions5.                                          

Ø  Research the efficacy of drug and by monitoring the adverse effects of drugs right from the lab to the pharmacy and then on for many years.

Ø  Pharmacovigilance keeps track of any drastic effects of drugs.                                       

Ø  Improve public health and safety in relation to the use of medicines.

Ø  Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.               

Ø  Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

The processes involved in the clinical development of medicines. Once put onto the market, a medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population. At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. In some cases as few as 500 subjects, and rarely more than 5000, will have received the product prior to its release.

For good reason, therefore, it is essential that new and medically still evolving treatments are monitored for their effectiveness and safety under real-life conditions post release.

More information is generally needed about use in specific population groups, notably children, pregnant women and the elderly, and about the efficacy and safety of chronic use, especially in combination with other medicines.6 Experience has shown that many adverse effects, interactions (i.e. with foods or other medicines) and risk factors come to light only during the years after the release of a medicine

Table 1 Classical example of serious and unexpected adverse reactions

Medicine

Adverse reaction

Aminophenazone (amidopyrine)

Agranulocytosis

Chloramphenicol

Aplastic anaemia

Clioquinol

Myelooptic neuropathy (SMON)

Erythromycin estolate

Cholestatic hepatitis

Fluothane

Hepatocellular hepatitis

Methyldopa

Haemolytic anaemia

Oral contraceptives

Thromboembolism

Practolol

Sclerosing peritonitis

Reserpine

Depression

Statins

Rhabdomyolysis

Thalidomide

Congenital malformations

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Sreevalli (not verified)
Hello Sir, This article has

Hello Sir,

This article has very good information on Pharmacovigilance... It is very useful. Really a great work. Thank you sir

annonymous (not verified)
Hi First of all i thank the

Hi
First of all i thank the author who posted this article.
It was a new information for me.
I am a M pharm(pharmacology) student.
I want to know that who all can involve in this pharmacovigilance studies and also is there any opportunity for m pharm students in this particular post.
pls reply for this to ma mail nuhman191@gmail.com

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Regarding plagiarism and content posting

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I read article fully and

I read article fully and understood about PHARMACOVIGILANCE. It contains full information abuot the topic. It not a copy and cut, it shows the work. It is compleate article about Challenges of health professionals

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Reply

 

Hello sir,

I am very
glad about your comment on my article ,as you said  it contains the data of WHO but I change it  in to my own way of presentation  and I reffered many of books and articles to submitt this article. Go through this article it will show the difference to the articles in the internet and my article. Please read the full article and give me your comment on this. It is full of my hardwork and dedication towards this article.

By reading this article the readers can understood about PHARMACOVIGILANCE without any confusion unlike other articles.

Thanks for your comment but read article fully and give me your comment, please

I need it to improve my future projects. Sir if you have any data on this topic please send to me. I am very interesting on this topic.

Thank you sir.

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singhalword
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Fraud Artical completely

Its a totaly fraud artical. there is a lot of  soft copy abailable on internet already about this topic. it is based on cut copy and paste. i am requesting to the administration of the pharma shine-2011. kindly see the matter before publication. it will lower the image of this competition.

Thanks and All the best

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Ryali.jithendra
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Pharmcovigilance Overview

 

Hello sir,

I am very
glad about your comment on my article ,as you said  it contains the data of WHO but I change it  in to my own way of presentation  and I reffered many of books and articles to submitt this article. Go through this article it will show the difference to the articles in the internet and my article. Please read the full article and give me your comment on this. It is full of my hardwork and dedication towards this article.

By reading this article the readers can understood about PHARMACOVIGILANCE without any confusion unlike other articles.

Thanks for your comment but read article fully and give me your comment, please

I need it to improve my future projects. Sir if you have any data on this topic please send to me. I am very interesting on this topic. Thank you sir 

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Dear Singhal, We found

Dear Singhal,

We found that Article is not fraud...And if it is then author will lose the marks...

PharmaShine is for express your way of presentation and information...

Winners will be announced only after checking all the parameters of the Article... Even we gave the information on pattern also that how to make articles for the competition. So if any one not reaching the impact mark then one will lose the marks.

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