Pharmacovigilance: An Overview
Nikita R. Nikam*, Rohan R. Vakhariya, Dr. C. S. Magdum
Rajarambapu College of Pharmacy, Kasegaon, Dist-Sangli Tal-Walwa, Maharashtra.
Pharmacovigilines can be defined as science and activity to identify, evaluate, understand and prevent against any adverse drug reaction or any other drug-related problems Data collected from PV recommendations on CVSCO CDSCO has already instructed the marketing authority holder (MAH) to comply with it and has also done research on Drugs and Cosmetics Act and Rules. The emergence of Pharmacovigilians in India is up to 1986, when the formal ADR monitoring system comprises of 12 regional centers, each has a population of 50 million. National Pharmacology Program established in January 2005. Operational overview of pharmacovigilens begins with a variety of sources of safety, in which everyone has the capability to create personal hair, including clinical trials data, safety call center, automatic reports and material discovery. The overall data is analyzed about security problems and the risks against profit are assessed and regular security update reports (PSURs) are submitted to the regulatory authority as additional security information is collected. It's been in the life of the product.
According to WHO, Pharmacovigilines is defined as “ADR or any other pharmaceutical problem, such as the introduction of, evaluation, understanding and prevention(1). Pharmacovigilants are actually maintained for marketing. After landing on the market, there are many reasons for the maintenance of medicines which are unnecessary. Components of concern can be classified mainly into two categories–
(A) Human component
(B) Post marketing topics.
Human factors considered:
i) Insufficient evidence of security from a clinical trial because they are of short duration, for most of the weeks
(ii)Most of the animals are not imitated by human pharmacodynamics and pharmacokinetics during clinical trials.
(iii)During clinical trials, population size is limited to -5000 and for most small 500 volunteers (iv) the population is narrow and age and gender are specific.
Adverse drug reactions (ADR) are defined by WHO as “any noxious and unintended response to a medicine which might occur at doses utilized for prophylaxis, diagnosis or treatment.”
Pharmacovigilance is defined as “science and activity to identify, evaluate and prevent adverse drug responses in humans.” Pharmacovigilance has been considered as a type of continuous monitoring of unwanted effects and other safety-related aspects of drugs, which are already marketed.
The pharmacovigilance has been known to play an important role in rational use of drugs, by providing information about the adverse effects possessed by the drugs in general population. The present review presents in brief about the relevance, need, functioning, role, and importance of pharmacovigilance. (2)
Pharmacovigilance during clinical research:
Adverse event during clinical practice
1. Present to the regulatory authority in the specified period of time
2. All Indicators and Ethics Committees Indicate
3. Drug Safety review by independent drug safety supervision boards
4. Annual Report Provides
5. Summary and analysis of all serious adverse events
6. Animal safety study new safety conclusions. (6)
PHARMACOVIGILANCE POLICIES, REGULATIONS, AND GUIDANCE DOCUMENTS:
Major regulatory shareholders pave the way for global regulation of pharmacovigilisation The United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japan Agency for Pharmaceuticals and Medical Devices (PMDA). To USA, The rules of the federal regulations are legally binding in accordance with European national laws and regulations.
The instruction reflects current reflections on a topic and requires members to normalize the condition Objective, it is necessary to apply in national law over a given period. Guiding. Documents, guidelines and recommendations are not legally binding, but must be respected and plays an important role in the current practice.
Global principles are assimilated by the International Conference on Harmonization (ICH). ICH E1eE2F focuses on clinical safety. ICH E 2 AEC (clinic) Security Data Management), E2D (Post-Approval Security Data Management: Definition and Rapid Notification), E2E (Pharmacovigilance Planning) and E2F Security Update Report).
ICHE6 (Good Clinical Practice) describes the responsibilities and expectations of all stakeholders in the conduct of clinical trials. (3)
History of pharmacovigilance in India:
However, in 1997, the WHO located in India in Uppsala (Sweden) joined the drug adverse reaction surveillance program. As this effort failed, the National Pharmacovigilance Program, sponsored by WHO and funded by the World Bank, was implemented as of 1 January 2005 for India. The national pharmacovigilance program, established in January 2005, was overseen by the National Anti-Drug Advisory Committee, which is part of the New Drug Organization (CDSCO).
Information gathered across the country and in the Apache monitoring center in Sweden, as well as in committees of two central-south-west departmental centers (located in the Department of Clinical Pharmacology, Seth GS Medical Collage and KEM Hospital, Mumbai) and in the Northeast Regional Center (Pharmacology, AIIMS section, New Delhi). Three regional centers will report to Mumbai Central and two to New Delhi.
Each regional center will have peripheral centers.There are currently 26 peripheral centers. (2)
In 1989, DCGI initiated the start of the Pharmacovision program in India, with 6 ADR monitoring centers in Delhi, Mumbai, Calcutta, Lucknow, Chandigarh and Pondicherry, for the primary purpose of automatic reporting, intensive hospital supervision and focus. As part of this program in 1998, India joined the WHO UMC and was known as the WHO Special Center of GS Sheth Medical College, KEM Hospital, and Mumbai. (2)
In 2004, an effort was made to develop an effective pharmacovigilance system in India with a fund of $ 0.1 million for a period of five years. Two regional centers have been established in this program in Mumbai and Delhi. Five Regional Centers have been set up in Kolkata, Mumbai, Nagpur, New Delhi and Pondicherry. 24 peripheral centers have been started in various medical colleges or pharmacy colleges across the country.
The National Pharmacovigal Program encourages reporting of all suspected adverse reactions to medicines and other medical substances, including herbal, traditional or alternative remedies. The recent schedule Y has been improved which includes the mandatory requirement of post-marketing surveillance of any new medicines. (4)
Ongoing PvPI programme:
Under the Department of Health and Family Welfare, Government of India, Central Drugs Standards Control Organization (CDSCO) introduced the third version of the pharmacovil system in 2010. India is a national coordination center in AIIMS, New Delhi, which was moved to the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in April 2011. (5)
Origin of pharmacovigilance:
After the incident in 1937, there was a new success in this area. Since 1932, sulfanilamide (Prontosil) was used for the treatment of staphtocalak infections; it was launched as syrup of dihydrogenolak solvent. Though tested for the aspects, flavor and odor, its safety was not evaluated before testing. 105 persons and 71 of the children died.) And Diothylanglikol was killed. Due to this tragedy, the American Congress had approved the Food Drug and Cosmetic Act in 1938, in which medicinal producers would have to show scientific evidence of security. Before leaving drugs for sale. Thalidoidide trejomedy is a mile stone of the origin and development of pharmacovigilines.
As a means of pooling existing data on ADRs, WHOs Programme for International Drug Monitoring was started in 1968. Initially a pilot project in 10 countries with established national reporting systems for ADRs, the network has since expanded significantly as more countries worldwide developed national pharmacovigilance centers for the recording of ADRs. Currently, 86 countries participate in the programme, which is coordinated by WHO together with its collaborating centre in Uppsala, Sweden.
The program has three general objectives:
1. A short-term goal is to promote the reporting culture,
2. In the media, a large number of health professionals must include information dissemination and intermediate intentions.
3. The program is a long-term goal as a reference for the maintenance of the drug in the world.
The Indian regulatory authority should be commended for its clinical trials involving suspected serious unexpected adverse reactions (SUSARS) for the planning and implementation of compliance and serious adverse events (SAE) complaints. However, there is a need for adverse effects to be transferred from post-marketing drugs to departmental centers and the WHO surveillance center at the Pharmacovan National Center. The health system also has a high financial cost in the GDR.
Without the need for a long-term safety study conducted by clinical authorities, with the addition of new drugs to market faster and the use of self-medicated drugs, the general public can also disclose themselves in the ADR, with a change to the over-the-counter post-balance. That's it.
The scope and objective are as follows
Prepare a national system for patient safety reports.
Identify and analyze new signals from reported cases.
Advantages of marketing the drug-risk analysis.
Prepare information on the safety of evidence based on the drug
Support regulators in the decision-making process regarding the use of drugs
To prevent / reduce risks, communicate information about the safety of different
stakeholders to drug use. Being a center of excellence for pharmacovil activities
Collaborate with other national centers to exchange information and manage data.
Provide training and consultation support to other national pharmacology centers around the world.
Improve patient care and safety in the use of drugs with medical and paramedical intervention
Demonstrate the effectiveness of the drug by reviewing the results of their adverse reaction profile from the laboratory to the pharmacy for many years.
Monitor the dangerous effects of drugs that improve public health and the safety of drug use;
Promote drugs for safe, logical and cost-effective use;
Encourage understanding, education and training in pharmacovigilance diagnosis; And effective communication with the general public. (5)
Importance of pharmacovigilance:
Drugs seem safe, but security in the "real world" is unclear
Drugs Chronic or frequent drug use
Use with other medicines
The safety of a weak group is unknown.
Persecution of women and elderly women, discrimination against children, torture, rumors and myths about some patients
Can comply, follow and destroy credibility (6)
Pharmacovigilance provide evidence
Drug Issues: Treatment Failure, Counterfeit / Poor Drugs, Drug Interactions, Abuse
Create evidence that will encourage public confidence.
The pharmacovigiline system is highly recommended
Does the reporting system exist?
Ability to monitor?
Risk Management Planning (RMP):
RMP is a strategic security program designed to reduce the risks associated with the product. The three main components
1. Safety report of preclinical and clinical stages
2. Pharmacovellel Plan - The Company should indicate how to resolve the uncertainty (eg additional exercises)
3. Risk Reduction Plan-A schedule of plans for companies experiencing adverse reactions (eg, specialized communication programs, educational exercises, patient or pharmacy registration programs) to reduce frequency or frequency. (6)
NEED OF PHARMACOVIGILANCE
Why do you need pharmacovigilance?
Insufficient amount of security for a diagnostic test
Drugs must be preserved in life.
To die of a disease is sometimes inevitable; To die of drugs is unacceptable. Lekhakhin c. Geneva 2005
It can reveal failures in best practices
· Counterfeit remedies
· Quality problem of dialogue
Adoption and abuse
The moral thing is to know something harmful for another person and say that it is immoral
Confirmation of public trust If something goes wrong, it will happen - Murphy's Law
Promoting the use of medicines and rational use. (7)
Qualification for pharmacovigilance:
Am I eligible to start career in pharmacovigilance?
If you are from any of the below qualification background, then you can foresee a bright career avenue in pharmacovigilance industry:
1. Pharmacy (B. Pharm, M. Pharm, D. pharm)
2. Medicine (BDS, MDS, MBBS, M.D., M.S, MCh)
3. Nursing (B.Sc., M.Sc.)
4. Healthcare industry personnel
5. Life science (B.sc., M.Sc.)
6. Alternative medicines (AYUSH)
Drug Safety Associate
Safety Regulatory Intelligence
PRA Health Science
Candidates of pharmacovigilance can pursue both certificate and diploma courses.
· A Certificate course in pharmacovigilance and pharmacoepidemiology is conducted by Symogen a KPO and can be obtained in 4 months. The fee for this course can cost Rs.50, 000 to Rs.80, 000 depending on where you enroll.
· The Post graduate diploma programme in pharmacovigilance is conducted by the institute of clinical research, India. It is a one year course that cost Rs.1.3 lakhs.
1. The Safety of Medicines in Public Health Programmes: Pharmacovigilance and essential tool, World Health Organizations, 2006, 7.
2. Dr. Subhash C. Mandal1 & Dr. Moitreyee Mandal2*,’Evolution of Pharmacovigilance Programme: Present status in India’, Pharma Times - Vol. 49 - No. 05 - May 2017, Page no.31 & 32.
3. Suzanne Gagnon*, Peter Schueler**, James (Dachao) Fan,’Pharmacovigilance and Risk Management’, Global Clinical Trials Playbook. DOI: 10.1016/B978-0-12-415787-3.00013-8, Page no.145.
4. Mandal S.C., Mandal M, “Regulatory Reformation During Last one Decade to Improve Quality, Safety and Efficacy of Herbal Medicines in India” in “Traditional Medicine and Globalization: The Future of Ancient Systems of Medicine”, 2012, Mukherjee PK Eds., Maven Publishers, Kolkata, 2013.
6. Jarir At Thobari, ‘Importance of Pharmacovigilance for Pharmaceutical Industry’.
7. Shanthi Pal, Quality Assurance and Safety of Medicines,’ The need for Pharmacovigilance’, Page no.6, 10, 12, 16.
Accepted on 28.04.2019 © A&V Publications All right reserved