Pharmacovigilance for Drug Safety Monitoring
B.N.S. Sailakshmi*1 and T. Yamini Latha2
1Department of Pharmaceutics, Sri Padmavathi Mahila University, Tirupathi, India
2Department of Pharmaceutical Chemistry, Sri Padmavathi Mahila University, Tirupathi, India
- *Corresponding Author:
- B.N.S. Sailakshmi
Department of pharmaceutics
M. Pharmacy, Sri Padmavathi Mahila University, Tirupathi, India
E-mail: [email protected]
Received Date: 21/07/2016; Accepted Date: 25/08/2016; Published Date: 28/08/2016
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Now a day’s usage of medicine has been increasing day by day and pharmaceutical companies are developing new drug products and humans begin taking more and effective drugs as well as investigational drugs. Safety and efficacy are the two major predominant considerations about any drug. In each and every phase of a products life cycle pharmacovigilance plays a critical role. Thus, significance of pharmacovigilance is developing and became very important and inseparable part of clinical research.
Pharmacovigilance, Adverse Drug Reaction, Post Marketing Surveillance.
Pharmacovigilance is majorly known as drug safety. It is a main integral part of clinical research. Throughout the product life cycle clinical trials safety and post marketing pharmacovigilance plays a critical role [1-3]. The word pharmacovigilance is derived from two words one Parmakon is a Greek word which means “drug” and another vigilare is a Latin word which means to keep awake or to keep watch.” Pharmacovigilance is “defined as the pharmacological science relating to the detection, understanding, assessment and prevention of adverse effects, particularly long term and short term adverse effects of medicines” [4-8].
According to WHO Pharmacovigilance (PV) is the pharmacological science relating to the detection, evaluation, understanding and prevention of adverse effects, especially long term and short term side effects of medicines .
Aims of Pharmaacovigilance
✓ To improve patient care & safety
✓ To contribute to assessment of benefit, harm & effectiveness of medicine
✓ To Identify previously unrecognized adverse effects of the drugs
✓ To Promote rational & safe use of medicine
✓ To Promote education & clinical training
✓ To Identify patient related risk factors of ADR such as dose, age, gender
✓ Any response to a drug which is unintended , occurs at particular doses
✓ To diagnose or therapy of disease, or for the modification, of physiological function.
Pharmacovigillance helps in removal of approved and licensed products from the market because of clinical toxicity, which is caused by adverse drug reactions in the body. Below is a short note on adverse drug reactions [10-19].
Adverse Drug Reactions
ADR is a response to drug, which alters the normal physiological function of the body, factors which causes ADR includes mainly multiple drug therapy, age & gender.
They are mainly two types of ADR
TYPE A: These are common, predictable, dose dependent, they are seldom fatal
TYPE B: These are uncommon, unpredictable, dose independent; they involve relatively high rates of serious morbidity [20-26].
High index of ADRs are to be successfully diagnosed by clinicians, it is the high level of awareness about the drugs being used. Pharmacovigilance, unify all the information in all aspects of benefit-risk ratio of drugs in a population [27-34]. Events that occur when a particular drug is administered are recorded in the patient’s notes by drug monitoring then an adverse reaction of the drug and the activity of the drug being monitored; these studies aim to detect ADR of drugs [34-39].
Reporting of ADRs after marketing must be actively encouraged and should involve all those concerned including doctors, pharmacists, nurses, patients and pharmaceutical companies. To develop and enhance this, a culture of learning about pharmacovigilance for health care students must be started in their early professional carrier [40-45]. This will help healthcare professionals to understand and also create awareness by giving adequate information to patients at their initial phase of treatment about the potential benefits and risks of the therapy [45-52].
In the process of development of a new pharmaceutical drug, there are many stages they are preclinical trails, then clinical trials this includes four phases. In this the first three phase’s helps in the determination of safety, efficacy and side effects of the developed drug product respectively, whereas in case of fourth phase post marketing studies are carried out for determining safety in patients. Thus post marketing surveillance helps in uplifting the knowledge of pharmacovigilance [53-59].
Post Marketing Surveillance
Pharmaceutical drug or medical device is monitored often after it has been released in to the market, Since drugs are approved based of clinical trials which involve relatively small number of people who do not have any other medical complications, post marketing surveillance play an important role to know the ADRs of drugs after they have released in to the market [60-67].
✓ spontaneous ADR reporting
✓ Prescription event monitoring
✓ Electronic health records
✓ Patient Registers
Spontaneous ADR Reporting
It is necessary to report ADRs to Pharmacovigilance department by doctors, health care professionals, they are provided with forms where they can notify the suspected ADRs they detect, these forms are greatly available to health care professionals to encourage the reporting, it helps in spontaneous reporting for all the drugs, it is affordable method of detecting rare ADRs. This spontaneous reporting helps to identify many unexpected ADRs, it helps in withdrawal of many marketed drugs, and information being provided which guide safer use of the product [68-76].
ADRs which occurred by particular drugs should be analyzed and reported, Pharmaceutical manufacturers have to communicate with the doctors at the clinical level regarding the ADRs by [77-82].
✓ Changing Medication formula if necessary
✓ Implementing new prescribing procedures
✓ Implementing new dispensing procedures
✓ Educating the professional staff
✓ Educating the professional staff
Prescription Event Monitoring
It involves health professionals submitting all the clinical events reported by the patient to the prescribed new drug .
This method mainly focusses on studying the safety of new medications that are used by general practitioners in this method .
In this method patients being prescribed by drugs are monitored .
Electronic Health Records
It is a computer stored collection of health information, about one person linked by a person identifier; it represents the basis for healthcare Information system development .
To bring together patient records, it is time consuming and less expensive .
Figure 1: The Pharmacovigilance Frame work
Pharmacovigilance Programme of India (PVPI)
It officially starts on 23rd November 2004 at New Delhi, is under the control of CDSCO (Central Drug Standard Control Organization), Directorate general of health services, Indian pharmacopeia commission (Ghaziabad) [88-94]. The program is conducting by NCC (National Coordinating Centre) to ensure that the benefits of use of medicine against the risks [95-103].
✓ To monitor ADRs
✓ To create awareness among health care professionals about ADRs
✓ To monitor benefit-risk profile of medicines
✓ Support the CDSCO
Pharmacovigilance gives information to assess the safety profile of a drug; the success of pharmacovigilance is largely dependent on the participation of professionals of health care countrywide to report ADRs/AEs, Current progress in Pharmacovigilance is marked by increase in use of databases to make the process more proactive and organized. It must be in everyone’s interest to develop safe and effective medicines to patients.
- De Carvalho PM et al.Brazilian Regulation in Pharmacovigilance: A Review. PharmaceutReg Affairs.2016;5:164.
- World Health Organization (WHO).The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products. WHO, Geneva2002.
- MuhannadRMS, et al. Physicians’ knowledge about pharmacovigilance in Iraq. J Pharmacovigilance.2016;4:214.
- GildeevaGN and Yurkov VI. Pharmacovigilance in Russia: Challenges, Prospects and Current State of Affairs. J Pharmacovigil. 2016;4:206.
- Rehan HS, et al. Physician's guide to pharmacovigilance: terminology and causality assessment.Eur J Intern Med. 2009;20:3-8.
- Saygi S, et al. Pharmacovigilance Awareness among the Community Pharmacists and Pharmacy Students in the Turkish Republic of Northern Cyprus. J Pharmacovigil. 2016;4:204.
- Rajesh R, et al. An educational intervention to assess knowledge attitude practice of pharmacovigilance among health care professionals in an Indian tertiary care teaching hospital. Int J PharmTech Res. 2011;3:678-692.
- Sanaa A, et al. Awareness and Perception of National Pharmacovigilance Center among Lebanese Medical Staff.J Pharmacovigilance.2016;4:199.
- KumarD, et al. PharmacovigilanceProgramme in India: Current Status and Its Per- spectives. J PharmacolToxicol Studies. 2014;3:34-36.
- Pimpalkhute SA, et al. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring in resident doctors of a tertiary care teaching hospital. Indian J Med Sci. 2012;66:55-61.
- Karampola MI andEmmanouilides CE.Pharmacovigilance for Biosimilars. J Pharmacovigil. 2016;4:196.
- TolentinoMJ. Macular Supplements Containing Zinc and Vitamin A Should Be Replaced with Meso-Zeaxanthin, Lutein and Zeaxanthin: An Ophthalmic Need for Pharmacovigilance. J Pharmacovigil. 2016;4:195.
- SethiMK. Pharmacovigilance: Challenges in India. J Pharmacovigil. 2016;4:194.
- Toklu HZ, et al. The Knowledge and Attitude of the Healthcare Professionals towards Pharmacovigilance and Adverse Drug Reaction Reporting in Northern Cyprus. J Pharmacovigilance. 2016;4:193.
- European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). 2012.
- Obara T,et al. Knowledge of and Perspectives on Pharmacovigilance among Pharmacists in the Miyagi and Hokkaido Regions of Japan. J Pharmacovigilance. 2016;4:192.
- Magyar I. An Overview on the Third Annual Pharmacovigilance Forum. ClinPharmacolBiopharm. 2015;5:e122.
- PredaA. Pharmacovigilance in the New Millennium: Challenges, Opportunities and New Directions. J Pharmacovigilance. 2013;1:e106.
- Kaur I, et al. Effective Reporting by Pharmacist in PharmacovigilanceProgramme of India.AdvPharmacoepidemiol Drug Saf. 2015;4:197.
- Hama R. The Mechanisms of Adverse Reactions to Oseltamivir: Part II. Delayed Type Reactions. ClinMicrobiol. 2015;4:224.
- KlepperMJ. The periodic safety update report as a pharmacovigilance tool. Drug Safety. 2004;27:569-578.
- Kowalski CJ and MrdjenovichAJ. Pharmacovigilance Observed: Why Watchful Waiting will Work. J ClinDiagn Res. 2015;3:114.
- Camacho LH and Pai N. Pharmacovigilance of Oncology Biosimilars. J Pharmacovigilance. 2015;S3:001.
- Khawaja TM, et al. Pharmacovigilance A Need for Best Patient Care in Pakistan A review. Journal of Pharmaceutical Science and research. 2011;3:1566-1584.
- Salim M, et al. The Current Perspective of Community Pharmacists towards Pharmacovigilance. J Pharmacovigil. 2015;3:180.
- Napoleone E andScasserra C. Pharmacovigilance in Pediatric Age: The Role of Family Pediatricians-Medicines for Children Research Network (FP-MCRN). J Pharmacovigilance. 2015;3:168.
- Raza A and Jamal H. Assessment of Knowledge, Attitudes and Practice among the Medical and Pharmacy Students towards Pharmacovigilance and Adverse Drug Reactions in Abbottabad, Pakistan. J Pharmacovigilance. 2015;3:173.
- Marisol HSO, et al. Implementation of a Robust Pharmacovigilance Method for Filgrastim Non-Innovator Products in Cancer Patients in Routine Clinical Practice Complying With Mexican Regulations for Biocomparables. J Pharmacovigilance. 2015;3:174.
- Livio F, et al. Pharmacovigilance. Rev Med Suisse. 2012;8:116-119.
- Chauhan A and Mittu B. An Outlook to Pharmacovigilance in India. Pharm Anal Acta. 2015;6:e179.
- Ozcagli E, et al.Biosimilar Drugs and Pharmacovigilance. Pharm Anal Acta. 2015;6:416.
- Reis CD, et al.Pharmacovigilance in Cabo Verde: Measuring the Awareness and Knowledge by Healthcare Professionals. J Pharmacovigil. 2015;3:177.
- Abjaude SAR, et al. Strategies to Stimulate Actions for Pharmacovigilance Decentralization. 2015;3:165.
- Priyanka R. Role of Pharmacovigilancecentre in Detection and Prevention of Medication Errors. J Pharm Pharmaceut Sci. 2013;3:85-88.
- Janarthanan VV. Pharmacovigilance Outsourcing and Career Advantages for Indian Professionals. 2013.
- KotturiN and KotturiPK. Role of Pharmacovigilance in Health Care Industry. J PharmacolToxicol Stud. 2015;3:7-9.
- Charfi R,et al. PRES Induced By Cyclosporin with Normal Blood Concentrations in a Bone MarrowRecipient. J Drug MetabToxicol. 2015;6:178.
- TananiSD,et al. Signal Management of Disproportionate Reporting in Moroccan Pharmacovigilance: The Lower Limb Edema Induced by Anti-Tuberculosis Drugs. J Pharmacovigilance. 2015;3:161.
- World Health Organisation. Safety monitoring of medicinal drugs: Guidelines for setting up and running up of pharmacovigilancecentre WHO. 2000.
- Vallano A,et al. Hospital Doctors’ Views and Concerns about Pharmacovigilance. J Pharmacovigilance. 2015;3:160.
- EChY. Pharmacovigilance for Novel Oral Anticoagulants: Why is It So Crucial?. J Pharmacovigilance. 2015;3:e135.
- Naik P. The Future of Pharmacovigilance. J Pharmacovigilance. 2015;3:159.
- Wertheimer A. The Impact of Personalized Medicine on Pharmacovigilance. J Pharmacovigilance. 2015;3:e133.
- Gould AL. Practical pharmacovigilance analysis strategies. Pharmacoepidemiol Drug Saf. 2003;12:559-574.
- Garlapati S andPriyanka S. Cradles of Signals for Pharmacovigilance Process. J Pharmacovigil. 2015;3:e126.
- Garlapati S andNagandla S. Risk Management Plan Its Importance and Emphasys on Pharmacovigilance Activities. AdvPharmacoepidemiol Drug Saf. 2015;4:e128.
- Elhassan GO. Pharmacovigilance: Clinical Perspectives towards Patient Safety. J Pharmacovigil. 2015;3:e129.
- Borg JJ, et al.Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Saf. 2011;34:187-197.
- Swain S andPatraCN. Impact of Pharmacovigilance in Healthcare System: Regulatory Perspective. PharmaceutReg Affairs. 2014;3:e143.
- Yerramilli A,et al. A Pharmacovigilance Study Using Tracer Techniques. AdvPharmacoepidemiol Drug Saf. 2014;3:165.
- Tawde SA. Generic Pharmaceuticals: Is Pharmacovigilance Required?. J Pharmacovigil. 2014;2:e124.
- Maldonado C, et al. Use of STOPP/ START Criteria to Perform Active Pharmacovigilance in the Elderly. J Pharmacovigilance. 2014;2:146.
- De Ponti F. New Approaches in Pharmacovigilance in the Pharmacogenomic Era: A Call for Papers. J Pharmacovigilance. 2014;2:e122.
- Zhang L,et al.Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: current status and future perspective. J Ethnopharmacol. 2012;140:519-525.
- Hamad F and Elnour A. The Role of Clinical Pharmacist in Pharmacovigilance. J Pharmacovigilance. 2014;2:e121.
- Allabi AC and Nwokike J. A Situational Analysis of Pharmacovigilance System in Republic of Benin. J Pharmacovigilance. 2014;2:136.
- Ortiz JAA. Pharmacovigilance Legal Requirements for Marketing Authorization Holders in Spain. J Pharmacovigilance. 2014;2:132.
- Miller V, et al. Pharmacovigilance and global HIV/AIDS.CurrOpin HIV AIDS. 2012;7: 299-304.
- Magyar I. The Surveillance of the Adverse Drug Reaction in Romania:Pharmacovigilance in Romania. ClinPharmacolBiopharm. 2014;S2:e001.
- Palaian S, et al. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract (Granada). 2011;9:228-235.
- Agrawal P. Drug Discovery and Development: An Insight into Pharmacovigilance. J Pharmacovigilance. 2014;2:e120.
- PatilJS. Pharmacovigilance in India. J Pharmacovigilance. 2014;2:e119.
- Richards NL, et al. Merging Wildlife and Environmental Monitoring Approaches with Forensic Principles: Application of Unconventional and Non-Invasive Sampling in Eco-Pharmacovigilance. J Forensic Res. 2014;5:228.
- Dunning T and Sinclair A. Glucose Lowering Medicines and Older People with Diabetes: The Importance of Comprehensive Assessments and Pharmacovigilance. J Nurs Care. 2014;3:160.
- Lu ZK, et al. Systematic Approach to Pharmacovigilance beyond the Limits: The Southern Network on Adverse Reactions (SONAR) Projects.AdvPharmacoepidemiol Drug Saf. 2014;3:149.
- SimonLS. Pharmacovigilance: towards a better understanding of the benefit to risk ratio. Ann Rheum Dis. 2002;61:ii88-ii89.
- ArifKhanM, et al. Pharmacovigilance in India: A Need Indeed. J Pharmacovigilance. 2014;2:126.
- Yongyang X, et al. Quantitative Pharmacovigilance Modeling for TCM Injections Adverse Event Reporting. J Pharmacovigilance. 2014;2:124.
- EChY. Pharmacovigilance and NSAIDs J Pharmacovigilance. 2014;2:e116.
- Limuaco OM, et al. The Extent of Pharmacovigilance Awareness among Pharmacy Senior Students ofCentro Escolar University, Manila, Philippines. J Pharmacovigilance. 2014;2:121.
- Madurga SM. Pharmacovigilance, the "mother" of all surveillances. OFIL Rev. 2014;24:201-203.
- Thota P, et al. Weight gain in Association with Insulin Use - An Analysis of Individual Case Safety Reports an Indian Database. J Pharmacovigilance. 2014;2:119.
- Zuniga L and Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf. 2010;19:661-669.
- Preda A. Pharmacovigilance and Beyond. J Pharmacovigilance. 2013;1:e114.
- Wertheimer AI. The Curious Path of Pharmacovigilance. J Pharmacovigilance. 2013;1:e109.
- Feng X, et al. Assessing Pancreatic Cancer Risk Associated with Dipeptidyl Peptidase 4 Inhibitors: Data Mining of FDA Adverse Event Reporting System (FAERS). J Pharmacovigilance. 2013;1:110.
- Preda A. Pharmacovigilance in the New Millennium: Challenges, Opportunities and New Directions. J Pharmacovigilance. 2013;1:e106.
- Bencheikh RS andBenabdallah G.Medication errors: pharmacovigilancecentres in detection and prevention. Br J ClinPharmacol. 2009;67:687-690.
- Mishra H and Kumar V. Pharmacovigilance: Current Scenario in a Tertiary Care Teaching Medical College in North India. J Pharmacovigilance. 2013;1:108.
- De Ponti F. Global Perspectives in Pharmacovigilance. J Pharmacovigilance. 2013;1:e108.
- ElkalmiRM, et al. The Teaching of Subjects Related to Pharmacovigilance in Malaysian Pharmacy Undergraduate Programs. J Pharmacovigilance. 2013;1:106.
- Prakasam et al. Knowledge, perception and practice of pharmacovigilance among community pharmacists in South India. Pharmacy Practice. 2012;10:222-226.
- KumarV. Challenges and Future Consideration for Pharmacovigilance. J Pharmacovigilance. 2013;1:102.
- Raschi E,et al. Macrolides and Torsadogenic Risk: Emerging Issues from the FDA Pharmacovigilance Database. J Pharmacovigilance. 2013;1:104.
- Al-AmiryMHA. Pyrazinamide Induced Photosensitivity: A Case Report from Iraq. J Pharmacovigilance. 2013;1:103.
- Chablani L. Pharmacovigilance of Biosimilars. J Pharmacovigilance. 2013;1:e107.
- Montanari-Vergallo G. Recent Developments in EU and US Pharmacovigilance Legislation. J Pharmacovigilance. 2013;1:e105.
- Meyboom RH, et al. Pharmacovigilance in perspective. Drug Saf. 1999;21:429-447.
- Flower DR. Pharmacovigilance, Drug Repositioning, and Virtual Screening. J Pharmacovigilance. 2013;1:e103.
- Dave VS. Current Trends in Pharmacovigilance. J Pharmacovigilance. 2013;1:e104.
- Abideen PS,et al. Implementation of Self Reporting Pharmacovigilance in Anti Tubercular Therapy Using Knowledge Based Approach. J Pharmacovigilance. 2013;1:101.
- Persaud-Sharma V and Zhou SF. Incorporation of New Technologies into Global Pharmacovigilance. J Pharmacovigilance. 2013;1:e102.
- Zorych I, et al. Disproportionality methods for pharmacovigilance in longitudinal observational databases. Stat Methods Med Res. 2013;22:39-56.
- Garlapati S.Pharmacoepidemiology&Pharmacovigilance: Powerful Emerging Areas to Conquer More. AdvPharmacoepidem Drug Safety. 2012;1:e110.
- Jeetu G and Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. J Young Pharm. 2010;2:315-320.
- Whitstock MT, et al.Randomised Controlled Trials and ‘Unexpected’ Adverse Events Associated with Newly Released Drugs: Improvements in Pharmacovigilance Systems are Necessary for Real-Time Identification of Patient Safety Risks. J Clinic Toxicol. 2011;S2:001.
- Labadie J. Forensic pharmacovigilance and substandard or counterfeit drugs. Int J Risk Saf Med. 2012;24:37-39.
- Gaïes E,et al.Caffeine Medication Error in Newborn Inducing Therapeutic Inefficiency: A Case Report. J Clinic Case Reports. 2012;2:112
- Garlapati S.Pharmacoepidemiology- A Lot beyond Pencil and Paper Research. AdvPharmacoepidem Drug Safety. 2012;1:e103.
- AlmenoffJS. Innovations for the future of pharmacovigilance. Drug Saf. 2007;30:631-633.
- Gaies E,et al. Methotrexate Side Effects: Review Article. J Drug MetabToxicol. 2012;3:125.
- Kane-Gill SL and McCartney LN. The Elusive Quest to Maximize Voluntary Incident Reporting and Optimize Pharmacovigilance: A Matter of the Reporting Mechanisms or More? AdvPharmacoepidem Drug Safety. 2012;1:e108.
- Harmark L and van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives.Eur J ClinPharmacol. 2008;64:743-752.