Role of Pharmacovigilance centre in Detection and Prevention of Medication Errors
Department of Pharmaceutical Analysis, MGR Medical University, Chennai, India
- *Corresponding Author:
- Priyanka R
Department of Pharmaceutical Analysis,
MGR Medical University, Chennai, India.
Received: 15 March 2015 Accepted: 22/12/2013 Accepted: 29 March 2015
Visit for more related articles at Research & Reviews in Pharmacy and Pharmaceutical Sciences
Adverse Events, Patient safety, Clinical Trials, Regulatory agencies
Review on Adverse events reporting system
Adverse events are nothing but any adverse change in health that occurs while the patient is under treatment with some medication [1-4]. Clinical trials plays major role to identify the adverse events or adverse drug reactions by conducting in different cohorts of subjects. These clinical trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and health authority / ethics committee approval is granted in the country where the clinical trial to be conducted [5-8]. Pharmacovigilance deals with the study of detection and prevention of adverse effects particularly in case of long term and short term side effects of drugs.
Regulatory agencies will monitor and concentrate on capturing the data regarding adverse events. They mainly focus on the following data [9-12]:
• To improve patient safety
• To keep proper records of efficacy
• Providing the optimal information to the end-users by conducting the awareness programs
• Finding out new information about hazards associated with drugs.
• Examine changes in Benefits and Risks
• Detecting unknown hazards of drugs which happened previously
Clinical trials are mainly carryout by doctors and sponsored by the investigators. Those who conduct the clinical trials should be reported to the sponsors if any adverse event happened at the earliest [13-17]. If any serious adverse event identified, it should be reported within 24hours via case report forms (CRF), eCRF, or SAE forms [18,19].
Adverse events reporting system process is followed as, collecting the data from various sources like literature, spontaneous data etc. Then the collected adverse event data should be captured in databases . Medical review has to be conducted on the captured case data. Once the review process has been completed then the result of case should be reported to the regulatory agencies.
Notification to the Regulatory Agencies:
• Unexpected serious adverse drug reactions to be submitted to the national regulatory authority within 15 days, if there should arise an occurrence of any life-threatening or death within 7 days it should be reported to regulatory authorities [21-23].
• The case safety reports also known as individual case submission reports for both sorts of early and after approval periods associated to the adverse drug reactions and adverse event reports .
There should be minimum criteria for reporting the adverse events such as:
• An identifiable patient – Age, gender, initials, date of birth, name or contact number of the particular patient. 
• A suspect medicinal product
• An identifiable reporting source
• Any one adverse event
Regulatory agencies mainly review the captured case date to find out either the drug is useful or harmful, to decide that the drug should be released or not, to keep the drug in the market or to withdraw it [26-28]. Every adverse event reported to pharmaceutical industry or regulatory agencies during the Pharmacovigilance process is known as the case study. Case report form and eCRF are used in clinical trials to report the data of patients to sponsor pharmaceutical companies by the physician [29,30].
Drug adverse events investigation and analysis is one of the principal objectives of any clinical trial, Pharmacovigilance science or medication safety depends vigorously on vital methodologies and operational advances that can be applied to any therapeutic areas [31-33]. Adverse event reporting system is done throughout the shelf life period of the pharmaceutical product or device or both before and after approval to examine and analyse its safety profile.
Adverse drug reactions occurred due to combination of drugs, patient’s body condition or overdose etc. There are different types of adverse drug reactions like dose dependent (predictable), dose independent (unpredictable), biological characteristics or delayed effects .
Analyses of ADEs typically concentrate on events surrounding the patient, the prescribing employees, the pharmacy employees, the administering employees, and also the selection of drug, and indeed several ADEs are associated with such procedural issues. These issues typically begin with the assumption that the drug as such has been approved for safe use within the marketplace in accordance with the approved directions. However, the main reason of a patient’s ADE might lie in the design of the randomized controlled trials (RCTs) that supported the approval of that drug for marketing .
Adverse drug events are major causes of morbidity in developed countries, however the medicine involved in these events are trialled and approved on the premise of randomized controlled trials (RCTs), considered the study design which will produce the most effective evidence. Though the main target on adverse drug events has been mainly on processes and outcomes related to the utilization of those approved drugs, attention must be directed to the manner during which the RCT study design is structured [14,24,36]. The implementation of controls to realize internal validity in RCTs is also the very controls that reduce external validity, and contribute to the degree of adverse drug events related to the release of a new drug to the wider patient population. An examination of those controls, and also the effects they can have on patient safety, underscore the importance of knowing regarding how the clinical trials of a drug are undertaken, instead of relying only on the recorded outcomes.
As the majority of recent medications are probably to be prescribed to older patients who have one or more comorbidities additionally to that targeted by a new drug and as the RCTs of those drugs typically under-represent the elderly and exclude patients with multiple comorbidities, timely assessment of drug safety signals is essential. It is unlikely that regulatory jurisdictions will undertake a reassessment of safety issues for drugs that are already approved . Instead, reliance has been placed on adverse drug event reporting systems. Such systems have a very low reporting rate, and most adverse drug events remain unreported, to the eventual cost to patients and healthcare systems. This makes it essential for near real-time systems that can pick up safety signals as they occur, so that modifications to the product information (or removal of the drug) can be implemented.
Adverse drug reactions or adverse events are major clinical problems and to avoid this “Adverse events reporting system” should be maintained regularly. Patients or subjects, doctors, sponsors (Pharmaceutical industries or investigators), and Pharmacovigilance plays major role in the Adverse event reporting system. The reporting system would be completely monitored by the respective regulatory agencies to enhance the drug safety by conducting awareness programs to the patients, doctors, and Pharmaceutical industries.
- Jhansi K . Review on Adverse Drug Reactions. AdvPharmacoepidem Drug Safety. 2015; 4:05-R.
- SoussiTanani D, Serragui S, Cherrah Y, AitMoussa L, El Bouazzi O, et al. Signal Management of Disproportionate Reporting in Moroccan Pharmacovigilance: The Lower Limb Edema Induced by Anti-Tuberculosis Drugs. J Pharmacovigilance.2015; 3:161.
- Vallano A, Castañeda PF, QuijadaManuitt MA, Simon PC, Pedrós C, et al. Hospital Doctors’ Views and Concerns about Pharmacovigilance. J Pharmacovigilance.2015; 3:160.
- Fredy IC, Palatty PL, Iqbal PT, Manikandan TV, Srinivasan R. Cardiovascular Medicine Safety Profile Evaluation among Urban Private Hospitals. AdvPharmacoepidemiol Drug Saf.2015; 4:175.
- Garlapati S, Anireddy KR. It’s All about Signals, Risk Management and How Important These Are? AdvPharmacoepidemiol Drug Saf. 2014; 3:e127.
- Yerramilli A, Veerla S, Chintala E, Guduguntla M, Velivelli P, et al. A Pharmacovigilance Study Using Tracer Techniques. AdvPharmacoepidemiol Drug Saf.2014; 3:165.
- Devi S. Use of Informatics in Identification of Adverse Drug Reactions. J BioequivAvailab. 2014; 6:e54.
- Elkalmi RM, Al-lela OQ, Jamshed SQ. Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewinâ€™s Force Field Analysis Theory: Analytic Approach. J Pharmacovigilance.2014; 2:130.
- Srba J. The Missing Voice of Non-Serious Adverse Drug Reactions from Marketing Authorisation Holders. AdvPharmacoepidemiol Drug Saf.2014; 3:154.
- Kharkar M, Bowalekar S. Extent of Under Reporting of Adverse Drug Reactions (ADRs) in India: Evaluation using Logistic Regression Analysis (LRA) Model. J Clin Trials.2014; 4:155.
- Zimmermann A. Reporting Adverse Drug Reactions in Poland â€“ The Legal Situation. J Pharmacovigilance. 2014; 2:e117.
- Srba J, Vlcek J. Position and Processing of Adverse Drug Reactions Directly Submitted by Patients to National Regulatory Authorities in Europe. J Pharmacovigilance.2014; 2:122.
- Radhakrishnan Rajesh, SudhaVidyasagar, MuralidharVarma D, Guddattu V, Hameed A. Evaluating the Impact of Educational Interventions on Use of Highly Active Antiretroviral Therapy and Adherence Behavior in Indian Human Immunodeficiency Virus Positive Patients: Prospective Randomized Controlled Study. J AIDS Clin Res. 2013; 4:231.
- Al-Hazmi N, Naylor IL .Attitude and Awareness of Adverse Drug Reaction Reporting by Health Professionals in Seven Hospitals in the Holy City of Makkah, Kingdom of Saudi Arabia. J Clin Trials.2013; 3:139
- Nahar R, Verma IC, Deb R, Saxena R, Takkar P, et al. Genetic Bleeding Risk Score (GBRS) for Patients on Oral Anticoagulant Therapy. Int J Genomic Med. 2013; 1:101.
- Prasad A, Datta PP, Bhattacharya J, Pattanayak C, Chauhan AS, et al. Pattern of Adverse Drug Reactions Due to Cancer Chemotherapy in a Tertiary Care Teaching Hospital in Eastern India. J Pharmacovigilance.2013; 1:107.
- Al-Hazmi NN, Naylor IL. A Study of Community Pharmacistsâ€™ Awareness and Contributions to Adverse Drug Reactions (ADRs) Reporting Systems in the Makkah, Kingdom of Saudi Arabia (KSA). J ClinTrials.2013; 3:127.
- Chen XW, Liu W, Zhou SF. Pharmacogenomics-Guided Approaches to Avoiding Adverse Drug Reactions. Clinic PharmacolBiopharm.2012; 1:104.
- Rishi RK, Patel RK, Bhandari A. Under Reporting of ADRs by Medical Practitioners in India - Results of Pilot Study. AdvPharmacoepidem Drug Safety.2012; 1:112.
- Yano S, Kobayashi K, Ikeda T. Adjunctive Corticosteroid to Counteract Adverse Drug Reactions from First-Line Antituberculous Drugs. Mycobac Dis. 2012; 2:113.
- Aagaard L, Meyer U, Schaefer M, Hansen EH. Pharmaceutical Production Problems Detected by Adverse Drug Reactions Reports: A Documentary Study from the German Democratic Republic, 1982 to 1990. J Clinic Toxicol.2012; 2:120.
- Obiako OR, Muktar HM, Garko SB, Ajayi-Tobi E, Olayinka AT, et al. Adverse Reactions Associated with Antiretroviral Regimens in Adult Patients of a University Teaching Hospital HIV Program in Zaria, Northern Nigeria: An Observational Cohort Study. J AntivirAntiretrovir. 2012; 4: 006-013.
- Quintas LEM, Gram KRS, da Silveira GPE, Lopes DVS, Pôças ESC. Pharmacokinetic Modifications and Drug-Drug Interactions in Clinical Monitoring of the Elderly: A Short Review. Pharm Anal Acta.2011; 2:141.
- Tomisaka M, Makino T, Marui E. Overcoming the Japanese “Vaccine Gap”: An Analysis of Medical Leaders’ Witness. J Vaccines Vaccin.2015; 6:263.
- Caporossi A, Brudieu E, Lehmann A, Seigneurin A, FranAsois P. An Experience Feedback Committee for Improving Medication Process Safety: An Observational Study in a Hospital Pharmacy Department. J Pharma Care Health Sys.2014;S1-010.
- Habarugira JMV, AgustÃ A, Makanga M. Serious Adverse Events Reporting and Follow-Up Requirements in the European and Developing Countries Clinical Trials Partnership-Funded Clinical Trials: Current Practice. J Pharmacovigil.2014; 2:148.
- Sahebzamani FM, Munro CL, Marroquin OC, Diamond DM, Keller E, et al. Examination of the FDA Warning for Statins and Cognitive Dysfunction. J Pharmacovigilance.2014; 2:141.
- Muchekeza M, Chimusoro A, NomaguguNcube, Kufakwanguzvarova W Pomerai2. Adverse Events Following Immunisation (AEFI) Surveillance in Kwekwe District, Midlands Province, Zimbabwe, 2009-2010.J Vaccines Vaccin.2014; 5:232.
- Gimenes FRE, Faleiros F. Nursing Challenges for the 21st Century. J Nurs Care.2014; 3:143.
- Nnenna TB, Davidson UN, Babatunde OI. Mothers? Knowledge and Perception of Adverse Events Following Immunization in Enugu, South-East, Nigeria. J Vaccines Vaccin.2013; 4:202.
- Dasgupta N, Proescholdbell S, Sanford C, Funk MJ, Casteel C, et al. Defining Controlled Substances Overdose: Should Deaths from Substance use Disorders and Pharmaceutical Adverse Events be included? J ClinToxicol.2013; 3:164.
- Beltrame A, Cattani G, Screm MC, Brillo F, Merelli M, et al. Successful Antibiotic Treatment of Mycobacterium abscessus Pulmonary Disease in an Immunocompetent Individual. J Infect Dis Ther. 2013; 1:103.
- Ekmekci A, Gungor B, Uluganyan M, Ozcan KS, Bozbay M, et al. Presence of Metabolic Syndrome is not an Independent Predictor of In-hospital Adverse Events in Patients with ST Elevation Myocardial Infarction that Underwent Primary Percutaneous Coronary Intervention. EndocrinolMetab Synd. 2013; 2:112.
- Oshikoya KA, Lawal S, Oreagba IA, Awodele O, Olayemi SO. Adverse Events in HIV- infected Children on Antiretroviral Therapy at a Teaching Hospital in Lagos, Nigeria: A Retrospective Study. AdvPharmacoepidem Drug Safety.2012; 1:117.
- Moore RD, Kumar R. Outcomes of Ritonavir-Boosted Protease Inhibitor versus Non-Nucleoside Reverse Transcriptase Regimens in a Clinical Practice Cohort.J AntivirAntiretrovir. 2010; 1: 013-019.
- Whitstock MT, Pearce CM, Eckermann EJ.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.