ICP 1 ADVERSE DRUG EVENT S: MONITORING AND REPORTING ABSTRACT : An adverse drug event (ADE) is an injury resulting from medical intervention to a drug. This includes medication error, adverse drug reaction, allerg ic reactions and overdoses. ADE s can happen anywhere in hospitals, long -term care setting and outpatient setting. Adverse drug reaction (ADR) is a part of adverse drug event . ADR is an injury caused by taking medication. This can happen following a single dose or result from the combination of two or more drugs. To overcome from these ADR and ADE and to reduce the cases the drug monitoring and reporting is done and necessary. The monitoring basically means “to observe and check the progress or quality of something over a period of time and keep under systematic review.” To overcome from ADE and ADR the drug monitoring is require d. Adverse drug monitoring is a systematic reporting and evaluation of certain or all adverse reaction to drugs including herbal drugs and vaccines . Along with monitoring the reporting is also required for specific conclusion. The reporting specifically means “giving a spoken or written account of something that one has observed, heard, done, or investigated.” In adverse drug reporting all suspected adverse drug reactions should be reported whether known or unknown, serious or not, including minor once. This monitoring and reporting of adverse drug event will reduce the no. of incidence of adverse drug reaction. An adverse drug event is an injury resulting from medical intervention related to the drug. Thi s includes: medication errors, allergic reactions, overdoses etc. Medication errors : A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm. Eg; writing illegibly so that ‘Panadol’ (paracetamol) i s dispensed instead of Priadel (lithium) Allergic reactions : It is an extraordinary response shown by a drug within a therapeutic dose which is undesired or unwanted. Eg; small quantity of quinine may cause ringing of ears. Overdoses : It is consumption of drug in unnecessary more quantity. ADE s can h appen anywhere in hospital long -term care settings and outpatient settings. Adverse drug reaction is the part which comes under adverse drug event. ADR: It is defined as injury to body that is caused by any other medication . Classification of ADR: On the basis of type of reaction: • Type A: reaction which can be predicted from the known pharmacology of the drug, it is dose dependent. Common skill management reduces this incidence. Eg; anticoagul ant causes bleeding. • Type B: these are predictable where the mechanism is known otherwiseunpredictable for an individual, although incidence may be known. It is dose independent and rarely happens, these accounts for most drug fatalities. Eg; penicillin c auses anaphylaxis. • Type C: reaction occur due to long time exposure eg; analgesic neuropathy causes dyskinesia with levodopa. • Type D: occurs due to prolonged exposure. It can happen due to accumulation of drug. Eg; carcinogenesis or short term exposure at critical time eg; teratogenesis. • Type E: occurs on the withdrawal specially when drug is stopped abruptly. Eg; phenytoin withdrawal causes seizures. Adverse drug reaction monitoring: It is a process of continuously monitoring of unpredictable effect suspec ted to be associated with the use of medicinal products. It facilitates collection of unbiased safety data observed during clinical practice in real life circumstances. The system of ADRs notification in Ta nzania is centralized reporting whereby suspected case rep orts of ADR are reported to CDSCO . Objectives of ADR monitoring : • To detect the nature and frequency of ADR’s including periodic evaluation of benefit risk ratio of medicinal products in order to assist health professionals to take appropriate actio n to minimize risk of ADR’s • Providing updated drug safety information to health care professionals including WHO ADR’s monitoring centres • Dissemination of information by design ing proper education programme to consumer and other users • Initiation of further studies for education value • To identify risk factors that may predispose , induce or influence the development, severity and incidence of adverse reaction in population Procedure for reporting ADE : 1. What to report? This should include – All ADE s as a result of prescription and non- prescription. Unexpected reactions regardless of their nature or severity. An observe increase in frequency of given reaction. ADE s occurring from overdose or medication error. 2. What information is required for an ADE case report? Patient information Adverse reaction descriptionInformation related to suspected drug and its adverse reaction 3. Who should report? All health care professionals Manufacturer of product registrants All government hospital as well as priva te hospital 4. Where to report? Preferably directly to CDSCO by post or online. 5. How to obtain reporting form? Website of CDSCO i.e. www.cdsco.nic.in Regional hospitals, district hospital, ADR focal person in hospital, clinics etc. Processing of collected ADE data : 1. Assessment of ADE case report: Quality of documentation Analysis of relationship between drug and action Quality control in respect to identification of duplicate report Causality assessment and transmission of assessed report to international drug monitoring centres. 2. Handling of ADR data Data should be stored in CDSCO for analysis The names of the reporter and patient will be removed before any details about ADR are use d. Suspected ADR report cannot be use in a court of law under any circumstances CDSCO is responsible for providing, reporting forms, collecting, analyzing and evaluation of report. 3. Utilization of ADR: Further investigation of signals eg; dose range of the medicine, pharmacological mechanism etc. Drug regulation and dissemination of information Education and training initiative to improve safe use of medication. Pharmacovigilance : It is a n evolving discipline in the Indian context. Although a formal adverse event monitoring system for reporting of adverse events was suggested for India in 1986, nothing much happened till 1997 when India joined World Health Organization adverse event monitoring program based in Uppsala, Sweden. A form al national pharmacovigilance program only started in India since January 2005 and was based on the hierarchy of peripheral, regional, and zonal centers for collection of adverse events that reported to Central Drug Standard Control Organization (CDSCO) an d Uppsala Monitoring Centre. It was aimed to order to collect and analyze safety data regarding a drug, communicate associated risk to thepracticing physicians and general public and arrive at regulatory intervention if necessary. Since 2010, the program has been reorganized as Pharmacovigilance Programme of India (PvPI) in collaboration with Indian Pharmacopoeia Commission, Gaziabad. Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India FDA Bhawan, ITO Kotla Road, New Delhi – 110002 www.cdsco.nic.in Monitoring of adverse drug reactions started in India about two decades ago (1982). Under the chairmanship of the Drug Controller of India, five centres were established with the idea of starting a monitoring programme nationwide. It consisted of three phases: the first one being monitoring of reactions in the institutes, second one in governmental bodies like CGHS, and the third phase proposed to include general practitioners. A multi- institutional pilot study involving 58,194 cases was done in 1987 under the aegis of Indian Council of Medical Research. Its nodal centre (National Pharmacovigilance Centre) is located in the Department of Pharmacology, All India Institute of Medical Sciences, New Delhi. It is affiliated to WHO collaborating Centre for ADR Monitoring, Uppsala, Sweden. The others are located in PGI (Chandigarh), JIPMER (Pondicherry), KGMC (Lucknow), and Seth GS Medical College (Mumbai) – special centre. It was envisaged to be a collaborative activity of both clinicians and pharmacologists; now in India, the pharmacologists with or without the involvement of clinicians usually do it9. Physicians, however, continue to play a meaningful role in the entire monitoring process, as the co -operation of the clinicians is needed to have an access to the patient data and at times in interpretation of the reports of suspected advers e drug reactions. In many other countries, the pharmacists or nurses usually carry it out under supervision. They are specially recruited for this purpose; physicians and pharmacologists are involved in the interpretation of the collected data or hypothesi stesting on the basis of the reports. These workers may involve a panel of the physicians in reviewing all the collected reports. Though the pattern of adverse reactions differs slightly from country to country, adverse reactions to analgesics (mainly, non- steroidal anti- inflammatory drugs) and antibiotics constitute about ha lf of all such reports in India . This may be partly due to the fact that these are the most commonly used drugs in therapeutics. Conclusion : Monitoring of adverse drug reactions is an ongoing, ceaseless, and continuing process. Though pharmacovigilance is still in its infancy in India, this is likely to expand in the times to come. Thus, it needs to be reinforced that pharmacovigilance is a responsibility of all including physician, nurse, pharmacist, drug company, and the regulator. Development of more solid programs, collaboration with private sector and increased awareness among all stakeholders can help us achieve a better pharmacovigilance system. Also, for this, students (both undergraduates and postgraduates) need to be trained in drug safety and a habit of rational drug use should be inculcated in them from the beginning. Continuing medical education programmes for physicians and other health professionals should be conducted to make them aware of the methodologies and other technical aspects of the drug monitoring process. References : Vikas Dhikav, Sindhu Singh, KS Anand,Adverse drug reaction monitoring in India, JIACM 2004; 5(1): 27- 33 Aditi Anand Apte, Reporting of adverse events for marketed drugs: Need for strengthening safety database, Perspectives in Clinical Research2016, Jul-Sep; 7(3): 111–114 www.cdsco.nic.in G Parthasarthi, Karin Nyfort -Hansen, Milap C Nahata, A Textbook of Clinical Pharmacy Practice, Orient Longman Private Ltd.
Table of Contents