The unfortunate thalidomide disaster was a watershed moment for the drug regulation. This incidence compelled the regulatory agencies across the world to make the drug approval process more stringent. Subsequently the concept of pharmacovigilance and drug safety was begun to prevent the occurrence of thalidomide like catastrophe. Though vaccines constitute less than one percent of the pharmaceutical products it plays a pivotal role in the modern healthcare delivery. Over the year use of vaccines have prevented many serious illnesses and disabilities and saves millions of children across the world. The diseases which were once considered deadly and caused havoc to mankind by inflicting severe damage in term of mortality and morbidly are now either eradicated or contained due to the extensive use of vaccines.
Vaccine is a biological preparation which functions by inducing the immune system of the body to elicit an immune response to a particular pathogen. Vaccines are usually considered safe but like any other drug products they are not completely risk free and adverse events might sometimes occurs following the administration of it. There are instances where adverse events were reported following immunisation with vaccines. It is noticed that even the minor incidence of adverse events due to vaccine has wider social and political ramifications. The public trust withers and vaccination drive gets severe blow when reports of adverse events following vaccination adorn the news headline. This is so because unlike other drugs vaccines are given to the healthy people, mostly to the vulnerable population like children, and the discernible benefit of vaccine is remote whereas associated adverse event is noticed immediately. The WHO/CIOMS working group has defined “adverse event following immunisation (AEFI) as any untoward medical occurrence which follows the immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory result, symptom or disease”. It could be vaccine product-related reaction, vaccine quality defect-related reaction, immunization error-related reaction, Immunization anxiety-related reaction, coincidental event.
The vaccine pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding and communication of adverse events following immunization and other vaccine- or immunization-related issues, and to the prevention of untoward effects of the vaccine or immunization. ” It was initiated to ensure the safety people receiving immunisation; it also helps in preventing negative perception of population towards immunisation. The pharmacovigilance practice for vaccines in other countries Majority of the countries runs an effective AEFI surveillance system. Vaccine Adverse Event Reporting System (VAERS) is the national safety monitoring to detect any possible adverse events following administration of any US licenced vaccines. This programme was initiated in 1990 and co-sponsored by programme United States Food and Drug Agency (USFDA)and Centre for Disease Control and Prevention (CDC). This is a spontaneous reporting system where anyone (vaccine manufactures, health care providers, vaccine recipients, parents) can report any clinically significant adverse events which occurs followingvaccination.
The Canadian Adverse Events Following Immunisation Surveillance System (CAEFISS) is the post marketing safety monitoring system of marketed vaccines in Canada. It is established by the collaborative effort of federal, provincial and public health authorities of Canada. It is managed by the public health agency‘s vaccine safety section. It follows both passive and active surveillance to gather data on adverse events following immunisation from different stake holders like provincial and territorial health department, health care professionals and the pharmaceutical industry. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for monitoring the safety of all marketed medicines including vaccines in UK. The suspected adverse events following the use of vaccines should be reported to the MHR through the yellow card scheme. The Indian Scenario AEFI programme in India India is one of the largest consumers, manufacturers and exporters of vaccine in the world. India also runs one of the largest immunisation programs in world, the Universal Immunisation Program (UIP) which targets approximately 27 million new-borns and 30 million pregnant women every year. In recent years Govt. of India has also introduced new vaccines with objectives to substantially reduce morbidity and mortality associated vaccine preventable diseases.
Govt is also aware with the rare risk involved with the immunisation and always try to put the system in place to ensure the safety of children and others who takes the vaccines. The Adverse Event Following Immunisation (AEFI) surveillance program is one such measure undertaken by the government of India for the rapid and correct detection of adverse events following immunisation, swift and appropriate management, and adequate action to prevent such events in future. India initiated the national AEFI surveillance program way back in 1986 shortly after the launching of Universal Immunisation Program (UIP) in 1985. However, for a considerable period of time the adverse event reporting was not optimal.
Keeping that in view Heath and Family Welfare department, Govt. of India put renewed effort by making first operational guideline in 2005 with the technical support of WHO and revised it again in 2010. In the meantime, national and state AEFI committee were set up in 2008 to strengthen the reporting of AEFI. With the intention to bring broader representation and wider perspective National AEFI committee was reorganised in 2012. In the same year foundation of the National AEFI Secretariat and National AEFI Technical Collaborating Centre were established at the Immunisation Technical Support Unit (ITSU) of Health &Family Welfare department and Lady Harding Medical College (LHMC), New Delhi respectively for the technical oversight and support. With its unceasing effort to ensure more effective implementation and surveillance on vaccine safety Govt of India surveillance brought out and another revised Adversary Event Following Immunisation Guideline prepared in accordance with the WHO/CIOMS guideline.
Effective communication is essential to build trust about immunisation among the general public particularly around AEFI, govt of India recognised this and launched communication guideline for building vaccine confidence around AEFI in 2013 for the health care providers. Stressing reporting on any vaccine rather than only paediatric vaccine, vaccine risk communication including media AEFI report handling. Documenting and reporting adverse events due to immunisation The 2015 guideline has broadly classified AEFIs in to three categories.
India like most other countries follows passive reporting procedure. The revised guideline emphasises to report all types of AEFIs. All severe AEFIs is required to be reported immediately in a case reporting format (CRF) by the medical officer in charge or any other reporter and send the report to the district immunisation officer (DIO) within 24 hours. The job of DIO is to verify the report diligently and dispatch it to the state and national level in next 24 hours. The other means of reporting AEFIs is through monthly progress report. All AEFIs (severe and minor reactions) shall be reported in monthly reporting format like health management system. It is also imperative for the peripheral health worker to submit a nil report if no reaction is reported during the entire month. The guideline also emphasises to make the in private players aware about the existing AEFIs reporting mechanism and motivate them to report AEFI.
The Adverse drug monitoring centre (AMC) working in different parts of the country as per the existing pharmacovigilance programme of India also should be involved in reporting and assisting AEFI. The documenting and reporting AEFIare a team work and seamless flow of information involves the role of different stake holders The role of peripheral health workers The role of peripheral medical officer The role of private practitioners The role of district immunisation officer The role of state immunisation officer The role AEFI secretariat The role of National AEFI committee The role of collaborating centre The role CDSCO Causality assessment Causality assessment is defined as the systematic measurement of strength of association between the exposure and occurrence of an event. There are many established scales to perform the causality assessment in adverse drug reaction and the most widely used is Naranjo ADR probability scale. Like wise for the adverse events associated with the vaccine causality assessment is essential. The causality assessment is done by the experts of AEFI at national level. The causality assessment subcommittee functions at LHMC and usually first round of causality assessment is performed by them.
The 2015 revised guideline has adopted the new revised CIOMS/WHO 2013 revised casualty assessment. This says that causality assessment should be done at the population as well as individual level and for the signal detection. The causality assessment process involves four steps, Eligibility, Checklist, Algorithm, and Classification. The deaths attributed to AEFI are rigorously reviewed again by an expert panel comprising chairs of 4 subcommittees (of national AEFI committee and chaired by chairman, National AEFI commitment result of causality assessment is periodically uploaded in the ministry website for the public consumption.
Role of PVPI Central Drug Standard Control organisation is the national regulatory agency for drugs and medical devices and functions under drug and cosmetic rules. The CDSCO along with the Indian Pharmacopeia Commission initiated Pharmacovigilance programme of India in 2010 with the objective to report adverse event associated with the uses drugs and safeguard the health of Indian population. Since its launch it has expanded and doing a great job in reporting adverse drug reactions from different part of the country. CDSCO has also played an immensely important role in. The pharmacovigilance division of human vaccine within the biological division of CDSCO headquarter is responsible for the collection, compilation of PMS, PSUR data from the marketing authorisation holder. Expert committee constituted by DGCI comprising members from AEFI secretariat, PvPI-NCC, CDC, Kasauli review the compiled data. AEFI secretariat shares the detail data of serious and severe cases pertaining to AEFI to the CDSCO.
The Road Ahead Due to its burgeoning population India is one of the largest users of vaccine in the world Though India has successfully travelled many distance but destination is yet to reach as far as reporting of AEFI is concerned. There is still a lot is required to be done make the monitoring programme more robust and vibrant. It requires concerted effort all stakeholders from bottom of the pyramid to top. A holistic proactive approach and sustained effort is required to make health care professionals, paramedical workers and all other concerns to report all cases of AEFIs. At present 10-20% of the immunisation is provided by the private practitioners and it is even more for the vaccines which are not included in the UIP.
The reporting of AEFI from the private vaccine givers is far from satisfactory. So, it is incumbent upon the government agencies to sensitise and encourage all those to report suspected AEFI regularly. Though CDSCO is playing a crucial role in the AEFI surveillance program, still more is required to be done to converge AEFI and PvPI at all level. The AEFI should be integrated more with the PvPI programme. There should be a concerted effort to converge the AEFI and ADR reporting at all level. Like the adverse drug reaction reporting which has expanded to all parts of India by setting up, that of PvPI, both private and government medical colleges can be involved in a better way for the reporting of AEFIs. There more in integrated more with the PvPi. MCI should ask the medical college to have a committee comprising the mebers
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