Adverse Drug Reaction Monitoring

Definitions, Goals and Procedures

Compiled by Alok Bains

Drugs have both beneficial and undesirable effects. The undesirable effects are called side effects, toxic effects or adverse events. Adverse events causing casualty are called adverse drug reactions (ADR).  "An adverse drug reaction (ADR) is a noxious and undesirable effect of the drug produced by the normal dose of medicine". ADR is the fourth leading cause of death in the US.

In the global scenario, adverse drug reactions (ADRs) are the major cause of morbidity, mortality, burden on healthcare resources, negative effect on the reputation of the prescriber, revenue loss of the manufacturer and extra hospitalisation costs to patients. FDA approve drugs after assessing their safety and efficacy during the clinical trial. But clinical trials cannot uncover the potential ADR of the drug because ADRs occur at low frequency. That can be easily missed out during clinical trials.

Thus, drugs continuous monitoring is required after their launch. This is carried out by ADR monitoring (Pharmacovigilance -PV). PV deals with the drug safety information of pharmaceuticals. PV is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem. In the US, PV is called pharmacoepidemiology. Adverse drug reaction reporting is an important tool to identify and minimise preventable adverse drug reactions.  

Adverse drug reaction Monitoring

In 1960, WHO launched the monitoring centre in Uppsala, Sweden. It is called Uppsala Monitoring Centre (UMC). It acts as WHO-Cllaborating Centre (WHO-CC). UMC has a web-based tool to collect information from countries having pharmacovigilance centres. These tools are named VigiFlow® and VigiLyze®. There are also four other collaborative centres each working in specialised areas. These are in the Netherlands, Morocco,  Norway and Ghana.

Adverse drug reaction Monitoring in India: Ministry of Health and family welfare, Government of India launched an adverse drug reaction reporting centre in 2004 in the Department of Pharmacology, All India Institute of Medical Sciences, New Delhi. Ministry of Health and family welfare, Government of India relaunched the nationwide pharmacovigilance program (PvPI) at All India Institute of Medical Sciences (AIIMS), New Delhi as a National Coordinating Centre (NCC) in 2010. This program was transferred to Indian Pharmacopoeia Commission (IPC) as NCC in April 2011. IPC-PvPI becomes the WHO collaborating centre for pharmacovigilance in July 2017. 

Government regulations supporting PvPI: Government of India support PvPI to establish ADRs Monitoring Centres (AMC). For this purpose, several drug regulatory reforms have been introduced in India.

1. Drugs and Cosmetics Rules, 1945 make it mandatory to establish an AMC in the drug manufacturing unit by amending Schedule Y of the Drugs and Cosmetics Rules.

2. Drugs and Cosmetics Rules, Schedule M amendment introduces "Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be reported to the licensing authority.”

3. The Pharmacy Council of India introduced a subject in the undergraduate pharmacy program curriculum. PCI issued a circular in  August 2021 to all Pharm D institutions to get enrol with the IPC PvPI.

4. The Medical Council of India has issued a circular to all hospitals, private hospitals, centres running public health programmes and approved medical colleges to establish ADR monitoring centres (AMCs). 

5. PvPI has collaborated with various public health programs such as the Revised National Tuberculosis Control Programme (RNTCP), antiretroviral therapy (ART) under National AIDS Control Organization (NACO), AEFI, and National Vector Borne Disease Control Programme (NVBDCP).

6. Indian Pharmacopoeia Commission, National coordination centre (IPC-NCC) for pharmacovigilance program ()PvPI) has signed MOU with National Accreditation Board for Hospitals (NABH) for the effective implementation of ADR reporting in hospitals. 

7. IPC-NCC of PvPI in collaboration with the Central Drugs Standard Control Organisation (CDSCO) issued a pharmacovigilance guidance document for pharmaceutical products marketing with effect from January 2018. It is applicable to PvPI, CDSCO and States/UTs Government Drugs Control Department. It ensures compliance with good Pharmacovigilance practices.

Goals of Adverse Drug Reactions Monitoring (PvPI)

1. To monitor adverse drug reactions (ADRs) in the Indian population,

2. To create awareness among healthcare professionals about the importance of ADR reporting in India,

3. To accept ADR reports from all over the country,

4. To work in collaboration with the Global ADR monitoring centre i.e. Uppsala Monitoring Centre (UMC), Sweden, established by WHO,

5. To helps Central Drug Standard Control Organisation (CDSCO) to take decisions for the safe use of medicines.

6. To monitor the benefit-risk profile of medicines.

The Procedure of Adverse Drug Reactions Monitoring (PvPI)

IPC-NCC of PvPI has introduced several tools to report ADR. These are

1. http://www.ipc.gov.in website of the Indian Pharmacopoeia Commission.

2. Toll-free No 1800 180 3024.

3. NCC-PvPI IPC Facebook Account.

4. @IPC NCC-PvPI Twitter Account.

5. pvpi.ipc@gov.in email.

6. ADR Mobile App available on Android Google Play Store. 

The following ADR reporting systems are followed

1. Medical practitioners, Dentists, Nurses, Pharmacists and consumers can send suspected adverse events or adverse reactions by using the above said tools. 

2. Healthcare professionals can fill suspected ADR form developed by IPC-NCC and send it to the nearest ADR monitoring centre (AMC) under PvPI. Details of AMC  are available on the IPC website www.ipc.gov.in. ADR form for healthcare professionals are also available on this website.

3. Healthcare professionals can send suspected ADR to manufacturers of drugs. Manufacturers send it to NCC-PvPI of IPC.  

4. Similarly, consumers can fill MEDICINES SIDE EFFECT REPORTING FORM (FOR CONSUMERS) available on the same website. They can fill it in Hindi or any vernacular language. Consumers can send it directly to NCC-IPC through the above-said tools or to the nearest AMC or to manufacturers of drugs. Manufacturers send it to NCC-PvPI of IPC

ADRs sent to AMC are received by the Coordinator/Deputy Coordinator of AMC. Clinicians, pharmacologists, and Pharmacovigilance Associates in AMC assess these data.  Pharmacovigilance Associates sent assessment data to the WHO database through VigiFlow® software.  These data are reviewed and scored on the basis of the information received. Then it is submitted to Uppsala Monitoring Centre (UMC), Sweden. 

 Compilled by Alok Bains