Adverse Event Reporting

The activity that is most commonly associated with Pharmacovigilance (PV), and which consumes a significant amount of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entering, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports from healthcare professionals or patients (or other intermediaries); solicited reports from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from the media (including social media and websites); and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The following are several facets of AE reporting:

Origin of pharmacovigilance

A new breakthrough in this field only happened after an episode occurring in 1937. In that year, Sulfanilamide (Prontosil), used since 1932 for treatment of streptococcal infections, was launched as a syrup, containing diethyleneglycol as solvent. Although tested regarding aspect, taste and odor, its safety was not evaluated before launching. It was responsible for the death of 105 individuals (34 children and 71 adults) and diethyleneglycol was incriminated. This tragedy caused the American Congress to approve in 1938 the Food Drug and Cosmetic Act, under which pharmaceutical product manufacturers would have to show scientific evidences of the safety of the drugs before releasing themfor sale.

The thalidomide tragedy is a milestone in the origin and development of pharmacovigilance. Thalidomide was introduced in 1957 and widely prescribed as an allegedly harmless treatment for morning sickness and nausea. It was tested in approximately 300 patients without toxicity. It was soon linked to a congenital abnormality phocomelia, which caused severe birth defects in children of women who had been prescribed this medicine during pregnancy. In 1962, after reports of numerous cases of phocomelia, it was discontinued. In the same year, the Kefauver-Harris amendment was approved, requiring scientific evidences of efficacy and safety before drug tests in humans. ^[2] 

As a means of pooling existing data on ADRs, WHO's Programme for International Drug Monitoring was started in 1968. Initially a pilot project in 10 countries with established national reporting systems for ADRs, the network has since expanded significantly as more countries worldwide developed national pharmacovigilance centers for the recording of ADRs. Currently, 86 countries participate in the programme, which is coordinated by WHO together with its collaborating centre in Uppsala, Sweden. The collaborating center is responsible for maintaining the global ADR database, Vigibase. At present the database contains more than four million ADR reports

History of pharmacovigilance in India

The origin of pharmacovigilance in India goes back to 1986, when a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. However, nothing much happened until a decade later when in 1997, India joined the WHO Adverse Drug Reaction Monitoring Program me based in Uppsala, Sweden. This attempt was unsuccessful and hence, from 1January 2005, the WHO-sponsored and World Bank-funded National Pharmacovigilance Program for India was made operational. 
The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. Two zonal centers-the South-West zonal center (located in the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai) and the North-East zonal center (located in the Department of Pharmacology, AIIMS, New Delhi), were to collate information from all over the country and send it to the Committee as well as to the Uppsala monitoring center in Sweden. Three regional centers would report to the Mumbai center and two to the New Delhi one. Each regional center in turn would have several peripheral centers reporting to it. Presently there are 26 peripheral centers. The program has three broad objectives: the short-term objective is to foster a reporting culture, the intermediate objective is to involve a large number of healthcare professionals in the system in information dissemination and the long-term objective is for the program to be a benchmark for global drug monitoring.

Given this background on pharmacovigilance in India to date, things have definitely changed for the better but at a very slow pace. The Regulatory Authority for India should be commended for introducing and implementing the Schedule Y and for reporting of all serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARS) from clinical trials. However, there is a need of spontaneous adverse event reporting from post-marketed medicines to the zonal centers and in turn to the National Pharmacovigilance Centers to the WHO Uppsala Monitoring Center, which at the moment is woefully lacking. Therefore, in these circumstances, the questions that arise are whether the strategy should be changed and if so, how?

Ethical issue in Clinical Research

History of Clinical Research

PLACEMENT TALK

Mr. Prashanth Krishna, Head Healthcare - IDS Infotech and Mr. Ravinder, Manager IDS- ARGUS were here to discuss career opportunities with our students............ the session was very informative & students had a chance to get the queries resolved ..... got some clicks from the event...........we are grateful to IDS for their time and knowledge they shared with us.

Indian researcher bags award for Alzheimer’s drug

London: London-based Indian researcher Mahaveer Golechha has been selected for an award for his work on a drug to cure Alzheimer’s. 
    The 27-year-old will be travelling to San Francisco to receive the Alzheimer’s Drug Discovery Foundation’s ‘Young Investigator Scholarship Award’ at the 7th Annual Drug Discovery for Neurodegeneration Conference to be held next month. 
    “I feel very proud that I have proved world class research in the area of medicine can be done in India,” Dr Golechha said on Thursday. 
    He has been recognized for his outstanding research on ‘naringin’, a bioflavonoid found in grape fruits and citrus fruits. In his study, he found that naringin possesses significant “anti-Alzheimer activity” and will form the basis of further research to develop as a cure for the degenerative disease in old age, which worsens as it progresses. 
    “Alzheimer’s disease is a neurodegenerative disorder that generally affects the elderly population. Till date the treatment was symptomatic but naringin will act at pathological level and have lesser side effects,” he said. 
    “I hope this award creates further avenues for budding scientists in my country to be recognized for their work and facilitated to follow their dreams,” said Golechha, who completed his Master’s and PhD from the All India Institute of Medical Sciences in New Delhi, where he was involved in research on Alzheimer’s and epilepsy. 
    His work on naringin has also been included for a poster presentation at the San Francisco conference. PTI