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Studies: Adverse drug reaction cases on the rise

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It's a fact that medicines can cure ailments but they can also lead to death. Basic paracetemol drugs, penicillin-based antibiotics and certain epileptic drugs among others can throw up deadly adverse drug reactions (ADRs) in patients.

How serious is ADR?
Although doctors say that reactions like Toxic Epidermal Necrolysis Syndrome (TENS) where a patient's skin peels off entirely are rare, there is no concrete data to prove this. dna had reported on December 11 that Kalyan resident Heena Khan, 28, had suffered from TENS after consuming Amoxycillin-based antibiotic, which was administered to her for curing fever. Though Heena has fortunately recovered from ill effects of TENS, some are not so lucky. In May, Sharmila Shinde, 57, died of infection after contracting TENS due to tablets she was consuming for controlling her uric acid levels.

In May 2014, 3,537 ADRs were reported in 150 ADR monitoring centres (AMCs) across India. Mumbai contributed 6% of all these reactions.
ADRs may vary from mild to severe cases, say doctors. "When we see a large volume of patients in public hospitals and ADRs are bound to crop up. It may manifest as rashes on the skin of a patient or may lead to more severe forms of acute renal or liver failure," said Dr Avinash Supe, dean, Sion Hospital.

How many cases in city hospitals?
While BMC-run KEM, Sion and Nair Hospitals reported 212 ADR cases in may 2014, the state-run JJ Hospital did not report a single case. Anyone in the city who has suffered from ADR or treated an ADR case should ideally notify the case to KEM, Sion, Nair and JJ hospitals — four nodal centres that are appointed by the central government to quantify ADR data.
"We are in the process of putting the reporting mechanism in place. No technical associate has been appointed in the hospital by the centre to help us with the process," said a senior doctor from pharmacology department in JJ Hospital.

Are there monitoring centres?
Of 150 AMCs, technical associates (TAs) are available in 56 centres only. TAs are responsible for collecting information from the patients, performing follow up with them, entering information in the prescribed software (Vigiflow) and sending them to the headquarters. Figures indicate that 63 per cent of the TA posts are lying vacant, including that in JJ Hospital from Mumbai.

Is reporting cases mandatory?
"Reporting of leprosy and tuberculosis cases has been made mandatory by the central government for the private doctors. Drug reactions are similarly dangerous. However, it is not compulsory to report them and thus doctors take such cases lightly," said Dr Vikas Mantole, private-run Inamdar Hospital. "The problem in our country is that people seldom follow rules. The government has to explain all treating physicians, the importance of reporting drug reactions."

Started in 2010, the pharmaco vigilance programme of the Union health ministry has set up 150 AMCs in India. But only 90 centres have the Swedish software Vigiflow which helps in accurate reporting of ADRs. More over the programme aims to cover over 360 medical colleges and over 2,500 pharmacy, dental and nursing institutes in India in future but has not pegged a deadline for this target.

ADR cases can be reported on helpline number: 1800 1803 024
 

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