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Tracking adverse drug reactions

FORTY-three-year-old Lalitha had no inkling of the nightmarish experience in store for her, when she skipped her daily medicines. The woman from Chikkaballapur eventually survived, thanks to timely medical attention.

Lalitha was on anti-epileptic drug called Carbamazepine for the last one year, which she was supposed to take every day. However, she stopped the medicines for about three days as she was heading out of town. She took the medicine on the fourth day. By next morning, Lalitha’s eyes were swollen. Her family took her to a local doctor, who gave her anti-allergic drug. But her condition kept getting worse. 

The next morning, Lalitha woke up with rashes all over her body, swollen lips and pus on legs. The doctors removed nearly one litre of pus from her body. To reduce the rashes, she was put on steroids for a week. Lalitha’s is a classic case of irrational use of drugs and adverse reaction to medicines. While chemists, in their rush to sell their stocks downplay side-effects, innocent patients are at risk because of poor awareness on proper drug use.

The Superbug controversy, which broke out earlier this year, finally shook up the Union Health Ministry, propelling it to enforce the setting up of Pharmaco Vigilance (PV) cells in medical colleges and hospitals. In Karnataka, six medical colleges and government hospitals are being considered for approval as PV centres, apart from the existing two – JSS Medical College and Hospital, Mysore, and Al Ameen College of Pharmacy, Bangalore.
Pharmaco Vigilance is the science of understanding and picking up adverse drug reactions (ADR) in people. The need for this was felt even more with India becoming a ‘dumping ground’ for many multi-national pharmaceutical companies in the last few years. 

So, why is this a concern? The drugs that are banned in other countries, especially Western nations that adhere to strict norms, are available here without any restriction. With bannable drugs and even banned drugs accessible in chemist shops, it poses a great risk of the health of the public, say experts in Pharmaco vigilance.

The department of Pharmacy Practices, Al Ameen College of Pharmacy, has been running a drug information centre and PV cell in Bangalore for over one decade. Based in St Martha’s Hospital (previously it was housed in Victoria Hospital), it has registered over 1,000 ADR cases from clinicians as well as public since 2001. Around 10 deaths were also reported during this time, most of them due to anti-epileptic, anti-TB and antibiotic drugs. However, the cases are only from hospitals which regularly alert the PV cell about ADRs.

 Although, the cell is a peripheral centre of the National Pharmacovigilance Programme launched by the health ministry in 2004, only few hospitals such as Victoria, Vani Vilas, Minto, Bowring and Sagar Hospital, apart from St Martha’s have reported ADR cases. But reporting could be better even in these hospitals, feels Dr Shobha Rani Hiremath, Professor and head, department of pharmacovigilance. 

“There is enough awareness about PV in hospitals but the reporting is not satisfactory. We have to constantly follow up with them to give all the information,” she says.  
According to her, a majority of the ADRs are attributed to profloxacin, an antibiotic used for urinary infection and typhoid. In the fatal cases, Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are the most common culprits are responsible for nearly 10 per cent of the ADR deaths.

Data collected from one private hospital showed 110 ADR cases last year. Another survey, which was carried out among four chemist shops, showed about 80 cases of side effects. “If these are the figures from such a small sample, imagine the entire City. There is definitely under reporting of ADRs,” she says. Even Ibuprofen, an anti-inflammatory drug, causes hypertension and prolonged use of paracetamol can lead to liver toxicity. 

While the PV cell has not come across ADRs due to banned drugs, Dr Hiremath admits that banned drugs are indeed available in the market. “In most cases, ADR occurs due to irrational use of drugs by doctors as well as chemists and people. At times, doctors either prescribe antibiotics where it is not necessary or give a higher dose when it is not required,” she states.

Another issue is of self medication, as many medicines are available over the counter. With lack of knowledge about usage of drugs, this could prove dangerous. However, awareness about PV and ADR has increased in the last four to five years, she observes.

(Published in Deccan Herald)


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