Strange but true. Consuming medicines may land you in hospital! Medicines are known to have side effects that range from mild to severe. Some adverse drug reaction (ADR) can even lead to death. ADR refers to an injury caused by a drug taken in normal or high dosages. It may also be caused if a drug is of sub-standard quality or has been used past its expiry date.
On Monday night, 28 women developed suspected ADR after being administered antibiotics Ceftriaxone and Cefotaxime at Kurla Bhabha Hospital. Of the 28, 47-year-old Suraiya Shaikh is critical and is being treated at KEM Hospital, Parel.
According to data with Indian Pharmacopoeia Commission run by Central Drug Standards Control Organization (CDSCO), of 3,537 ADR cases registered in Indian hospitals, 212 (6%) originated from Mumbai. KEM Hospital Parel reported 102 cases, Nair Hospital had 93 and Sion Hospital 17. No data on ADRs is available for 15 civic-run peripheral hospitals in Mumbai.
World Health Organization (WHO) reported 85 lakh ADR cases in the world last year, with Indian contribution being close to one per cent.
"A little less than ADR 85,000 cases have been reported by DCGI in India," a senior official told dna. DCGI however has not released data on number of deaths caused by ADRs every year in India.
This March alone, 2,862 ADR cases were reported under PvPI; 222 cases (8%) were reported from BMC-run hospitals—KEM Parel, Sion Hospital and Nair Hospital.
DCGI has upgraded its Pharmacovigilance Programme of India (PvPI) to include 90 ADR monitoring centres (AMC) across the country. Central Drug Safety and Control Organization (CDSCO), New Delhi under DCGI compiles the data reported by AMCs. Last October, DCGI started a toll free number – 1800-180-3024 for doctors and patients to report ADRs.
ADRs may vary from mild to severe cases, say doctors.
"ADR may manifest as rashes on the skin, or could take more severe form of acute renal or liver failure. Earlier people never quite understood the gravity of ADR but pharmacovigilance has been stepped up in the past few years," said Dr Avinash Supe, dean, Sion Hospital.
Officials said data from across 90 ADR centres had revealed that some of the drugs perceived to be safe earlier had adversely been affecting patients over the years. "Once the report is submitted and reviewed by drug regulatory authority, steps will be taken to address the matter," Dr SK Gupta, advisor, PvPI had told the media in June last year.
However, to date no such report on ADR has been released.
FDA officials say the reported ADR cases (85,000) in India may just be tip of the iceberg.
In the US (population 31cr) which has a robust reporting system, one lakh patients die of ADR a year. US Food and Drug Administration (US-FDA) issues ADR alerts on potent medicines on a timely basis. In India, ADR cases go un-notified as doctors and hospitals may not voluntarily report such incidences to Central Drugs Standard Control Organization (CDSCO), New Delhi.