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Mumbai: Even as the results of her blood tests were awaited, drugs were being injected into Tanya (name changed) to control her symptoms of high fever and crippling weakness. One of the drugs made her instantly dizzy and breathless.
When the doctor was summoned, he snapped off that drip and gave her saline. Tanya recalls, “It was traumatic. But the doctor simply said
that nobody reacts to this and left it at that”.
A different kind of substance abuse is happening in out medical clinics and hospitals. Unknowingly, patients are subjected to an ill-advised drug or a higher dose simply because there is no monitoring worth its name of the drug’s side effects. Reporting of adverse drug reaction (ADR) requires constant vigilance for a drug reaction in every
clinical situation.
While some drugs produce nominal side-effects like rashes or itching, some others can lead to life-threatening complications. Ephedra products, for instance, are a powerful stimulant that help lose weight, but are believed to have caused deaths when combined with caffeine, points out G. M. Bhatia of the Association of Medical consultants.
Apart from their lethal implications for life and health, unknown side-effects also push up health care costs. Doctors say they need a database that will answer questions in their day-to-day practice. For instance, if a woman has taken an anti-malarial drug and later discovers she’s pregnant, should she abort the child for fear of passing on an infection?
If there is data that shows anomalies deriving from the use of the drug, she could decide to abort. But what if she does that and has no way of finding out that the child would have been normal?
“Drugs with known toxicity like Thalidomide, drugs that are very potent like anti-cancer drugs, and drugs marketed in the past five years particularly need monitoring.” Says S. M. Sapatnekar, director of Haffkine Institute. Vaccines, too, are a key area of concern.
However, there is little in the name of ADR monitoring, also called pharamaco-vigilance. Attempts to police the pharmaceutical field are largely confined to sub-standard or spurious drags. There is the National Pharmaco-vigilance
Center (NPC) at the All India Institute of Medical Sciences, New Delhi, and three ADR monitoring centers across the country that seek to evaluate the effects of drugs, but all these entities are largely unheard of, and which are about to be replaced by 30 new centers because of their non-performance.
Nilima Kshirsagar, Dean of KEM hospital here and head of an ADR monitoring
center, says the KEM center received “little general feedback from doctors exception instances where we cited specific drugs.”
Currently, there is no worth-while ADR monitoring in India. “Whatever data is
filled by the centers hardly constitutes pharmaco-vigilance,” contends Brijesh Regal, World Health Organisation consultant to the Drugs Controller General of India.
In addition, pharmaceutical companies are supposed to carry out post-marketing surveillance (PMS) – data on the efficacy of drugs collected from patients and doctors. But experts say only a few companies collect this data while the Central Drugs Standard Control Organisation, tasked with enforcing PMS, does not have adequate machinery to do so.
The Indian scene is riddled with its own peculiarities. Firstly, in the absence of product patents, there is a surfeit of drug brands over 6,000 licensed drug manufacturers, big and small and over 60,000 branded formulations. Therefore, all brands may not be surveyed, as the active ingredient in all the brands may be the same. Points out S. S. Mahajani, a pharmacology with Haffkine Institure.
For instance, Nimesulide, a non-steroid, anti-inflammatory analgesic, has 57 licensed brands. Not all would carry out PMS.
Secondly, says medical research consultant Arun Nanivadekar; “practising doctors, who are the sense organs of pharmaco-vigilance, are not trained of accustomed to suspect and report adverse events either to manufacturers or to regulatory authorities.”
Sure, there is a theoretical exposure to the allopathic medical students in the curriculum. And there are medical journals that often cover ADRs. But experts say this is not enough.
A constant vigil on the way drugs impact health is mandatory. As the NPC proforma points out, ADR can be a serious matter causing death, danger to life, hospitalization, birth defects, and significantly, “ increased investigation or treatment costs”.
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