The Hindu Business Line : Patient-safety: 'ADR reporting must be made mandatory'

HOW often does a patient ask his doctor on the possible "side-effects" of a medicine he has been prescribed? Hardly ever, say pharmaceutical industry officials and medical practitioners, pointing out the significant role that patients play in the chain of reporting `adverse drug reactions' (ADRs).

Patient-safety lies at the core of the ADR reporting system that involves rigorous monitoring of drugs in the marketplace, subject to constant audit.

"ADR reporting is in its infancy in India and the Government needs to make it mandatory to make pharma companies more accountable for the drugs they churn into the market," point out industry watchers.

"Every medicine in the market has an adverse event rate ranging between two per cent and eight per cent. The impact could be a mild headache or something more serious and requiring hospitalisation. Reporting side-effects back to the doctor, who takes it forth to the company is important because, the pharma company then evaluates whether the reaction was in line with research findings. But if new side-effects are perceived, then the drug company would have to act quickly, before the drug causes more harm," points out Dr Shoibal Mukherjee, Senior Director, Medical and Research Division, Pfizer Ltd.

Globally, there have been sensational cases of ADRs, like the Thalidomide disaster in Europe, where pregnant mothers who took the drug for morning sickness gave birth to deformed babies.

About four years ago in India, patients who took a particular vaccine complained of pain at the site of injection. The company marketing the vaccine recalled that batch on finding them defective, recount pharma officials.

India does not have a yellow card system, like the West, where it is mandatory for practicing physicians or registered chemist to report ADRs, observes Dr Ramananda S. Nadig, Medical Director, Eli Lilly and Company (India) Pvt. Ltd.

Further, industry analysts point out: "Domestic and multinational companies may have in place pharmaco-vigilance cells to report ADRs. But how many actually follow the rules?"

At Lilly, says Dr Nadig, all employees are required to report any ADR that may be associated with Lilly's drug or device. "On an average, Lilly handles about 10-15 ADR situations, including innocuous ones dealing with handling devices, ignorance of its usage etc," he elaborates.

Pfizer's Dr Mukherjee says that it is mandatory for the company's field-force to report ADRs. "About 300-500 ADRs are reported annually, but more than 95 per cent of them are not drug related."

This is further followed up by audit procedures and the data goes into a central global pool, he adds.

Follow-up action taken by drug companies to an ADR report ranges from re-labelling of a product (if new reactions have been observed) to withdrawing the product, if need be.

Medical professionals admit that while the Government has about two or three centres in place for ADR reporting — "often even doctors are not aware that they exist."

Echoing Dr Nadig's sentiments on making ADR mandatory, Pfizer's Dr Mukherjee sums it up: "Anyone authorised to sell a drug should be mandated to have an adverse event reporting system in place, that is monitored and audited from time to time."

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