Spike in paracetamol poisoning cases cause concern as Antidote remains unregistered

"They can apply for registration" — Dr. Hemantha Beneragama



Confronted with a spike in paracetamol poisoning cases, medical practitioners are grappling with the growing threat as the antidote commonly recommended still remains unregistered in Sri Lanka.

"It has to be procured from "outside" because this vital drug, though not given the green light by the Cosmetics, Devices and Drugs Authority (CDDA), is freely available in the market", medical officials said last week.

As paracetamol is a widely used, over-the-counter pain reliever, unhindered access has led to a significant increase in poisoning cases, they pointed out. "The drug is marketed under diverse brand names and advertising is also permitted".

"In most cases of poisoning, patients are admitted to government medical facilities where they are asked to purchase the antidote Mucomix, which is smuggled into the country", they said.

More often, physicians prescribe relatively expensive paracetamol products available under different brand names. It so happens that patients, in a bid to relieve pain or symptoms of influenza, add two more tablets of a popular brand of paracetamol to the dosage unaware the drug has already been prescribed to them, the officials explained.

"Two tablets more will not be fatal but the long-term impact could be disastrous", they said.

Paracetamol-addicts run the risk of suffering liver damage over a period of time, they warned. "An overdose can be fatal".

It is the same story with Bupropion and Acamprosate widely prescribed by physicians to cure tobacco and alcohol addiction, respectively despite both drugs not registered for legitimate prescribing, they noted.

The CDDA issue licenses to patients to import drugs for their personal use but the absence of a recognized official agency to undertake the task of bring down the stocks on their behalf has compounded the problem, they pointed out. "The matter ends there as a result".

With most pharmacies and companies shying away from handling these imports because of the tedious process involved, a thriving smuggling ring feeds the underground blackmarket, the officials said. "Patients have no option but to buy the drugs at exorbitant prices".

If there are any drugs that need to be considered for registration, their respective representatives can forward the products to the Drug Selection Sub Committee (DSSC), says Dr. Hemantha Beneragama, CDDA’s Director.

"We do a risk benefit assessment to ascertain risk against benefit – whether the risk is more than the benefit", he elaborated. "There are medical practitioners of all specialties represented on the DSSC".

He said that there was an importer who submitted a dossier for the registration of a substitute for smoking, but the DSSC found that the product itself contained nicotine that can cause addiction. "It was rejected".

"We get prescriptions even from government hospitals for these drugs", a pharmacist, who asked not to be identified, said. "Doctors use the drugs index for prescriptions and it seems irrelevant to them whether the products are registered or not as what they want is to cure patients".

It is illegal for a physician to prescribe an unregistered drug, Beneragama countered. "Only CDDA registered drugs can be dispensed under the law".

It is common knowledge in the market that any unregistered drug ranging from products for abortions to potent aphrodisiacs can be procured from the ‘underground’, the pharmacist said. "Of course, they come at a cost because stocks are brought into the country through unconventional channels".

"There are also nicotine chewing gum and sprays available at a price", he continued. "You name it and the stuff is yours if there’s cash".

In some areas, 90% of government hospital prescriptions are dispensed from the private sector, the pharmacist noted. "With unregistered drugs galore from India and Pakistan, it is roaring business".

On the continuing ban on Corex and Corex-D, the CDDA chief replied, "We are still awaiting the reports of the JMO and the National Drugs Quality Assurances Laboratory (NDQAL). The ban on the two products will continue to be in force".

The two cough syrups are still under investigation following the death of six persons recently.

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