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Over 27,000 patients affected by warning over valsartan

The government has not ruled out obtaining emergency supplies

A patient holding a packet of Nisisco antihypertensive drug and its French generic version, valsartan/hydrochlorothiazide sandoz. Photo: AFP

A patient holding a packet of Nisisco antihypertensive drug and its French generic version, valsartan/hydrochlorothiazide sandoz. Photo: AFP

More than 27,000 patients in Malta take valsartan for blood pressure or heart-related issues free of charge through the government’s Pharmacy of Your Choice scheme.

They have been advised to contact their doctors or pharmacists to be prescribed – or dispensed with – an alternative medicinal product as a precautionary measure.

According to the European Medicines Agency, the key ingredient – from an external supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China – was found to contain an impurity: a chemical that poses a potential cancer risk.

The authorities in the 22 countries with affected supplies were faced with dilemmas: the number of patients taking this common drug, the scale of the contamination from a single supplier and finding stocks of alternatives.

“Recalls are very common. What made this case different is that it was not related to just one or two batches but to the whole output from this Chinese company,” Anthony Serracino Inglott, chairman of the Medicines Authority, told the Times of Malta.

Added to this was the danger that would have been posed by recalling the drug before other options were in place, he said.

He stressed that no patients had suffered any serious side effects as a result of the contamination and an assessment of the actual risks was ongoing. However, one thing was clear: the risk of continuing to take the medication in the short term was lower than the risk of stopping it abruptly, Prof. Serracino Inglott noted.

Challenged on whether he would allow his mother or daughter to carry on taking a contaminated drug, he replied: “I would say: go to your doctor and follow his advice, which would be to consider the alternatives. It depends what you are taking it for. I don’t want to worry people but remember that every medicine carries a risk and some level – no matter how minimal – of impurities. We set standards to ensure they have the least possible levels. But they cannot really ever be eliminated completely.”

Mistakes are much more common when people rush

That was the main reason why the European authorities had not recalled the drug but focused instead on a meticulous plan – requiring days of burning the midnight oil – that would build up stocks of alternatives and switch patients gradually as they became approved, registered and, thus available, he added.

“When you have a crisis, you should not be less careful about quality but more diligent,” he said. “Mistakes are much more common when people rush.”

Valsartan was developed by Novartis but once the patent on it expired, some companies started producing a generic (unbranded) version. Among them was a company owned by Novartis itself, with a firm in China providing the active ingredient for a large chunk of them.

Prof. Serracino Inglott said that the government’s Central Procurement and Supplies Unit upon receiving the alert, kicked off an urgent process to identify stock of non affected products and ensured alternative medicines.   The government formulary has 21 drugs used for the management of hypertension listed in the GFL. Changing of treatment is possible as long as it done with medical oversight.

“Most of the time, the drugs have only slight differences and patients end up with one rather than another because of clinical bias and experience with regard to potential allergic reactions and so on,” he said.

The government has not ruled out obtaining emergency supplies of the branded drugs and Prof. Serracino Inglott insisted that “at no stage was the cost of this move ever raised. If we need to get products at any cost, this is what we will do,” he said.

Given the considerable output of the Chinese supplier, he warned it would take months for the situation to be resolved and, thus, the key was for decisions to be well thought through.

“The worst thing we could do would be to make rash decisions that would turn out to have even worse consequences,” he said. “We are working with various entities and with the clinicians to consider every factor. The most important thing is that patients, clinicians, doctors and pharmacists do not panic. This would just cause more harm than good.”

Pharmacists have been told they should continue to dispense valsartan to patients with prescriptions for the drug if these are not in the affected list which was published while doctors have been advised to prescribe alternative drugs to new patients. The bureaucracy associated with changing drugs on the ‘yellow cards’ for chronic conditions had also been cut to a minimum, Prof. Serracino Inglott said.

Sources close to the industry said stocks of the Novartis drugs, which are not affected, were being rationed between pharmacies to make sure each one had a supply until new stocks can be brought in.

“This situation is one of the problems of globalisation and we will have to start facing more and more of them in the future,” Prof. Serracino Inglott said. “However, the fact that the contamination was identified shows that the levels of governance are working well.”

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