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Pharma firms keeping doctors and patients in the dark over medicine shortages

Pharmaceutical firms should notify the regulator when there are supply issues, but that does not always happen and doctors can end up writing prescriptions that can't be filled.

A red pill capsule with some smaller medicines.
Medicine shortages are not always notified in the proper way, and that can cause problems for patients. Image: Juha Virranniemi / Yle
  • Yle News

When the pharmacy doesn't have your medicine, it could be down to a supply issue that the pharmaceutical firm has not properly announced.

The law mandates that pharmaceutical companies must notify the Finnish Medicines Agency, Fimea, of any supply issues.

However, during September and October, there were hundreds of cases where companies did not notify authorities about supply issues. The shortages could last a while: the next delivery might be in weeks or months after the last one.

That data is based on material gathered by licensed pharmacist and Phd candidate Reko Ravela from pharmacies' wholesale ordering systems.

Those systems have real-time data on which medicines are available and which are not.

Ravela looked at the system three times in September and once in October, checking which medicines were available and cross-referencing with Fimea's list of medicines suffering supply shortages.

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Notifications a legal requirement

The results suggest that a lot of supply issues go unreported. In September around 150 medicines were subject to shortages that were not reported to Fimea. In October there were more than 200 similar shortages, when around 650 reports of supply problems had been made to Fimea.

The law states that companies should report supply chain disruption two months before any disruption begins.

That way other firms can react and increase production to fill any gaps. Doctors writing prescriptions are reliant on the notifications on the Fimea list to be aware of any supply issues.

In practice, these hidden shortages become apparent when doctors prescribe medicines that are not at that moment available. The pharmacy could switch to a generic medicine instead, but that is not always possible.

In those cases, the patient leaves without their medication and the doctor is asked to write a new prescription.

Fimea: Finland at the mercy of pharma firms

Timo Mauriala, Head of Unit at Fimea, told Yle that there are issues with the notification process.

"Shortages cause extra work, and additional visits to pharmacies," said Mauriala. "In the worst case people are forced to get a new prescription when they realise that the medicine they need is unavailable."

Reko Ravela says that oversight of the system is too lax. He has conducted academic research on medicine shortages and compared different European countries. Finland's situation is better than many countries', but there's still room for improvement.

He noted that the EU directive on medicine supply chains is a dead letter, because there is no will to intervene in pharmaceutical firms' practices.

Fimea says that Finland is such a small market that punishments for pharmaceutical firms is not an option.

"This is a difficult issue in the sense that Finland is very dependent on imports of medicines, and European pharmaceutical firms operate here," said Mauriala. "If a small country like Finland started building a sanctions regime on its own, then these operators could easily leave the Finnish market and that would affect availability itself."

"That's why it's important to consider this at the EU level, the possibility of bringing in sanctions, and do it that way."

Yle contacted several patients' organisations, who said that although most patients weren't too badly affected, some issues had arisen. Diabetics' hormone medicines, for instance, have been subject to shortages.

New normal

Inka Puumalainen, Managing Director of the Association of Finnish Pharmacies, says that supply issues have become more common in the last few years.

"It's sad to say, but these kinds of shortages or supply disruptions have become the new normal in pharmacies," said Puumalainen.

She added that pharmacists should have freer hands to resolve these problems on the spot. For instance if a doctor prescribes a four milligram dose, but only two milligram tablets are available, the pharmacist should be able to replace the unavailable tablets with double the amount of the lower-dose tablets.

A law change to that effect is currently being prepared.

Fimea says that the main reason for late notifications is lack of information from the firms themselves. For instance if a shipment bound for Finland is diverted at the last minute to go somewhere else, then it is not possible to give two months' notice.

"But in addition to that, there is definitely a certain desire to protect market share," noted Mauriala.

It can be beneficial for firms to fail to notify Fimea so that competitors do not get to enter the market and supply the lacking medicines.

Industry wants action from politicians

The largest share of shortages affect generic medicines. The generic medicines association's Managing Director Heikki Bothas says that Finland is the only country in the Nordics that levies a fee for notifications.

He says it costs companies 280 euros every time they report a shortage.

"Reports should be free, and Fimea should increase oversight so that all firms make their reports as required by law," said Bothas. "Pharmaceutical firms' first priority is to sell medicines, so shortages are an unwelcome surprise from their perspective."

He said that low prices in Finland, combined with the small market size, could be factors contributing to the problem. Finland is not all that interesting a destination for international pharmaceutical operations.

"If there's a desire to improve availability, it has to become a higher priority for officials and political decision makers," said Bothas. "For some reason we have been forced into a situation where there's no will to pay an amount for medicines that could ensure uninterrupted supply."

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