Medicines' supply problems have become more frequent

Supply problems hitting more and more drugs
Supply problems hitting more and more drugs Source: Siim Lõvi /ERR

The number of medicinal products difficult to find due to supply problems has grown over the years. Last year's total number of supply problems was hit in the first six months of this year, while pharmaceutical companies have been unable to market certain drugs for years.

Pharmacies are often forced to turn people and their prescriptions away as certain medicinal products can be difficult to find, especially in rural areas where pharmacies are few and far apart.

For example, a drug for Parkinson's disease called Sinemet has been unavailable for months, with people forced to look for it in Finland. Medicines' supply problems have only grown worse in recent years.

Unfortunately, supply problems hit pharmacies at the same times as they are down to pharmaceutical manufacturers and can last for several years. In that case, shortages hit all countries simultaneously, meaning that visiting drug stores abroad is of no use.

The State Agency of Medicines lists 257 medicines experiencing supply problems or the end of life of which has been announced since the middle of 2015.

The problem has gotten worse over the years. While the agency received just 67 notifications of supply problems in 2014, the figure had grown to 163 by last year. The first six months of this year have seen almost as many disruptions as the whole of 2018 for a total of 153 cases.

Merck Sharp and Dohme Parkinson's drug Sinemet people have sought in Finland is similarly out of stock everywhere, the agency says, while it remains unknown when supply might be restored.

"The State Agency of Medicines has talked to the association of Estonian neurologists and neurosurgeons that finds the product can be replaced with similar drugs for Parkinson's that are available in pharmacies. If these alternatives are unsuitable for the patient, their family physician can apply for a permit for the use of a drug that has no marketing permit. A satisfied application gives wholesalers the right to supply another manufacturer's drug made for a different country's market but consisting of the same active substances in the same concentration as Sinemet. Availability of drugs that do not have a marketing permit in turn depends on availability in other countries," said Klara Saar, senior inspector with the agency's monitoring department.

Supply problems usually do not depend on whether the drug is widespread or rare, cheap or expensive, original or generic as all medicinal products are subject to disruptions.

A list of drugs that shouldn't be sought in pharmacies can be found on the agency's home page, the register of medicinal products (links in Estonian) or subscribed to in the form of a newsletter sent to the person's email address.

The agency admits the problem is serious, while the EU is trying to solve it by creating working groups.

The medicines' agency does not order drugs itself. "In truth, it is the drug's license holder who decides whether the product reaches a particular country. We work with pharmaceutical manufacturers, wholesalers and medical associations to solve problems, while our efforts are not always sufficient to make sure patients in Estonia have access to the drugs they need," Saar says.

Supply problems are most often the result of manufacturing hiccups and delayed shipments, inaccurate sales forecasts, but also sudden spikes in demand.

License holders are obligated to notify the agency of supply problems two months before potential disruptions. That is enough time for the agency to react and find solutions to ensure continuous treatment by allowing the use of packaging with foreign markings, introducing export restrictions or allowing the use of drugs without a marketing permit. Unfortunately, not all suppliers stick to the two months rule.

The State Agency of Medicines urges people to notify their doctor of shortages so they could prescribe them alternative medicines. Problems are greater when no alternative drugs exist and the person's treatment plan needs to be altered.

No sanctions

If supply is not restored after three consecutive years, the agency has the right to suspend the drug's marketing license, while it has not exercised that right as it would do nothing to solve supply problems. The agency has similarly not sanctioned license holders who have failed to notify it of problems inside two months.

"We prioritize cooperation and more effective exchange of information to prevent supply problems or find solutions in emergencies to minimize the effects of supply disruptions," Saar explains.

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Editor: Marcus Turovski

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