State medicines agency: Supply issues not a major threat to public health

Pharmacy. Photo is illustrative.
Pharmacy. Photo is illustrative. Source: Siim Lõvi/ERR

Among the medicines which have been experiencing delivery difficulties in Estonia, the public are most lacking diabetes treatment Ozempic and also antibiotics suitable for children Stella Sulaoja, specialist at the State Agency of Medicines (Raviamet) says.

Almost a hundred medicines are permanently absent, though most of these can be substituted for, she added.

Other medications in shortage include Zyrtec, a popular over-the-counter anti-allergy product administered either in tablet or syrup form, though supply chain issues should be resolved within a few days, the agency says.

Sulaoja, who heads the board's import and export supervision department, said: "Deliveries of Ozempic and liquid antibiotics suitable for children are going ahead, but not enough fully to cover the needs of all patients; some patients are having to use alternative medication until the supply difficulties end."

In the last five years, at any given time in Estonia, nearly a hundred medicines have similarly experienced supply difficulties, she added. "Most delivery issues do not cause problems for patients, because the missing medicine can be substituted for either by a drug with the same active ingredient, dose level and dosage format, or by another active drug but one which has the same indication. To replace some drugs, the patient must contact their doctor in order to get a new prescription, if a solution cannot be found at the pharmacy, " she said.

In the event that the a medicine's supply difficulties are long-winded, or if the manufacturer opts to completely stop marketing a medicine, the State Board of Medicines, in cooperation with local marketing authorization holders, wholesalers and professional associations of medical professionals, will search for ways to deliver to Estonia those medicines, albeit in foreign language packaging, which have marketing authorization in other countries. "If a delivery problem affects the whole of Europe, it will however be hard for wholesalers to find medicines even under foreign language packaging," Sulaoja noted.

It may also be the case that a prescription drug with a certain active ingredient has not been available in pharmacies for over a year. This has happened, for example, with the dermatological drug Soolantra. "According to the sales license holder, this is a matter of logistical problems, which, according to the latest information, is expected to be resolved by the beginning of the third quarter of this year," Sulaoja went on.

In a situation where a medicine needed by the patient is not available in Estonia, and in the issuing doctor's opinion it is not possible to replace the medicine by prescribing another medicine with an Estonian marketing authorization used for the same indication, the physician can issue a prescription application to the board for the usage of a medicine but without a marketing authorization, or for a medicine with a marketing authorization in another European country which is sold in foreign language packaging.

"If that application receives a positive decision, the patient then turns to the pharmacy, and the pharmacy, in cooperation with wholesalers, finds options for ordering the corresponding drug from outside of Estonia," Sulaoja continued.

Another option, which many Estonian citizens and residents in any case also use due to difficulties in drug supply chains, is found in medical tourism, i.e. traveling to a nearby state, in this case to purchase medicine rather than obtain treatment.

This has also been helped by the advent of Estonian digital prescriptions, which can be used not only in neighboring Finland, a country with among the highest standards of healthcare in the world, but in several other European states, including in warmer climes where people might vacation.

"These days, people travel a lot, and medicines are also bought daily from pharmacies in foreign countries. Based on a digital prescription issued in Estonia, medicines can also be purchased in Finland, Poland, Croatia and Portugal, and vice versa," Sulaoja said.

However, caution should be used here, she said – shortages of drugs can sometimes lead to a black market in often counterfeit drugs.

"To avoid dangerous counterfeits and to protect your health, buy medicines only from a licensed pharmacy, or an online pharmacy bearing the EU logo."

Liis Prii, head of the supervision department at the State Agency of Medicines, said that supply chain issues can always lie beyond Estonia's borders and even be global, rather than pertaining to Estonia alone. Moreover, no country is immune to such problems, she said.

"So far, no country has managed to eliminate supply difficulties, although it is being worked on very actively," Prii told Vikerraadio show "Uudis+".

"The main emphasis has been placed on rapid solutions to ensure that producers have information about needs, because the producer has the obligation to ensure production according to the need, but if the producer's forecast has been different from the actual different from the situation, you can't conjure them up from the ground."

"It is easier when several manufacturers can produce the same active ingredient and therefore medicine, but this may not resolve a situation either, if the cause of the problem is the availability of that active ingredient, or if one manufacturer pulls out, leading other manufacturers to also get in trouble as they have not taken into account changes in the market," Prii went on.


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Editor: Mari Peegel, Andrew Whyte

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