Thousands of patients could lose access to pharmacy-made medicines

Yle reports that tens of thousands of patients in Finland could lose access to medicines made by Töysä Pharmacy when its contract to manufacture medicines for other pharmacies ends. The pharmacy’s change of ownership threatens the availability of several medicines and strengths across the country.

Only two pharmacies in Finland manufacture medicines for other pharmacies: Töysä Pharmacy in Alavus and Yliopiston Apteekki, a pharmacy chain. The activity requires a permit from Fimea, the Finnish Medicines Safety and Development Centre, which no longer grants new permits for this type of operation.

The two pharmacies manufacture partly different medicines. Fimea said on Monday that the departure of one of the two major contract manufacturers could cause availability problems during the transition, particularly for widely used products. It cited doxepin, which is used to treat insomnia, as an example.

Medicines at risk

According to the list compiled by Yle, the following medicines or strengths made by Töysä Pharmacy may no longer be available when the pharmacist changes:

Doxepin 1 milligram and 25 milligrams, an antidepressant also used in low doses to treat insomnia; quetiapine 5 milligrams and 12.5 milligrams, used to treat severe depression, schizophrenia and bipolar disorder, and in low doses to treat insomnia; mirtazapine 1 milligram and 7.5 milligrams, an antidepressant that can also be used for insomnia; mirtazapine 1 milligram for animals, used, among other things, to increase appetite or treat nausea; and gabapentin 50 milligrams for animals, used, for example, to treat pain and epilepsy.

Juha-Matti Salo, a pharmacist at Töysä Pharmacy, said that at least these medicines or strengths would no longer be manufactured if the pharmacy’s agreement with Fimea is not continued. The pharmacy makes other medicines as well, but Salo said those products could be replaced with alternatives.

Salo estimated that the medicines made by the pharmacy are used by tens of thousands of patients each year.

Yliopiston Apteekki already makes some of the medicines on the list, including doxepin, but not in the same strengths. If Töysä Pharmacy stops making all the necessary strengths, patients will need to contact a doctor, who will assess whether to prescribe another medicine or change the dosing instructions.

“At worst, an effective medication treatment will be interrupted when the medicine has to be changed to another one,” Salo said.

Production will continue for at least a year

Yliopiston Apteekki cannot expand its production enough to replace all of Töysä Pharmacy’s output. It can make medicines for individual patients, but doing so is not economically viable.

Kati Vuorikallas, the pharmacy’s pharmaceutical director, said it was important that pharmacies retain the ability to manufacture medicines in small batches to ensure availability.

Töysä Pharmacy will continue to manufacture medicines for at least another year. Salo said there was no need for patients to stockpile them because the products are currently available.

“There is a year now to resolve this issue in Finland,” he said.