Retirement threatens compounded medicine supply across Finland

The retirement of the pharmacist at Töysä Pharmacy in Alavus, South Ostrobothnia, could disrupt access to compounded medicines at more than 700 pharmacies across Finland, Yle reports.

Finland has only two pharmacies that manufacture medicines for other pharmacies: Töysä Pharmacy and the University Pharmacy of Helsinki. The two pharmacies produce partly different products.

Compounded medicines may be needed when a patient requires a different concentration from that available in a factory-produced medicine. For example, a medicine used to treat depression may be prescribed in a small dose for insomnia, while the factory-produced version has a higher concentration.

In practice, a pharmacy orders the prescription medicine for its customer from one of the two pharmacies that manufacture medicines under contract.

Permit will end with pharmacist’s retirement

Any pharmacy can in principle prepare medicines when needed without a separate permit. However, manufacturing medicines for other pharmacies requires authorisation from the Finnish Medicines Agency, Fimea. The agency no longer grants new permits for the type of operation currently run by Töysä Pharmacy.

Fimea says Töysä’s permit will end when current pharmacist Elina Järvenpää retires and gives up her pharmacy licence. A new pharmacist could apply for a permit, but is unlikely to receive one.

According to Fimea, the issue is that medicines may not be manufactured in advance for storage. The position is based on EU legislation and decisions by the Court of Justice of the European Union in other countries.

Järvenpää acknowledges that medicines should not be manufactured for storage on a large scale, but says they cannot realistically be produced only when orders arrive. Töysä’s contract manufacturing is led by senior pharmacist Tiina Holm, who said that creating comparable facilities in the back room of another pharmacy could be a major undertaking even if that pharmacy had only one customer needing a particular medicine.

The medicine production facilities in Töysä are sterile, and outsiders are not allowed to enter except in exceptional circumstances. Fimea says the system has so far met the national need for pharmacy-produced medicines.

Pharmacists’ association concerned about continuity

Contract manufacturing has helped preserve jobs, opening hours and the pharmacy in Töysä, where customer numbers are not always high. The operation employs 10 professionals.

The Finnish Pharmacists’ Association is concerned that expertise in medicine production could disappear. The association says the expertise will deteriorate if contract manufacturing declines, while Fimea also acknowledges that the future of producing individual extemporaneous preparations in Finland must be resolved.

The association warns that if Finland is left with only one contract medicine manufacturer, the availability of all medicines may not be guaranteed. This could affect the continuity of treatment for some patients, and may also raise concerns about security of supply in crises.

Fimea says pharmacy production would not be able to replace imported medicines in a major crisis. If Finland were unable to receive high-demand products, pharmacies would not have the capacity to meet such a large need.