Drug shortage in BiH, some drugs unavailable until end of year

The reasons for the shortages include delays by manufacturers in production, supply chain issues, manufacturers' decisions not to renew permits, limited production capacities, reorganization of production, and globally disrupted supply chains.

In December 2024 and during this year, a temporary or permanent disruption in the availability of 33 medications was reported. The Agency for Medicines and Medical Devices of Bosnia and Herzegovina stated that for a larger number of medications, so-called generic parallels exist, meaning that if a medication from one manufacturer is unavailable, a medication with the same active substance, strength, and pharmaceutical form from another manufacturer will be available.

Other reported shortages include Klavocin bid, Ventolin, Levemir, and Carboplatin. There are also shortages of certain medications for the treatment of diabetes, high blood pressure, and those used by cancer patients.

Manufacturers are required to notify the Agency in the event of a supply disruption. The disruptions can be either temporary or permanent.

In the case of temporary disruptions, the expected date for the medication to return to the market must be provided. Manufacturers are also obliged to specify the reasons for the disruption in the market supply of the medication.

As for permanent disruptions reported by manufacturers (such as the cancellation of permits and failure to enter the permit renewal process), they usually occur for commercial reasons, according to the Agency for Medicines and Medical Devices of BiH.

Temporary disruptions happen due to issues in the production process itself, changes in the production process, reorganization of production, problems in sourcing raw materials, problems in obtaining packaging materials, and globally disrupted supply chains.

“We are in daily communication with manufacturers and wholesalers. Last year, we prevented shortages by significantly improving the dynamics of processing requests for granting/renewing/amending permits for the marketing of high-quality, efficient, and safe medicines in BiH, which has helped speed up the arrival of medicines to patients. Additionally, we approve the marketing of medications produced for other markets, in accordance with specifications approved by our agency,” the Agency for Medicines and Medical Devices of Bosnia and Herzegovina further explains.

They also mention that they still learn about some shortages from patients, healthcare institutions, and other sources, after which they contact manufacturers to check the availability of medicines and explore ways to overcome the unavailability of medications for patients.

Since 2018, the Agency has had an information system that allows all reported shortages by manufacturers to be publicly accessible.