Hot signal

Hot signal

Broken rhythm of drug imports and withdrawal of products from Bulgaria - leading causes for patient alerts

his shows the aggregated annual data from the BAMPTD online shortage drug search platform

450 drugs were searched for one year on the online patient signaling platform, which was created and maintained by the non-governmental sector. In the last two weeks, the signals have increased due to the broken rhythm of imports and the depletion of drug stocks that are in the process of stopping sales in Bulgaria. Alerts were also received for products that are deregistered in recent years in our country. Many of the signalized drugs with problematic imports have alternatives. But with regard to withdrawn medicines from our market, the only option for patients remains to seek individual solutions through their relatives or traveling abroad, reports the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD) in connection with the annual analysis of the results on the platform.

In 62% of cases, the causes of drug shortages are related to temporary or permanent discontinuation of drugs imports. 20% of all signals are due to market withdrawal and deregistration of medicinal products, according to data from the platform at BAMPTD also maintains a shortage hotline on the territory of the whole country, which operates 24 hours a day. The summary data from the first year of the platform's operation show that patient feedback is within 12 to 24 hours. It was established by BAMPTD and is working as part of a joint action program between it and the Federation of Bulgarian Patient Forum (FBPF) to facilitate patients' access to therapy. The two organizations have created an Internet-based form of alerts that, for convenience and speed, requires only residential area, telephone number and the sought-after drug.

One of the main problems for access to medicines in our country, confirmed by the reaction of the end users, is the continuing deregistration process of a number of medicines from Bulgaria, states BAMPTD. 158 medicines were withdrawn from the Bulgarian market in 2018, according to the National Council for Prices and Reimbursement of Medicinal Products. For 2014 - 2017 the number of deregistered products is 1512, according to the annual report of the Bulgarian Drug Agency. BDA document also states that only 327 drugs were withdrawn in 2017 without any of them having a drug safety problem.

That is why BAMPTD calls for regulatory changes to create a regime for access of Bulgarian patients to medicines that have proven medical safety but already dеregistered in our country due to lack of economic interest. The association also proposes to regulate parallel imports in the establishment of temporary shortages due to production or other reasons that prevent manufacturers from delivering rhythmic supplies and sufficient quantities of medicines to Bulgarian patients.

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