Patient Access to Deregistered Drugs Requests BAMPTD
560 missing medicinal products signals were submitted to the Online Patient Alert Platform as of August 1, 2019. In June and July, they were mainly due to impaired import rhythm and depletion of medicines in the process of being discontinued or withdrawn from Bulgaria. This was announced by the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD). According to the organization, patients need to have access to deregistered medicines.
Many of the signalized medicines with problematic imports have alternatives, in which case patients are advised to consult their physician. When it comes to deregistered drugs from our market, sick people find themselves forced to look for a way to get them from abroad. Special trips are organized to buy the missing medicine or get it through relatives living abroad.
The platform for signaling drug shortage was created and supported by the NGO sector. It is located at www.parallel-trade-development.org . BAMPTD has announced a hotline for drug shortages across the country, which operates in 24/7 regimen.
Aggregated data from the first 14 months of the platform indicates that patient feedback is within 12 to 24 hours. It was built by the organization and operates as part of a joint action program between BAMPTD and the Federation of Bulgarian Patients Forum (FBPF) to facilitate patient access to therapy. The organizations have created an internet-based alert form that, for ease and speed, requires only a residential area, a feedback telephone and the sought after drug.
In 65% of cases, the causes of drug shortages are related to the temporary or permanent suspension of drug imports. 22% of all alerts are due to market withdrawal and deregistration of medicinal products, platform data shows.
The ongoing process of deregistration of a number of medicines from Bulgaria is worrying patients and is being reported by the institutions. 158 medicines were withdrawn from the Bulgarian market in 2018 according to data from the National Council for Prices and Reimbursement of Medicinal Products. For 2014-2017, the number of deregistrant products is 1512, according to the annual report of the Executive Agency for Medicines. The BDA document also states that in 2017 alone, 327 medicines were withdrawn without any of them having a problem with pharmacovigilance.
As a non-governmental organization, BAMPTD continues to call for regulatory changes in the next revision of the Law on Medicinal Products in Human Medicines to create a regime for Bulgarian patients to access medicines with proven pharmacovigilance but been withdrawn due to lack of economic interest. BAMPTD also proposes to regulate expeditious intra-community delivery in the event of temporary shortages due to manufacturing or other reasons that prevent manufacturers from making rhythmic deliveries and sufficient quantities of medicines for Bulgarian patients.