Destruction of expired medications – review of the regulations in Bulgaria

Abstract

Introduction: The proper management of unused and expired pharmaceuticals by community pharmacies, wholesalers and pharma companies in Bulgaria is a long and hard process. Drugs should be treated as dangerous products, so only specially licensed companies for waste transportation and destruction are allowed to deal with expired medicines. In order to protect our natural resources and keep medication out of the hands of our children, animals ect. the best way of drug destruction is incineration. Materials and Methods: The aim of this study is to compare the Bulgarian regulations for destruction of expired drugs to best practices in other countries, European union and USA. Results: Before the process of destruction of drugs in Bulgaria, there has to be a set of documentation prepared and submitted to the Bulgarian Drug Agency (BDA). This set consists of several documents, certifying permission by different authorities for destruction of the listed expired drugs. A part of the requested documentation is a list of pharmaceuticals, which must include: brand name, manufacturer, dosage form, package size, batch number. Only after the order is disclosed by the Bulgarian Drug Agency, the expired medications could be submitted for destruction by incineration. In our country we have only one working incinerator in Bulgaria. It is situated in Sofia and unfortunately does not work all the time, which leads pharmaceutical companies to prefer contracting a company for transportation and destruction of expired drugs abroad. Conclusion: The problem of destruction of expired drugs is ongoing not only in Bulgaria, but also in many other countries. To avoid the risks of abuse and accidental poisoning, as well as other problems that unused, unwanted or expired pharmaceuticals pose, they shouldn‘t be kept in homes. If thrown away or flushed down a toilet, however, antibiotics, hormones and other drugs can get into lakes, rivers and other water supplies, where they can affect humans and animals, the researchers said. Many countries have implemented national strategies and programs for unwanted drug returns in open pharmacies and then for them to be returned back to sponsor companies. However, considering the current Regulations and situation in Bulgaria, Pharmaceutical companies are not motivated to support drug return.