Availability of Essential Medicines in Hungary shows summary tables that compare the World Health Organization Essential Medicines List (WHO EML) with the National Substitution List (NL) by system organ class. The graphs are color-coded for easier orientation: WHO EML products are marked blue, NL products are green, and products included in both lists are yellow. A number of registrations include the number of individual drug forms including package sizes and dosage forms rather than a single registration number. This is because different dosage forms may have different indications. Drugs are categorized by ATC Code; that means some active ingredients are listed in all relevant forms and system organ classes.
The dataset is presented as a summary and then in detail by organ class and ATC subclass as relevant/appropriate. The focus of the following analysis is on essential medicines that are not available in the Hungary, and evaluation of the situation in the context of public health needs and global drug shortages. To this end, the Essential List of Medicines defined by the World Health Organization (WHO) is compared to the Substitution List, which can be found on the website of The National Institute of Pharmacy and Nutrition. The Substitution List defines interchangeability of essential marketed products in regards to bioavailability and intended use according to approved Summary of Product Characteristics (SPC). Parenteral formulations are not included on this list because bioequivalence studies are not required for them as long as the conditions specified in Directive CPMP/EWP/QWP/1401/98 are met. Compounded drugs can be issued if no alternative is available (“Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet”, 2017). Substitution List can, therefore, be treated as the National List of Essential Medicines; bearing in mind, it does not include parenteral formulations. Information on indications as listed in this section and in Appendix 3 was extracted from the current product labels as approved by the FDA and the MHRA and from Doctors Without Borders Essential Medicines guide (Pilon, 2016). U.S. labels were obtained from the NIH U.S. National Library of Medicine (“DailyMed”, 2017).