Background and importance The European Public Assessment Report (EPAR) is a document that summarises the scientific–technical characteristics of drugs. The information that the EPAR should provide is described in the directive 2004/27/CE, but sometimes it is not enough to cover all scenarios in patients in the oncohaematological pharmaceutical care consultation.
Aim and objectives To evaluate if the information in the EPAR for oral antineoplastic drugs that are dispensed in the outpatient consultation service (OCS) is enough for the management of these drugs in patients with swallowing problems or with nasogastric tubes.
Material and methods We reviewed the EPAR oral antineoplastics drugs dispensed in the OCS. Additionally, articles were searched on Pubmed using the following requests: ‘oral antineoplastic’, ‘swallowing’ and ‘feeding tube’. If the searches did not provide enough information, we contacted the laboratories by telephone. All information was compiled in an Excel table to analyse the results.
Results The information in the EPAR about oral administration of 32 cytostatics was reviewed. For 20 drugs, the EPAR indicated that the tablets cannot be crushed, bitten or split, and the whole tablet must be swallowed; for five drugs there was no reference about how to administer it; and for five drugs it specified that there was a possibility of dispersing the tablet and indicated how to do it. The EPAR for two drugs was not found.
We performed a bibliographic search of drugs when we did not have enough information (27). Relevant information was found for 11 but information was very limited for 4 (isolated cases of administration outside of what is specified in the EPAR). Finally, for the drugs that we had no information (12), we requested information from 10 laboratories. For five drugs, no additional information was available. Five laboratories told us that they did not advise this type of procedure but that there were isolated cases described in the bibliography. No response was obtained for two drugs.
Conclusion and relevance The information collected in the EPAR is insufficient to resolve doubts for an oncohaematological pharmaceutical care consultation in most cases and it is necessary to perform bibliographic searches to obtain quality information. Laboratories should provide all available information and implement trials to evaluate the efficacy of drugs in real practice.
Conflict of interest No conflict of interest
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