ABSTRACT
Objective: Pharmaceutical documents such as the common technical document, package inserts (PIs), and interview forms (IFs) are available at the website of the Pharmaceuticals and Medical Devices Agency. However, because these documents were created with an emphasis on human readability in paper form, it is difficult to use the information included and interoperate these documents with computers. Using IFs, we will investigate how to structure pharmaceutical documents in the AI era to achieve both human and machine readability.Design/Methods: The IFs of arbitrary selected ten drugs were structured into Resource Description Framework (RDF) according to the Drug Interview Form Description Guidelines 2018 (updated version in 2019). The data were manually extracted from the IFs and entered into a spreadsheet before being converted to RDF by a written script. The PIs were converted to RDF in addition to the IFs. To examine the linkage with external databases, IDs in ChEMBL, which is a manually curated database of bioactive molecules with drug-like properties, were embedded in the RDF.Results: We demonstrated that the conversion of IFs and PIs into RDF makes it possible to easily retrieve the corresponding part of the PIs cited in the IFs. Furthermore, we quickly obtained the relevant data from ChEMBL, demonstrating the feasibility of linking IFs with an external database. Our attempt to RDFization of IFs is expected to encourage the development of web applications for healthcare professionals and the development of datasets for AI development.Conclusion: We could easily interoperate IFs with other pharmaceutical documents and an external database by converting IFs into RDF following the description guidelines. However, problems such as how to deal with items that were not described in the description guidelines were indicated. We hope that discussions will grow based on this effort and that related industries will move toward accomplishing effective use of these documents.
ABSTRACT
Los medicamentos genéricos desempeñan un papel importante en los sistemas de atención de salud, ya que representan una alternativa eficaz más asequible para la población. En el Perú, se estableció un reglamento que regula la intercambiabilidad de medicamentos genéricos (también llamados multifuentes), que define los procedimientos y requisitos a seguir para desarrollar estudios de equivalencia terapéutica in vivo e in vitro, siguiendo el enfoque de aplicación gradual y el criterio de riesgo sanitario. El cumplimiento de este reglamento permitirá un mayor acceso a medicamentos genéricos eficaces, seguros y de calidad. Mientras tanto, se siguen comercializando genéricos en ausencia de estudios de equivalencia terapéutica. Los estudios demuestran que algunos medicamentos fallaron en las comparaciones in vivo e in vitro con el medicamento de referencia. Esta implementación representa un gran desafío para los laboratorios fabricantes y los titulares de registros sanitarios a fin de demostrar la intercambiabilidad de sus productos farmacéuticos con el medicamento de referencia.
Generic drugs play an important role in healthcare systems as they represent an effective and more affordable alternative for the population. In Peru, a regulation of interchangeability of generic drugs (also called multisource drugs) was stablished to define the procedures and requirements for developing in vivo and in vitro therapeutic equivalence studies, following the gradual application approach and sanitary risk criteria. Compliance with the new regulation will allow greater access to effective, safe and quality generic drugs. Meanwhile, drugs continue to be marketed in the absence of therapeutic equivalence studies. Findings show that some drugs failed in in vivo and in vitro comparisons with the reference product. This regulation represents a great challenge for manufacturers and holders of sanitary registrations in order to demonstrate the interchangeability of their pharmaceutical products with the reference product.
ABSTRACT
La crisis económica y su impacto en las finanzas públicas en la mayoría de los países desarrollados, están originando políticas de contención del gasto en los servicios de salud. Las leyes actuales del medicamento exigen calidad, seguridad y eficacia de estos productos. Algunos países incluyen criterios de eficiencia para los nuevos medicamentos que desean ser incluidos en la financiación pública. El consumo apropiado de genéricos y "medicamentos biosimilares" es muy importante para mantener el equilibrio financiero de los servicios de salud. El problema en América Latina es que no todos los productos multifuentes son bioequivalentes y no todos los países tienen los recursos necesarios para realizar los estudios de bioequivalencia in vivo. La Agencia Europea del Medicamento en 2005 aprobó la directriz sobre "medicamentos biosimilares" y después se han autorizado trece de ellos para su comercialización. El referenciamiento de este modelo por otros países seria importante. La influencia de la industria farmacéutica sobre las áreas políticas y administrativas es necesario controlarla. Las compañías farmacéuticas afirman que actúan con responsabilidad social corporativa, por ello, se debería garantizar el cumplimiento de la misma con la sociedad.
The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.